diff --git "a/36_years1991-08.jsonl" "b/36_years1991-08.jsonl"
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+++ "b/36_years1991-08.jsonl"
@@ -0,0 +1,322 @@
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/43d13fa1-2273-42c3-9d15-7501bd7e2133", "title": "WRITTEN QUESTION No. 1783/91 by Mr Christian de la MALENE to the Commission. Retailing of veterinary medicinal products", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "DE LA MALENE,European Parliament", "date": "1991-09-01", "subjects": "approximation of laws,legal person,liability,natural person,retail selling,veterinary legislation,veterinary medicinal product,veterinary medicine", "workIds": "celex:91991E001783", "eurovoc_concepts": ["approximation of laws", "legal person", "liability", "natural person", "retail selling", "veterinary legislation", "veterinary medicinal product", "veterinary medicine"], "url": "http://publications.europa.eu/resource/cellar/43d13fa1-2273-42c3-9d15-7501bd7e2133", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/99a5b7dc-e743-4b7e-b82b-0850a863beb3", "title": "Proposal for a COUNCIL DECISION concerning an Agreement between the European Economic Community, the Kingdom of Norway and the Kingdom of Sweden on civil aviation", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_other,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-30", "subjects": "Norway,Sweden,agreement (EU),civil aviation,competition", "workIds": "celex:51991PC0299,comnat:COM_1991_0299_FIN", "eurovoc_concepts": ["Norway", "Sweden", "agreement (EU)", "civil aviation", "competition"], "url": "http://publications.europa.eu/resource/cellar/99a5b7dc-e743-4b7e-b82b-0850a863beb3", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 299 f i na| \n\nBrussels, 30 August 1991 \n\nProposal for a \n\nCOUNCIL DECISION \n\nconcerning an Agreement between the European \n\nEconomic Community, the Kingdom of Norway and the \n\nKingdom of Sweden on civil aviation \n\n(presented by the Commission) \n\n\fEXPLANATORY MEMORANDUM \n\n1. By its decision of 18-19 June 1990 the Council authorized the \n\nCommission to open negotiations with Norway and Sweden using as a \n\nbasis the negotiating directives drafted for the purpose of the \n\nnegotiations between the Community and the EFTA States. 2. The Commission has in coordination and close consultation with \n\nMember States conducted negotiations with a Joint delegation from \n\nNorway and Sweden. Agreement could be reached on a text which \n\nwill make all Community legislation affecting the air transport \n\nsector applicable in Norway and Sweden. 3. The draft Agreement which is annexed to the attached proposal for a \n\nCouncil Decision is structured in six chapters, an Annex and three \n\nProtocols. Chapter I \n\ndeals with the scope of the Agreement. It \n\nestablishes that the \"acquis communautaire\" and \n\ninterpretations of the Court of Justice of the \n\nEuropean Communities and of the Commission shall be \n\napplicab le. Chapter 11 \n\ncontains a transcription of the competition articles \n\nof the Treaty. Chapter 111 \n\ncreates the rights for the Commission to implement \n\nthe competition articles and the Regulations and \n\nDirectives which form part of the \"acquis\" directly \n\nin Norway and Sweden. -2-\n\nChapter IV \n\nestablishes a Joint Committee and spells out its \n\ntasks. It contains provisions for consultations and a \n\nprocedure to ensure that future Community legislation \n\nconcerning air transport will also become part of the \n\nagreement. Chapter V \n\ncontains provisions for consultation and a procedure \n\nto deal with relations with third countries and with \n\ninternational organisations. Chapter VI \n\ndeals with provisions regarding entry into force and \n\nreview of the Agreement. This chapter also contains \n\nthe provision that the Agreement shall cease to be in \n\nforce from the date an agreement between EEC and the \n\nEFTA countries on the European Economic Area enters \n\ninto force. Annex \n\nlists the relevant \"acquis communautaire\" and extends \n\nthe scope of the Regulations and Directives to Norway \n\nand Sweden. Protocol 1 \n\ndeals with future legislation by the Community. Parties \n\nagree \n\nthat \n\nrelevant \n\nRegulations \n\nand \n\nDirectives which will be developed by the Community \n\nshall be considered for inclusion in the Agreement. Protocol 2 \n\ntranscribes declarations from the Council and from \n\nthe Commission concerning the implementation of \n\nspecific articles of various Council Regulations and \n\nDirectives so as to ensure that the Agreement will be \n\nimplemented in the same way in all Contracting \n\nParties. -3-\n\nProtocol 3 : \n\ndescribes the position taken by the Council with \n\nregard to the problems of air traffic congestion in \n\nEurope. 4. The Commission believes that this Agreement meets the negotiating \n\ndirectives as established by the Council and proposes that the \n\nCouncil adopts the attached proposal for a decision. PROPOSAL FOR A COUNCIL DECISION \n\nconcerning the conclusion of an Agreement between the European \n\nEconomic Community, the Kingdom of Norway and the Kingdom \n\nof Sweden on civiI aviation. THE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity and in particular article 113 thereof, \n\nHaving regard to the proposal from the Commission^1) \n\nWhereas the Council has decided at its meeting of 18-19 June 1990 that \n\nnegotiations with Norway and Sweden should not be further delayed and \n\nhas authorized the Commission to open negotiations with these two \n\ncountries, using as a basis the negotiating directives drafted for the \n\npurpose of the negotiations between the Community and the EFTA States; \n\nWhereas the Commission has conducted the negotiations in close \n\ncoordination and consultation with the Member States throughout the \n\nnegotiating process; \n\nWhereas the Agreement permits the creation, in the area covered by the \n\nEuropean Economic Community, the Kingdom of Norway and the Kingdom of \n\nSweden, of a set of rules applicable to civil aviation, thus permitting \n\nthe establishment of a uniform system of rules concerning market \n\naccess, airline capacity as well as price fixing in that field; \n\nWhereas, as a consequence, the conclusion of the agreement is part of \n\nthe common commercial policy and should therefore be based on article \n\n113 of the EEC Treaty, requirements of a technical nature would be \n\nconsidered as supplementary to the above mentioned provisions; \n\n(1) \n\n\f-2-\n\nWhereas finally the agreed text resulting from the negotiations meets \n\nthe negotiating directives for the conclusion of an agreement between \n\nthe EEC and EFTA States on air transport. HAS DECIDED AS FOLLOWS \n\nArticle 1 \n\nThe Agreement between the European Economic Community, the Kingdom of \n\nNorway and the Kingdom of Sweden on civil aviation is hereby approved \n\non behalf of the Community. The text of the Agreement is attached to this Decision. Art icle 2 \n\nThe President of the Council shall carry out the necessary formalities \n\nas provided for in Article 23 of the Agreement. Art icle 3 \n\nThe Commission, assisted by with representatives of the Member States, \n\nshall represent the Community in the Joint Committee set up by \n\nArticle 13 of the Agreement. -3-\n\nArticle 4 \n\nThis Decision shall enter into force on the day following its \n\npublication in the Official Journal of the European Communities. Done at \n\nFor the Council \n\nThe President \n\n\fAGREEMENT BETWEEN THE EUROPEAN ECONOMIC COMMUNITY,THE KINGDOM \n\nOF NORWAY AND THE KINGDOM OF SWEDEN ON CIVIL AVIATION \n\nThe Contracting Parties; \n\nDesiring to set out rules for civil aviation within the area covered by \n\nthe EEC, the Kingdom of Norway and the Kingdom of Sweden, rules which \n\nare without prejudice to those contained in the EEC Treaty and in \n\nparticular to existing Community competences under Articles 85 and 86 \n\nof the EEC Treaty and the competition rules derived therefrom; \n\nAgreeing that it is appropriate to base these rules on the legislation \n\nin force within the European Economic Community; \n\nDesiring to prevent, in full deference to the independence of the \n\ncourts, divergent interpretations and to arrive at as uniform an \n\ninterpretation as possible of the provisions of this Agreement and \n\nthose provisions of Community legislation which are substantially \n\nreproduced in this Agreement; \n\n\f- 2 -\n\nWhereas this Agreement shall not prejudge the outcome of the \n\nnegotiations between EEC and the EFTA countries on the European \n\nEconomic Area and in particular in respect of the rules of competition \n\nand state aid and shall be terminated on-the date on which an agreement \n\nbetween the EEC and the EFTA countries on the said European Economic \n\nArea enters into force ; \n\nHave agreed as follows: \n\nCHAPTER 1 \n\nArticle 1 \n\n1. This Agreement sets out rules for the Contracting Parties in the \n\nfield of civil aviation. These rules are without prejudice to \n\nthose contained in the EEC Treaty and in particular to existing \n\nCommunity competences under Articles 85 and 86 of the EEC Treaty \n\nand the competition rules derived therefrom. For this purpose the provisions laid down by the Regulations and \n\nDirectives specified at any time in the Annex shall apply under the \n\nconditions set out hereafter. The interpretations of the said \n\nprovisions shall be in accordance with the interpretations provided \n\n\f- 3 -\n\nby the Court of Justice of the European Communities or the EEC \n\nCommission (hereafter called the Commission) applicable to articles \n\n4 to 6, to the corresponding articles of the EEC Treaty and to \n\nthose Regulations and Directives. Such interpretations handed down \n\nafter the signature of the agreement shall be communicated to \n\nNorway and Sweden. On request by a Contracting Party the Joint Committee shall \n\nexchange views pursuant to Article 13 on the implications of such \n\ninterpretations for the proper functioning of the Agreement. 3. The Parties to this Agreement shall take all appropriate measures \n\nwhether general or particular, to ensure fulfilment of the \n\nobligations arising out of this Agreement and shall refrain from \n\nany measure which would jeopardize attainment of the objectives of \n\nthis Agreement. Article 2 \n\nAny service covered by this Agreement, operated by the Scandinavian \n\nAirlines System (SAS) between one of the States in which the parent \n\ncompanies are registered and another State within the Community is \n\nconsidered as a third or fourth freedom service. 3) \n\n\f- 4 -\n\nCHAPTER 2 \n\nArticle 3 \n\nThe provisions in Articles 4 to 6 and the Annex shall apply to the \n\nextent that they concern air transport or an associated matter \n\nmentioned in the Annex. Article 4 \n\n1. The following shall be prohibited as incompatible with this \n\nAgreement : all agreements between undertakings, decision by \n\nassociations of undertakings and concerted practices which may \n\naffect trade between Contracting Parties and which have as their \n\nobject or effect the prevention, restriction or distortion of \n\ncompetition within the territory covered by this Agreement, and in \n\nparticular those which : \n\na) directly or indirectly fix purchase or selling prices or \n\nany other trading conditions; \n\nb) limit \n\nor \n\ncontrol \n\nproduction, markets, technical \n\ndevelopment, or investment; \n\n\f- 5 -\n\nc) share markets or sources of supply; \n\nd) apply dissimilar conditions to equivalent transactions with \n\nother trading parties, thereby placing them at a \n\ncompetitive disadvantage; \n\ne) make the conclusion of contracts subject to acceptance by \n\nthe other parties of supplementary obligations which, by \n\ntheir nature or according to commercial usage, have no \n\nconnection with the subject of such contracts. 2. Any agreements or decisions prohibited pursuant to this Article \n\nshall be automatically void. 3. The provisions of paragraph 1 may, however, be declared \n\ninapplicable in the case of : \n\n- any agreement or category of agreements between \n\nundertakings; \n\n- any decision or category of decisions by associations of \n\nundertakings; \n\nany concerted practice or category of concerted practices; \n\nwhich contributes to improving the production or distribution of \n\ngoods or to promoting technical or economic progress, while \n\nallowing consumers a fair share of the resulting benefit, and which \n\ndoes not : \n\n\f- 6 -\n\na) impose on the undertakings concerned restrictions which are \n\nnot indispensable to the attainment of these objectives; \n\nb) afford such undertakings the possibility of eliminating \n\ncompetition in respect of a substantial part of the \n\nproducts in question. Article 5 \n\nAny abuse by one or more undertakings of a dominant position within the \n\nterritory covered by this Agreement or in a substantial part of it \n\nshall be prohibited as incompatible with this Agreement in so far as it \n\nmay affect trade between Contracting Parties. Such abuse may, in particular, consist in : \n\na) directly or indirectly imposing unfair purchase or selling \n\nprices or other unfair trading conditions; \n\nb) limiting production, markets or technical development to the \n\nprejudice of consumers; \n\n\f- 7 -\n\nc) applying dissimilar conditions to equivalent transactions with \n\nother trading parties, thereby placing them at a competitive \n\ndisadvantage; \n\nd) making the conclusion of contracts subject to acceptance by the \n\nother parties of supplementary obligations which, by their \n\nnature or according to commercial usage, have no connection \n\nwith the subject of such contracts. Article 6 \n\n1. Save as otherwise provided in this Agreement, any aid granted by \n\nNorway or Sweden or by a Member State of the EEC or through State \n\nresources in any form whatsoever which distorts or threatens to \n\ndistort competition by favouring certain undertakings or the \n\nproduction of certain goods shall, in so far as it affects trade \n\nbetween Contracting Parties, be incompatible with this Agreement. 2. The following shall be compatible with this Agreement : \n\na) aid having a social character, granted to individual \n\nconsumers, provided that such aid is granted without \n\ndiscrimination related to the origin of the products \n\nconcerned; \n\nb) aid to make good the damage caused by natural disasters or \n\nexceptional occurrences. - 8 -\n\n3. The following may be considered to be compatible with this \n\nAgreement : \n\na) aid to promote the economic development of areas where the \n\nstandard of living is abnormally low or where there is \n\nserious under-employment; \n\nb) aid to promote the execution of an important project of \n\ncommon European interest or to remedy a serious disturbance \n\nin the economy of a Contracting Party; \n\nc) aid to facilitate the development of certain economic \n\nactivities or of certain economic areas, where such aid \n\ndoes not adversely affect trading conditions to an extent \n\ncontrary to the common interest. Article 7 \n\n1. The rules laid down in Article 6 shall be enforced: \n\nas regards Norway and Sweden, by application of the provisions \n\nof paras. 2 to 6 and the appropriate national rules and \n\nregulations of those States; \n\n- as regards the EEC, under the Treaty of Rome. 9 -\n\n2. With regard to aids granted by Norway and Sweden the Commission \n\nshall, in cooperation with Norway and Sweden, keep under constant \n\nreview all systems of aid existing in those States. It shall \n\npropose to the latter any appropriate measures required by the \n\nprogressive development or by the functioning of this Agreement. If, after giving notice to the parties concerned to submit their \n\ncomments, the Commission finds that aid granted by one of those \n\nStates or through State resources is not compatible with this \n\nAgreement having regard to Article 6, or that such aid is being \n\nmisused, it shall inform the State concerned and shall request that \n\nsuch aid be abolished or altered within a period of time to be \n\ndetermined by the Commission. 4. Unless the State concerned notifies the other Contracting Parties \n\nthat it is not in agreement with the action requested, it shall \n\ntake the necessary measures and inform the Commission thereof. 5. If the State concerned is not in agreement with the action \n\nrequested by the Commission the matter shall within 21 days be \n\nsubmitted to the Joint Committee, which shall meet within 14 days \n\nof the date of submission. - 10 -\n\n6. The Commission shall be informed, in sufficient time to enable it \n\nto submit its comments, of any plans to grant or alter aid. If it \n\nconsiders that any such plan is not compatible with this Agreement \n\nhaving regard to Article 6, it shall without delay initiate the \n\nprocedure provided for in paragraph 3. The State concerned shall \n\nnot put its proposed measures into effect until this procedure has \n\nresulted in a final decision. CHAPTER 3 \n\nArticle 8 \n\n1. Norway and Sweden shall ensure that the Commission is given the \n\ninformation foreseen in the Annex in respect of the application of \n\nthe rules in Articles 4-5 and the Annex. In instances where the Commission may obtain information directly \n\nfrom undertakings as provided for in the Annex to this Agreement \n\nNorway and Sweden shall upon request provide the Commission with \n\nsuch information and/or arrange if requested for a direct visit on \n\na specified date and invite the Commission to participate, while \n\nrespecting the relevant procedural guarantees laid down by national \n\nlaw. - 11 -\n\nArticle 9 \n\n1. Norway and Sweden shall ensure that Articles 4, 5 and 6 and the \n\nprovisions of the Regulations and Directives specified in the Annex \n\nare applied in their territories and enforced with the same effect \n\nas in the EEC. The Contracting Parties shall ensure that the rights which devolve \n\nfrom Articles 4, 5, 6, 7 and the above-mentioned Regulations and \n\nDirectives may be invoked before the national courts. Article 10 \n\nAll questions concerning the validity of decisions of the institutions \n\nof the Community, pursuant to Articles 4, 5, 6, 7 and the Regulations \n\nand Directives specified in the Annex to this Agreement shall be of the \n\nexclusive competence of the Court of Justice of the European \n\nCommunities. (4) \n\n\f- 12 -\n\nArticle 11 \n\n1. Whenever a decision contains a request for action to be taken by \n\nNorway and/or Sweden pursuant to the Regulations and Directives \n\nspecified in the Annex then, unless the State concerned notifies \n\nthe other Contracting Parties that it is not in agreement with the \n\naction requested, it shall take the necessary measures and inform \n\nthe Commission thereof. 2. If the State concerned is not in agreement with the action \n\nrequested by the Commission the matter shall within 21 days be \n\nsubmitted to the Joint Committee referred to in Article 13 which \n\nshall meet within 14 days of th\u00e9 date of submission. CHAPTER 4 \n\nArticle 12 \n\n1. The Agreement shall be without prejudice to the right of each \n\nContracting Party, subject to compliance with the principle of non \n\ndiscrimination and the provisions of this Article and of Article 13 \n\nparagraph 2, unilaterally to amend its domestic legislation on a \n\npoint regulated by this Agreement. - 13 -\n\n2. As soon as a Contracting Party has adopted an amendment of its \n\ndomestic legislation it shall inform the other Contracting Parties \n\nvia the Joint Committee referred to in Article 13, eight days \n\nafter adoption at the latest. The Joint Committee shall within 14 \n\ndays thereafter hold an exchange of views on the implications of \n\nsuch an amendment for the proper functioning of the Agreement. 3. The Joint Committee shall : \n\neither adopt a decision revising the provisions of the \n\nAgreement so as to integrate therein, if necessary on a \n\nbasis of reciprocity, the amendments made to the \n\nlegislation in question; \n\nor adopt a decision to the effect that the amendments to \n\nthe legislation in question shall be regarded as in \n\naccordance with the Agreement; \n\nor decide any other measure to safeguard the proper \n\nfunctioning of the Agreement. Article 13 \n\n1. A Joint Committee is hereby established which shall be responsible \n\nfor the administration of the Agreement and shall ensure its proper \n\nimplementation. For this purpose it shall make recommendations \n\nand take decisions by unanimity. The decisions of the Joint \n\nCommittee shall be put into effect by the Contracting Parties in \n\naccordance with their own rules. 14 -\n\n2. For the purpose of the proper implementation of this Agreement, the \n\nContracting Parties shall exchange information and, at the request \n\nof either party, shall hold consultations within the Joint \n\nCommittee. 3. The Joint Committee shall adopt its own rules of procedure at the \n\nlatest 21 days after the entry into force of this Agreement. 4. The Joint Committee shall consist of one representative each of \n\nNorway and Sweden on the one hand and the EEC on the other hand. 5. Norway or Sweden and the EEC shall preside in turn over the Joint \n\nCommittee in accordance with the arrangements to be laid down in \n\nits rules of procedure. 6. The chairman shall convene meetings of the Joint Committee at least \n\nonce a year in order to review the general functioning of the \n\nAgreement and whenever special circumstances so require, at the \n\nrequest of either Contracting Party. 7. The Joint Committee shall, in addition, meet in conformity with \n\narticles 1, 7, 11 and 12. In the case of disagreement the decision \n\nshall be referred to a subsequent meeting of the Joint Committee to \n\nbe held within two months from the date of referral in accordance \n\nwith the conditions to be laid down in its rules of procedure. - 15 -\n\n8. The Joint Committee may decide to set up any working party that can \n\nassist it in carrying out its duties. Article 14 \n\n1. A D\u00e9cision of the Joint Committee shall be binding upon the \n\nContracting Parties. If, in the view of one of the Contracting Parties, a decision of the \n\nJoint Committee is not properly implemented by another Contracting \n\nParty concerned, the former may request that the issue shall be \n\ndiscussed by the Joint Committee. If the Joint Committee cannot \n\nresolve the issue within two months of its referral, the Agreement \n\nshall cease to be in force. The decision of the Joint Committee shall be published in the \n\nOfficial Journal of the European Communities. Each decision shall \n\nstate the date of its implementation in the three Contracting \n\nParties and any other information likely to concern economic \n\noperators. The decisions shall be submitted if necessary for \n\nratification or approval by the Contracting Parties in accordance \n\nwith their own procedures. - 16 -\n\n4. The Contracting Parties shall notify each other of the completion \n\nof this formality. If upon the expiry of a period of twelve months \n\nafter adoption of a decision by the Joint Committee such \n\nnotification has not taken place, paragraph 5 shall apply mutatis \n\nmutandis. 5. If the Joint Committee does not take the decisions pursuant to \n\narticles 1. 2, 7. 5, 9. 1, 11. 2 and 12. 3 within six months of the date \n\nof referral , this Agreement shall cease to be in force. 6. As regards legislation covered by article 12 between the signature \n\nof the Agreement and its entry into force of which the other \n\nContracting Parties have been informed the date of referral in \n\nparagraph 5 shall be taken as the date on which the information was \n\nreceived. The date on which the Joint Committee shall reach a \n\ndecision can not be earlier than 2 months after the date of entry \n\ninto force of the Agreement. Chapter 5 \n\nArticle 15 \n\nThe Contracting Parties shall consult each other, at the request of \n\neither party, in accordance with the procedures laid down in \n\nArticles 16, 17 and 18 \n\n\f- 17 -\n\n(a) on air transport questions dealt with in international \n\norganizations ; and \n\n(b) on the various aspects of developments which have taken place in \n\nrelations between Contracting Parties and third countries in air \n\ntransport, and on the functioning of the significant elements of \n\nbilateral or multilateral agreements concluded in this field. The consultations shall be held within one month of the request or as \n\nsoon as possible in urgent cases. Article 16 \n\n1. The main aims of the consultations provided for in Article 15(a) \n\nshall be : \n\n(a) to determine jointly whether the questions raise problems of \n\ncommon interest; and \n\n(b) depending upon the nature of such problems : \n\nto consider jointly whether Contracting Parties' action \n\nwithin the international organizations concerned should be \n\ncoordinated, or \n\n- to consider jointly any other approach which might be \n\nappropriate. 2. The Contracting Parties shall as soon as possible exchange any \n\ninformation of relevance to the aims described in paragraph 1. - 18 -\n\nArticle 17 \n\n1. The main aims of the consultations provided for in Article 15(b) \n\nshall be to examine the relevant issues and to consider any \n\napproach which might be appropriate. For the purposes of the consultations referred to in paragraph 1, \n\neach Contracting Party shall inform the other Contracting Parties \n\nof developments which have taken place in the field of air \n\ntransport and of the operation of bilateral or multilateral \n\nagreements concluded in that field, if it considers this likely to \n\ncontribute to the identification of problems of common interest. Article 18 \n\n1. The consultations provided for in articles 15, 16 and 17 shall take \n\nplace within the framework of the Joint Committee. 2. The information and consultations provided for in articles 15, 16 \n\nand 17 shall be covered by professional secrecy. - 19 -\n\nCHAPTER 6 \n\nArticle 19 \n\n1. This Agreement shall remain in force unless denounced by one of the \n\nContracting Parties. 2. Each Contracting Party may denounce the Agreement by notifying the \n\nother Contracting Parties. The Agreement shall cease to be in force \n\n1 year after the day of notification. 3. This Agreement shall cease to be in force from the date an \n\nagreement between EEC and the EFTA countries on the European \n\nEconomic Area enters into force. Article 20 \n\nThis Agreement shall be reviewed after request by any Contracting Party \n\nand at any event after one year of its entry into force. - 20 -\n\nArticle 21 \n\nNorway and Sweden shall bring their legislative and administrative \n\nprovisions into conformity with this Agreement before the entry into \n\nforce of the Agreement. Article 22 \n\nThis Agreement shall supersede the relevant provisions of bilateral \n\narrangements in force between Norway and/or Sweden on the one hand and \n\nCommunity Member States on the other hand. Article 23 \n\n1. This Agreement shall be subject to approval or ratification in \n\naccordance with the Contracting Parties own procedures and the \n\nParties shall notify each other of the completion of the procedures \n\nnecessary for that purpose. 2. This Agreement shall enter into force on the date on which the last \n\ninstrument of ratification has been deposited. - 21 -\n\n3. This Agreement and the instruments of ratification shall be \n\ndeposited in the archives of the Secretariat of the Council of the \n\nEuropean Communities, which shall deliver a certified copy thereof \n\nto each Contracting Party. Article 24 \n\nThis Agreement is drawn up in all official languages (Danish, Dutch, \n\nEnglish, French, German, Greek, Italian, Portuguese, Spanish) of the \n\nCommunity as well as in the Norwegian and Swedish languages, all these \n\ntexts being equally authentic. - 22 -\n\nANNEX \n\nFor the purposes of this Agreement Norway and Sweden shall be \n\nconsidered as falling within the terms \"Member States\" and \"Community\" \n\nreferrred to in the following EEC Directives and Regulations. 1. 90/2343/EEC \n\nCouncil Regulation of 24 July 1990 on access for air carriers to \n\nscheduled intra-Community air service routes and on the sharing of \n\npassenger capacity between air carriers on scheduled air services \n\nbetween member States \n\nArticles 1, 2, 3 para I, 4-10, 11 with the exception of para 2, 12-\n\n14, 17 \n\n2. 90/2342/EEC \n\nCouncil Regulation of 24 July 1990 on fares for scheduled air \n\nservices \n\nArticles 1-11, 14 \n\n\f- 23 -\n\n3. 91/294/EEC \n\nCouncil Regulation of 4 February 1991 on the operation of air cargo \n\nservices between Member States \n\nArticles 1, 2, 3 para 1, 4-11 \n\n4. 62/17/EEC \n\nCouncil Regulation of 6 February 1962 implementing Articles 85 and \n\n86 of the Treaty, as amended by Regulation 59, by Regulation \n\n118/63/EEC and by Regulation 2822/71/EEC \n\nArticles 1-9, 10 para 1 and 2, 11-14, 15 with the exception of \n\npara 3, 16 para 1 and 2, 17-24 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 5. 87/3975/EEC \n\nCouncil Regulation of 14 December 1987 laying down the procedures \n\nfor the application of the rules of competition to undertakings in \n\nthe air transport sector. Articles 1-7, 8 para 1 and 2, 9, 10, 11, 12 with the exception of \n\npara 3, 13 with the exception of para 3, 14-20 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 6. 87/3976/EEC \n\n- 24 -\n\nCouncil Regulation of 14 December 1987 on the application of \n\nArticle 85 (3) of the Treaty to certain categories of agreements \n\nand concerted practices in the air transport sector. Articles 1-5, 7, 9 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 7. 90/2344/EEC \n\nCouncil Regulation of 24 July 1990 amending Regulation (EEC) \n\nNo 3976/87 on the application of Article 85 (3) of the Treaty to \n\ncertain categories of agreements and concerted practices in the air \n\ntransport sector \n\nArticles 1, 2 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. - 25 -\n\n8. 91/82/EEC \n\nCommission Regulation of 5 December 1990 on the application of \n\nArticle 85 (3) of the Treaty to certain categories of agreements, \n\ndecisions and concerted practices concerning ground handling \n\nservices \n\nArticles 1-5 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 9. 91/83/EEC \n\nCommission Regulation of 5 December 1990 on the application of \n\nArticle 85(3) of the Treaty to certain categories of agreements \n\nbetween undertakings relating to computer reservation systems for \n\nair transport services \n\nArticles 1-13 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. - 26 -\n\n10. 91/84/EEC \n\nCommission Regulation of 5 December 1990 on the application of \n\nArticle 85(3) of the Treaty to certain categories of agreements, \n\ndecisions and concerted practices concerning joint planning and \n\ncoordination of capacity, consultations on passenger and cargo \n\ntariffs rates on scheduled air services and slot allocations at \n\nairports \n\nArticles 1-6. Any reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 11. 91/295/EEC \n\nCouncil Regulation of 4 February 1991 establishing common rules for \n\na denied boarding compensation system in scheduled air transport \n\nArticles 1-10 \n\n12. 89/2299/EEC \n\nCouncil Regulation of 24 July 1989 introducing a code of conduct \n\nfor the use of computer reservation systems. Articles 1-22 \n\n\f- 27 -\n\n13. 80/1266/EEC \n\nCouncil Directive of 16 December 1980 on future cooperation and \n\nmutual assistance between the Member States in the field of air \n\naccident investigation \n\nArticles 1-2 \n\n14. 80/51/EEC \n\nCouncil Directive of 20 December 1979 on the limitation of noise \n\nemissions from subsonic aircraft as amended by Council Directive \n\n83/206/EEC of 21 April 1983 \n\nArticles 1-8 \n\n15. 89/629/EEC \n\nCouncil Directive of 4 December 1989 on the limitation of noise \n\nemission from civil subsonic jet aeroplanes \n\nArticles 1-7 \n\n\f- 28 -\n\n16. 90/314/EEC \n\nCouncil Directive on package travel, package holidays and package \n\ntours \n\nArticles 1-9 \n\n17. 89/4064/EEC \n\nCouncil Regulation of 21 December 1989 on the control of \n\nconcentrations between undertakings \n\nArticles 1-8, 9 para 1-8, 10-18, 19 para 1 and 2, 20-23, 25 \n\nAny reference to Articles 85 or 86 in this Regulation shall be \n\nunderstood to mean Articles 4 or 5 of this Agreement respectively. 18. 80/723/EEC \n\nCommission Directive of 25 June 1980 on the transparency of \n\nfinancial relations between Member States and public undertakings, \n\nas amended by Commission Directive 85/413/EEC of 24 July 1985. Articles 1-8 \n\n\f- 29 -\n\n19. 90/2367/EEC \n\nCommission Regulation of 25 July 1990 on the notifications, time \n\nlimits and and hearings provided for in Council Regulation 4064/89 \n\nArticles 1-20 \n\n20. 88/4261/EEC \n\nCommission Regulation of 16 December 1988 on the complaints, \n\napplications and hearings provided for in Council Regulation \n\n3975/87 \n\nArticles 1-15 \n\n\f- 30 -\n\nPROTOCOL 1 \n\nTHE CONTRACTING PARTIES \n\nconsidering that whereas the Agreement envisages the incorporation of \n\nfuture legislation in civil aviation; \n\nwhereas the EEC has already announced legislative action in a number of \n\nareas; \n\nwhereas such action should not lead to future difficulties. are agreed that action i. a. in the following areas : \n\n- Consultation between airports and users \n\nMutual acceptance of Licences and harmonisation \n\nSlot allocation \n\nLicensing of air carrier and allocation of route rights \n\n- Common specifications for ATC equipment \n\nCabotage \n\nValue added tax \n\n- Abolition of tax free sales between the Contracting Parties \n\nRelations with third countries \n\n__ Predatory practices \n\nshall be considered under Article 12 for inclusion in the Agreement. 31 -\n\nPROTOCOL 2 \n\nTHE CONTRACTING PARTIES \n\nconsidering that the agreements must be implemented in the same way for \n\nall the Contracting Parties; \n\nwhereas the Council and the Commission of the EEC have already \n\npronounced indications of importance for implementation of specific \n\narticles \n\nare agreed that : \n\n1. In applying the matching provisions of Article 3(5) in point 2 of \n\nthe Annex in respect of non-scheduled air fares it is the product \n\nwhich is in the market which must be equivalent in terms of quality \n\nand conditions. Elements of importance for the assessment would \n\nbe the inclusion or not of additional services such as \n\naccommodation and also whether the non-scheduled product is legally \n\non the market in a regular way according to the definition in \n\nArticle 2(b)(iii)(2) while the Commission may need to assess \n\nmatching of fares with respect to the rules concerning predatory \n\nbehaviour. - 32 -\n\n2. Member States which benefit from the special conditions under \n\nparagraph 3 of Article 10 in point 1 of the Annex will not, on pain \n\nof losing such special conditions which they have, grant new rights \n\nregarding the airports concerned, on terms which would put their \n\nCommunity partners at a disadvantage by comparison with carriers \n\nfrom third countries outside the Community. and that \n\n3. In a situation where Article 12(2) in point 1 of the Annex is \n\ninvoked, the Commission will examine, in addition to capacity \n\nutilization, the marketing efforts and the products of air carriers \n\nfrom the Member State with the lower market share and will consider \n\nwhether a higher market share should normally be expected. If \n\nthis is the case, the Commission will further consider whether the \n\npossibilities of the air carriers concerned of competing in the \n\nmarket are reduce by virtue, in particular of difficulties \n\nexperienced by congestion at airports, market structure and/or the \n\ndirect impact of the large presence of non-scheduled traffic. In arriving at a decision to reduce the 7. 5 percentage points, the \n\nCommission will be guided by the following relationships : \n\nMarket share \n\nReduced growth rate \n\nbetween 30 and 25% \n\nless than 25% \n\n5 \n\n4 \n\n\f- 33 -\n\nPROTOCOL 3 \n\nTHE CONTRACTING PARTIES \n\naffirm the need for continuation and intensification of the work in \n\nEurocontrol to tackle and resolve the problems of air traffic \n\ncongestion in Europe ; \n\nnote that accession to the Eurocontrol Convention of all Member \n\nStates should be seriously considered ; \n\ninvite Member States to co-operate to ensure that more airspace is \n\nmade available for civil traffic and that it is used more flexibly \n\nand rationally ; \n\n- welcome the efforts made in the relevant fora to make progress in \n\nestablishing compatible technical and performance specifications \n\nfor air traffic control systems and equipments. ISSN 0254-1475 \n\nCOM(91) 299 final \n\nDOCUMENTS \n\nEN \n\n1107 \n\nCatalogue number : CB-CO-91-378-EN-C \n\nISBN 92-77-75488-5 \n\nOffice for Official Publications of the European Communities \n\nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/69d4592f-5bd5-4921-8c7a-c3e59ab63aa7", "title": "AMENDED PROPOSAL FOR A COUNCIL DIRECTIVE RELATING TO THE COORDINATION OF PROCEDURES ON THE AWARD OF PUBLIC SERVICE CONTRACTS", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_directive_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-30", "subjects": "award of contract,provision of services,public contract,single market,works contract", "workIds": "celex:51991PC0322,comnat:COM_1991_0322_FIN,oj:JOC_1991_250_R_0004_01", "eurovoc_concepts": ["award of contract", "provision of services", "public contract", "single market", "works contract"], "url": "http://publications.europa.eu/resource/cellar/69d4592f-5bd5-4921-8c7a-c3e59ab63aa7", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC O M ( 9 1 ) 3 22 final - S YN 2 93 \n\nB r u s s e l s, 30 August 1991 \n\nA m e n d ed proposal for a \n\nC O U N C IL D I R E CT IVE \n\nr e l a t i ng to the c o o r d i n a t i on of p r o c e d u r es on t he award \n\nof public s e r v i ce c o n t r a c ts \n\n(presented by the C o m m i s s i on pursuant to A r t i c le 1 4 9 ( 3) \n\nof the E EC T r e a t y) \n\n\u00ab;, v \n\n*w: \n\nSi: SMB. ,' \nEs*! \n\nm!m \n'\u00db$m:-\n\nw\u00a3'-'' * \n\n\f* z -\n\nTable of contents \n\nI. State of procedure \n\np. 3 \n\nI I. Comments on the major EP amendments not \n\nretained in the amended proposal \n\np. 3 \n\nIII. The amended proposal. p. 4 \n\n(a) Changes which do not alter the \n\nsubstance of the proposal \n\n(b) Definition of public service \n\ncontracts \n\n(c) \n\nConcessions \n\n(d) Thresholds \n\n(e) \n\nPr ior i ty and \n\nresidual services \n\n(f) Contents of indicative notices \n\n(g) Nature of tenderers \n\n(natural or legal persons) \n\n(h) Abnormally low tenders \n\n(I) Preference schemes. (J) Statistical reports \n\n(k) Non-EC tenders \n\nAMENDED PROPOSAL \n\nPreamble \n\nArticles \n\nAnnexes \n\np. p. p. 13 \n\n17 \n\n44 \n\n\f\f- 3 -\n\nI. STATE OF PROCEDURE \n\n1. In June 1990, the Commission presented its initial proposal for \n\nthis Directive d ). 2. The Economic and Social Committee adopted its opinion on 29 May \n\n1991<2>. 3. On 15 May 1991, Parliament adopted its opinion on the proposal, \n\nIncluding a number \n\nof amendments^3). The majority of \n\nParliament's amendments aim at clarifying the proposal, inter \n\nalia as regards its scope, as well as simplifying certain \n\nprovisions of the Directive. Parliament's amendments also \n\nconcern a number of Important issues such as exclusions of \n\ncontracts for certain services and the coverage of others; \n\nthresholds; concessions; variants; the nature of bidders \n\n(natural or legal persons); statistics; or the treatment of non-\n\nEC tenders, \n\n4. The Commission has accepted the majority of Parliament's \n\namendments, in particular those that aim at a higher degree of \n\nclarity and simplicity, although in certain cases modifying \n\nthem as appropriate In the context of the Directive. In \n\nparticular as regards the provisions on concessions, further \n\nchanges were necessary in the Interests of clarity. I I. Comments on Parliament's amendments not retained In the amended \n\nproposal \n\n5. As regards the indicative notices provided for in Article 16, \n\nthe Commission Is of the opinion that more flexibility is needed \n\nthan Parliament's amendment would allow. Experience with the \n\ncorresponding requirements under the other Directives suggests \n\n(1) 0J. No. C 23, 31. 1. 1991 \n\n(2) 0J. No. C \n\n(3) OJ. No. C \n\n\f- 4 -\n\nthat contracting authorities should be allowed to choose the \n\ndescriptive headings which correspond to their own practice and \n\nthat an exhaustive listing would not be helpful. However, the \n\nCommission will continue to reflect on this proposal in the \n\nlight of experience being gained with the Supplies and Public \n\nWorks Direct Ives. 6. As regards the provision on abnormally low offers the Commission \n\nconsiders that this should be aligned on the provisions of the \n\nother Directives which relate to public authorities, notably the \n\nPublic Works Directive (71/305/EEC)<4), and not on that of the \n\n\"Utilities \n\nDirective\" \n\n(90/531/EEC)(5) \n\nwhich \n\nrelates \n\nto \n\ndlfferent entItles. 7. The Commission has not retained a number of amendments which \n\nwere adopted by Parliament and which seek to ensure a closer \n\nsupervision of the respect by bidders of their obligations \n\nunder social and environmental legislation. In the Commission's \n\nview the supervision of such obligations is better carried out \n\nin the context of the relevant social or environmental \n\nlegislation. To use \n\nEC procurement rules for this purpose \n\nwould reduce their effectiveness In meeting their principal goal \n\nof ensuring the non-discriminatory award of public contracts. III. THE AMENDED PROPOSAL \n\n8. Changes compared to the initial proposal are underlined. The \n\nfollowing explanations take the Articles in their order. (a) Changes which do not alter the substance of the proposal \n\n9. Following the opinion of the Parliament, the Commission, In its \n\namended proposal, has replaced the term \"supplier\" by \"service \n\nprovider\". It has also, at a number of places, inserted \n\n(4) OJ. No. L 185, 16. 8. 1971 \n\n(5) OJ. No. L 297, 29. 10. 1990 \n\n\f- 5 -\n\ntexts where previously there had been a cross reference to a \n\ntext In the Public Works Directive. This applies to Art 1(b) \n\n(contracting authorities); Art 8(8) (calculation of thresholds); \n\nArt 20 (variants); Art 31 (lists of recognized suppliers). While \n\nconstituting no change of substance, the Commission accepts the \n\nParliament's view that this will assist understanding by making \n\nthe text more readable. It further has introduced minor changes \n\nIn the Articles 1, 2, 13, 14, 15, 18, 19, 22, 26, 27, 29, 30, \n\n33, 39, 40, and In Annexes IA, IB, 1 M B, C, D, E. It had to \n\nrenumber the Articles because of the deletion of Articles as \n\na consequence of explained modifications. (b) Definition of public service contracts \n\n10. The provisions of Article 1(a) have been changed in two \n\nrespects: \n\nthe text alms to make it clear that contracts for \n\nfinancial \n\nservices are covered by the Directive, \n\nIrrespective of the fact that they may be awarded in \n\nconnection with contracts In connection with land, \n\nbuildings, or immovable, property (subparagraph (ii)), \n\nwhich are themselves excluded; \n\nthe exclusion of contracts awarded by the \"utilities\", \n\nwhich was included in the initial proposal as Article 6, \n\nhas been inserted in Article 1(a) (viii). - 6 -\n\n(c) Concessions \n\n11. The amended proposal brings together all the provisions relating \n\nto the award of public service concessions In \n\nArticle 1(h) (definition), and \n\nArticle 4 (award of concessions; rules applicable to the \n\naward of contracts by concessionaires). 12. The definition in Article 1(h) aims to distinguish, in the field \n\nof concessions which are intended to ensure that a service is \n\nmade available to the public, between \"public service \n\nconcessions\" which are covered In Article 4 of this Directive \n\nand \"public works concessions\", which are covered by the \n\nprovisions of the Public Works Directive. The principle Is that \n\nany concession which includes provision for works to be carried \n\nout should be considered to be a public works concession. All \n\nothers should be public services concessions. 13. Article 4 provides the conditions under which public service \n\nconcessions should be awarded (paragraph 1 and 2 ); the \n\nconditions under which a concessionaire which Is a public \n\nauthority should award its own contracts (paragraph 3 ); and the \n\nconditions under which their concessionaires should award their \n\nown contracts (paragraph 4 ). 14. The principle which is applied to the award of public service \n\nconcessions is one of publicity where the turnover Involved Is \n\nECU 200. 000 or more per year. This provision, which is the same, \n\napart from the threshold, as that applied to the award of public \n\nworks concessions In the Public Works Directive, ensures that \n\n\f- 7 -\n\nInterested service providers will be made aware that a \n\nconcession is being awarded. However, It also, implicitly, \n\nrecognizes the differences between concessions and public \n\nservice contracts. 15. A public service concession concerns the provision of a service \n\nto the public, while a public service contract Involves the \n\nprovision of a service to the public authority. A concessionaire \n\naccepts the financial risk In providing a public service, in \n\nreturn for the chance of profit while a contractor seeks his \n\nprofit in the more limited context of the price for delivering \n\nof a particular service. 16. For this reason, the award of public service concessions (like \n\npublic works concessions under the Public Works Directive) is \n\nnot subject to the detailed requirements which are considered \n\nappropriate for public service contracts. The rules of the \n\nTreaty do, of cause, apply. Nevertheless, in parallel with the \n\nPublic Works Directive, provision Is made for contracting \n\nauthorities to Impose, should they so wish, certain requirements \n\nconcerning the extent to which concessionaires award contracts \n\nto third part les. 17. Public authorities which are concessionaires do not, thereby, \n\nescape from their obligations under the Directives on the award \n\nof public supply contracts, public works contracts or public \n\nservice contracts. In order to ensure that the use of concessions does not limit \n\nthe scope \n\nfor \n\nthe development \n\nof the \n\nInternal \n\nmarket \n\nconcessionaires which are not public authorities or which are \n\nnot covered by the Utilities Directive are to be required to \n\npublicize their supplies, works and services contracts. This \n\n(2) \n\n\f- 8 -\n\nrequirement Is, however, set aside when the conditions for award \n\nwithout publicity laid down in the relevant Directives apply \n\nand when the contract Is awarded to an undertaking which is a \n\nmember of the group to which the concession has been awarded, or \n\nto one of Its affiliates. 18. In presenting the provisions relating to the award of public \n\nservice concessions in this way, the Commission has followed the \n\nsubstance of the relevant amendments of the European Parliament. It has, however, gone somewhat further in bringing together all \n\nthe texts relating to concessions. In this way It has sought to \n\nmeet the Parliament's desire for the clearest possible text. (d) \n\nThresholds \n\n19. The Commission also follows Parliament on the provisions of \n\nArticle 8. This article should be considered also in the light \n\nof Article 2, which provides for a distinction on the basis of \n\nmajority content between supplies contracts and services \n\ncontracts. Contracts In practice often contain a mixture of \n\nsupplies and services. Further, the distinction between many \n\nsupplies (for example In cases of rental) and services can be \n\nrather fine. For this reason, and in order to avoid creating a \n\npotential source of conflict as to the correct classification of \n\ncontracts, It Is proposed to apply the same threshold to service \n\ncontracts as to supplies contracts awarded by the same entity. To this effect, the threshold is ECU 200. 000 except for those \n\nauthorities which are subject to the GATT Government Procurement \n\nAgreement, for which the threshold Is ECU 130. 000. Special \n\nthresholds for particular types of services, as the discussions \n\nin Parliament have shown, risk creating uncertainties and \n\ndisputes. Given that the way in which service providers are \n\nremunerated may vary, additional provisions are made relating to \n\ncalculation of the contract value. - 9 -\n\n(e) \n\nPriority and residual services \n\n20. The amended proposal maintains the concept of two-tier-\n\napplication of the Directive, as laid down In Articles 9 to 11. However, following the Parliament's opinion and In the light of \n\ndiscussion with the sectors concerned, all types of financial \n\nservices covered by the Directive are now listed In category 6 \n\nof Annex IA including those which were previously listed in \n\ncategory 21 of Annex IB. (f) \n\nContents of Indicative notices \n\n21. Article 16 has been amended In consequence of the modification \n\nto Article 8 (thresholds). Contracting authorities have to \n\npublish the Intended total procurement in each of the service \n\ncategories listed in Annex IA which they envisage awarding \n\nduring the next twelve months where the estimated value reaches \n\nECU 750. 000. (g) \n\nThe nature of tenderers (natural or legal persons) \n\n22. In accordance with the amendment of the European Parliament, the \n\nCommission has amended and rearranged its proposal on the nature \n\nof tenderers with a view to its clarification (Article 22). 23. In certain service sectors national regulations prohibit the \n\nestablishment of service operators as legal persons, only allow \n\nparticular forms of legal persons, or require the owners to be \n\nmembers of a particular profession. Such requirements, which are \n\nof general application, could constitute a major obstacle to the \n\nliberalization of public procurement of services, for example If \n\ncontracting authorities could reject tenderers from other Member \n\nStates for the sole reason that they are legal persons. - 10 -\n\n24. The European Court of Justice has repeatedly stated, notably in \nits Judgement of 17. December 1981 (Webb))<6>, that the \n\nprovisions of the Treaty on the freedom to provide services \n\nImply that the rules of the country where the service Is \n\nprovided can only be applied to the provision of services \n\nacross frontiers Insofar as they are Justified In the public \n\nInterest, and the subject matter Is not covered by equivalent \n\nrules In the country of establishment. Further, the rules of the \n\ncountry where the service Is performed may only be applied to \n\ncross \n\nfrontier \n\nservice \n\nactivities \n\nInsofar \n\nas \n\nthey \n\nare \n\nproportionate, necessary and appropriate to solve the subject \n\nmatter. 25. In order to Implement these principles for public procurement of \n\nservices, the proposal contains two provisions: \n\nIn accordance \n\nwith \n\nthe \n\nprinciple \n\nof \n\nhome-country \n\nregulation, status as a natural or a legal person is not, \n\nof itself, to be a ground for rejection of a bidders; \n\nthe contracting authority is, however, permitted to \n\nestablish the names and qualifications of those who will \n\nwork on a project. (h) \n\nAbnormally low tenders \n\n26. In accordance with the general approach of the Parliament, the \n\nCommission has aligned Its provision on abnormally low offers as \n\nfar as possible on the Public Works Direct Ive. (6) \n\nCase 279/80, Webb, [1981] ECR 3304. - 11 -\n\n( I ) \n\nPreference schemes \n\n27. The modified proposal no longer contains provisions covering \n\npreferential award criteria (Arts 33(3) and 35 of the initial \n\nproposal). These deletions are in line with Parliament's \n\namendments, recent \nJustice^7) \n\nand \n\ndecisions of the European Court \n\nof \n\nthe \n\nCommission's \n\nviews \n\nregarding \n\nthe \n\ncompatibility of preference systems with Article 30 of the \n\nTreaty. Further, It Is now clear that the directive will not \n\nenter with force before 31 December 1992, the date on which the \n\nprovisions of Art 35 would have ceased to apply. (J) \n\nStatistical reports \n\n28. Pursuing the objectives of the European Parliament, the amended \n\nproposal aligns the provisions of Article 35 on those of the \n\nPublic Works Directive In order to provide a coherent set of \n\nrules for all types of contracts. (k) \n\nNon-EC tenders \n\n29. The provisions of the Directive regarding third countries \n\nprovide for a combination of erga omnes opening of contracts \n\nwith a problem-solving mechanism to deal with any trade \n\nproblems that may arise. Thus Article 37 provides, In its paragraphs 1 and 2, for the \n\nexchange of information between Member States, Commission and \n\nCouncil regarding relations with third countries in the field \n\nof public service contracts. (7) \n\nCase 21/88, Du Pont de Nemours, Judgement of 20. 3. 1990, not yet \n\nreported in ECR. - 12 -\n\nParagraph 3 provides for the Commission to seek to resolve, by \n\nnegotiation, situations where Community undertakings do not \n\nreceive effective access, national treatment or most favoured \n\nnatIon status. Paragraph 4 provides for corrective measures to be taken, as \n\nrapidly as may be necessary, where one of the problems referred \n\nto In paragraph 3 arises. - 13 -\n\nAmended Proposal for a \n\nCOUNCIL DIRECTIVE \n\nrelating to the coordination of procedures \non the award of public service contracts \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic Community, \nand in particular Articles 57(2), 66, 100a and 113 thereof, \n\nHaving regard to the proposal from the Commission, \n\nIn cooperation with the European Par Iiament^1), \n\nHaving regard to the opinion of the Economic and Social Committee^2), \n\nWhereas the European Council has concluded In successive meetings on the \nneed to complete the internal market; \n\nWhereas measures aimed at progressively establishing the Internal market \nduring the period up to 31 December 1992 need to be taken; whereas the \ninternal market is an area without Internal frontiers in which the free \nmovement of goods, persons, services and capital Is ensured; \n\nWhereas these objectives require the coordination of the procurement \nprocedures on th\u00e9 award of public service contracts; \n\nWhereas the White Paper on the completion of the internal market contains \nan action programme and a timetable for opening up public procurement \nmarkets, including in the field of services Insofar as this Is not already \ncovered by Council Directive 71/305/EEC of 26 July 1971 concerning the \ncoordination of procedures for the award of public works contracts^), as \nlast amended by Directive 90/531/EEC(4>, and Council Directive 77/62/EEC \nof 21 December 1986 coordinating procedures for the award of public supply \ncontracts(5), as last amended by Directive 88/295/EEC(6); \n\nWhereas this Directive should be applied by all contracting authorities in \nthe sense of the aforementioned Directives; \n\nWhereas service providers may be natural or legal persons, without \nprejudice to the national rules of their country of establishment that are \ncompatible with the Treaty; \n\n(1) \n(2) \n(3) \n(4) \n(5) \n(6) \n\nOJ No c \nOJ No c \nOJ No L 185, 16. 08. 1971. p. 5 \nOJ No L 297, 29. 10. 1990. p. 1 \nOJ No L 13. 15. 1. 1977, p. 1 \nOJ No L 127, 20. 5. 1988. p. \\ \n\n\f- 14 -\n\nWhereas the field of services is best described, for the purpose of \napplication of procurement rules, and for monitoring purposes, by \nsubdividing It Into categories corresponding to particular positions of the \nCentral Product Classification (CPC); \n\nWhereas the provision of services Is covered by this Directive only Insofar \nas it is based on contracts; whereas the provision of services on other \nbases, such as law or regulations, or employment contracts, is not covered; \n\nWhereas as far as research and development (R&D) is concerned, this \nDirective only covers R&D services whose results accrue exclusively to the \ncontracting authority; \n\nWhereas, in order to ensure coherent award procedures, public service \nconcessions should be covered by this Directive; \n\nWhereas contracts relating to the acquisition or rental of Immovable \nproperty have particular characteristics, which make the application of \nprocurement rules inappropriate; \n\nWhereas the award of contracts for certain audio-visual services in the \nbroadcasting \nthe \napplication of procurement rules Inappropriate; \n\nby considerations which make \n\nis governed \n\nfield \n\nWhereas arbitration and conciliation services are usually provided by \nbodies or individuals which are agreed on, or selected, in a manner which \ncannot be governed by procurement rules; \n\nWhereas the financial services sector includes activities in connection \nwith the application of Instruments of monetary policy; the particular \ncharacteristics of this area require their exclusion from this Directive; \n\nWhereas In the field of services the same derogations as In the \naforementioned Directives should apply, as regards State security or \nsecrecy and the priority of other procurement rules such as those pursuant \nto international agreements, the stationing of troops, or the rules of \ninternational organisations; \n\nWhereas this Directive does not prejudice the application of, in \nparticular, Articles 55, 56 and 66 of the Treaty; \n\nWhereas the rules concerning service contracts as contained In Council \nDirective 90/531/EEC of 17 September 1990 on the procurement procedures of \nentities operating In the water, energy, transport and telecommunications \nsectors should remain unaffected by this Directive; \n\nWhereas contracts with a designated single source of supply may under \ncertain conditions be fully or partly exempted from this Directive; \n\n\f15 -\n\nin order \n\nWhereas this Directive should not apply to small contracts below a certain \nthreshold, \nthe \nthreshold may in principle be the same as that for public supply contracts; \nwhereas the calculation of contract value, the publication and the method \nof adaptation of the thresholds should be the same as in the other \nCommunity procurement directives; \n\nto avoid unnecessary \n\nformalities; whereas \n\nWhereas, to eliminate practices that restrict competition In general and \nparticipation in contracts by other Member States' nationals in particular, \nit is necessary to improve the access of service providers to procedures \nfor the award of contracts; \n\nWhereas full application of the Directive must be limited, for a \ntransitional period, to contracts for those services where Its provisions \nwill enable the full potential for increased cross-frontier trade to be \nrealised; whereas contracts for other services need to be monitored for a \ncertain period before taking a decision on the full application of the \nDirective; whereas the mechanism for such monitoring needs to be set up by \nthe Directive; whereas it should at the same time enable those interested \nto share the relevant information; \n\nWhereas the rules for the award of public service contracts should be as \nclose as possible to those concerning public supply contracts and public \nworks contracts; \n\nprocurement rules contained in Directives 71/305/EEC and \nWhereas the \n77/62/EEC can be applied, with necessary adaptations so as to take into \naccount special aspects of procurement of services such as the choice of \nthe negotiated procedure, design contests, variants, the legal form under \nwhich the service providers operate, the reservation of certain activities \nto certain professions, registration and quality assurance matters; \n\nWhereas use may be made of the negotiated procedure with prior publication \nof a notice when the service to be provided cannot be specified with \nsufficient precision, particularly In the field of Intellectual services, \nwith the result that the contract cannot be awarded by selection of the \nbest tender in accordance with the rules governing the open and restricted \nprocedures; \n\nWhereas the relevant Community rules on mutual recognition of diplomas, \ncertificates or other evidence of formal qualifications apply when evidence \nof a particular qualification is required for participation in an award \nprocedure or a design contest; \n\nWhereas the objectives of this Directive do not require any changes in the \ncurrent state at national level, as regards the admission, or regulation, \nof price competition between service providers of certain services; \n\nWhereas contracting authorities must be able to reject tenders which, \nbecause they are based on State aids, are unreliable; whereas tenders \n\n(3) \n\n\f- 16 -\n\ncreate the risk of distortions \nwhich are submitted by public bodies may \nof competition when they are influenced by the availability of public \nfinancing; whereas \nparticular \nconditions, inform the Commission of their attitude towards such tenders; \nwhereas this Directive does not prejudice the application of Articles 92 et \nseq. of the Treaty; \n\nshall, under \n\ncontracting \n\nauthorities \n\nWhereas Community undertakings should be granted access to the award of \npublic service contracts and concessions In non-Community countries; \nwhereas negotiations may be Initiated to that effect when such access, in \nlaw or in fact, is found to be restricted; whereas the possibility should \nexist under certain conditions to take measures as regards access,by \nuntertakings originating In the non-Community country concerned, to public \nservice contracts and concessions awarded by the contracting authorities \nwho are subject to this Directive; \n\nWhereas the operation of this Directive should be reviewed at the latest \nthree years after the date for compliance of national procurement rules; \nwhereas the review should extend In particular to the possibility of making \nthe Direct Ive fully applicable to a wider range of service contracts; \n\nHAS ADOPTED THIS DIRECTIVE: \n\n\f17 -\n\nTITLE 1 \n\nGeneral provisions \n\nArticle 1 \n\nFor the purpose of this Directive: \n\n(a) \"public service contracts\" are contracts for pecuniary interest \nconcluded in writing between a service provider and a contracting \nauthority, which are not \n\n(i) \n\n(ii) \n\npublic supply contracts within the meaning of Article 1(a) of \nDirective 77/62/EEC or public works contracts within the \nmeaning of Article 1(a) of Directive 71/305/EEC; \n\nproperty \n\ncontracts for the acquis it Ion or rental, by whatever \nfinancial means, of land, existing buildings, or other \nimmovable \nthereon-, \nnevertheless, financial service contracts (leasing, loans, \nleasing or hire purchase contracts, with or without option to \nbuy) concluded at the same time as, before or after, the \ncontract of acquisition or rental, In whatever form, shall be \nsubject to this Directive-, \n\nconcerning \n\nrights \n\nor \n\n( M i) \n\ncontracts for the acquisition of programme material by \nbroadcasters within the meaning of Council Directive \n89/552/EEC (7), and contracts for broadcasting time; \n\n(iv) \n\ncontracts for voice telephony, telex, radiotelephony, paging \nand satellite services; \n\n(v) \n\ncontracts for arbitration and conciliation services; \n\n(vi) \n\npublic service concessions in the sense of point (h); \n\n(vii) \n\ncontracts concerning primary issues of government bonds and \nother activities In the area of public debt management; \n\n(vill) contracts awarded by contracting entities within the \n\nmeaning of Article 2(1) of Directive 90/531/EEC which \ncorrespond at the same time to the definition of contracting \nauthorities pursuant to article K b) of this Directive; \n\n(b) \"contracting authorities\" (hereafter \"authorities\") shall be the \nState, regional or local authorities, bodies governed by public law, \nassociations formed by one or several of such authorities or bodies \ngoverned by public law and all other bodies listed In Annex I to \nDirective 80/767/EEC. A body governed by public law means any body: \n\n- established for the specific purpose of meeting needs in the \ngeneral Interest, not having an Industrial or commercial character, \nand \n\n(7) \n\n0J No L 298. 17. 10. 1989. p. 23 \n\n\f- 18 -\n\n- having legal personality, and \n\n- financed, for the most part, by the State, or regional or local \nauthorities, or other bodies governed by the public law; or \nsubject to management supervision by those bodies; or having an \nadministrative, managerial or supervisory board, more than half \nof whose members are appointed by the State, regional or local \nauthorities or by other bodies governed by public law. The lists of bodies or of categories of such bodies governed by public law \nwhich fulfil the criteria referred to In the second subparagraph are set \nout In Annex I to Directive 71/305/EEC. (c) \"Service providers\" are natural or legal persons, Including public \nbodies which offer services. A service provider who submits a tender \nshall be designated by the term \"tenderer\", and one who has sought \nan invitation to take part in a restricted or negotiated procedure by \nthe term \"candidate\"; \n\n(d) \"open procedures\" are those national procedures whereby all Interested \n\nservice providers may submit a tender; \n\n(e) \"restricted procedures\" are those national procedures whereby only \nthose service providers invited by the authority may submit a tender-, \n\n(f) \"negotiated procedures\" are those national procedures whereby \nauthorities consult service providers of their choice and negotiate \nthe terms of the contract with one or more of them; \n\n(g) \"design contests\" are those national procedures which aim at providing \nthe authority with a plan or design, mainly in the fields of area \nplanning, town planning, architecture and civil engineering, or data \nprocessing, and which are selected by a jury on the basis of \ncompetition with or without the award of prizes; \n\n(h) a \"public service concession\" is a contract other than a public works \nconcession within the meaning of Article 1(d) of Directive \n71/305/EEC, concluded between an authority and another entity of Its \nchoice whereby the former transfers the execution of a service to the \npublic lying within its responsibility to the latter and the latter \nagrees to provide the activity in return for the right to exploit the \nservice or this right together with payment, if the concession \ncontract covers even partially either the Implementation or the joint \nImplementation and design of works in connection with one of the \nactivities referred to In Annex II of Directive 71/305/EEC or the type \nof work defined in Article 1(c) of Directive 71/305/EEC or the \ncarrying out, by whatever means, of work in accordance with precise \nspecifications laid down by the contracting authority, only Directive \n71/305/EEC shall apply, even If the contract falls partly within the \ndefinition of a public service concession. Contracts for the award of \nrights to perform broadcasting activities are excluded from this \ndefInition. - 19 \n\nArticle 2 \n\nIf a public contract is intended to cover both products within the meaning of \nDirective 77/62/EEC and services within the meaning of Annexes IA and IB of \nthis Directive, it shall fall within the scope of this Directive If the value \nof the services In question exceeds that of the products covered by the \ncontract. Article 3 \n\n1. 2. 3. 1. Member States shall take the necessary measures to ensure that \nauthorities comply with this Directive when they award public service \ncontracts or public service concessions, or hold design contests. Authorities shall ensure that there Is no discrimination between \ndifferent service providers. Member States shall take the necessary measures to ensure that the \nauthorities comply or ensure compliance with this Directive where they \nsubsidize directly by more than 50% service contracts awarded by an \nentity other than themselves in connection with works contracts to \nwhich Article 1a(2) of Directive 71/305/EEC relates. Article 4 \n\nWhere the authorities Intend to award a public service concession, the \nadvertising rules set out In Article 16(3), Article 17 (1) and (2) and \nArticle 18 shall apply when the value of the concession, defined as the \nconcessionaire's turnover In carrying out the contract, equals or \nexceeds ECU 200. 000 a year, excluding VAT. 2. Where authorities intend to award a concession, they may \n\n- either require the concessionaire to award contracts representing a \nminimum of 30% of the total value of the services for which the \nconcession is to be awarded, to third parties, at the same time \nproviding the option for candidates to Increase this percentage. This \nminimum percentage shall be specified In the concession contract, \n\n- or request the candidates for a concession to specify in their \ntenders the percentage, if any, of the total value of the concession \nwhich they intend to assign to third parties. 3. a concessionaire \n\nWhen \nof \nArticle K b ), it shall comply, inc the award of contracts to third \nparties, with the provisions of: \n\nis an authority within \n\nthe meaning \n\n- this Directive in the case of service contracts; \n- Directive 77/62/EEC In the case of supply contracts; \n- Directive 71/305/EEC In the case of works contracts. - 20 -\n\n4. When a concessionaire Is not an authority within the meaning of \nArticle K b ), or a contracting entity within tfie meaning of Article 2 \nof Directive 90/531/EEC, Member States shall take the necessary steps \nto ensure that It shall comply, In the award of contracts to third \nparties, with the provisions of: \n\n- the advertising rules as set out in Articles 17, 18 and 19 of this \nDirectIve In the case of service contracts listed in Annex IA, when \nthe value of the contract exceeds the thresholds fixed In Article \n8(1), and unless the conditions of Article 12(3) apply; \n\n- the advertising rules as set out In Articles 9 to 16 of Directive \n77/62/EEC In the case of supply contracts, when the value of the \ncontract exceeds the thresholds fixed in Article 5(1) (a) and \nunless the conditions of Article 6(4) of that Directive apply; \n\n- the advertising rules as set out in Articles 12 to 19 of \nDirectives 71/305/EEC In the case of works contracts, when the \nvalue of the contract exceeds the thresholds fixed In Article 4a \nand unless the conditions of Article 5(3) of that Directive apply. Undertakings which have formed a group in order to obtain the \nconcession, or undertakings affiliated to them, shall not be regarded \nas third parties within the meaning of paragraph 4 under the \nconditions specified in Article 1b(4) of Directive 71/305/EEC. Article 5 \n\n1. This Directive shall apply to service contracts awarded by \nauthorities In the field of defence, except for contracts to which the \nprovisions of Article 223 of the Treaty apply. 2. This Directive shall not apply to services which are declared secret \nor the execution of which must be accompanied by special security \nmeasures In accordance with the laws, regulations or administrative \nprovisions in force in the Member State concerned or when the \nprotection of the basic interests of that State's security so \nrequires \n\nArticle 6 \n\nThis Directive shall not apply to contracts governed by different \nprocedural rules and awarded: \n\n(a) pursuant to an International agreement concluded between a Member \nState and one or more non-member countries and covering services \nintended for the joint implementation or exploitation of a project by \nthe signatory States; every agreement shall be communicated to the \nCommission, which may consult the Advisory Committee for Public \nContracts set up by Council Decision 71/306/EEC(8); \n\n(b) to undertakings in a Member State or a non-member country in pursuance \nof an international agreement relating to the stationing of troops; \n\n(c) pursuant to the particular procedure of an international organisation. (8) \n\n0J No L 185, 16. 8. 1971. p. 15 \n\n\f- 21 -\n\nArticle 7 \n\nThe provisions of this Directive shall not apply to the award of public service \ncontracts which authorities have to award to an entity which is Itself a \ncontracting authority within the meaning of Article K b) pursuant to an \nexclusive right established by a published law, regulation or administrative \nprovision which is compatible with the Treaty. Article 8 \n\n1. 2. 3. The provisions of this Directive shall apply to service contracts whose \nestimated value net of VAT Is not less than ECU 200. 000 or, in the case \nI to Council \nof the contracting authorities \nDirective 80/767/EEClM), ECU 130. 000. In Annex \n\nIncluded \n\nFor the purposes of calculating the estimated value of the contract, the \nauthority shall Include the estimated total remuneration of the service \nprovider, taking account of the provisions of paragraphs 3 to 8. The selection of the valuation method shall not be used with the \nintention of avoiding the application of this Directive, nor shall any \nprocurement requirement for a given amount of services be split up with \nthe intention of avoiding the application of this Article. 4. In assessing the estimated contract value for the following types of \nservices account shall be taken of, where appropriate: \n\n- as regards Insurance services, the premium payable-, \n\n- as regards banking and other financial services, fees, commissions \n\nand Interests as well as other types of remuneration; \n\n- as regards contracts which Involve design, the fee or commission \n\npayable. Where the services are subdivided into several lots, each one the subject of a \ncontract, the value of each lot must be taken into account for the purpose of \ncalculating the amount referred to above. Where the value of the lots is not \nless than the amount referred to above, the provisions of this Directive shall \napply to all lots. Authorities shall be permitted to depart from the provisions \nof paragraph 1 for lots which have an estimated value net of VAT of less than \nECU 80. 000, provided that the total estimated value of all the lots exempted \ndoes not, in consequence, exceed 20% of the total estimated value of all lots. 5. In the case of contracts which do not specify a total price, the basis \nfor calculating the estimated contract value shall be: \n\nin the case of fixed term contracts, the total contract value for its \ndur\u00e2t Ion; \n\nin the case of the contracts for an indefinite period or in cases \nwhere there is doubt as to the duration of the contracts, the monthly \ninstalment multiplied by 48. (9) \n\n0J No L 215. 18. 8. 1980. p. 1 \n\n\f- 22 -\n\n6. In the case of regular contracts or of contracts which are to be \nrenewed within a given time, the contract value may be established on \nthe basis of: \n\n7. 8. - either the aggregate cost of similar contracts for the same \ncategories of services awarded over the previous fiscal year or \n12 months, adjusted, where possible, for anticipated changes in \nquantity or value over the subsequent 12 months-, \n\n- or the estimated aggregate cost during the 12 months following \nfirst performance or during the term of the contract, where this is \ngreater than 12 months. In cases where a proposed contract specifies option clauses, the basis \nfor calculating the contract value shall be the highest possible total \ninclusive of the option clauses. The value of the thresholds In national currencies shall be revised \nevery two years with effect from 1 January 1994. The calculation of \nthese values shall be based on the average dally values of these \ncurrencies In terms of the ecu over the 24 months terminating on the \nlast day of October immediately preceding the 1 January revision. The \nvalues shall be published In the Official Journal of the European \nCommunities at the beginning of November. The method of calculation referred to In the preceding subparagraph \nshall be examined, on the Commission's Initiative, within the Advisory \nCommittee for Public Contracts In principle two years after its \ninitial applicat ion. - 23 -\n\nTITLE 1 1 \n\nTwo-tier application \n\nArticle 9 \n\nContracts which have as their object services listed In Annex IA shall be \nawarded in accordance with the provisions of Titles III to VI. Contracts which have as their object services listed in Annex IB shall be \nawarded in accordance with Articles 16 and 18. Article 10 \n\nArticle 11 \n\nContracts which have as their object services listed In both Annexes IA and IB \nshall be awarded in accordance with the provisions of Titles III to VI where \nthe value of the services listed in Annex IA Is greater than the value of the \nservices listed In Annex IB. Where this is not the case, they shall be awarded \nin accordance with Articles 16 and 18. TITLE III \n\nChoice of award procedures; and rules on design contests \n\nArticle 12 \n\nIn awarding public service contracts the authorities shall apply the \nprocedures defined In Article 1 (d), (e) and (f), adapted to this \nDirect ive. The authorities may award their public service contracts by negotiated \nprocedure, with prior publication of a tender notice in the following \ncases: \n\n(a) \n\nin the event of irregular tenders in response to an open or \nrestricted procedure or in the event of tenders which are \nunacceptable under national provisions that are in accordance with \nthe provisions of Articles 19 to 24, Insofar as the original \nterms of the contract are not substantially altered. The authority \nneed not publish a tender notice where it includes in such \nnegotiated procedure all the tenderers satisfying the criteria of \nArticles 25 to 31 which, during the prior open or restricted \nprocedure, have submitted tenders in accordance with the formal \nrequirements of the tendering procedure; \n\n(b) \n\nin exceptional cases, when the nature of the services or the risks \nattaching thereto do not permit overall pricing-, \n\n(4) \n\n\f- 24 -\n\n(c) \n\nwhen the nature of the services to be procured, in particular In \nthe case of Intellectual services and services falling within \ncategory 6 of Annex IA, Is such that contract specifications \ncannot be established with sufficient precision to permit the \naward of the contract by selecting the best tender according to \nthe rules governing open or restricted procedures. 3. The authorities may award public service contracts by negotiated \nprocedure without prior publication of a tender notice, in the \nfol lowing cases: \n\n(a) \n\n(b) \n\n(c) \n\n(d) \n\n(e) \n\nin the absence of tenders or of appropriate tenders in response \nto an open or restricted procedure Insofar as the original terms \nof the contract are not substantially altered and provided that \na report is communicated to the Commission at its request; \n\nwhen, for technical or artistic reasons, or for reasons \nconnected with the protection of exclusive rights, the services \nmay only be provided by a particular service provider. when the contract concerned is part of the follow-up to a design \ncontest and must, according to the relevant national rules, be \nawarded to one of the winners of that contest provided that al 1 \nthe winners are Included In the procedure; \n\nbrought \n\nInsofar as Is strictly necessary when, for reasons of extreme \nurgency \nthe \nauthorities In question, the time-limit for the open, restricted \nor negotiated procedures referred to in Article 18 cannot be \nkept. The circumstances Invoked to Justify extreme urgency must \nnot in any event be attributable to the authorities; \n\nunforeseeable \n\nevents \n\nabout \n\nby \n\nby \n\nfor additional services not Included in the project initially \nconsidered or In the contract first concluded but which have, \nthrough unforeseen circumstances, become necessary for the \ncarrying out of the service described therein, on condition that \nthe award is made to the service provider carrying out such \nservice; \n\n- when such services cannot be technically or economically \nseparated from the main contract without great inconvenience \nto the author it les; \n\n- or when such services, although separable from the execution \nof the original contract, are strictly necessary for Its \nlater stages. However, the aggregate estimated value of contracts awarded for \nadditional services may not exceed 50% of the amount of the main \ncontract ; \n\n\f- 25 -\n\n(f) \n\nfor new services consisting of the repetition of similar \nservices entrusted to the service provider to which the same \nauthorities awarded an earlier contract, provided that such \nservices conform to a basic project for which a first contract \nwas awarded according to the procedures referred to In paragraph \n4. As soon as the first project Is put up for tender, notice \nmust be given that this procedure might be adopted and the total \nestimated cost of subsequent services shall be taken Into \nconsideration by the authorities when they apply the provisions \nof Article 8. This procedure may be applied solely during the \nthree years following the conclusion of the original contract. 4. In all other cases, the authorities shall award their public service \ncontracts by the open procedure or by the restricted procedure. Article 13 \n\n1. 2. The authority shall, within 15 days of the date on which the request \nis received, Inform any eliminated candidate or tenderer who so \nrequests in writing of the reasons for rejection of his application or \nhis tender, and, In the case of a tender, the name of the successful \ntenderer. The authority shall inform candidates or tenderers who so request In \nwriting of the grounds on which it decided not to award a contract In \nrespect of which a prior call for competition was made, or to \nrecommence the procedure. It shall also Inform the Office for \nOfficial Publications of the European Communities of that decision. 3. For each contract awarded the authorities shall draw up a written \nreport which shall Include at least the following: \n\nits name and address, the subject and value of the contract; \n\n- the names of the candidates or tenderers admitted and the reasons \n\nfor their selection; \n\n- the names of the candidates or tenderers rejected and the reasons \n\nfor their rejection-, \n\n- the name of the successful tenderer and the reasons for his tender \nhaving been selected and, if known, any share of the contract the \nsuccessful tenderer may intend to subcontract to a third party; \n\n- for negotiated procedures, the circumstances referred to In Article \n\n12 which justify the use of these procedures. This report, or the main features of it, shall be communicated to the \nCommission at its request. 26 -\n\nArticle 14 \n\nDesign contests shall be subject to the rules set out below. When \ndesign contests are held as a separate procedure, these rules are \napplicable only when the total amount of contest prizes and payments \nto participants is not less than ECU 200 000. The admission of participants to design contests shall not be limited \nby reference to the territory or part of the territory of a Member \nState. In the case of design contests with a limited number of participants, \nauthorities shall apply the rules laid down in Article 23. The jury shall be composed only of persons who have no financial \nconnections or special relationships with participants in the contest. Whenever a particular professional qualification is required from \nparticipants in a contest, the majority of the jury members shall have \nthe same qualifications. The Jury shall be autonomous in Its decisions. It shall take its \ndecisions based on projects presented In an anonymous way, and solely \non the grounds of the criteria Indicated in the invitation for \nprojects in the sense of Annex IV. Member States may oblige authorities to award subsequent contracts to \none of the winners of a design contest. TITLE iV - Common rules In the technical field \n\nArticle 15 \n\nThe technical specifications defined in Annex II shall be given in \nthe general documents or the contractual documents relating to each \ncontract. Without prejudice to the legally binding national technical rules and \ninsofar as these are compatible with Community law, such technical \nspecifications shall be defined by the authorities by reference to \nnational standards implementing European standards or by reference to \nEuropean technical approvals or by reference to common technical \nspecif I cat Ions. An authority may depart from paragraph 2 if: \n\na) the standards, European technical approvals or common technical \nspecifications do not include any provisions for establishing \nconformity, or technical means do not exist for establishing \nsatisfactorily the conformity of a product to these standards, \nEuropean technical approvals or common technical specifications; \n\n\f- 27 -\n\nb) the application of paragraph 2 would prejudice the application of \nCouncil Directive 86/361/EEC of 24 July 1986 on the initial stage \nof the mutual recognition of type approval for telecommunications \nterminal equipment^10), or Council Decision 87/95/EEC of 22 \nDecember 1986 on standardisation In the field of Information \ntelecommunlcations^11 ) or \nCommunity \ntechnology \nInstruments in specific service or product areas; \n\nother \n\nand \n\nc) use of these standards, European technical approvals or common \ntechnical specifications would oblige the authority to acquire \nproducts or materials incompatible with equipment already in use or \nwould entail disproportionate costs or disproportionate technical \ndifficulties, but only as part of a clearly defined and recorded \nstrategy with a view to change-over, within a given period, to \nEuropean standards, European technical approvals or common \ntechnical specifications; \n\nd) the project concerned Is of a genuinely innovative nature for which \nuse of existing European standards, European technical approvals or \ncommon technical specifications would not be appropriate. 4. Authorities invoking paragraph 3 shall record, wherever possible, the \nreasons for doing so in the tender notice published In the Official \nJournal of the European Communities or in the contract documents and \nin all cases shall record these reasons in their \nInternal \ndocumentation and shall supply such information on request to Member \nStates and to the Commission. 5. In the absence of European standards or European technical approvals \nor common technical specifications, the technical specifications: \n\n(a) shall be defined by reference to the national technical \nspecifications \nthe basic \nrequirements listed In the Community directives on technical \nharmonisation, In accordance with the procedures laid down In \nthose directives, and In particular In accordance with the \nprocedures laid down In Council Directive 89/106/EEC(12); \n\nas complying \n\nrecognised \n\nwith \n\n(b) may be defined by reference to national technical specifications \nrelating to design and method of calculation and execution of \nworks and use of materials; \n\n(c) may be defined by reference to other documents. In this case, it Is appropriate to make reference in order of \npreference to: \n\n(I) national standards Implementing international standards \n\naccepted by the country of the authority-, \n\n(10) OJ No L 217. 5. 8. 1986. p. 21 \n(11) OJ No L 36. 7. 2. 1987. p. 31 \n(12) OJ No L 40. 11. 2. 1989. p. 12 \n\n\f- 28 -\n\n(il) other national standards and national technical approvals \n\nof the country of the authority; \n\n(ill) any other standard. Unless it is Justified by the subject of the contract, Member States \nshall prohibit the introduction into the contractual clauses relating \nto a given contract of technical specifications which mention products \nof a specific make or source or of a particular process and which \ntherefore favour or eliminate certain undertakings. In particular, \nthe Indication of trade marks, patents, types, or of specific origin \nor production shall be prohibited. However, If such indication is \naccompanied by the words \"or equivalent\", it shall be authorised in \ncases where the authorities are unable to give a description of the \nsubject of the contract using specifications which are sufficiently \nprecise and intelligible to all parties concerned. - 29 -\n\nTiTLE V \n\nCommon Advertising rules \n\nArticle 16 \n\n1. 2. 3. 4. 1. 2. 3. 4. 5. Authorities shall make known, by means of an Indicative notice to be \npublished as soon as possible after the beginning of their budgetary \nyear, the Intended total procurement In each of the service categories \nlisted In Annex IA which they envisage awarding during the coming 12 \nmonths where the total estimated value, taking account of the \nprovisions of Article 8, is equal to or greater than ECU 750 000. Authorities who wish to award a public service contract by open, \nrestricted or, under the conditions laid down In Article 12, \nnegotiated procedure, shall make known their intention by means of a \nnot ice. Authorities who wish to award a public service concession shall make \nknown their intention by means of a notice. Authorities who wish to carry out a design contest shall make known \ntheir intention by means of a notice. Article 17 \n\nAuthorities who have awarded a contract or a public service \nconcession, or which have held a design contest shall send a notice \nof the results of the award procedure to the Office for Official \nPublication of the European Communities. In cases of public service contracts for services listed in Annex IA, \npublic service concessions and design contests, the notice shall be \npublished In accordance with the provisions referred to in Article 18. In the case of public service contracts for services listed In Annex \nIB, the authorities shall indicate In the notice whether they agree on \nIts publ(cat ion. The Commission shall draw up the rules for establishing regular \nreports on the basis of the notices referred to in paragraph 3, and \nfor the publication of such reports in accordance with the procedure \nlaid down in Article 36(3). Insofar as release of information on the contract award would Impede \nlaw enforcement or otherwise be contrary to the public interest or \nwould prejudice the legitimate commercial Interests of a particular \nenterprise, public or private, or might prejudice fair competition \nbetween service providers, such Information may not be published. - 30 -\n\nArticle 18 \n\nThe notices shall be drawn up In accordance with the models set out In \nAnnexes III, IV and V, and shall specify the Information requested In \nthose models. The authorities may not require any conditions but \nthose specified In Articles 27 and 28 when requesting information \nconcerning the economic and technical standards which they require of \nservice providers for their selection (Point 13 of Annex 1 M B, point \n12 of Annex I M C, and point 11 of Annex III D ). The following provisions of Directive 71/305/EEC shall apply: \n\n(I) Article 12(6) and (8) to (13) concerning publication of notices; \n\n(II) Articles 13 to 15 concerning minimum tlme-llmlts for the phases \nof award procedures and communications between authorities and \ncandidates; \n\n(III) Articles 15a and 15b concerning minimum time-limits for the \naward of public service concessions and contracts to be awarded \nby concessionnaires; \n\n(iv) Article 19 concerning voluntary publication of notices in the \n\nOfficial Journal of the European Communities. The conditions for the establishment, transmission, reception, \ntranslation, accumulation and distribution of the notices referred to \nin paragraphs 1 and 2 and in Articles 16 and 17, and of the \nstatistical reports provided for In Articles 17(4) and 35 and the \nreference in the notices to particular CPC positions within the \ncategories of services listed In Annexes IA and IB may be modified in \naccordance with the procedure laid down in Article 36(3). - 31 -\n\nTITLE VI \n\nChapter 1 \n\nCommon rules on participation \n\nArticle 19 \n\nContracts shall be awarded on the basis of the criteria laid down in \nChapter 3, taking into account Article 20, after the suitability of the \nservice providers not excluded under Article 25 has been checked by the \nauthorities in accordance with the criteria referred to In Articles 27 and \n28. Article 20 \n\n1. Where the criterion for the award of the contract Is that of the \neconomically most advantageous tender, authorities may take account \nof variants which are submitted by a tenderer and meet the minimum \nspecifications required by the authorities. The author It les shal I \nstate in the contract documents the minimum specifications to be \nrespected by the variants and any specific requirements for their \npresentation. They shall Indicate In the tender notice whether \nvariants will be considered. Authorities may not reject the submission of a variant on the sole \ngrounds that It has been drawn up with technical specifications \ndefined by reference to national standards transposing European \nstandards, to European technical approvals or to common technical \nspecifications referred to In Article 15(2) or again by reference to \nnational technical specifications referred to in Article 15(5) (a) and \n(b). Authorities which have admitted variants pursuant to paragraph 1 may \nnot reject a variant on the sole grounds that it would lead, if \nsuccessful, to a supply contract rather than a public service contract \nwithin the meaning of this Directive. Article 21 \n\nIn the contract documents, the authority may ask the tenderer to \nindicate in his tender any share of the contract he may intend to sub \ncontract to third parties. This indication shall be without prejudice to the question of the \nprincipal service provider's liability. - 32 -\n\nArticle 22 \n\n1. 2. Tenders may be submitted by groups of service providers. These groups \nmay not be required to assume a specific legal form In order to submit \nthe tender; however, the group selected may be required to do so when \nIt has been awarded the contract. Candidates or tenderers, who under the law of the Member State In \nwhich they are established, are entitled to carry out the relevant \nservice activity, shall not be rejected on the sole grounds that, \nunder the law of the Member State In which the contract Is awarded, \nthey would have been required to be either a natural or a legal \nperson. 3. Legal persons may be required to indicate In the tender or the request \nfor participation the names and relevant professional qualifications \nof the staff to be responsible for the performance of the service. Article 23 \n\n1. 2. In restricted and negotiated procedures the authorities shall, on the \nbasis of information given relating to the service provider's position \nas well as to the information and formalities necessary for the \nevaluation of the minimum conditions of an economic and technical \nnature to be fulfilled by him, select from among the candidates with \nthe qualifications required by Article 25 to 31 those whom they will \ninvite to submit a tender or to negotiate. Where the authorities award a contract by restricted procedure, they \nmay prescribe the range within which the number of providers of \nservices which they Intend to invite will fall. In this case the \nrange shall be indicated In the contract notice. The range shall be \ndetermined in the light of the nature of the service to be provided. The range must number at least five service providers and may be up to \ntwenty. In any event, the number of candidates invited to tender shall be \nsufficient to ensure genuine competition. 3. Where the authorities award a contract by negotiated procedure as \nreferred to In Article 12, the number of candidates admitted to \nnegotiate may not be less than three, provided that there is a \nsufficient number of suitable candidates. 4. Each Member State shall ensure that authorities issue invitations \nwithout discrimination to those nationals of other Member States who \nsatisfy the necessary requirements and under the same conditions as to \nits own nat ionais. - 33 -\n\nArticle 24 \n\nThe authority may state In the contract documents, or be obliged by a \nMember State to do so, the authority or authorities from which a \ncandidate may obtain the appropriate information on the obligations \nrelating to the employment protection provisions and the working \nconditions which are In force In the Member State, region or locality \nIn which the services are to be performed and which shall be \napplicable to the services provided on site during the performance of \nthe contract. The authority which supplies the Information referred to In paragraph \n1 shall request the tenderers or those participating in the contract \nprocedure to indicate that they have taken account, when drawing up \ntheir tender, of the obligations relating to employment protection \nprovisions and the working conditions which are in force in the place \nwhere the service is to be carried out. This shall be without \nprejudice to the application of the provisions of Article 33 \nconcerning the examination of abnormally low tenders. CHAPTER 2 \n\nCriteria for qualitative selection \n\nArticle 25 \n\nAny service provider may be excluded from participation In the contract \nwho: \n\n(a) is bankrupt or Is being wound up, whose affairs are being administered \nby the court, who has entered into an arrangement w[th creditors, who \nhas suspended business activities or who is In any analogous situation \narising from a similar procedure under national laws and regulations; \n\n(b) is the subject of proceedings for a declaration of bankruptcy, for an \norder for compulsory winding up or administration by the court or for \nan arrangement with creditors or of any other similar proceedings \nunder national laws or regulations-, \n\n(c) has been convicted of an offence concerning his professional conduct \n\nby a Judgement which has the force of res Judicata; \n\n(d) who has been guilty of grave professional misconduct proven by any \n\nmeans which the authorities can Justify-, \n\n(e) has not fulfilled obligations relating to the payment of social \nsecurity contributions In accordance with the legal provisions of the \ncountry in which he Is established or with those of the country of the \nauthor ity; \n\n(f) has not fulfilled obligations relating to the payment of taxes In \n\naccordance with the legal provisions of the country of the authority; \n\n(g) is guilty of serious misrepresentation In supplying or failing to \nsupply the information that may be required under this chapter. - 34 -\n\nWhere the authority requires of the service provider proof that none of the \ncases quoted in (a), (b), (c), (e), or (f) appiles to him; It shall accept \nas sufficient evidence: \n\nfor (a), (b), or (c), the production of an extract from the 'judicial \nrecord' or, failing this, of an equivalent document Issued by a \ncompetent judicial or administrative authority in the country of \norigin or In the country whence that person comes showing that these \nrequirements have been met, \n\nfor (e) or (f), a certificate Issued by the competent authority in \nthe Member State concerned. Where the country concerned does not issue such documents or certificates, \nthey may be replaced by a declaration on oath made by the person concerned \nbefore a Judicial or administrative authority, a notary or a competent \nprofessional or trade body, in the country of origin or in the country \nwhence that person comes. Member states shall, within the time-limit referred to \nin Article 40, \ndesignate the authorities and bodies competent to issue these documents and \nshall forthwith inform the other Member States and the Commission thereof. Article 26 \n\n1. 2. Insofar as candidates for a public contract have to possess a \nparticular authorisation or to be members of a particular organisation \nin their home country in order to be able to perform the service \nconcerned, the authority may require them to prove that authorisation \nor membership. Any candidate or tenderer may be requested to prove his enrollment, as \nprescribed in his country of establishment, In one of the professional \nor trade registers or to provide a declaration or certificate as \ndescribed in paragraph 3 below. 3. The relevant professional and trade registers or declarations or \n\ncert IfIcates are: \n\nin Belgium, the \"registre du commerce - Handelsreglster\" ; \n\nin Denmark, the \"Erhvervs- og Selskabsstyrelsen\", (the \"Aktiesel-\nskabsregistret\"; \"Forenings-Registret\", or \"Handelsregistret\") ; \n\nin Germany, the \"Handelsregister\" and the \"Handwerksrolle\"; \n\nin Greece, a declaration on the exercise of the profession \nconcerned made on oath before a notary may be required; \n\n- in Spain, the \"Registro Oficial de Contratlstas del Minlsterio de \n\nIndustrla y Energla\" ; \n\nin France, the \"registre du commerce\", and the \"r\u00e9pertoire des \nmetlers\"; \n\n\f- 35 -\n\n- In Italy, the \"Reglstro della Camera dl commerclo, Industrla, \nagricoltura e artigianato\" or the \"Reglstro del le commlsslonl \nprovincial I per l'art Igianato\" -, \n\n- In Luxembourg, the \"registre aux firmes\" and the \"r\u00f4le de la \n\nChambre des m\u00e9tiers\"; \n\n- in The Netherlands, the \"Handelsregister\"; \n\n- in Portugal, the \"Commlss\u00e2o de Alvar\u00e2s de Empresas de Obras \nP\u00fbbllcas e PartIculares\" (CAEOPP) or the \"Reglstro naclonal das \nPessoas Colectivas\"; \n\n- in the United Kingdom and Ireland, the service provider may be \nrequested to provide a certificate from the \"Registrar of \nCompanies\" or the \"Registrar of Friendly Societies\" or, if he is \nnot so certified, a certificate stating that the person concerned \nhas declared on oath that he is engaged in the profession in \nquestion in the country in which he is established in a specific \nplace under a given business name. Article 27 \n\n1. Proof of the service provider's financial and economic standing may, \nas a general rule, be furnished by one or more of the following \nreferences: \n\n(a) appropriate statements from banks or evidence of relevant \n\nprofessional risk Indemnity Insurance, \n\n(b) \n\nthe presentation of the service provider's balance sheets or \nextracts therefrom, where publication of the balance sheets Is \nrequired under company law in the country in which the service \nprovider is established, \n\n(c) a statement of the undertaking's overall turnover and Its \nturnover In respect of the services to which the contract \nrelates for the three previous financial years. The authorities shall specify in the notice or In the Invitation to \ntender which reference or references they have chosen and which \nreferences other than those mentioned under paragraph 1 are to be \nproduced. If, for any valid reason, the service provider is unable to provide \nthe references requested by the authority, he may prove his economic \nand financial standing by any other document which the authority \nconsiders appropriate. Article 28 \n\nThe ability of service providers to perform services may be evaluated \nIn particular with regard to their skills, efficiency, experience and \nreliablIity. Evidence of the service provider's technical capability may be \nfurnished by one or more of the following means according to the \nnature, quantity and purpose of the services to be provided: \n\n2. 3. 1. 2. - 36 -\n\n(a) \n\nservice \n\nprofessional \nthe \nqualifications and/or those of the firm's managerial staff, and \nin particular, those of the person or persons responsible for \nperforming the services; \n\neducational \n\nprovider's \n\nand \n\n(b) a list of the principal services provided In the past three \nyears, with the sums, dates and recipients, public or private, \nof the services performed; \n\n* where provided to authorities, evidence to be In the form of \ncertificates Issued or countersigned by the competent \nauthor ity; \n\n* where provided to private purchasers, delivery to be \ncertified by the purchaser or, failing this, simply declared \nby the service provider to have been effected; \n\n(c) \n\nindication of the technicians or technical bodies involved, \nwhether or not belonging directly to the service provider, \nespecially those responsible for quailty control ; \n\n(d) a statement of the service provider's average annual manpower \n\nand the number of managerial staff for the last three years; \n\n(e) a statement of the tool, plant or technical equipment available \n\nto the service provider for carrying out the services; \n\n(f) a description of the service provider's measures for ensuring \n\nquality, and his study and research facilities; \n\n(g) where the services to be provided are complex or, exceptionally, \nare required for a special purpose, a check carried out by the \nauthority or on its behalf by a competent official body of the \ncountry In which the service provider Is established, subject to \nthat body's agreement, on the technical capacities of the \nservice provider and, If necessary, on his study and research \nfacilities and quality control measures; \n\n(h) \n\nindication of the share of the contract which the service \nprovider may intend to sub-contract; \n\n3. The authority shall specify, in the notice or in the Invitation to \n\ntender, which references It wishes to receive. 4. The extent of the Information referred to In Article 27 and paragraphs \n1 to 3 of this Article must be confined to the subject of the \ncontract. Authorities shall take Into consideration the legitimate \nInterests of the service providers as regards the protection of their \ntechnical or trade-related secrets. Article 29 \n\nShould authorities require the production of certificates drawn up by \nindependent bodies for attesting conformity of the provider of services to \ncertain quality assurance standards, they shalI refer to quaMty assurance \nsystems based on the relevant EN 29000 European standards series certified \n\n\f- 37 \n\nby bodies conforming to the EN 45000 European Standards series. bodies \nequivalent \nAuthorities shall \nestablished in other Member States. They shall also accept other evidence \nof equivalent quality assurance measures from service providers who have \nno access to such certificates, or no possibility of obtaining them within \nthe relevant time limits. certificates \n\nrecognise \n\nfrom \n\nArticle 30 \n\nWithin the limits of Articles 25 to 28, the authority may Invite the \nservice providers to supplement the certificates and documents submitted or \nto clar ify them. Article 31 \n\n1. Member States who have official lists of recognised service providers \nmust adapt them to the provisions of Articles 25(a) to (d) and (g) and \nof Articles 26 to 28. 2. 3. Service providers registered in these lists may, for each contract, \nsubmit to the authority a certificate of registration issued by the \ncompetent authority. This certificate shall state the references \nwhich enabled them to be registered In the list and the classification \ngiven in this list. Certified registration in such lists by the competent bodies shall, \nfor the authorities of other Member States, constitute a presumption \nof suitability corresponding to the service provider's classification \nonly as regards Articles 25(a) to (d) and (g), 26, 27(b) and (c) and \n28(a). Information which can be deduced from registration In official lists \nmay not be questioned. However, with regard to the payment of social \nsecurity contributions, an additional certificate may be required of \nany registered service provider whenever a contract is offered. The authorities of other Member States shall apply the above \nprovisions only In favour of service providers who are established In \nthe country holding the official list. 4. When registering providers of services from other Member States on \nsuch a list, no proof or statement can be required In addition to \nthose required of national providers of services and, in any case, \nnone in addition to those required in Articles 25 to 29. 5. Those Member States that have official lists shall be obliged to \nInform the other Member States of the address of the body to which \napplications for registration should be sent. CHAPTER 3 \n\nCriteria for the award of contracts \n\nArticle 32 \n\n1. Without prejudice to national law, regulation or administrative \nprovision on the remuneration of certain services, the criteria on \nwhich the authority shall base the award of contracts may be: \n\n\f- 38 -\n\n(a) when the award Is made to the economically most advantageous \ntender, various criteria relating to the contract: for example, \nquality, \nfunctional \ncharacteristics, technical assistance and service, delivery \ndate, delivery period or period of completion, price, or \n\naesthetic \n\ntechnical \n\nmerit, \n\nand \n\n(b) \n\nthe lowest price only. Where the contract is to be awarded to the economically most \nadvantageous offer, authorities shall state in the contract documents \nor In the tender notice the award criteria which they intend to apply \nand, If possible, the intended ranking or weighting which they intend \nto use. Article 33 \n\nIf, for a given contract, tenders appear \nto be abnormally low in \nreject those tenders the \nrelation to the transaction, before it may \nauthority shall request, In writing, details of \nthe constitutent \nelements of the tender which It considers relevant \nand shal I ver ify \nthose constituent elements taking account of the explanations \nreceived. const I tuent \n\nThe authority may take Into consideration explanations which are \nJustified on objective grounds Including the economy of the service \nmethod, or the technical solutions chosen, or the exceptionally \nfavourable conditions available to the tenderer for the provision of \nthe service, or the originality of the service proposed by the \ntenderer. If the documents relating to the contract provide for its award at the \nlowest price tendered, the authority must communicate to the \nCommission the rejection of tenders which it considers to be too low. In the case of a tender submitted by a public authority or a public \nenterprise, the authority shall In particular enquire whether the \ntender is influenced by public funds a-l located for \n\n(a) \n\nthe setting-off of operating losses; \n\n(b) \n\nthe provision of capital; \n\n(c) non-refundable grants, or loans on privileged terms; \n\n(d) \n\nthe granting of financial advantages by foregoing profits or the \nrecovery of sums due; \n\n(e) \n\nthe foregoing of a normal return on public funds used; \n\n(f) compensation for financial burdens Imposed by the public \n\nauthor It les. It shall Inform the Commission if it intends to award a contract to a \ntenderer whose tender is influenced by any of these characteristics. - 39 -\n\n3. Authorities may reject tenders which are abnormally low owing to the \nreceipt of State aid only if they have consulted the tenderer and If \nthe tenderer has not been able to show that the aid In question has \nbeen notified to the Commission pursuant to Article 93(3) of the \nTreaty or has received the Commission's approval. Authorities which \nreject a tender under these circumstances shall inform the Commission \nthereof. - 40 -\n\nTiTLE Vil \n\nFinal Provisions \n\nArticle 34 \n\nThe calculation of tlme-llmlts shall be made In accordance with Council \nRegulation (EEC, EURATOM) No 1182/71 of 3 June 1971, determining the rules \napplicable to periods, dates and time limits^13). Article 35 \n\n1. 2- \n\nIn order to permit assessment of the results of applying the \nDirective , Member States shall forward to the Commission a \nstatistical report on the service contracts awarded by authorities by \n31 October 1995 at the latest for the preceding year and there after \nby 31 October of every second year. This report shall detail at least the number and value of contracts \nawarded by each authority or category of authority above the \nthreshold, subdivided as far as possible by procedure, category of \nservice and the nationality of the service provider to whom the \ncontract has been awarded, and in the case of negotiated procedures, \nsubdivided In accordance with Article 12, listing the number and value \nof the contracts awarded to each Member State and to third countries. 3. The Commission shall determine the nature of any additional \nstatistical information, which is required In accordance with this \nDirective, In accordance with the procedure laid down in Article \n36(3). Article 36 \n\n1. 2. 3. The Commission shall be assisted by the Advisory Committee for Public \nContracts set up by Decision 71/306/EEC. As regards procurement of telecommunications services falling within \ncategory 5 of Annex IA, the Commission shall also be assisted by the \nAdvisory Committee on Telecommunications Procurement set up by \nDirective 90/531/EEC. Where reference Is made to the procedure laid down in this paragraph, \nthe representative of the Commission shall submit to the Committee a \ndraft of the measures to be taken. The Committee shall deliver its \nopinion on the draft within a time-limit which the chairman may lay \ndown according to the urgency of the matter, If necessary by taking a \nvote. The opinion shall be recorded in the minutes; in addition, each Member \nState shall have the right to ask to have Its position recorded in the \nminutes. (13) \n\n0J No L 124, 8. 6. 1971, p. 1 \n\n\f- 41 -\n\nThe Commission shall take the utmost account of the opinion delivered \nby the Committee. It shall Inform the Committee of the manner In \nwhich its opinion has been taken into account. 4. The Committees shall examine, on the initiative of the Commission or \nat the request of a Member State, any question relating to the \napplication of this Directive. Article 37 \n\n1. The Member States shall Inform the Commission of any general \ndifficulties encountered, in law or In fact, by their undertakings In \nsecuring the award of public service contracts or public service \nconcessions In third countries. 2. 3. The Commission shall report to the Council, before 31 December 1992 \nand then periodically, on the opening up of public service contracts \nand concessions in third countries and on the state of negotiations \nwith these countries on this subject, part icularly in the GATT \nframework. Whenever the Commission establishes, either on the basis of the \nreports referred to in paragraph 2, or on the basis of other \ninformation, that a third country, as regards the award of public \nservice contracts or concessions, \n\n(a) does not grant Community undertakings effective \n\naccess \ncomparable to that granted by the Community to undertakings from \nthat country, \n\n(b) does not grant Community undertakings national treatment or the \nsame competitive opportunities as available to national \nundertakings, or \n\n(c) grants undertakings from other third countries more favorable \n\ntreatment than Community undertakings, \n\nthe Commission may Initiate negotiations In order to remedy the \nsitu\u00e2t Ion. 4. Under the conditions referred to in paragraph 3, the Commission may \ndecide, In addition to action taken pursuant to that paragraph, that \nthe award of public service contracts or concessions to \n\n(a) undertakings governed by the law of the third country In \n\nquestion, \n\n(b) undertakings affiliated to the undertakings specified In (a) and \nhaving their registered office in the Community but having no \neffective and continuous link with the economy of a Member \nState, \n\n(c) undertakings submitting tenders concerning services originating \n\nIn the third country In question. - 42 -\n\nmay be suspended or restricted during a period to be determined In the \ndecision. The Commission may decide on the appropriate measures either on Its \nown Initiative or at the request of a Member State, after consulting \nthe Member States In accordance with the procedure laid down in \nArticle 36(3). Where the Commission Is asked to take action by a \nMember State, it shall take a decision within a maximum period of \nthree months of receipt of the request. It shall notify the Council and the Member States of the decisions \ntaken. Any Member State may refer the Commission's decision to the Council \nwithin a maximum period of four weeks from the date of the decision. The Council, acting by qualified majority, may take a different \ndecision within a maximum period of three months of such referral. 5. This Article Is without prejudice to the obligations of the Community \nIn relation to non-Member countries. Article 38 \n\nArticle 1(1) of Council Directive 89/665/EEC(14> is replaced by the \nfol lowing: \n\n\"1. The Member States shall take the measures necessary to ensure that, as \nregards contract award procedures falling within the scope of \nDirectives 71/305/EEC, 77/62/EEC, and. /. /EE\u00c7<15>, decisions \ntaken by the contracting authorities may be reviewed effectively and, \nin particular, as rapidly as possible in accordance with the \nconditions set out in the following Articles, and, in particular, \nArticle 2(7) on the grounds that such decisions have Infringed \nCommunity law In the field of public procurement or national rules \nimplementing that law. \" \n\nArticle 39 \n\nNot later than three years after the time limit for compliance with this \nDirective the Commission, acting in close cooperation with the Committees \nreferred to In Article 36, shall review the manner In which this Directive \nhas operated Including, In particular, the effects of the application of \nthe Directive to procurement of services listed In Annex IA and the \nprovisions concerning \nevaluate, In \nparticular, the prospects for the full application of the Directive to \nprocurement of other services listed In Annex IB, and the effects of In-\nhouse performance of services on the effective openlng-up of the market In \nthis area. It shall make the necessary proposals to adapt the Directive \naccordingly. standards. It shall \n\ntechnical \n\n(14) 0J No L 395. 30. 12. 1989. p. 33. (15) OJ No L \n\n\f- 43 -\n\nArticle 40 \n\nMember States shall implement the laws, regulations and administrative \nprovisions necessary to comply with this Directive by 1 March 1992. They \nshall forthwith Inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference \nto this Directive or shall be accompanied by such reference at the time of \ntheir official publication. The procedure for such reference shall be \nadopted by Member States. Article 41 \n\nMember States shall ensure that the texts of the basic provisions of \ndomestic law, whether laws, regulations or administrative provisions, which \nthey adopt to implement this Direct Ive, are communicated to the Commission. This Directive is addressed to the Member States. Article 42 \n\nDone at Brussels \n\nFor the Council \nThe President \n\n\f- 44 -\n\nANNEX I A \n\nServices in the sense of Article \n\nCat. No. : Subject \n\n: \n\nCPC Reference No. Maintenance and repair services \n\n6112, 6122, 633. 886 \n\n1 \n\n2 \n\n3 \n\n: Land transport services, including \narmoured car services, and courier \nservices, except transport of mail \n\n: Air transport services of passengers \nand freight, except transport of \nmail \n\n4 \n\nTransport of mail by land, except \n\n5 \n\n6 \n\n7 \n\n8 \n\n9 \n\n: rail, and by air \n\nTelecommunications services \n\n: Financial services \n\na) Insurance services \n\nb) Banking and investment services** \n\n: Computer and related services \n\n: R&D services*** \n\n: Accounting, auditing and book- \n\nkeeping services \n\n10 \n\n11 \n\n: Market research and public \nopinion polling services \nManagement consulting services \nand related services \n\n12 \n\n: Architectural services; \n\n~\" ~\" \n\nEngineering services and inte- \ngrated engineering services; \nUrban planning and landscape \narchitectural services; \nRelated scientific and tech- \nnical consulting services; \nTechnical testing and analysis \nservices \n\n13 \n\n: Advertising services \n\n14 \n\n: Building-cleaning services \n\nand property management services \n\n15 \n\n: Publishing and printing services \n\non a fee or contract basis \n\n16 \n\n: Sewage and refuse disposal; \n\nsanitation and similar services \n\n: \n\n: \n\n: \n\n: \n\n: \n\n: \n\n: \n\n: \n\n: \n: \n: \n: \n: \n: \n\n~: \n: \n\n: \n: \n: \n\n: \n\n: \n: \n\n: \n: \n\n: \n: \n\n712 (except 71235) 7512 \n87304 \n\n73 (except 7321) \n\n71235. 7321 \n\n752* \n\nex 81 \n812. 814 \n\n84 \n\n85 \n\n862 \n\n864 \n\n865. 866**** \n\n867 \n\n871 \n\n~~ \n\n874 \n82201, 82202 \n\n88442 \n\n94 \n\nexcept voice telephony, telex, radiotelephony, paging and satellite services \nexcept activities involving primary government bonds and activities involving public debt \nmanagement \nas defined in the ninth recital \nexcept arbitration and conciliation services \n\n\u2022 *\u2022 \n**\u2022* \n\n\f- 45 -\n\nANNEX I B \n\nServices in the sense of Article 10 \n\nCat. No. Subject \n\n: CPC Reference No. 17 \n\n: Hotel and restaurant services \n\n: \n\n64 \n\n18 \n\n: Transport services by rail \n\n: \n\n711 \n\n19 \n\n: Water transport services \n\n72 \n\n20 \n\n: Supporting and auxiliary transport \n\n: \n\n: services \n\n74 \n\n* \n\n' \n\n21 \n\n: Legal services \n\n: \n\n861 \n\n22 \n\n: Placement and supply services of \n\n: personnel \n: Investigation and security services \n: (except armoured car services) \n\n872 \n\n873 (except 87304 \n\n23 \n\n24 \n\n: Education and vocational educational : \n: \n: services \n\n25 \n\n: Health and social services \n\n26 \n\n: Recreational, cultural and sporting : \n: services \n\n27 \n\n: Other services \n\n92 \n\n93 \n\n96 \n\n\f- 46 -\n\nANNEX II \n\nDEFINITION OF CERTAIN TECHNICAL SPECIFICATIONS \n\nFor the purpose of this Directive the following terms shall be defined as follows: \n\n1. Technical specifications: the totality of the technical prescriptions contained in \nparticular In the tender documents, defining the characteristics required of a work, \nmaterial, product or supply, which permits a work, a material, a product or a supply to be \ndescribed in a manner such that it fulfils the use for which it is intended by the \ncontracting authority. These technical prescriptions shall include levels of quality, \nperformance, safety or dimensions, including the requirements applicable to, the material, \nthe product or to the supply as regards quality assurance, terminology, symbols, testing \nand test methods, packaging, marking or labelling. They shall also include rules relating \nto design and costing, the test, inspection and acceptances for works and methods or \ntechniques of construction and all other technical conditions which the contracting \nauthority is in a position to prescribe, under general or specific regulations, in relation \nto the finished works and to the materials or parts which they involve. 2. Standard: a technical specification approved by a recognised standardising body for \nrepeated and continuous application, compliance with which is in principle not compulsory. 3. European standard: a standard approved by the European Committee for Standardisation (CEN) \nor by the European Committee for Electrotechnlcal Standardisation (Cenelec) as \"European \nStandards (EN)\" or \"Harmonisation documents (HD)\" according to the common rules of these \norganisations or by the European Telecommunications Standards Institute (ETSI) as a \n\"European Telecommunication Standard\" (ETS). 4. European technical approval: a favourable technical assessment of the fitness for use of a \nproduct, based on fulfillment of the essential requirements for building works, by means of \nthe inherent characteristics of the product and the defined conditions of applications and \nuse. The European agreement shall be issue by an approval body designated for this purpose \nby the Member State. 5. Common technical specification: a technical specification laid down in accordance with a \nprocedure recognised by the Member States to ensure uniform application in all Member \nStates which has been published in the Official Journal of the European Communities. 6. Essential requirements: requirements regarding safety, health and certain other aspects in \n\nthe general interest, that the construction works can meet. - 47 -\n\nANNEX III \n\nModel controct notices \n\nA. Prior Information \n\n1. The name, address, telegraphic address, telephone, telex and facsimile numbers of the \nauthority, and, if different, of the service from which additional information may be \nobtained; \n\n2. Intended total procurement in each of the service categories listed in Annex IA; \n\n3. Estimated date for initiating the award procedures, per category; \n\n4. Other information; \n\n5. Date of dispatch of the notice; \n\n6. Date of receipt of the notice by the Office for Official Publications of the European \n\nCommunities \n\n\f- 48 -\n\nB. Open Procedure \n\n1. The name, address, telegraphic address, telephone, telex and facsimile numbers of the \n\nauthority; \n\n2. Category of service and description; \n\nCPC reference number; \n\n3. Place of delivery; \n\n4. (a) Indication whether the execution of the service is by law. regulation, or \n\nadministrative provision reserved to a particular profession; \n\n(b) Reference of the law, regulation or administrative provision; \n\n(c) Indication whether legal persons should indicate the names and professional \nqualifications of the staff to be responsible for the execution of the service; \n\n5. Indication whether suppliers can tender for a part of the services concerned; \n\n6. Variants \n\na) Where opplicable. minimum specifications, \n\nb) Where applicable. desirable elements; \n\n7. Duration of contract or time limit for completion of the service; \n\n8. (a) Name and address of the service from which the relevant documents may be requested: \n\n(b) Final date for making such requests: \n(c) Where applicable, the amount and terms of payment of any sum payable for such \n\ndocuments; \n\n9. (a) Persons authorised to be present at the opening of tenders: \n\n(b) Date, time and place of the opening; \n\n10. Where applicable, any deposits and guarantees required. 11. The main terms concerning financing and payment and/or references to the relevant \nprovisions. 12. Where applicable, the legal form to be taken by the grouping of suppliers winning the \ncontract. 13. Information concerning the suppliers' own position, and information and formalities \nnecessary for an appraisal of the minimum economic and technical standards required of \nthe supplier. 14. Period during which the tender is bound to keep open his tender. 15. Criteria for the award of the contract and their ranking. Criteria other than that of \nthe lowest price shall be mentioned if they do not appear in the contract documents. 16. Other information. 17. Date of dispatch of the notice. 18. Date of receipt of the notice by the Office of Official Publications of the European \nCommuni t ies. - 49 -\n\nC. Restricted Procedure \n\n1. 2. The name, address, telegraphic address, telephone, telex and facsimile number of the \nauthority; \n\nCategory of service and description; \nCPC reference number; \n\n3. Place of delivery; \n\n4. (a) Indication whether the execution of the service is by law. regulation or \n\nadministrative provision reserved to a particular profession: \n\n(b) Reference of the law, regulation or administrative provision; \n\n(c) Indication whether legal persons should indicate the names and professional \nqualifications of the staff to be responsible for the execution of the service; \n\n5. Indication of whether the supplier can tender for a part of the services concerned; \n\n6. Envisaged number of suppliers, or range, which will be invited to tender; \n\n7. Variants \n\na) Where applicable, minimum specifications. b) Where applicable, desirable elements; \n\n8. Duration of contract, or time limit for completion of the service; \n\n9. Where applicable, the legal form to be assumed by the grouping of suppliers winning the \nAcontract; \n\n10. (a) Where applicable, justification for the use of the accelerated procedure, \n(b) Final date for the receipt of requests to participate, \n(c) Address to which they must be sent, \n(d) Language(s) in which they must be drawn up; \n\n11. Final date for the dispatch of invitations to tender; \n\n12. Where applicable, any deposits and guarantees required; \n\n13. Information concerning the supplier's own position, and the information and formalities \nnecessary for an appraisal of the minimum economic and technical standards required of \nhim; \n\n14. Criteria for the award of the contract and their ranking if these are not stated in the \ninvitation to tender; \n\n15. Other information; \n\n16. Date of dispatch of the notice; \n\n17. Date of receipt of the notice by the Office for Official Publications of the European \nCommunities. - 50 -\n\nD. Negotloted Procedure \n\n1. 2. The name, address, telegraphic address, telephone, telex and facsimile number of the \nauthority; \n\nCategory of service and description; \nCPC reference number; \n\n3. Place of delivery; \n\n4. (a) Indication whether the execution of the service is by law, regulation or \n\nadministrative provision reserved to a particular profession: \n\n(b) Reference of the law, regulation or administrative provision; \n\n(c) Indication whether legal persons should indicate the names and professional \nqualifications of the staff to be responsible for the execution of the service; \n\n5. Indication of whether the supplier can tender for a part of the services concerned; \n\n6. Envisaged number of suppliers, or range, which will be invited to tender; \n\n7. Variants \n\na) Where applIcable, minimum specifications, \nb) Where applicable, desirable elements; \n\n8. Duration of contract, or time limit for completion of the service; \n\n9. Where applicable, the legal form to be assumed by the grouping of suppliers winning the \ncontract; \n\n10. (a) Where applicable, justification for the use of the accelerated procedure. (b) Final date for the receipt of requests to participate, \n(c) Address to which they must be sent, \n(d) Language(s) in which they must be drawn up; \n\n11. Where applicable, any deposits and guarantees required; \n\n12. Information concerning the supplier's own position, and the information and formalities \nnecessary for an appraisal of the minimum economic and technical standards required of \nhim; \n\n13. Where applicable, the names and addresses of suppliers already selected by the awarding \nauthority; \n\n14. Other information; \n\n15. Date of dispatch of notice; \n\n16. Date of receipt of the notice by the Office for Official Publications of the European \nCommunities; \n\n17. Date(s) of previous publications in the Official Journal of the European Communities. - 51 -\n\nE. Controct Awords \n\n1. Name and address of the authority; \n\n2. Award procedure chosen; in case of negotiated procedure without prior publication of a \ntender notice, justification (Article 13(3)); \nCPC reference number; \n\n3. Category of service and description; \n\n4. Date of award of contract; \n\n5. Criteria for award of contract; \n\n6. Number of tenders received; \n\n7. Name and address of supplier(s); \n\n8. Price or range of prices (minimum/maximum) paid; \n\n9. Where appropriate, value and proportion of contract likely to be subcontracted to third \nparties; \n\n10. Other information; \n\n11. Date of publication of the tender notice in the Official Journal of the European \nCommunities; \n\n12. Date of dispatch of the notice; \n\n13. Date of receipt of the notice by the Office for Official Publications of the European \nCommunities; \n\n14. In the case of contracts for services listed in Annex IB, agreement, by the contracting \nauthority, on publication of the notice (Article 18(3)). - 52 -\n\nANNEX IV \n\nDesign Contest Notices \n\nThe name, address, telegraphic address, telephone, telex and facsimile numbers of the \nauthority and of the service from which the relevant documents may be obtained; \n\nProject description; \n\nNature of the contest: open or restricted; \n\nIn the case of open contests: final date for receipt of projects; \n\nIn the case of restricted contests: \n\na) the envisaged number of participants, or range; \nb) where applicable, names of already selected participants; \nc) the criteria to be applied in the selection of participants; \nd) final date for receipt of requests to participate; \n\nWhere applicable, indication whether participation is reserved to a particular profession; \n\nThe criteria to be applied in the evaluation of projects; \n\nWhere applicable, names of selected members of the jury; \n\nIndication whether the decision of the jury is binding for the authority; \n\nWhere applicable, the number and value of the prizes to be awarded; \n\nWhere applicable, details on payments to all participants; \n\nIndication whether the prize-winners are entitled to be awarded any follow-up contracts; \n\nOther information; \n\nDate of dispatch of the notice. Date of receipt of the notice by the office for Official Publications of the European \nCommunities. B. Results of Design contests \n\nThe name, address, telegraphic address, telephone, telex and facsimile numbers of the \nauthority; \n\nProject description; \n\nTotal number of participants; \n\nNumber of foreign participants; \n\nWinner(s) of the contest; \n\nWhere applicable, the prize(s); \n\nOther information; \n\nReference of the design contest notice; \n\nDate of dispatch of the notice; \n\n1. 2. 3. 4. 5. 6. 7. 8. 9. 10 \n\n11 \n\n12 \n\n13 \n\n14 \n\n15 \n\n1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Date of receipt of the notice by the Office for Official Publications of the European \nCommunities. - 53 -\n\nANNEX V \n\nA. Model Notice on Public Service Concessions \n\n1. The name, address, telegraphic address, telephone, telex and facsimile numbers of the \n\nauthority; \n\n2. (a) The place of delivery: \n\n(b) The subject of the concession, nature and extent of the services to be provided: \n(c) Duration of contract; \n\n3. (a) Final date for receipt of candidatures: \n(b) The address to which they must be sent: \n(c) The language or languages in which they must be drawn up; \n\n4. Personal, technical and financial conditions to be fulfilled by the candidates; \n\n5. The criteria for the award of the contract; \n\n6. Where applicable, the minimum percentage of the total value of the concession contract to \n\nbe awarded to third parties; \n\n7. Other information; \n\n8. Date of dispatch of the notice; \n\nB. Concession awards \n\n1. The name, address, telegraphic address, telephone, telex and facsimile numbers of the \n\nauthority; \n\n2. The subject of the concession, nature and extent of the services to be provided; \n\n3. Date of award of the concession; \n\n4. Number of tenders received; \n\n5. Name and address of the concessionnaire; \n\n6. Other information; \n\n7. Date of publication of the tender notice in the Official Journal of the European \n\nCommunities; \n\n8. Date of dispatch of the notice; \n\n9. Date of receipt of the notice by the Office for Official Publications of the European \n\nCommunities; \n\n\fISSN 0254-1475 \n\nCOM(91) 322 final \n\nDOCUMENTS \n\nEN \n\n06 08 \n\nCatalogue number : CB-CO-91-363-EN-C \n\nISBN 92-77-75071-5 \n\nOffice for Official Publications of the European Communities \n1^2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/6ff6e16c-9cee-421f-acda-55af94bd317f", "title": "Bulletin of the European Communities. No 6/1991, Volume 24.", "langIdentifier": "ENG", "mtypes": "pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#publication_general,http://publications.europa.eu/ontology/cdm#work", "authors": "Secretariat-General", "date": "1991-08-30", "subjects": "ECSC,EU activity,EU competition policy,EU energy policy,EU policy,EU publication,EU regional policy,EU research policy,Economic and Monetary Union,European Community,European social policy,common agricultural policy,common fisheries policy,common strategy,common transport policy,competition policy,deepening of the European Union,enlargement of the Union,international relations", "workIds": "genpub:PUB_CMAA91006", "eurovoc_concepts": ["ECSC", "EU activity", "EU competition policy", "EU energy policy", "EU policy", "EU publication", "EU regional policy", "EU research policy", "Economic and Monetary Union", "European Community", "European social policy", "common agricultural policy", "common fisheries policy", "common strategy", "common transport policy", "competition policy", "deepening of the European Union", "enlargement of the Union", "international relations"], "url": "http://publications.europa.eu/resource/cellar/6ff6e16c-9cee-421f-acda-55af94bd317f", "lang": "eng", "formats": ["pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/806d2f3a-57cc-4a37-aaf5-b4f39f6d0eb6", "title": "Commission Regulation (EEC) No 2606/91 of 29 August 1991 fixing, for unginned cotton, the actual production for the 1990/91 marketing year and the estimated production, the adjustment in the maximum guaranteed quantity and the reduction in the aid for the 1991/92 marketing year", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-29", "subjects": "cotton,production aid", "workIds": "celex:31991R2606,oj:JOL_1991_243_R_0053_056", "eurovoc_concepts": ["cotton", "production aid"], "url": "http://publications.europa.eu/resource/cellar/806d2f3a-57cc-4a37-aaf5-b4f39f6d0eb6", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/d25466f5-2a7b-40c2-910d-160818421f87", "title": "Proposal for a COUNCIL REGULATION ( EEC ) establishing a support system for soya beans, rape-seed and sunflower-seed", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-29", "subjects": "EU aid,area of holding,regional aid,soya bean,sunflower", "workIds": "celex:51991PC0318,comnat:COM_1991_0318_FIN,oj:JOC_1991_255_R_0008_01", "eurovoc_concepts": ["EU aid", "area of holding", "regional aid", "soya bean", "sunflower"], "url": "http://publications.europa.eu/resource/cellar/d25466f5-2a7b-40c2-910d-160818421f87", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OP THE EUROPEAN COMMUNITIES \n\nC0M(91) 318 final \n\nBrussels, 31 July 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\nestablishing a support system for soya beans, \n\nrapaseed and sunflowerseed \n\n(presented by the Commission) \n\n\f\fEXPLANATORY MEMORANDUM \n\nSubject : Future Support for Producers of Oilseeds \n\nA. Introduction \n\n1. In the communication of the Commission to the Council (COM[91]100 of 1 \nFebruary 1991) and the follow-up document (C0M[91]258) of 11 July 1991), \nthe Commission set out its reflections on the present state of the \nCommon Agricultural Policy, why it needed fundamental change and the \ndirection of change. 2. The Commission concluded that existing price guarantees, through their \ndirect link to production, provide no solution to the problems of farm \nincomes generally and were insensitive to the dual role of farmers as \nproviders of primary products and managers of the countryside. In \nparticular, \nprices with \nadvocates \nsubstantial compensation for farmers in the form of a system of direct \npayments. the Commission \n\nlower market \n\n3. In the particular case of oilseeds, the Community has accepted the \nconclusions of a GATT Panel, colloquially known as the Soya Panel; the \ntext of the Conclusions (in English) are reproduced in Annex I. In \nits support \nconsequence, the Community has undertaken to adapt \narrangements for oilseeds in order to bring the relevant Regulations \nInto conformity with the General Agreement. 4. As part of the deliberations on the 1991/92 proposals on prices and \nrelated measures, the Commission undertook to table proposals to reform \nthe support arrangements for oilseeds by 31 July 1991, while the Council \npledged that it would take the necessary decisions by 31 October 1991. This document fulfills the undertaking given by the Commission. - 2 -\n\n5. The Commission has recently tabled its proposals for \"The Development \nand Future of the Common Agricultural Policy\" (C0M[91]258) of 11 July \n1991). The relevant proposals for oilseeds are set out on pages 9 to 11, \nnotably: \n\n\". support for oilseeds. will be provided fully in the form of a \nstandardized compensatory payment system with per hectare aids paid \ntraditional \ndirect \ninstitutional prices will be redundant and will no longer apply. In this context, \n\nthe producer. the \n\nto \n\nA reference price for the world market will be established for the \npurpose of calculation of the compensatory amounts. In line with the requirements of the reformed market organization, \nnew market management instruments will be developed by the Commission \nto facilitate the orderly marketing of each crop \n\nThe current Maximum Guaranteed Quantities and their associated \nstabilizer mechanisms are based on the traditional system of \ninstitutional prices. These mechanisms will expire with the full \nimplementation of the new common market organization. \" \n\nVegetable pi is \n\n6. The European Community is a major importer of vegetable oils (measured \nin terms of oils and oilbearing seeds for the production of oil) \nimporting (nett) 40% of its requirements, 48% if one excludes olive oil \nfrom the balance. Some imports of vegetable oils are subject to an ad \nvalorem duty of 10%. QiImeals \n\n7. The compound feed industry of the European Community is a major user of \noilmeals. The demand for oilmeals, notably soyameal has continued to \ngrow as graphic number 1 illustrates. Suffice to say that out of an \nestimated demand of over 30 Mio t, imports account for over 75%; and \nthat mostly soya. Imports of oiimeals are duty free. Q\u00bbI seeds \n\n8. The Community support system for the producers of oilseeds has hitherto \nbeen based on the principle of supporting the price for oilseeds \nharvested in the Community and applied to each tonne of produce \nmarketed. However, for administrative convenience this support has been \nchannelled through the hands of a limited number of operators, notably \nprocessors or first buyers, rather than directly to producers. - 3 -\n\nWhile oilseeds have always been grown in Western Europe, a substantial \nincrease in plantings occurred from 1984 and onwards as graphics 2, 3 \nand 4 illustrate. The increased interest In cultivating these crops \ncoincided with improved varieties and cultivation techniques leading to \nhigher yields. The rate of expansion was sharply curtailed by the \nimplementation of the current stabilizer arrangements from the beginning \nof the 1988/89 marketing year, which has led to sharp reductions in \nsupport per tonne (for 1990/91: Rapeseed Intervention Buying In Price \n-18%, Sunflower Seed Intervention Buying In Price -24%, Soyabeans \nMinimum Price - 3 4 % ). The historical development is shown in graphic 5. B. The content of the proposal (see also attached draft regulation) \n\n1. This proposal is a measure implementing a \"compensatory payment system \nwith per hectare aids paid direct to the producer. \" This proposal would \nhave the advantage of providing a more stable income to producers, \nlargely independent of the volume of oilseeds which they harvest in a \nparticular year. On the one hand, the compensatory payment will only \ncompensate partially for the movements in world market prices. On the \nother hand, these proposals offer producers more stable receipts. 2. This proposal applies to Oilseeds (defined for the purposes of this \nregime as Rapeseed, Sunflower Seed and Soyabeans) harvested after 30 \nJune 1992. Because of the residual rights of those holding old stocks \n(farmers, merchants, traders, industrialists, public authorities) the \ncurrent legislative arrangements will be cancelled at a later date once \nthey are completely redundant. Any operator wishing to benefit from the \ncontinued application of the present provisions will be obliged to \nprove that the merchandise in question was harvested prior to the \nbeginning of the 1992/93 marketing year notably by meeting the current \n\"identification\" conditions. Mechanism to establish the direct aid scheme of compensatory payments \n\n3. The objective is to provide an aid for oilseeds which as between \noilseeds and cereals does not provide a particular incentive to opt for \none crop rather than another. To achieve this objective, it has been \ncalculated, requires a price relationship of 2. 1:1. The \"compensatory \npayment system\" will be based on a regionalized system of per hectare \naids, paid directly to the producers. 4. In order to calculate the aid, it is necessary to prescribe a Projected \nReference Price (currently announced as 163 Ecu/t) defined as the \nexpected medium term equilibrium price for oilseeds (notably soyabeans) \non a stabilized world market. This represents the approximate price \nwhich a producer might expect to receive for his produce. 5. Since the objective is to not provide a particular incentive to opt for \none crop as opposed to another, producers will require a compensatory \npayment (per hectare) in order to maintain their incomes. It has been \ncalculated that based on the EC average yield for cereals (4. 6 t/ha) and \noilseeds (2. 36 t/ha) the Community Reference Amount for oilseeds should \nbe set at 384 Ecu/ha taking account of the Projected Reference Price \n(see below). - 5 \n\n6. Because of the substantial regional variations which exist, the aid \nshould be regionalized in order to reduce the risk of systematic over-\nor under-compensation of producers. Since a strong correlation exists \nbetween the yields of cereals and oilseeds in various regions, it is \nproposed to correct the Community Reference Amount for oilseeds \naccording to the regional yield for cereals (compared with the Community \naverage), i. e. if the regional yield for cereals is double the Community \naverage, oilseeds producers in that region would receive double the \nCommunity Reference Amount per hectare; if the cereals yield was half, \nthey would receive half the Community Reference Amount. 7. The regionalization plan: \n\n- for the purposes of establishing the aid to be paid per hectare, each \nMember State will draw up a regionalization(*) plan for its territory \nwhich must be submitted to the Commission; each Member State should \nsubmit this plan and the criteria upon which the regions are based \nbefore 15 November 1991. - Member States shall submit all relevant supporting information to the \n\nCommission notably statistics of area, production and yield; \n\n- each region(*) must be of a minimum size, for which a historical three \nyear average cereals yield (and if possible oilseed yields including \nwhere appropriate for each individual oilseed) will be calculated. This should be based on the average of three of the last five \nmarketing years (1986/87 to 1990/91) i. e. after eliminating the lowest \nand the highest figure. This regional average yield will be the basis \nfor translating the Community compensatory payment into a personalized \npayment ; \n\n- the regionalization plan may be revised. - the Commission will verify that the regionalization programmes are \nconsistent with the historical references for each Member State and \nthe Community, notably the average yields for cereals (EC average 4. 6 \ntonnes/hectare) and oilseeds (EC average 2. 36 tonnes/hectare). (*) The term 'region\" is intended to provide the necessary flexibility for the \nrecognition of distinctive homogeneous zones and allow for specific \nstructural characteristics that influence yields (e. g. soil fertility). - 6 -\n\nThe aid calculation \n\n8. The Commission aid calculation is made in two stages: \n\n- a provisional calculation made on the basis of the Projected Reference \n\nPrice (currently announced as 163 Ecu/t); \n\n- a final calculation (made about half way through the marketing year) \n\nmade on the basis of the Observed Reference Price. 9. The provisional calculation leads to a provisional aid (per hectare) \n\nwhich will be regionalized according to the regionalization plans. 10. The final calculation (made by the Commission about half way through the \n\nmarketing year) will also be regionalized. 11. However, when making the final calculation, the Commission shall not \ntake account of price variations within 8% of the Projected Reference \nPrice. Exceptionally, notably for the first year, the Commission may \nmake the final calculation separately for each oilseed, in order to \navoid favouring one oilseed rather than another and to take account of \nthe possible application of the Maximum Guaranteed Area system. Payments \n\n12. The aid for oilseeds will be paid in two parts. The first part may be \npaid after the crop has been planted but before it is harvested, \nprovided that the grower is the holder of an appropriate cultivation \ncontract from an approved first buyer ox if the grower has already \ndeposited a precise cultivation plan with the relevant national \norganization. Following the final calculation, the second part of the \naid will be payable during the second part of the marketing year (see \nparagraph 11). 13. No aid shall be payable for any application lodged after the 30 April \npreceding the marketing year, by which time the seed must have been \nplanted, i. e. no payments will be made for catch-cropping. However, \nshould exceptional weather conditions delay planting of Spring sown \noilseeds, notably rapeseed, this date may be varied for specific \nreasons. 14. Payments may be enhanced a manner conducive to orderly marketing. In \nparticular a bonus will be paid to producers who can demonstrate that \nthey delayed selling their crop. For illustrative purposes this has been \ncalculated as an average 10 Ecu/ha for a 3 month delay or 20 Ecu/ha for \na 6 month delay. 7 -\n\n15. Payments will be financed by FEOGA Guarantee. 16. To ensure that the system is implemented as intended, payments should be \nmade within 90 days of the date when entitlement is established. If this \ntimetable is not respected, the total amount due will no longer be \neligible for reimbursement by FEOGA Guarantee. Other provisions (transitional arrangements) \n\nSpain and Portugal \n\n17. Until the end of the transitional period foreseen by the Treaty of \nAccession, producers of Sunflower Seed in these countries will continue \nto benefit from a separate calculation. This will be made in the form \nof a standard bonus, calculated annually by the Commission to reflect \nthe differential foreseen in current legislation. Maximum Guaranteed Area \n\nfor producers of crops (proposed by the Commission \n\n18. Temporarily, pending the application of the integrated approach to \nsupport \nin \nC0M[91]258), an analogous stabilizer based on area planted will apply; \ninstead of the existing stabilizer arrangements which are related to \nquantities. However, since the system is intended as a budgetary safety \nnet, the Maximum Guaranteed Area is set at the current level of \nplantings except for producers of sunflower seed in Spain and Portugal \nwho will continue to be subject to a separate quarantee threshold. In \naddition, aid will only be paid on land previously cultivated (i. e. areas not cultivated with arable crops during the reference years \n(1989/90 to 1990/91), with the exception of an area that has been set \naside in previous years under publicly funded setaside arrangements, \nwill not be eligible for aid). Oilseed Rape - Quality Policy \n\n19. Access to the aid for growers of oilseed rape will in future be \nrestricted to those using certified seed (from the national list) which \nhas been demonstrated to normally produce a harvest of less than \n25 fM moles of glucosinolates. This standard may be reinforced over time \nin the light of scientific progress and market developments. 8 -\n\n20. Since growers may already have committed themselves to planting other \nseed in 1991, exceptionally for the first marketing year (1992/93) other \nseed may be tolerated, subject to appropriate checks being made. 21. In such circumstances, the aid will only be paid after completion of \n\nsuch checks. 22. The same provisions are made in order to continue to support the \ncultivation of HEAR, rapeseed varieties rich in erucic acid, grown under \ncontract for industrial purposes. Other \n\n23. The new support arrangements will require additional administrative \nmechanisms and in particular new control procedures. These subjects will \nbe examined in depth by the services of the Commission, in conjunction \nwith the representatives of national administrations, on the basis of \nthe experience developed in the light of R/2069/91/EC (the detailed \nrules for the temporary fallowing scheme approved in 1991). 24. The Commission will continue to be aided by the Management Committee on \n\n'0iIs and Fats'. 9 -\n\nANNEX \n\nCONCLUSIONS (of the GATT Panel) \n\n155. The panel found that the Community Regulations providing for \npayments to seed processors conditional on the purchase of oilseeds \noriginating in the Community are inconsistent with Article III-. 4 of the \nGeneral Agreement, according to which imported products shall be given \ntreatment no less favourable than that accorded to like domestic \nproducts \ninternal \nin respect of all regulations affecting their \npurchase. The Panel recommends that the CONTRACTING PARTIES request the \nCommunity to bring these Regulations into conformity with the General \nAgreement. 156. The Panel further found that benefits accruing to the United States \nunder Article II of the General Agreement in respect of the zero tariff \nbindings for oilseeds in the Community Schedule of Concessions were \nimpaired as a result of the introduction of production subsidy schemes \nwhich operate to protect Community producers of oilseeds completely from \nthe movement of prices of imports and thereby prevent the tariff \nconcessions from having any impact on the competitive relationship \nbetween domestic and imported oilseeds. The Panel recommends that the \nCONTRACTING PARTIES suggest that the Community consider ways and means \nto eliminate the impairment of its tariff concessions for oilseeds. 157. The Panel finally considered that, as the inconsistency with \nArticle lll:4 and the impairment of the tariff concessions arise from \nthe same Community Regulations, a modification of these Regulations in \nthe light of Article lll:4 could also eliminate the impairment of the \ntariff concessions. The Panel therefore recommends that the CONTRACTING \nPARTIES take no further action under Article XXI I 1:2 in relation to the \nimpairment of the tariff concessions until the Community has had a \nreasonable opportunity to adjust its Regulations to conform to Article \nI I 1:4. EC - IMPORTS of Soya \n\nGRAPH 1 \n\n25ooo \n\n20000 \n\n15oooh \n\n10oooh \n\n5ooo h \n\n0 \n\n1966 \n\n\fSoya- Eur12 \n\nGRAPH 2 \n\n2500 \n\n2000 h \n\n1500 h \n\n1000 h \n\n500 h \n\n\fRapeseed - EurlO \n\nGRAPH 3 \n\n1981 \n\n82 \n\n83 \n\n84 \n\n85 \n\n86 \n\n87 \n\n88 \n\n89 \n\n1990 \n\n\f3500 \n\nSunflower- EurlO \n\nGRAPH 4 \n\n\fCEE - Graines Ol\u00e9agineuses \nPrix de Soutien Effectifs (1) \n\nECU/100 Kg \n55 \n\nGRAPH 5 \n\n50 h \n\n45 \n\n40 h \n\n35 \n\n30 \n\n1980/81 \n\n8 1 / 82 \n\n8 2 / 83 \n\n8 3 / 84 \n\n8 4 / 85 \n\n1985/86 \n\n8 6 / 87 \n\n8 7 / 88 \n\n8 8 / 89 \n\n89/90 1990/91 \n\nCAMPAGNES DE COMMERCIALISATION \n\n(1) -Colza et tournesol : prix \"d'achat \u00e0 l'Intervention\" (\u00e0 partir de la campggne 1987/88) \n\nincluant \u00e9galement les abattements QMG. -Soja : prix minimal, tenant compte des abattements QMG. 1 -\n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\nestablishing a support system for soya beans, \n\nrapeseed and sunflowerseed \n\nTHE COUNCIL OF THE EUROPEAN ECONOMIC COMMUNITY, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular Articles 42 and 43 thereof, \n\nHaving regard to the proposai from the Commission, \n\nHaving regard to the Opinion of the European Parliament, \n\nWhereas a new support system for the producers of soya beans, rapeseed \n\nand sunflowerseed harvested within the Community, \n\nhas to be \n\nestablished; whereas the best way to achieve this objective is to \n\nprovide tor a compensatory payment for producers who sow and intend to \n\nharvest such products; whereas this system shall be applied with effect \n\nfrom those plantings intended for harvest in 1992 thereby superseding \n\nthe provisions relating to oilseeds aids contained \n\nin Council \n\nRegulation 136/66/EEC and Council Regulation (EEC) 1491/85; \n\nWhereas such compensatory payments should reflect the specific \n\nstructural characteristics that influence yields and that the drawing \n\nup of a regionalization plan based on objective criteria should be left \n\nto the Member States; whereas the regionalization plans must be \n\nconsistent with the average yields of each region achieved in a given \n\nperiod; whereas a specific procedure should be provided in order to \n\nexamine these plans on the Community level; \n\nWhereas in order to calculate a compensatory payment it is necessary to \n\nestablish a Projected Reference Price, a Community Reference Amount, \n\nthe calculation method and appropriate corrective measures; \n\n\f_ 2 -\n\nWhereas it is necessary to specify when producers shall be paid; \n\nWhereas rules must be established in order to take into account the \n\nspecific situation in Spain and Portugal; \n\nWhereas as long as an integrated approach to support for the producers \n\nof arable crops as proposed by the Commission is not in application, it \n\nseems appropriate to ensure a system of Maximum Guaranteed Areas; \n\nWhereas a quality policy for rapeseed is required; \n\nWhereas the Member States should enact appropriate measures in order to \n\nensure the respect of Community legislation concerning oilseeds; \n\nWhereas it is necessary to provide for transitional measures, in \n\nparticular to preserve the acquired rights of operators holding stocks \n\nof oilseeds on 30 June 1992 as foreseen by the Treaty of Accession; \n\nHAS ADOPTED THIS REGULATION ; \n\nArticle 1 \n\n1. This regulation hereby establishes a support system for producers \n\nof soya beans, rapeseed and sunflowerseed. 2. This system shall be applied with effect from those plantings \n\nintended for harvest in 1992 thereby superseding the provisions \n\nrelating to oilseeds aids contained \n\nin Council \n\nRegulation \n\n136/66/EEC and Council Regulation (EEC) 1491/85. 3. The marketing year for the products listed in paragraph 1 shall run \n\nfrom 1 July to 30 June. - 3 ~ \n\nArt icle 2 \n\n1. Producers established in the Community who sow and intend to \n\nharvest the products listed in Article 1 shall be entitled to apply \n\nfor a compensatory payment. The compensatory payment shall be paid \n\ndirectly to the producer who makes the application, provided that \n\nentitlement to the payment is recognized by the Member State on \n\nwhose territory the production holding is located. 2. In order to qualify for payment of the compensatory aid, a producer \n\nmust, by, at the latest the 30 April preceding the marketing year \n\nin which the product is to be harvested; \n\n- have sown the seed \n\n- have lodged an application in accordance with Article 5 \n\nparagraph 3. 3. The application must be accompanied by the references enabling the \n\nplanted area to be identified. Applications may only be made in \n\nrespect of arable land cultivated during the period 1989/90 -\n\n1990/91, including land fallowed in conformity with a publicly \n\nfunded scheme. Article 3 \n\nEach Member State shall establish a regionalization plan setting \n\nout the criteria for the establishment of separate production \n\nregions. The criteria used must be appropriate, objective and \n\nprovide \n\nthe \n\nnecessary \n\nflexibility \n\nfor \n\nthe \n\nrecognition \n\nof \n\ndistinctive homogenous zones of a minimum size and allow for \n\nspecific structural characteristics that influence yields such as \n\nsoil fertility. - 4 \n\n2. For each production region, the Member State shall give details of \n\nthe areas and yields of cereals and oilseeds produced in that \n\nregion during the five year period 1986/87 - 1990/91. An average \n\ncereals yield shall be calculated for each region by excluding the \n\nyear with the highest and the year with the lowest yield during \n\nthat period. 3. Member States shall submit their regionalization plan to the \n\nCommission by 15 November 1991 together with all available \n\nsupporting information. 4. The Commission shall examine the regionalization plans submitted by \n\nthe Member States and shall ensure that each plan is based on \n\nappropriate, objective criteria and is consistent with available \n\nhistorical information, notably the Community average yield for \n\ncereals (4. 6 tonnes/hectare) and oilseeds (2. 36 tonnes/hectare). Plans which are not in conformity or not compatible with the \n\naverage yield shall be subject to adjustment by the Member State \n\nconcerned after consultation with the Commission. 5. The regionalization plan may be revised by the Member State \n\nconcerned at the request of the Commission in accordance with the \n\nsame procedure as outlined in the preceding paragraphs. Article 4 \n\n1. A Projected Reference Price for oilseeds is set at 163 Ecu/tonne. 2. A Community Reference Amount \n\nfor oilseeds is set at 384 \n\nEcu/hectare. 3. For each region identified under Article 3, a Projected Regional \n\nReference Amount shall be established by the Commission which \n\nreflects the comparison between the cereals yield for that region \n\nand \n\nthe \n\naverage \n\ncereals \n\nyield \n\nfor \n\nthe \n\nCommunity \n\n(4. 6 \n\ntonnes/hectare). 5 -\n\n4. Before 30 January in each marketing year the Commission, in \n\naccordance with the procedure laid down in Article 38 of Regulation \n\n136/66/EEC, shall calculate a Final Regional Reference Amount based \n\non the Observed Reference Price for oilseeds. This Final \n\ncalculation shall be made by substituting the Observed Reference \n\nPrice for the Projected Reference Price; no account shall be taken \n\nof price variations within 8% of the Projected Reference Price. 5. Exceptionally, notably for the 1992/93 marketing year, the \n\nCommission may make the final calculations separately for each \n\noilseed in order to avoid favouring one oilseed rather than another \n\nand to take account of the possible application of Article 7. 6. The Commission shall publish the aforementioned amounts in the \n\nOfficial \n\nJournal. The publication shall \n\ninclude a succinct \n\nexplanation of the calculations made. Article 5 \n\n1. The Final Regional Reference Amount shall be payable provided that \n\nproof is supplied that the crop has been harvested. 2. Those producers who lodge a contract or a plan in accordance with \n\nArticle 2 shall be entitled to an advance payment of no more than \n\n50% of the Provisional Regional Reference Amount. Member States \n\nshall carry out the necessary checks to ensure entitlement to the \n\nadvance is Justified. 3. In order to qualify for an advance payment a producer must have \n\nlodged with the competent agency of the Member State by 30 April at \n\nthe latest \n\neither, \n\n- a contract with an approved first buyer for the cultivation of \n\noi I seeds, \n\nor, \n\n- a detailed cultivation plan for his holding showing the land to \n\nbe used for cultivating oilseeds. 6 -\n\nWhere an advance has been made a balance shall be paid equal to the \n\ndifference, if any, between the amount of the advance and the Final \n\nRegional Reference Amount subject to proof of harvesting being \n\nprovided. Where a producer demonstrates that he has retained ownership of the \n\nproduct for a period to be determined, an orderly marketing bonus \n\nmay be payable. The amount of the bonus and the conditions \n\ndetermining eligibility shall be set by the Commission in \n\naccordance with the procedure referred to in Article 38 of \n\n136/66/EEC. Payment shall be made by the Member State to each eligible producer \n\nwithin a period of 90 days after publication of the amounts \n\n(advances and final payments) in the Official Journal. Where a \n\nMember State fails to comply with this provision it shall be \n\nobliged to pay the amount without reimbursement from the EAGGF. Article 6 \n\nUntil the end of the 1994/95 marketing year, a standard bonus for \n\nsunflowerseed cultivation will be payable in Spain and Portugal. These amounts, which are in addition to the compensatory payment, \n\nwill be calculated by the Commission annually for Spain and \n\nPortugal \n\nto reflect \n\nthe differential \n\nforeseen \n\nin current \n\nlegislation. The amounts will be subject \n\nto the possible \n\napplication of Article 7. - 7 -\n\nArticle 7 \n\n1. For the 1992/93 marketing year, a system of Maximum Guaranteed \n\nAreas shall apply for payments. The Maximum Guaranteed Areas shall \n\nbe : \n\nSoya beans \n\nEC12 \n\nRapeseed \n\nEC12 \n\nSunflowerseed \n\nSpain \n\nPortugal \n\n509,000 hectares, \n\n2,377,000 hectares, \n\n1,411,000 hectares \n\n122,000 hectares \n\nThe rest of the Community \n\n1,202,000 hectares \n\n2. if the area planted to an oilseed exceeds the Maximum Guaranteed \n\nArea then the relevant compensatory aids will be reduced by 1% for \n\neach 1% overshoot. The relevant compensatory aids will be reduced \n\nby the Commission when the Final Regional Representative Amounts \n\nare calculated. Article 8 \n\nAccess to the compensatory payment for growers of oilseed rape is \n\nrestricted to those using certified seed from the national list. The Commission, in accordance with the procedure laid down in \n\nArticle 38 of 136/66/EEC, may specify that certain varieties of \n\nrapeseed included in the national list are ineligible for aid. - 8 -\n\nArticle 9 \n\nThe determination of the amounts, the rules governing the payment \n\nof the compensatory aid, including the determination of the minimum \n\nsize of a region and \n\nthe other \n\ndetailed \n\nrules for \n\nthe \n\nimplementation of this Regulation shall be decided on by the \n\nCommission in accordance with the procedure laid down in Article 38 \n\nof Council Regulation 136/66/EEC. Article 10 \n\n1. Member States shall take all action necessary to ensure that the \n\nprovisions of this Regulation are fully respected. 2. Detailed rules for the application of this Regulation shall be \n\nadopted in accordance with the procedure laid down in Article 38 of \n\nRegulation 136/66/EEC, and in particular : \n\nthose relating to the minimum area to be cultivated; such rules \n\nshall take particular account of the monitoring requirements \n\nand of the sought-after effectiveness of the scheme in \n\nquest ion, \n\nthose relating to monitoring; such rules shall include, inter \n\nalia, the use of means of remote sensing and/or plausibility \n\nmonitoring on the basis of binding official documents that are \n\nalready available in the national administrations, \n\nthe date of 30 April referred to in Article 2 paragraph 2 and \n\nArticle 5 paragraph 3 may be varied for specific regions to \n\ntake account of exceptional circumstances. - 9 -\n\nArticle 11 \n\n1. The provisions of Council Regulation (EEC) No 1491/85 and the \n\nrelated provisions in the regulations in force on 30 June 1992 \n\nshall continue to apply after that date to soya beans harvested in \n\nthe Community and identified by 30 June 1992. 2. The provisions of Council Regulation No 136/66/EEC and the related \n\nprovisions in the regulations in force on 30 June 1992 shall \n\ncontinue to apply after that date to rapeseed and sunflowerseed \n\nharvested in the Community and identified by 30 June 1992. 3. The relevant provisions relating to the Community support system \n\nfor the products mentioned in paragraphs 1 and 2 above shall remain \n\napplicable until the products in question are no longer eligible \n\nfor Community \n\nsupport. Transitional \n\nmeasures necessary to \n\nfacilitate the disposal or orderly marketing of the products \n\nmentioned in paragraphs 1 and 2 of this article shall be adopted in \n\naccordance with the procedure laid down in Article 38 of Regulation \n\n136/66/EEC. 4. Regulation 136/66/EEC and Regulation (EEC) No 1491/85 as well as \n\nthe implementing rules thereof shall remain in force in so far as \n\nthey are compatible with the provisions of this Regulation. Article 12 \n\nShould additional or transitional measures be necessary to facilitate \n\nthe transition from the system in force to that established by this \n\nRegulation, in particular if the introduction of this system would give \n\nrise to substantial difficulties in respect of certain products such \n\nmeasures shall be adopted in accordance with the procedure laid down in \n\nArticle 38 of Regulation 136/66/EEC. - 10 -\n\nArticle 13 \n\nThe present regulation shall enter onto force on the third day after \n\nits publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly \n\napplicable in ail Member States. Done at Brussels \n\nFor the Council \n\n\fFICHE FINANCIERE \n\n(RS/91/FF/003) \n\nDATE \n\n29. 07. 1991 \n\n1. LIGNE BUDGETAIRE : Articles 125 et 127 et Postes 1260, \n1261 et 1262 \n\nCREDITS : 3. 721 Mio ECU \n\n2. INTITULE DE LA MESURE : \n\nR\u00e8glement du Conseil \u00e9tablissant un r\u00e9gime de soutien pour les graines de soja, de \ncolza et de tournesol. 3. BASE JURIDIQUE : Articles 42 et 43 du Trait\u00e9 \n\n4. OBJECTIFS DE LA MESURE : \n\nEtablir un nouveau r\u00e9gime de soutien aux producteurs de \ngraines ol\u00e9agineuses sur la base de paiements compensatoires directs. 5. INCIDENCES FINANCIERES \n\n5. 0 DEPENSES A LA CHARGE \n\n- DU BUDGET DES CE \n\nPERIODE DE \n12 MOIS \n\nEXERCICE EN \nCOURS (91) \n\nEXERCICE \nSUIVANT (92) \n\n(REST ITUT IONS/1NTERVENTIONS) \n\n- 1. 091 Mio ECU \n\n- DES BUDGETS NATIONAUX \n- D'AUTRES SECTEURS \n\np. m. 5. 1 RECETTES \n\n- RESSOURCES PROPRES DES CE \n\n(PRELEVEMENTS/DROITS DE DOUANE) \n\n- SUR LE PLAN NATIONAL \n\n1993 \n\n1994 \n\n1995 \n\n1996 \n\n5. 0. 1 PREVISIONS DES DEPENSES \n5. 1. 1 PREVISIONS DES RECETTES \n\n- 403/-1. 091 \n\n5. 2 MODE DE CALCUL \n\nVoir annexe. 6. 0 FINANCEMENT POSSIBLE PAR CREDITS INSCRITS AU CHAPITRE CONCERNE DU BUDGET \n\nEN COURS D'EXECUTION \n\n6. 1 FINANCEMENT POSSIBLE PAR VIREMENT ENTRE CHAPITRES DU BUDGET EN COURS \n\nD'EXECUTION \n\n6. 2 NECESSITE D'UN BUDGET SUPPLEMENTAIRE \n\n6. 3 CREDITS A INSCRIRE DANS LES BUDGETS FUTURS \n\nOBSERVATIONS \n\nOU I/NON \n\nOU I/NON \n\nOUI/NON \n\nOU I/NON \n\n\fVl-G-1 \n\nANNEXE A LA FICHE FINANCIERE \n\nI. CALCUL DES DEPENSES \n\nAides \n\nPays \n\nSurface \nestIm\u00e9e \n\nRendement \nc\u00e9r\u00e9ales \n\nAide \nol\u00e9agineux \n\nD\u00e9penses \n\nDT \n\nD\u00e9penses \n\n1000 ha \n\nt/ha \n\nECU (A)/ha \n\nMio ECU \n(A) \n\nMio ECU \n(B) \n\na \n\nb \n\nc \n\nd- 2M x c \n4,6 \n\ne - b x d \n\nf \n\nBelgique \nDanemark \nAllemagne \nEx DDR \nGr\u00e8ce \nEspagne \nFrance \nIrlande \nItal le \nLuxembourg \nPays Bas \nPortugal \nRoyaume Uni \n\n8 \n285 \n656 \n294 \n20 \n1. 103 \n1. 780 \n6 \n504(1) \n\n6 \n77 \n450 \n\n6,2 \n5,2 \n5,5 \n4,6 \n3,4 \n2,5 \n6 \n5,5 \n5,7(2) \n3,5 \n6,6 \n1,6 \n5,8 \n\n517 \n434 \n459 \n384 \n284 \n208 \n500 \n459 \n476 \n292 \n550 \n133 \n484 \n\n4 \n124 \n301 \n113 \n6 \n230 \n891 \n3 \n240 \n\n3 \n10 \n218 \n\n1 ,145 \n1 ,145 \n1 ,145 \n1 ,145 \n1,119 \n1,206 \n1 ,145 \n1,145 \n1 ,145 \n1,145 \n1 ,145 \n1 ,165 \n1,145 \n\n5 \n142 \n345 \n129 \n6 \n277 \n1. 020 \n3 \n275 \n\n4 \n12 \n249 \n\nEUR-12 \n\n5. 189 \n\n2. 143 \n\n1,151 \n\n2. 467 \n\nCe chiffre ne tient pas compte de 190. 000 ha de soja pr\u00e9vus en \ndouble culture. Moyenne estim\u00e9e des zones de production d'ol\u00e9agineuses. (1) \n\n(2) \n\nBonus \n\n- Bonus tournesol Espagne et Portugal (*) \n\nEspagne : 73 ECU/ha x 1,073 mio ha x 1,206 (DT) \nPortugal : 100 ECU/ha x 0,077 mio ha x 1,165 (DT) \n\n94 Mio ECU (B) \n9 Mio ECU (B) \n\nTOTAL \n\n103 Mio ECU. (B) \n\n- Bonus pour ventes retard\u00e9es \n\n(5,189/3) mio ha x 10 ECU/ha x 1,151 (DT) \n(5,189/3) mio ha x 20 ECU/ha x 1,151 (DT) \n\nTOTAL \n\nTotal bonus : (103+ 60) Mio ECU - 163 Mio ECU \n\n20 Mio ECU (B) \n40 Mio ECU (B) \n\n60 Mio ECU (B) \n\n(*) Chiffres Drovisoires \n\n\f2 -\n\n3. D\u00e9penses totales \n\n2. 467 Mio ECU (aides) + 163 Mio ECU (bonus) - 2. 630 Mio ECU \n\nII. INCIDENCE POUR 12 MOIS \n\nD\u00e9pense corespondant \u00e0 la lettre rectificative \u00e0 l'APB 1992 \n\nColza \nTournesol \nSoja \n\n1. 757 Mio ECU \n1. 417 Mio ECU \n547 Mio ECU \n\nTOTAL \n\n3. 721 Mio ECU \n\nIncidence : (2. 630 - 3. 721) Mio ECU - - 1. 091 Mio ECU \n\nI N. INCIDENCE PAR EXERCICE BUDGETAIRE \n\nL'abolition du r\u00e9gime actuel \u00e0 la fin de la campagne 1991/92 entra\u00eene la \ncessation des paiements des aides \u00e0 la production pour lesquels la pr\u00e9vision \ndans I'APB 1992 est de : \n\nColza \nTournesol \nSoja \n\n445 Mio ECU \n148 Mio ECU \n29 Mio ECU \n\nTOTAL \n\n622 Mio ECU \n\nLes avances seront fonction des disponibilit\u00e9s budg\u00e9taires (respect de la \ngui deline). Pour 1993 l'\u00e9conomie sera comprise dans une fourchette allant de 403 \u00e0 1. 091 \nen fonction de l'avance qui sera octroy\u00e9e pour les campagnes 1992/93 et \n1993/94. ISSN 0254-1475 \n\nCOM(91) 318 final \n\nDOCUMENTS \n\nEN \n\n03 \n\nCatalogue number : CB-CO-91-362-EN-C \n\nISBN 92-77-75017-0 \n\nOffice for Official Publications of the European Communities \nLr2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/49f56d57-07ad-45c8-8692-492bcb724bf5", "title": "PROPOSAL FOR A COUNCIL RECOMMENDATION ON CHILD CARE", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_recommendation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-28", "subjects": "child care,ergonomics,family policy,gender equality,vocational training", "workIds": "celex:51991PC0233,comnat:COM_1991_0233_FIN,oj:JOC_1991_242_R_0003_01", "eurovoc_concepts": ["child care", "ergonomics", "family policy", "gender equality", "vocational training"], "url": "http://publications.europa.eu/resource/cellar/49f56d57-07ad-45c8-8692-492bcb724bf5", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 233 final \n\nBrussels, 28 August 1991 \n\nsW \n\nWM^' \n\nProposal for a \n\nCOUNCIL RECOMMENDATION \n\non chiId care \n\n(presented by the Commission) \n\nJii^lSSfeK \n\n\f- 2 -\n\nEXPLANATORY MEMORANDUM \n\nA. BACKGROUND \n\n1. 2. 3. 4. 5. (1) \n\n(2) \n\n(3) \n\nIn 1989, eleven Member States of the European Community adopted the \nCommunity Charter of basic social rights of workers with certain \nundertakings regarding the development of equal opportunities for men \nand women (Paragraph 16) and the reconciliation of occupational and \nfamiIy obiigat ions. In its action programme implementing the Community Charter, the \nCommission has included among its aims the adoption of a \nRecommendation concerning child care. Studies have shown inadequacies and gaps in all the Member States and \nthat measures are required to reconcile family responsibilities \narising from the care and upbringing of children with the employment, \neducation and training of parents and other adults with family \nresponsibilities for children; and the adverse effects of this \nsituation on the attainment of equal opportunities for men and women \nin employment, training and education and the well-being of their \nfamilies<1M2)(3). The Commission Action Programme implementing the Community Charter of \nbasic social rights for workers notes that, as early as 1982, the \nFirst Action Programme on Equality highlighted the link between \nemployment and childcare. The Second Community Action Programme on \nthe Promotion of Equal Opportunities for Women (1985-1990) noted \nthat: MA sine qua non for the promotion of true equality at work is \nthe sharing of family and occupational responsibilities, particularly \nthe development of adequate child-minding facilities and a review of \nsocial infrastructures in general\". The Third Medium-Term Community Action Programme on Equal \nOpportunities for Women and Men (1991-1995), in the context of \nimproving the working conditions and the reconciliation between work \nand family responsibilities for men and women, envisages the \nCommission undertaking measures concerning the development of child \ncare facilities and leave for family reasons. \"Childcare and Equality of Opportunity\". Consolidated Report to the \nEuropean Commission, Peter Moss, Co-ordinator, Childcare Network, \nbased on national reports of Network representatives in the Twelve \nMember States, April 1988. \"Infrastructure and Women's Employment : Centre for Research on \nEuropean Women (CREW) and James McLoone and Maire 0'Leary, \nUniversity \n1989. \"Who Cares for Europe's Children ?\". by A. PHI I lips and P. MOSS, \nBrussels, European Commission, 1989. V/174/90-EN, \n\nCollege, \n\nGalway, \n\nOctober \n\n\f- 3 -\n\n6. 7. The communication from the Commission on Family Policies of 8 August \n1989(4) mentions the need to continue actions to reconcile \nprofessional and family life and to encourage the sharing of family \nresponsibilities \nthe \nintensification of current work relating to the \"Childcare Network\". It also draws attention in this context to the need for job \nflexibility, the development of atypical working timetables and Job \nstatus, and the provision of adequate basic infrastructures (working \nhours of public and private services, transport). particular \n\nimportance \n\nattaches \n\nand \n\nto \n\nIn the present economic context, there is a clear need for closer \napproximation in levels of support for employed parents, including \nservices providing care for children, in order to eliminate \nimbalances in the labour market and facilitate mobility between \nMember States. The Single Market will produce new Jobs and women \nwill be able to take advantage of these, if support measures, \nincluding services providing care for children are available and \naffordable. These support services are also essential, if women are \nto undertake training and retraining which is crucial during periods \nof labour market restructuring. Finally, these support services are \nequally essential, if the Community is to make the optimum use of \nwomen's skills, talents and abilities. It is thus economically and \nsocially desirable to improve the quantity and quality of services \nproviding care for children and other measures intended to reconcile \nresponsibilities arising from the care and upbringing of children \nwith the employment, education and training of parents. B. SITUATION IN THE MEMBER STATES \n\n1. 2. 3. The Employment Position of Women and Men with Children \n\nAnnex 1 provides an overview of some aspects of the employment \nposition of women and men with children. This Annex shows the \ncontinuing differential \nimpact of children and their care on \nparticipation by men and women in the labour market; 44% of women \nwith children aged 0-9 were employed in 1988, less than half the \nlevel for men with children (92%) and substantially lower than the \nemployment rate for childless women of childbearing age (71%). Women \nwith children were more likely to be employed part-time, compared to \nmen with children or childless women. There is little data on the qualitative aspects of parents' \nemployment (for example, type of occupation, pay and conditions, \nprospects, etc. ), which would permit an assessment of the impact of \nchildren and their care on these aspects of the employment position \nof men and women. Gaps in Service Provision \n\nAnnex 2 shows the number of places in pub 11cIy-funded serv i ces for \nchildren up to the age of 10, as a percentage of the child \npopulation; it excludes children attending primary school, which is \ncompulsory in all the Member States, but shows the hours that \nchildren attend primary schools, and therefore the \ncontribution \nthat these schools make to children's care. Although information on \nthe private sector is more sketchy, there are indications of \nsubstantial unmet need for services throughout the Community, even in \nthe country with the highest level of provision. (4) \n\nCOM (89) 363 final. - 4 -\n\n4. 5. 6. 7. !n addition to levels of provision varying substantially between \nMember States, differences also exist within individual Member \nStates, so that there are disparities between regions regarding \naccess to services. In general, cities tend to be better served than \nrural areas regarding public provision. Ages of Children covered by existing services \n\nThere is a high level of unmet need for children under three, with \nplaces for 5% or less of children under three in services in eight \nMember States. Places in publicly-funded pro-primary schooling or \nkindergartens for children over the age of three, but below \ncompulsory school age, are more common. Four countries provide such \nprovision for over 80% of children-, six for 50%-80%; and two for \nunder 50%. In many countries, however, the hours of opening of these \nservices, like primary schools are such that they need to be \nsupplemented by services providing \"outside school hours\" care. There is, however, also a high level of unmet need for services \nproviding this type of care with very low levels of provision in many \ncountries*5^ (see Annex 1, last column). Public funding may be supplemented by other sources of funding, for \nexample from parents and employers. At present the extent of public \nfunding varies widely, not only between Member States, but also for \ndifferent age groups of children within Member States. Except in one \nMember State, most parents with children under 3 must rely on \nprivately funded services; parents with children under 3 using \npublicly funded services, and parents with older children at \nkindergarten, have to pay according to income, although levels of \npayment vary between Member States; parents with children in pre-\nprimary or primary school make no payment although they may have to \npay for \"outside school hours\" care. In five countries, there is \nsome degree of tax relief to parents for costs incurred in using \nservices, but this subsidy is much less than that given to parents \nusing publicly-funded services and is not income-related so as to \ngive more assistance to lower income families. Moreover, research suggests that a barrier to increased labour force \nparticipation rates, and more particularly employment rates, among \nwomen is the presence or absence of suitable childcare arrangements \nCare \nfor children from 0 to 10 and not merely creches for babies. for children of school age fails to be provided for more than a third \nof children in any country and is virtually non-existent or very low \nin nine Member States. While variations can partly be explained by \ndifferent levels of need and national income, this is only a partial \nexplanation for the unequal access to services that exists. (5) \n\n\"Childcare in the European Communities. 1985-1990\". Published in \n\"Women in Europe\", August, 1990. Peter Moss, Co-ordinator, Childcare \nNetwork. - 5 -\n\n8. 9. Major gaps in information make it impossible to provide comprehensive \nand comparative data on the position in Member States, not only as \nregards services providing care for children, but also leave \narrangements for employed parents with responsibility for the care \nand upbringing of children, the environment, structure and \norganisation \nfamily \nresponsibilities which are component parts of a broad approach to \nchild care (see section C below). the workplace \n\nsharing \n\nthe \n\nand \n\nof \n\nof \n\nInformation on privately funded childcare services is generally \ninadequate, if available at all. Many women, however, seek private \nsolutions. Surveys show that relatives provide childcare for most \nchildren under 3 in all Member States but one and private or \nworkplace nurseries provide less than 2% of care for the under-threes \nin a 11 countries. Leave Arrangements for employed parents with responsibility for the care \nand upbringing of children \n\n10. Annex 3 provides an overview of Parental Leave. Main points about \nthis provision are that parental leave is offered in 8 countries, one \noffers a more general leave which can be used for child care \npurposes; there is no provision in three countries. Periods of leave \nvary from 10 weeks to nearly 3 years. Except for Denmark, parents \ntaking leave receive either no payment or else a payment that is low \nin relation to normal earnings; leave is also inflexible in terms of \nthe degree of choice available to parents in how they may take leave \n(for example, parents may not choose between taking leave on a full-\ntime or part-time basis, or between taking it in one bloc of time or \nseveral). Leave is taken overwhelmingly by mothers. 11. In addition to this form of leave, six countries provide some \nstatutory leave to care for sick children, but this is only paid in \nthree cases. Only Denmark provides statutory Paternity Leave. Environment, structure and organisation of the workplace \n\n12. As regards initiatives to reconcile working and family life in the \ncontext of the environment, structure and organization of the \nworkplace, national studies in a few Member States suggest that \ndevelopments have, so far, been limited and uneven in application \n<6) (7) (8). Sharing of Family Responsibilities \n\n13. A major change that has taken place in employment in the past \n20 years is the growing proportion of women (especially married \n\n(6) \n(7) \n\n(8) \n\n\"The Industrial Relations Review and Report\". UK, May-June, 1989. \"Retaining Women Employees\". Hilary Metcalf, Institute of Manpower \nStudies Report, UK, 1990. \"Maternity Rights: the Experience of Women and Employers\". S. McRae, \nW. W. Daniel, Policy Studies Institute, UK, 1991. - 6 -\n\nwomen) in the labour force. However, women's increased participation \nin the world of work has not been accompanied by the measures \nnecessary to achieve a matching reduction in women's share of family \nresponsibilities, and to facilitate the reconciliation of employment \nand family responsibilities for both men and women. Many women are \nstill forced into making undesirable choices between a career at \nwork, carrying the double burden of also being mainly responsible for \nthe family or a career at home, and in the main expected to make \narrangements for caring for children and relatives and giving up \ntheir leisure time and even part or all of their work, if the need \narises. C. THE BROAD APPROACH TO CHILD CARE \n\n1. 2. An essential component of child care services is the need for \nquality. Quality in child care must mean that which is conducive to \nthe welfare and development of the child. It is important to break \ndown the false distinction between care and education, so that there \nis no stigmatisation of \"care\", in so much as it is seen as a \n\"parking service\" for parents at work. Services should be flexible, \nlocal, and multi-functional. Good quality child care is an \ninseparable issue from that of the people who work to provide those \nservices. Moreover, services of poor quality will constrain women's \nemployment, deterring some from entering the labour market and \nproviding an additional source of stress for women already employed. Reconciling family responsibilities arising from the care and \nupbringing of children with employment, education and training \nrequires measures in four areas : high quality services to provide \ncare for children while parents with family responsibilities for \nchildren are employed or receiving education or training; leave \narrangements for parents with responsibility for the care and \nupbringing of children; changes in the culture and structure of \nindividual workplaces, to make workplaces supportive of the needs of \nworkers with responsibilities for the care and upbringing of \nchildren; the more equal sharing of family responsibilities arising \nfrom the care and upbringing of children, particularly between men \nand women. Each area \nnot sufficient. A \ncomprehensive and coherent programme, covering all these areas, is \nneeded. is necessary, but \n\nD. SERVICES TO PROVIDE CARE FOR CHILDREN \n\n1. There is a range of services which may be provided in institutions \nsuch as nurseries, kindergartens, pre-primary or primary schools, \ncentres providing out-of-school care; or by childminders in organised \nchildcaring schemes. 2. The main points about such child care services are: \n\n(i) There are major and unjustifiable inconsistencies, or lack of \ncoherence, between services in a number of important areas, \nincluding \naccessibility; funding and costs to parents; \navailability of places; hours of opening*, orientation and \npurpose; administrative responsibility; training, pay and \nconditions of workers. - 7 -\n\n(ii) Services need to work closely with local communities and with \nparents. This includes : responsiveness to local and parental \nneeds and circumstances; regular contact and exchanges of \ninformation; and creating opportunities for parents and local \ncommunities to influence the objectives and management of \nservices. (ill) Although Annex 2 covers only services for children until the \nage of 10, it should be recalled that family responsibilities \narising from the care of children are wide-ranging and continue \nto exist at least until children leave school, although the \nnature of these responsibilities change, as children get older \nand become less dependent. (iv) Nearly all workers in the relevant services, whether publicly \nor privately funded, are women. The conditions and training of \nworkers in child care services should be improved to reflect \nthe importance of their work. (v) While some parents use private arrangements from choice, many \nothers do so for lack of publicly-funded services. Increased \nservices at an affordable cost are therefore necessary to \nensure that there is a closing of the gap between demand and \nthe existing level of services. Given that the need for child \ncare is not a matter concerning parents alone, but is of \neconomic and social consequence, public funding should also \nmake an important contribution to provision. (vi) Where public funding is supplemented by other sources of \nfunding, for example from parents and employers, this should be \npart of a coherent and comprehensive policy on the funding of \nservices. Where services are provided \nin workplaces or \notherwise supported by individual employers, this should be \nregarded as a supplement to locally based, integrated services \nand not as an alternative and should be provided within the \nframework of a fully developed equal opportunities policy. E. LEAVE ARRANGEMENTS FOR EMPLOYED PARENTS WITH RESPONSIBILITY FOR THE \nCARE AND UPBRINGING OF CHILDREN \n\nWorking parents may not always be able or willing to leave the care \nof their children to professional or other chiIdminders. An \nintrinsic feature of child care is therefore the need for various \nforms of leave from work to enable parents to be absent from \nemployment at key times and return without loss of Job, seniority or \ninterruption of their contractual relationship*9). (9) \n\n\"The impact of the Completion of the Internal Market on Women in the \nEuropean Community\". - 8 -\n\nF. THE ENVIRONMENT. STRUCTURE AND ORGANISATION OF THE WORKPLACE \n\n1. 2. The working environment, workplace practice and attitudes are also a \ncrucial element in a broad approach to childcare. Arrangements in \nthese areas may additionally permit continuity of working careers and \ncontribute towards reducing the costs of staff turnover. There is therefore a need to increase understanding amongst employers \nand trade unions of the importance of improving the environment, \nstructure and organisation of individual workplaces and of the means \nto do this. Measures are needed to review the situation in \nworkplaces, to introduce appropriate initiatives and to monitor their \neffectiveness, to stimulate, evaluate and disseminate innovative \nmeasures of good employment practice. Examples of such practice \ninclude the hours at which meetings are held to avoid incompatibility \nwith the need to collect children rom creches; the importance of \ngiving adequate notice of the need to travel; the need for flexible \nworking hours, etc. G. SHARING OF FAMILY RESPONSIBILITIES \n\nWomen carry too great a share of responsibilities and that is one of \nthe fundamental causes of women's unequal position on the labour \nmarket and consequent inequalities in employment and income. Wage \nrates and occupation position - central criteria for assessing \nquality - are not determined purely by market forces, but by the \nsocial costs of reproduction which are unequally distributed. A \ngreater involvement of men in family responsibilities seems crucial, \nif women are to enter the labour market on an equal footing and to \nimprove the quality of their working and personal lives. As well as \ntaking a fair share of family responsibilities, men should equally be \nable to benefit from the full range of measures to reconcile family \nand professional life without Jeopardising their own chances of \ncareer development or running the risk of hostile attitudes. Changes \nin male attitudes are needed both in the home and workplace to make \nthe working environment more sympathetic and responsive to the needs \nof chiIdren. H. THE NEED FOR INFORMATION \n\nThere is a need to make appropriate arrangements to gather regularly \ninformation on : the supply and distribution of care and education \nservices for children; the take-up and use of services by families \nand the costs for families; the take-up and use of leave-, the \nprovision of employment benefits resulting from collective or \nworkplace agreements intended to provide support to workers with \nfamily responsibilities, and the use of these benefits; and the level \nof participation by men In the care of children. In gathering \ninformation and reviewing progress in achieving policy objectives, \nparticular attention should be paid to the position of certain groups \nof families, including : lone parents; low income families; rural \nfamilies; and families with special and/or other special needs. - 9 -\n\nJ. OVERALL CONCLUSIONS \n\n1. 2. 3. In the Commission's view, it emerges from the analysis of the issues \nexamined above that the Member States should undertake measures to \nenable women and men to reconcile employment, education and training \nwith responsibilities arising from the care and upbringing of \nchildren. The Commission therefore recommends that the Member States \nshould undertake a number of specific initiatives, in order to ensure \nthat all parents with such responsibilities have access to locally-\nbased and good quality services. Given that there are major gaps of information, particularly \nconcerning the supply of privately funded services, the care \narrangements made for children while parents are employed and the \nquality of services, it will be necessary to take steps to rectify \nthese inadequacies. This process should aim to increase the level \nof knowledge about the provision of care for children to that which \nalready exists on the educational system in general. The Commission undertakes : (a) to promote, in collaboration with the \nMember States and the Social Partners, the exchange, assessment and \ndissemination of information and experience in this field-, and (b) to \nsupport projects which are innovative and of transnational relevance \nand disseminate the results. Annexes: 3 \n\n\f% employed -\nwomen with child \nunder 10 \n\n% employed - men \nwith child under \n10 \n\nParental Employment, 1988 \n\n% employed -\nwomen aged 20-\n39, without \nchildren \n\nChange in % \nemployed, 1985-88 \n\u2022 women with child \nunder 10 \n\n% unemployed -\nwomen with child \nunder 10 \n\n% unemployed -\nmen with child \nunder 10 \n\nGermany \n\nFrance \n\nItaly \n\nNetherlands \n\nBelgium \n\nLuxembourg \n\n38% (21%) \n\n56% (16%) \n\n42% (5%) \n\n32% (27%) \n\n54% (16%) \n\n38% (10%) \n\nj United Kingdom \n\n46% (32%) \n\n[ Ireland \n\n| Denmark \n\n1 tiroecc \n\nPortugal \n\nSp. tin \n\nKuropoan \nCommunity \n\n23% (7%) \n\n79% (32%) \n\n4 1% (5%) \n\n62% (4%) \n\n28% (4%) \n\n44% (17%) \n\n94% (1%) \n\n93% (1%) \n\n95% (2%) \n\n91% (9%) \n\n92% (1%) \n\n98% (-) \n\n88% (1%) \n\n79% (1%) \n\n95% (2%) \n\n95% (1%) \n\n95% (1%) \n\n89% (1%) \n\n92% (2%) \n\nKt/y. Figures in brackets = % employed part-time \n\n75% (15%) \n\n75% (11%) \n\n55% (4%) \n\n68% (30%) \n\n68% (13%) \n\n69% (5%) \n\n83% (20%) \n\n67% (6%) \n\n79% (6%) \n\n52% (3%) \n\n69% (6%) \n\n44% (5%) \n\n+2. 6% (+2. 5%) \n\n6% \n\n+ 1. 3% (+1. 9%) \n\n10% \n\n+3. 6% (+0. 7%) \n\n+8. 2% (+7. 7%) \n\n8% \n\n8% \n\n+2. 8% (+2. 4%) \n\n12% \n\n+3. 7% (0. 6%) \n\n+7. 5% (+6%) \n\n+5. 1% (+1. 5%) \n\n+2. 6% (-1. 5%) \n\n+3. 8% (-0. 2%) \n\nNo Information \n\nNo Information \n\n2% \n\n8% \n\n8% \n\n8% \n\n6% \n\n6% \n\n10% \n\n8% \n\n71% (13%) \n\nNo Information \n\no \nI \n\n3% \n\n5% \n\n3% \n\n5% \n\n5% \n\n1% \n\n8% \n\n17% \n\n3% \n\n3% \n\n2% \n\n8% \n\n5% \n\nI > \nI z \nI z \ni m \ni x \ni \n\n\fPlaces in publicly funded childcare services as % of all children in the age group \n\nDate to which data \nrefer \n\nFor children under \n3 \n\nFor children from 3 \nto compulsory \nschool age \n\nAge when \ncompulsory \nschooling begins \n\nLength of school \nday (including \nmidday break) \n\n6-7 years \n\n4-5 hours (a) \n\nGermany \n\nFrance \n\nItaly \n\nNetherlands \n\nBelgium \n\nLuxembourg \n\nUnited Kingdom \n\nIreland \n\nDenmark \n\nGreece \n\nPortugal \n\nSpain \n\n1987 \n\n1988 \n\n1986 \n\n1989 \n\n1988 \n\n1989 \n\n1988 \n\n1988 \n\n1989, \n\n1988 \n\n1988 \n\n1988 \n\n3% \n\n20% \n\n5% \n\n2% \n\n20% \n\n2% \n\n2% \n\n2% \n\n48% \n\n4% \n\n6% \n\n? \n\n65-70% \n\n95%+ \n\n85% + \n\n50-55% \n\n95%+ \n\n55-60% \n\n35-40% \n\n55% \n\n85% \n\n65-70% \n\n35% \n\n65-70% \n\n6 years \n\n6 years \n\n5 years \n\n6 years \n\n5 years \n\n5 years \n\n6 years \n\n7 years \n\n\u2022 \n\n5Vi years \n\nj 6 years \n\n6 years \n\nOutside school \nhours care for \nprimary school \nchildren \n\n4% \n\n? \n\n? \n\n1% \n\n? \n\n1% \n\n(-) \n\n(-) \n\n8 hours \n\n4 hours \n\n6-7 hours \n\n7 hours \n\n4-8 hours (a) \n\n6V6 hours \n\n4'/i-6,/i hours (b) \n\n3-5V* hours (a,b) \n\n29% \n\n4-5 hours (b) \n\n6Vi hours \n\n8 hours \n\n(-) \n\n6% \n\n(-) \n\nNB. This Table should be read in conjunction with the national reports, which contain important qualifications and explanations. The Table shows the \nnumber of places in publicly funded services as a % of the child population; the % of children attending may be higher because some places are used on \na part-time basis. Provision at playgroups in the Netherlands has not been included, although 10% of children under 3 and 25% of children aged 3-4 \nattend and most playgroups receive public funds. Average hours of attendance - 5-6 hours per week - are so much shoner than for other services, that it \nwould be difficult and potentially misleading to include them on the same basis as other services; however playgroups should not be forgotten when \nconsidering publicly funded provision in the Netherlands. Key: ?\u00bb no information; (-) - less than 0. 5%; (a) - school hours vary from day to day; (b) \u00ab school hours increase as children get older. II > \nII \nz \nII \nz \nil m \nit x \nil \n\n\f\\ \n\nj \n\n& \n\nAnnex 3 \n\nParental Leave \n\n* \n\nCicmiany \n\n18 months. Low flat-rate payment for 6 \nmonths; payment then depends on family \nincome, so higher income family gets less \n\nFrance \n\nI Until child is 3. No payment unless 3 or \n\nmore children; then low, flat-rate payment \n\nItaly \n\n6 months. 30% of earnings \n\nBelgium \n\nNetherlands \n\nNone, but workers can take leave for family \nor personal reasons (sec national report) \nNone, but Government proposal for part-\ntime leave has been made \n\nLuxembourg \n\nNone \n\nUnited \nKingdom \n\nNone \n\nIreland \n\nNone \n\n\u00ab \n\nDenmark \n\n10 weeks. 90% of earnings (up to a \n\nmaximum level) \n\nGreece \n\n3 months per parent. Unpaid \n\nPortugal \n\n24 months. Unpaid \n\nSpain \n\n12 months. Unpaid \n\nParental leave means entitlement to leave of a given \nduration to wage-earners/ fathers, mothers, including \nstaff working in the public sector, consequential \nupon the birth of a child, during the period following \nthe termination of maternity leave, or to workers as \ndefined above, or the adoption of a child during the \nperiod following its reception in the adoptive parents' \nhousehold, during which period of leave the beneficiary \ntakes responsibility for the actual care of the child. i \n\n\f- 13 -\n\nProposal for a \nCOUNCIL RECOMMENDATION \n\non chlId care \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic Community, \nand in particular Article 235 thereof; \n\nHaving regard to the proposal submitted by the Commission(1) \n\nHaving regard to the opinion of the European Parliament of. Having regard to the opinion of the Economic Social Committee of. Whereas point 16 of the Community Charter of the Fundamental Social Rights \nof Workers calls for measures to be developed to enable men and women to \nreconcile their occupational and family obligations; \n\nWhereas the Commission in its action programme implementing the Community \nCharter has included among its aims the adoption of a recommendation \nconcerning child care; \n\nWhereas the Community Charter notes that child-care methods, parental leave \nand maternity leave form part of a whole which enables people to combine \ntheir family responsibilities and occupational ambitions, and a Community \nresponse alone will not suffice, if this objective is to be attained; \n\nWhereas in its Third Medium-Term Action Programme on Equal Opportunities \nfor Women and Men (1991-1995), the Commission identified the need for \nfurther action in this area; \n\nWhereas the Communication from the Commission on Family Policies^2* draws \nattention to the need to continue actions to reconcile professional and \nfamily life and encourage the sharing of family responsibilities, and \nemphasises the importance of intensifying work relating to child care; \n\nWhereas the reconciliation of professional and family life has to be viewed \nin a wide perspective and it is important for the Community to promote a \nglobal policy aiming to achieve this reconciliation; \n\nWhereas it is essential to promote the well-being of children and families, \nensuring that the needs of all children and families are met and taking \ninto account that responsibilities arising from the care and upbringing of \nchildren continue up to and throughout the period of children's schooling, \nand to recognise the diversity that exists in the employment and household \ncircumstances of parents; \n\n(1) \n(2) C0M(89) 363 final, 8. 8. 1989. - 14 \n\nWhereas inadequate provision of good quality, affordable services providing \ncare for children and other measures to reconcile responsibility for the \ncare and upbringing of children with the employment, education and training \nof parents constitutes a major barrier to women's access to and full \nparticipation in employment, education and training, on equal terms with \nmen, as well as full participation in all areas of society; \n\nimprovements \n\nWhereas \nin services and other measures to reconcile \nresponsibilities for the care and upbringing of children with the \nemployment, education and training of parents are crucial in order to \nenable women to take full and equal advantage of the favourable effects of \nthe Single Market; \n\nWhereas furthermore, adequate services providing care for children could \nfacilitate freedom of movement of workers and mobility on the European \nlabour market; \n\nWhereas child care is a broad concept which involves good quality service \nprovision, the development of a working environment which is supportive of \nparents with responsibility for the care and upbringing of children, and \nthe sharing of family responsibilities between women and men; \n\nWhereas lack of services providing care for children and other measures to \nreconcile the care and upbringing of children with the employment, \neducation and training of parents hinders the effective use of women's \ntalents, skills and abilities and whereas demographic trends and structural \nchanges on the labour market call for these to be better used; \n\nWhereas some of the Member States have undertaken initiatives in this area \nbut the measures involved have often remained limited; \n\nWhereas in all Member States the demand for good quality, affordable care \nfor children considerably exceeds the existing supply; \n\nWhereas, moreover, disparities exist in good quality, affordable services \nproviding care for children and other measures to reconcile the care and \nupbringing of children with the employment, education and training of \nparents between Member States and between regions within Member States; \n\nWhereas the standard clause included in the Community Support Frameworks \nfor structural policy stipulates that the actions and measures taken within \nsuch a framework must conform with and, where appropriate, contribute to \nthe implementation of Community policy and legislation relating to \nequality of opportunity between women and men, and that in particular, \nconsideration must be given to training and infrastructure requirements \nwhich facilitate labour force participation by women with children; \n\nWhereas, furthermore, in the NOW Community Initiative for the promotion of \nequal opportunities for women in the field of employment and vocational \ntraining, child-care measures are provided to assist women with children \nto have access to the labour market and to vocational training courses; \n\n\f- 15 -\n\nWhereas it is therefore important to establish Community guidelines for \ncarrying out a number of specific comprehensive actions, in order to ensure \nthe development of good quality and affordable services providing care for \nchildren and other measures to reconcile the care and upbringing of \nchildren with the employment, education and training of parents, \n\nHEREBY RECOMMENDS AS FOLLOWS \n\nArticle 1 \n\nIt is recommended that Member States develop measures in order to enable \nwomen and men to reconcile their occupational and their family obligations, \narising from the care and upbringing of children. Article 2 \n\nIt is recommended that, to this end, the Member States develop with the \nappropriate involvement of central, regional and local authorities, the \nSocial Partners and other relevant organisations, measures in the following \nfour areas: \n\n(i) the provision of care for children while parents are in or \n\nseeking employment, education or training; \n\n(II) leave arrangements for employed parents with responsibility for \n\nthe care and upbringing of children-, \n\n( I N) the environment, structure and organisation of the workplace, \n\nto make it responsive to the needs of workers with children; \n\n(iv) the sharing of family responsibilities arising from the care \n\nand upbringing of children between women and men. Article 3 \n\nIn relation to the provision of services providing care for children, it is \nrecommended that Member States should take measures designed to: \n\n(a) \n\nenable all parents in or seeking employment, education or \ntraining to have access to locally based and good quality \nservices. This requires that services are affordable, services \ncombine safe and secure care with a broad education or \npedagogical approach, the needs of parents and children are \ntaken into account in determining access to services, services \nshould be available In all areas and regions of Member States, \nboth urban and rural areas, services should ensure access to \nchildren with special needs, with linguistic needs and to \nchildren in lone parent families, and be responsive to those \nneeds ; \n\n\f- 16 -\n\n(b) encourage flexibility and diversity of services, as part of a \nstrategy to increase choice and meet the different preferences, \nneeds and circumstances of children and families. Thi^ should \nbe combined with coherence between different services; \n\n(c) seek to improve the training (both initial and continous) of \nworkers in child-care services, with the objective of ensuring \nthat this training is appropriate to the great importance and \nsocial and educative value of their work; \n\n(d) encourage services to work closely with parents and with local \ncommunities involving regular contact and exchanges of \ninformation, so as to be responsive to local parental needs and \ncircumstances; \n\n(e) ensure that public funding makes an essential contribution to \nthe development of affordable, good quality, coherent services \nwhich offer choice to parents. Article 4 \n\nIn relation to leave arrangements for employed parents with responsibility \nfor the care and upbringing of children, it is recommended that Member \nStates should continue to develop measures to take realistic account of \nwomen's increased participation in the labour force. This requires the \nprovision of leave to enable all employed parents, both men and women, to \ndischarge effectively their dual working and family responsibilities, with, \ninter al la. flexibility in how leave may be taken. In relation to the environment, structure and organisation of the \nworkplace, it is recommended that Member States should: \n\nArticle 5 \n\n(a) encourage both sides of industry to promote action, inter \nai la. within the framework of collective agreements, to make \nthe environment, structure and organisation of individual \nworkplaces supportive of the needs of all working parents with \nresponsibilities for the care and upbringing of children; \n\n(b) undertake initiatives to improve the employment conditions of \nworkers in services providing care for children and ensure that \nthe social value of their work is recognized; \n\n(c) promote action especially in the public sector which might \n\nserve as an example in developing initiatives in this area. - 17 -\n\nArticle 6 \n\nIn relation to responsibilities arising from the care and upbringing of \nchildren, it is recommended that Member States promote and encourage \nincreased participation by men, in order to achieve a more equal sharing of \nparental responsibilities between men and women. Article 7 \n\nThe Member States shall inform the Commission, within three years of the \ndate of the adoption of this Recommendation, of the measures taken to give \neffect to it, in order to allow the Commission to draw up a report on all \nsuch measures. Done at Brussels, \n\nFor the Council \n\nThe President \n\n\f\fISSN 0254-1475 \n\nCOM(91) 233 final \n\nDOCUMENTS \n\nEN \n\n05 \n\nCatalogue number : CB-CO-91-371-EN-C \n\nISBN 92-77-75325-0 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/3935bb7a-339e-43f7-b5a1-c0382d823e9b", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) ON ACCESS TO THE MARKET FOR THE CARRIAGE OF GOODS BY ROAD IN THE EUROPEAN COMMUNITY TO OR FROM THE TERRITORY OF A MEMBER STATE OR PASSING ACROSS THE TERRITORY OF ONE OR MORE MEMBER STATES", "langIdentifier": "ENG", "mtypes": "pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-27", "subjects": "carriage of goods,common transport policy,intra-EU transport,road transport,transport licence", "workIds": "celex:51991PC0293,comnat:COM_1991_0293_FIN,oj:JOC_1991_238_R_0002_01", "eurovoc_concepts": ["carriage of goods", "common transport policy", "intra-EU transport", "road transport", "transport licence"], "url": "http://publications.europa.eu/resource/cellar/3935bb7a-339e-43f7-b5a1-c0382d823e9b", "lang": "eng", "formats": ["pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/330ea40a-a25a-4169-bbf0-e217b11ae01b", "title": "Commission Regulation (EEC) No 2546/91 of 26 August 1991 amending Regulation (EEC) No 1582/91 laying down certain detailed rules for the application of Council Regulation (EEC) No 598/91 for the supply of canned beef intended for the people of the Soviet Union", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-26", "subjects": "USSR,award of contract,beef,emergency aid,preserved product", "workIds": "celex:31991R2546,oj:JOL_1991_239_R_0005_016", "eurovoc_concepts": ["USSR", "award of contract", "beef", "emergency aid", "preserved product"], "url": "http://publications.europa.eu/resource/cellar/330ea40a-a25a-4169-bbf0-e217b11ae01b", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/457e3d9a-4df3-4113-b9aa-6686bd9dd4c0", "title": "PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MEDICAL DEVICES", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_directive_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-23", "subjects": "harmonisation of standards,medical device,occupational safety,public health,radiation protection,radiobiology", "workIds": "celex:51991PC0287,comnat:COM_1991_0287_FIN,oj:JOC_1991_237_R_0003_01", "eurovoc_concepts": ["harmonisation of standards", "medical device", "occupational safety", "public health", "radiation protection", "radiobiology"], "url": "http://publications.europa.eu/resource/cellar/457e3d9a-4df3-4113-b9aa-6686bd9dd4c0", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0MC91) 287 final - SYN 353 \n\nBrussels, 23 August 1991 \n\nProposal for a \n\nCOUNCIL DIRECTIVE \n\nconcerning medical devices \n\n(presented by the Commission) \n\n\f\f2 -\n\nEXPLANATORY MEMORANDUM \n\nI. GENERAL FRAMEWORK \n\nThis proposal for a directive has been prepared in the \ncontext of the White Paper on completing the internal \nm a r k e t, the work programme of which provides for \nharmonization of the laws relating to electro-medical \nequ i pment. In this c o n t e x t, the Council adopted a first directive \nrelating to active implantable medical devices \n(Directive 9 0 / 3 8 5 / E E C) on 20 June 1990. With the adoption \nof this d i r e c t i v e, a preponderant part of the field of \nmedical devices will be covered by harmonized laws. H o w e v e r, medical devices intended for \nnot included in the scope of this proposal. These products \nwill be dealt w i t h, in view of their particular n a t u r e, in a \nspec ific d i e c t i v e. diagnosis are \n\nin vitro \n\nBefore starting on the preparation of its p r o p o s a l, the \nCommission examined the regulations relating to the medical \ndevices sector. The results of this examination confirmed \nthat there are considerable differences between the Member \nStates as regards both the technical design and production \nrequirements and the administrative procedures for the \ne x a m i n a t i o n, testing, inspection and authorization for \nm a r k e t i n g, and the putting into service and after-sales \nsurveillance of medical devices. The current legislative situation in the Member States is \ncharacterized by a marked lack of uniformity if the various \nnational laws are compared with regard to their scope and \nthe kind of risks covered. A large number of specific laws \ncover certain groups of products such as electro-medical \ne q u i p m e n t, disposable p r o d u c t s, equipment for the disabled, \nsterile p r o d u c t s, and even specific p r o d u c t s. In several \nMember S t a t e s, a range of medical devices (in particular in \nthe field of sterile and disposable products) are covered, \nin the absence of specific laws, by the regulations on \nmedicinal p r o d u c t s. The fact that medical e q u i p m e n t, which \nas a general rule acts physically, is sometimes treated the \nsame as medicinal p r o d u c t s, which act p h a r m a c o l o g i c a l l y, has \nled in several cases to technical b a r r i e r s. - 3 -\n\nW i th t he r e g a rd to the m e a ns of. control u s ed to e n s u re the \ns a f e ty a nd h e a l th p r o t e c t i on of p a t i e n ts a nd u s e r s, t wo \nd i f f e r e nt a p p r o a c h es w e re f o u nd in the C o m m u n i t y. A l a r ge \nn u m b er of t he M e m b er S t a t es a p p ly s y s t e ms b a s ed on t he \ni n s p e c t i on of p r o d u c ts b e f o re t h ey a re p l a c ed on t he m a r k et \nby m e a ns of t y p e - e x a m i n a t i o ns or a p p r o v al s y s t e m s, w h i le \no t h e rs a sk c o m p a n i es to a p p ly g o od m a n u f a c t u r i ng p r a c t i c e s. W h e re t he d e v i c es a re s u b j e ct to the r u l es on m e d i c i n al \np r o d u c t s, b o th p r o d u ct c e r t i f i c a t i on and a u t h o r i z a t i on \np r o c e d u r es for c o m p a n i es a p p l y. T he i n f o r m a t i on o b t a i n ed p u r s u a nt to D i r e c t i ve 8 3 / 1 8 9 / E EC \nl a y i ng d o wn an i n f o r m a t i on p r o c e d u re in the f i e ld of \nt e c h n i c al r e g u l a t i o ns c o n f i r ms the lack of u n i f o r m i ty in the \nl e g i s l a t i ve a p p r o a ch t a k en w i th r e g a rd to m e d i c al d e v i c e s. B e t w e en 1 9 88 and 1 9 9 0, s o me 25 s e ts of d r a ft n a t i o n al \nr e g u l a t i o n s, m o st of t h em r e l a t i ng to s p e c i f ic p r o d u c t s, \nw e re n o t i f i ed to the C o m m i s s i o n. L a s t l y, it s h o u ld be s a id that s o me of the M e m b er S t a t es a re \na w a re of t he u n s a t i s f a c t o ry s i t u a t i on and h a ve i n d i c a t ed \nt h e ir d e s i re to e s t a b l i sh an o v e r a ll legal f r a m e w o rk for the \nm e d i c al d e v i c es f i e l d. In v i ew of t he d i f f e r e n c es in a p p r o a c h, w h i ch by t h e ir \nn a t u re a re i n c o m p a t i b le w i th a s i n g le C o m m u n i ty m a r k et in \nm e d i c al d e v i c e s, it is e s s e n t i al to set up a C o m m u n i ty \ns y s t em of laws b a s ed on A r t i c le 100a of the E EC T r e a ty to \na b o l i sh a nd p r e v e nt t e c h n i c al b a r r i e rs to t r a d e. T he a im of t h is d i r e c t i v e, t h e r e f o r e, is to e n s u re t he \ns a f e ty a nd h e a l th p r o t e c t i on of p a t i e n ts a nd u s e rs by m e a ns \nof a u n i f o rm s e c t o r al a p p r o a ch and to c r e a te an a p p r o p r i a t e, \ns u i t a b le f r a m e w o rk for the t e c h n o l o g i c al d e v e l o p m e nt of the \np r o d u c ts c o n c e r n e d. T he m e d i c al d e v i c es s e c t or is a large m a r k e t: w o r ld \nc o n s u m p t i on of t h e se p r o d u c ts in 1 9 90 h as b e en put at \nECU 5 4. 1 b i l l i o n, i n c l u d i ng ECU 23. 1 b i l l i on in t he U SA a(1 \nECU - 1. 2 U S $) and ECU 1 5. 0 b i l l i on in the C o m m u n i ty \n( s o u r c e: H e a l th I n d u s t ry M a n u f a c t u r e rs A s s o c i a t i on \n( H I M A ) ). T he C o m m u n i ty s h a re of w o r ld p r o d u c t i on h as b e en c a l c u l a t ed \nto be E CU 16. 1 b i l l i on ( U S A: 2 5. 7 - J a p a n: 8. 0 ). B e t w e en \n1 9 86 a nd 1 9 8 9, the a n n u al a v e r a ge g r o w th in c o n s u m p t i on w as \n9. 5% ( U S A: 9. 9% - J a p a n: 8. 6 % ). T he n u m b er of J o bs in t h is \nb r a n ch of i n d u s t ry w i t h in the C o m m u n i ty t o t a l l ed o v er \n2 00 0 00 in 1 9 9 0. - A -\n\nIn v i ew of t he r a p id s p e ed of i n n o v a t i on in t h is s e c t o r, \nC o m m u n i ty l e g i s l a t i on w i ll p r o v i de an a p p r o p r i a te f r a m e w o rk \nw h i ch w i ll h e lp to m a i n t a in a nd to p r o m o te t h is f a v o u r a b le \nd e ve I o p m e n t. T he p r o p o s al for a d i r e c t i ve h as b e en d e s i g n ed a nd \ns t r u c t u r e d, as r e g a r ds t e c h n i c al r e q u i r e m e n t s, in t he light \nof t he C o u n c il R e s o l u t i on of 7 M ay 1 9 85 on a n ew a p p r o a ch to \nt e c h n i c al h a r m o n i z a t i on a nd s t a n d a r d i z a t i on \nl e g i s l a t o rs a l r e a dy a p p l i ed t he p r i n c i p l es s et o ut in t he \nR e s o l u t i on w i th t he a d o p t i on of C o u n c il \na b o v e m e n t i o n ed \nD i r e c t i ve 9 0 / 3 8 5 / E EC of 20 J u ne 1 9 90 r e l a t i ng to a c t i ve \ni m p l a n t a b le m e d i c al d e v i c es \ni n c l u d es w h at h as b e en a c h i e v ed w i th t h at D i r e c t i ve a nd \nt r a n s p o s es it to t he m e d i c al d e v i c es w h i ch it c o v e r s. T h is p r o p o s al t h e r e f o re \n\nT he \n\nT he i m p l e m e n t a t i on of t he c o n c e pt of r e f e r e n ce to s t a n d a r ds \nw i ll be f a c i l i t a t ed by t he f a ct t h at s o me of t he h a r m o n i z ed \nE u r o p e an s t a n d a r d s, in p a r t i c u l ar t h o se of a h o r i z o n t al \nn a t u r e, w i ll a l r e a dy be a v a i l a b le f r om t he a p p l i c a t i on of \nt he D i r e c t i ve r e l a t i ng to a c t i ve i m p l a n t a b le m e d i c al \nd e v i c e s. F u r t h e r m o r e, i m p o r t a nt w o rk on t he e s t a b l i s h m e nt of \na s e c t o r al s y s t em of h a r m o n i z ed s t a n d a r ds h as a l r e a dy b e en \ns t a r t ed by C E N / C E N E L E C. T he p a rt of t he d i r e c t i ve r e l a t i ng to p r o c e d u r es for t he \na s s e s s m e nt of c o n f o r m i ty is b a s ed on t he m o d u l ar a p p r o a ch \nset o ut in C o u n c il D e c i s i on 9 0 / 6 8 3 / E EC of 13 D e c e m b er 1 9 90 \n\nT he a p p r o a ch f o l l o w ed w i th r e g a rd to t he a s s e s s m e nt of \nc o n f o r m i ty e n a b l es a d i s t i n e t i on to be m a de w i th r e g a rd to \nv e r i f i c a t i o ns c a r r i ed o ut by a t h i rd p a r ty a c c o r d i ng to t he \nn a t u re of t he p o t e n t i al r i sk i n h e r e nt in m e d i c al d e v i c e s. For t h is r e a s on a nd in v i ew of the d i v e r s i ty of p r o d u c ts \nc o n c e r n e d, t he d e v i c es c o v e r ed by t he d i r e c t i ve h a ve b e en \nd i v i d ed i n to f o ur c l a s s es for the p u r p o se of a s s e s s m e nt \np r o c e d u r es. T he i n t e r v e n t i on of t he c e r t i f i c a t i on b o d i es ( n o t i f i ed \nb o d i e s) h as b e en g r a d e d. For d e v i c es in C l a ss I, c o n f o r m i ty \nis e s t a b l i s h ed as a g e n e r al r u le u n d er t he r e s p o n s i b i l i ty \nof t he m a n u f a c t u r er a l o n e. C l a ss Ma d e v i c es r e q u i r e, in \nv i ew of t he r i s ks m o re c l o s e ly a s s o c i a t ed w i th m a n u f a c t u r e, \nt he i n t e r v e n t i on of a n o t i f i ed b o dy w i th r e g a rd to t he \nm a n u f a c t u re s t a g e. t he o t h er h a n d, v e r i f i c a t i on by a n o t i f i ed b o dy is \nn e c e s s a ry w i th r e g a rd to d e s i gn a nd t he m a n u f a c t u r i ng \ns t a g e. F u r t h e r m o r e, C l a ss III d e v i c es w h i ch a re c r i t i c al \nd e v i c es s h o u l d, as a g e n e r al r u l e, u n d e r go a c l i n i c al \ne v a l u a t i on u n d er t he r e s p o n s i b i l i ty of t he m a n u f a c t u r e r. T he c o n f o r m i ty of t h e ir d e s i gn m u st be e x p l i c i t ly c e r t i f i ed \nby a n o t i f i ed b o dy b e f o re t h ey a re p l a c ed on t he m a r k e t. For d e v i c es in C l a s s es Mb a nd I I I, on \n\nOJ No C 1 3 6, \nOJ He L 1 89 , \n\nCD \nic) \n(3) OJ No L 3 80 \n\n4. 6. 1 9 8 5, p. 1. 2 C. 7. i 9 9 0, p. 1 7. 3 1. 1 2. 1 9 9 0, p \n\n13 \n\n\fI I. C O N T E N TS OF T HE P R O P O S AL \n\n1 \u2022 \n\nA r t i c le 1 - S c o pe \n\nS e v e r al d e f i n i t i o n s, in p a r t i c u l ar t h o se of a \" m e d i c al \nd e v i c e \", a \" c u s t o m - m a de d e v i c e\" a nd a \" d e v i ce i n t e n d ed for \nc l i n i c al i n v e s t i g a t i o n\" h a ve b e en t a k en f r om t he D i r e c t i ve \nr e l a t i ng to a c t i ve i m p l a n t a b le m e d i c al d e v i c e s. S i n ce t he \ns c o pe of t h is p r o p o s al is b r o a d er t h an that of t he \na b o v e m e n t i o n ed D i r e c t i v e, a few s l i g ht a m e n d m e n ts h a ve \nt h e r e f o re b e en m a d e. T he t e rm \" m e d i c al d e v i c e\" m e a ns p r o d u c ts t he f u n c t i on of \nw h i ch is s o l e ly or p r i n c i p a l ly m e d i c a l. A s e r i es of p r o d u c ts \nw h o se f u n c t i on is not e s s e n t i a l ly m e d i c al a re t h e r e f o re \ne x c l u d ed f r om t he s c o p e, e v en if t h e se p r o d u c ts m ay be u s ed \nto p r e v e nt d i s e a se or a l l e v i a te a h a n d i c a p, e. g. c o s m e t ic \np r o d u c t s, m u l t i p l e - u se d a t a - p r o c e s s i ng e q u i p m e n t. T he m e d i c al f u n c t i on of a m e d i c al d e v i ce m ay be f u l f i l l ed \ne i t h er by m e a ns of a p r o d u ct u s ed on its o wn or as t he \nr e s u lt of t he c o m b i n a t i on of s e v e r al p r o d u c t s, e. g. d i s p o s a b le t u b i n gs c o m b i n ed w i th an i n f u s i on p u m p. T he c r i t e r i on for t he d i s t i n c t i on b e t w e en a m e d i c al d e v i ce \na nd a m e d i c i n al p r o d u ct is the p r i n c i p al a c t i on p r o d u c e d. A \np r o d u ct w h i ch a c h i e v es its p r i n c i p al a c t i on by \np h a r m a c o l o g i c a l, i m m u n o l o g i c al or m e t a b o l ic m e a ns is not \nc o n s i d e r ed to be a m e d i c al d e v i c e. H o w e v e r, a m e d i c al d e v i ce \nm ay i n c l u de a m e d i c i n al s u b s t a n ce as an i n t e g r al p a rt in \no r d er to i n c r e a se its e f f e c t i v e n e s s, e. g. a h e p a r i n - c o a t ed \nc a t h e t er. W h e re t he a c t i on p r o d u c ed by the p r e s e n ce of t he m e d i c i n al \ns u b s t a n ce is s e c o n d a ry to the p r i n c i p al a c t i on of t he \nd e v i c e, t he c o n f o r m i ty a s s e s s m e nt p r o c e d u re for a u t h o r i z i ng \nt he p l a c i ng of t he p r o d u ct c o n c e r n ed on t he m a r k et is \nc o v e r ed by t h is p r o p o s al for a d i r e c t i v e. As far as s a f e ty \na s p e c ts c o n c e r n i ng the p r e s e n ce of the s u b s t a n ce a re \nc o n c e r n e d, t he v e r i f i c a t i o ns r e q u i r ed a re c a r r i ed o u t, w h e re \na p p r o p r i a t e, by a n a l o gy to the m e t h o ds c o n t a i n ed in \nD i rect i ve 7 5 / 3 1 8 / E E C. - 6 -\n\nOn t he o t h er h a n d, w h e re a d e v i ce is i n t e n d ed to a d m i n i s t er \na m e d i c i n al p r o d u ct a nd t h e r e f o re c o n s t i t u t es a c o n t a i n er \nfor t h at p r o d u c t, e. g. a p r e - f i l l ed s y r i n g e, t he a s p e c ts \nr e l a t i ng to t he s a f e ty of t he d e v i ce a re c o v e r ed by t h is \np r o p o s a l, w h i le t he p l a c i ng of the m e d i c i n al p r o d u ct on t he \nm a r k et is s u b j e ct to t he C o m m u n i ty l e g i s l a t i on r e l a t i ng to \nm e d i c i n al p r o d u c ts ( s ee A r t i c le 1, p a r a. 3 ). T he k ey legal d e f i n i t i o ns i n c l u de d e f i n i t i o ns of \" p l a c i ng on \nt he m a r k e t\" a nd t he \" m a n u f a c t u r e r \". T he \" p l a c i ng on t he \nm a r k e t\" m e a ns t he p h y s i c al t r a n s f er of a m e d i c al d e v i ce f r om \nt he m a n u f a c t u r er or a p e r s on a u t h o r i z ed by h im to t he \nd i s t r i b u t or or u s e r. P l a c i ng on the m a r k et m u st not be \nc o n f u s ed w i th t he r i g h t, u n d er the d i r e c t i v e, to m a r k et \nm e d i c al d e v i c es in the E u r o p e an C o m m u n i t y. T he d e f i n i t i on of \nt he m a n u f a c t u r er is u s e f ul in o r d er to be a b le to d e t e r m i ne \nt he n a t u r al or legal p e r s o ns s u b j e ct in p a r t i c u l ar to t he \nc o n f o r m i ty a s s e s s m e nt p r o c e d u r es ( A r t i c le 1 0 ). T he s c o pe of t h is p r o p o s al i n c l u d es m e d i c al d e v i c es w h i ch \ne m it i o n i z i ng r a d i a t i o n. It t h e r e f o re s p e c i f i es t he \nr e q u i r e m e n ts r e l a t i ng to the d e s i gn and m a n u f a c t u re of t he \ne q u i p m e nt c o n c e r n ed a nd t he c o n f o r m i ty a s s e s s m e nt \np r o c e d u r e s. T he d i r e c t i ve d o es n o t, h o w e v e r, a f f e ct t he \na u t h o r i z a t i on r e q u i r ed u n d er D i r e c t i ve 8 0 / 8 3 6 / E u r a t om for \nt he p u t t i ng into s e r v i ce a nd u se of s u ch e q u i p m e n t. A r t i c l es 2 a nd 3 \n\nT h e se a re c o n v e n t i o n al A r t i c l es b a s ed on t he n ew a p p r o a ch \nr e l a t i ng to p l a c i ng on the m a r k e t, p u t t i ng into s e r v i ce and \ne s s e n t i al r e q u i r e m e n t s. A r t i c le 4 - F r ee m o v e m e n t, d e v i c es i n t e n d ed for s p e c i al \np u r p o s es \n\nIn a d d i t i on to t he c o n v e n t i o n al c l a u se c o n c e r n i ng f r ee \nm o v e m e n t, t h is A r t i c le r e f e rs to d e v i c es i n t e n d ed for \ns p e c i al p u r p o s e s, i. e. d e v i c es i n t e n d ed for c l i n i c al \ni n v e s t i g a t i on a nd c u s t o m - m a de d e v i c e s. D e v i c es i n t e n d ed for c l i n i c al i n v e s t i g a t i on a re m a de \na v a i l a b le to m e d i c al p r a c t i t i o n e rs w h en t o t al c o m p l i a n ce \nw i th t he e s s e n t i al r e q u i r e m e n ts s t i ll h as to be e s t a b l i s h ed \nso t h at t he d e v i ce c an u n d e r go an a s s e s s m e nt of c o n f o r m i ty \np r o c e d u r e. T he c a r r y i ng o ut of c l i n i c al \ns p e c i f i c a l ly m a k es it p o s s i b le to c o n f i rm c o n f o r m i ty w i th \nt he r e l e v a nt e s s e n t i al r e q u i r e m e n t s. do not b e ar t he CE m a r k. i n v e s t i g a t i o ns \n\nS u ch d e v i c es t h e r e f o re \n\n\f- 7 -\n\nC u s t o m - m a de d e v i c es a re m a de in a c c o r d a n ce w i th t he \np r e s c r i p t i on of a m e d i c al s p e c i a l i st or a ny o t h er a u t h o r i z ed \np e r s on g i v i ng t he s p e c i f ic d e s i gn c h a r a c t e r i s t i cs of t he \nd e v i ce c o n c e r n e d. C o m p l i a n ce w i th the r e q u i r e m e n ts of t he \nd i r e c t i ve is t h e r e f o re e s t a b l i s h ed u n d er t he J o i nt \nr e s p o n s i b i l i ty of t he m a n u f a c t u r er a nd t he p e r s on i s s u i ng \nt he p r e s c r i p t i on a nd t h is is w hy s u ch d e v i c es do not h a ve to \nb e ar t he CE m a r k. A r t i c le 5 - R e f e r e n ce to s t a n d a r ds \n\nT he r e f e r e n ce to h a r m o n i z ed s t a n d a r ds c l a u se is b a s ed on t he \nC o u n c il R e s o l u t i on of 7 M ay 1 9 8 5. By m e a ns of t he r e f e r e n ce to c e r t a in m o n o g r a p hs of t he \nE u r o p e an P h a r m a c o p o e ia in p a r a g r a ph 2, t he C o m m u n i ty is \nd i s c h a r g i ng t he o b l i g a t i o ns i n c u m b e nt on t he M e m b er S t a t es \np u r s u a nt to t he C o n v e n t i on of 22 J u ly 1 9 64 on t he \np r e p a r a t i on of a E u r o p e an P h a r m a c o p o e i a. In t he f i e ld of t he m e d i c al d e v i c es c o v e r ed by t h is \np r o p o s a l, t he E u r o p e an P h a r m a c o p o e ia h as p r e p a r ed s e v e r al \nm o n o g r a p hs r e l a t i ng in p a r t i c u l ar to s u t u r es a nd t he \ni n t e r a c t i on b e t w e en c e r t a in m a t e r i a ls u s ed for d e v i c es a nd \nm e d i c i n al p r o d u c t s. S u b j e ct to A r t i c le 5, p a r a g r a ph 2, t h e se \nm o n o g r a p hs w i ll h a ve t he s a me s t a t u s, u n d er t h is p r o p o s a l, \nas h a r m o n i z ed s t a n d a r d s. T he a p p l i c a t i on of t he m o n o g r a p hs \nw i ll t h e r e f o re r e m a in v o l u n t a r y. T he C o m m i s s i on h as p r o p o s ed to the C EN a nd t he E u r o p e an \nP h a r m a c o p o e ia t he c o n c l u s i on of a m e m o r a n d um of \nu n d e r s t a n d i ng to d e t e r m i ne the r e s p e c t i ve f i e l ds of a c t i v i ty \nand to e s t a b l i sh c o l l a b o r a t i on in a r e as of c o m m on i n t e r e s t. A r t i c l es 6 a nd 7. - C o mm i t t e es \n\nR e g a r d l e ss of t he c o n v e n t i o n al r o le of t he C o m m i t t ee set up \nu n d er D i r e c t i ve 8 3 / 1 8 9 / E EC ( c f. A r t i c le 5 ( 3 ) ), t he f i e ld of \na c t i v i ty of t he A d v i s o ry C o m m i t t ee set up u n d er D i r e c t i ve \n9 0 / 3 8 5 / E EC h as b e en e x t e n d ed to the s e c t or c o v e r ed by t he \np r o p o s a l. A ny m a t t er r e l a t i ng to the i m p l e m e n t a t i on a nd \np r a c t i c al a p p l i c a t i on of t he D i r e c t i ve m ay be b r o u g ht b e f o re \nt h is C o mm i 1 1 e e. - 8 -\n\nW i th r e g a rd to t he c l a s s i f i c a t i on of m e d i c al d e v i c es into \nf o ur c l a s s es of p r o d u c ts ( s ee A r t i c l es 8 a nd 1 2 ), r e g u l a t o ry \nm e a s u r es h a ve to be laid d o wn at C o m m u n i ty level for t he \np r o d u c ts c o n c e r n e d. In v i ew of the n a t u re of t h e se m e a s u r es \na nd t he c o n s e q u e n c es as r e g a r ds the level of i n t e r v e n t i on of \nt h i rd p a r t i e s, t he m e a s u r es s h o u ld be a d o p t ed in a c c o r d a n ce \nw i th t he \" R e g u l a t o ry C o m m i t t e e\" p r o c e d u re ( v a r i a nt Ilia of \nC o u n c il D e c i s i on 8 7 / 3 7 3 / E EC of 13 J u ly 1 9 87 l a y i ng d o wn the \np r o c e d u r es for t he e x e r c i se of i m p l e m e n t i ng p o w e rs c o n f e r r ed \non t he C o m m i s s i o n ). A r t i c le 8- S a f e g u a rd c l a u se \n\nT h is A r t i c le is b a s ed on the C o u n c il R e so \n7 M ay 1 9 85 c o n c e r n i ng the n ew a p p r o a c h. ut i on of \n\nA r t i c l es 9 a nd 13 - C l a s s i f i c a t i on \n\nM e d i c al d e v. c es a re d i v i d ed into f o ur p r o d u ct c l a s s es in \no r d er to be a b le to d e c i de on the a p p r o p r i a te level of \ni n t e r v e n t i on by t he n o t i f i ed b o d i e s. T he c l a s s i f i c a t i on \nr u l es set o ut in A n n ex 9 e n a b le m a n u f a c t u r e rs to c l a s s i fy \nt h e ir p r o d u c ts a c c o r d i ng to the r e l e v a nt c l a s s. W h e re t h e re \nis d o u b t, m a n u f a c t u r e rs m ay c o n t a ct the c o m p e t e nt \na u t h o r i t i es w h i c h, for t h e ir p a r t, m a y, if n e c e s s a r y, \ni n i t i a te t he C o m m u n i ty d e c i s i o n - m a k i ng p r o c e s s. D e c i s i o ns m ay h a ve to be t a k en w i th r e g a rd to t he \nc l a s s i f i c a t i on of m e d i c al d e v i c es in p a r t i c u l ar w h e r e: \n\nt he c l a s s i f i c a t i on r u l es and the C o m m i s s i on g u i d e l i n es do \nnot e n a b le a s t r a i g h t f o r w a rd c l a s s i f i c a t i on to be made-, \n\nt he e x p e r i e n ce o b t a i n ed w i th s p e c i f ic f a m i l i es of \np r o d u c ts j u s t i f i es a r e c l a s s i f i c a t i on by w ay of \nd e r o g a t i on f r om the c l a s s i f i c a t i on r u l e s; \n\nt he c l a s s i f i c a t i on r u l es n e ed to be a d j u s t ed in t he light \nof t e c h n i c al d e v e l o p m e nt a n d / or e x p e r i e n ce w i th g i v en \nd ev i c es. - 9 -\n\nA r t i c le 10 - I n f o r m a t i on on i n c i d e n ts o c c u r r i ng f o l l o w i ng \np l a c i ng of d e v i c es on t he m a r k et \n\nT h is A r t i c le s e ts up a C o m m u n i ty w a r n i ng s y s t em r e g a r d i ng \ni n c i d e n ts o c c u r r i ng w i th d e v i c es a l r e a dy p l a c ed on t he \nm a r k e t. T h is s y s t em w i ll e n a b le t he M e m b er S t a t es to t a ke \na p p r o p r i a te m e a s u r es e a r ly on w h e re an i n c i d e nt s u g g e s ts \nt h a t, b e c a u se of a d e s i gn or m a n u f a c t u r i ng f a u l t, a d e v i ce \nm ay s e r i o u s ly d a m a ge t he h e a l th of p a t i e n ts or u s e r s. T he o b l i g a t i o ns on m a n u f a c t u r e rs to n o t i fy c e r t a in i n c i d e n ts \na re set o ut in A n n ex 2, p o i nt 3. 1, A n n ex 4, p o i nt 3, A n n ex \n5, p o i nt 3. 1, a nd A n n ex 6, p o i nt 3. 1. E a ch M e m b er S t a te m u st \nset up a c e n t r al u n it to r e c o rd and e v a l u a te t he r e p o r ts \no b t a i n e d. W h e re m e a s u r es h a ve to be t a k en by t he n a t i o n al \na u t h o r i t i e s, t he M e m b er S t a te c o n c e r n ed m u st i n f o rm t he \no t h er M e m b er S t a t es a nd the C o m m i s s i o n. A r t i c le 1 1r A n n e x es 2 to 7 - C o n f o r m i ty a s s e s s m e nt \np r o c e d u r es \n\nS u i t a b le c o n f o r m i ty a s s e s s m e nt p r o c e d u r es h a ve b e en s e l e c t ed \nf r om a m o ng t h o se a d o p t ed in C o u n c il D e c i s i on 9 0 / 6 8 3 / E EC of \n13 D e c e m b er 1 9 90 a nd s u p p l e m e n t ed a c c o r d i ng to s e c t o r al \nr e q u i r e m e n t s. to t he d o c u m e n t a t i on r e q u i r e d, the s a f e ty of c o m b i n ed \nd e v i c e s, s t e r i l i z a t i on p r o c e d u r es and c l i n i c al d a t a. T he \nf o l l o w i ng p r o c e d u r es a p p ly to the four c l a s s es of d e v i c e s: \n\nT he m i n or a d d i t i o ns m a de r e f er in p a r t i c u l ar \n\nC I a ss I \n\nt he m a n u f a c t u r er a l o ne is r e s p o n s i b le for the \na s s e s s m e nt of c o n f o r m i ty ( m o d u le A of C o u n c il \nD e c i s i on 9 0 / 6 8 3 / E E C) \n\nC I a ss I I a t he m a n u f a c t u r er h i m s e lf is r e s p o n s i b le for \n\na s s e s s i ng the p r o d u ct d e s i g n. T he \ni n t e r v e n t i on of a n o t i f i ed b o dy is r e q u i r ed \nat t he p r o d u c t i on s t a ge ( m o d u le A c o m b i n ed \nw i th e i t h er m o d u l es D, E or F ). F u r t h e r m o r e, \nt he m a n u f a c t u r er m ay opt for full q u a l i ty \na s s u r a n ce ( m o d u le H ), a l t h o u gh t he p r o c e d u re \ns p e c i f i ed in that m o d u le is m o re r e s t r i c t i ve \nt h an t h o se m e n t i o n ed a b o v e. - 10 -\n\nC I a ss I I b \n\n- \n\nC l a ss I I I \n\nt he d e s i gn and m a n u f a c t u re of t he p r o d u ct \nm u st be r e f e r r ed to a n o t i f i ed b o d y. T he \nm a n u f a c t u r er m ay f o l l ow e i t h er t he full \nq u a l i ty a s s u r a n ce p r o c e d u re ( m o d u le H) or \ns u b m it a p r o t o t y pe for t y p e - e x a m i n a t i on \n( m o d u le B ). In the c a se of t he l a t t e r, t he \nm a n u f a c t u r er m u st a l so a p p ly o ne of t he \np r o c e d u r es r e f e r r ed to in m o d u l es D, E or F \n\nt he p r o c e d u r es a re b r o a d ly t he s a me as t h o se \nset out for C l a ss M b. H o w e v e r, if full \nq u a l i ty a s s u r a n ce is a p p l i ed ( m o d u le H) t he \nf i le r e l a t i ng to the p r o d u ct d e s i gn m u st be \ne x a m i n e d. F u r t h e r m o r e, r e g a r d l e ss of t he \np r o c e d u re f o l l o w ed the d e s i gn f i le m u st as a \ng e n e r al r u le i n c l u de an a s s e s s m e nt of \nc o n f o r m i ty b a s ed on c l i n i c al d a ta ( s ee \nA n n ex 1 0, po i nt 1. 1 ). T he m a n u f a c t u r e r s' c h o i ce of s e v e r al p r o c e d u r es w i ll m a ke it \np o s s i b le to s e l e ct the m o st a p p r o p r i a te p r o c e d u re t a k i ng \na c c o u nt in p a r t i c u l ar of the p r e - e x i s t i ng r e g u l a t o ry s y s t em \na nd t he n a t u re and s i ze of the c o m p a n y. 10 \n\nA r t i c le 12 - A s s e m b ly and s t e r i l i z a t i on \n\nT h is A r t i c le r e f e rs to a s s e m b ly and s t e r i l i z a t i on a c t i v i t i es \nc a r r i ed o ut c o m m e r c i a l l y. It a p p l i es to d e v i c es a l r e a dy \nb e a r i ng t he CE m a r k. T he p e r s on w ho c a r r i es o ut t he \na c t i v i t i es c o n c e r n ed is not c o n s i d e r ed to be the \nm a n u f a c t u r er as l e g a l ly d e f i n ed w h e re t he a c t i v i t i es a re \nc a r r i ed o ut in a c c o r d a n ce w i th the m a n u f a c t u r e r 's \ni nst r u ct i o n s. If, h o w e v e r, a s s e m b ly and s t e r i l i z a t i on go b e y o nd the l i m i ts \nlaid d o wn by t he m a n u f a c t u r er of the d e v i c e s, t h ey a re \ns p e c i f ic m a n u f a c t u r i ng a c t i v i t i es w h i ch a re t h en s u b j e ct to \nt he p r o c e d u r es set out in A r t i c le 1 0. T he p r o c e d u r es r e f e r r ed to in A r t i c le 11 a p p ly r e g a r d l e ss of \nt he c l a s s i f i c a t i on of the d e v i c e. - 11 -\n\n1 1\u2022 \n\nA r t i c le 14 - R e g i s t r a t i on of p e r s o ns r e s p o n s i b le for p l a c i ng \nd e v i c es on t he m a r k et \n\nT h is A r t i c le a p p l i es to d e v i c es w h i ch a re not s u b j e ct to \ni n s p e c t i on by a n o t i f i ed b o dy b e f o re b e i ng p l a c ed on t he \nm a r k e t. T h e se a re the C l a ss I d e v i c es and c u s t o m - m a de \nd e v i c e s. For t h e se d e v i c e s, the m a n u f a c t u r er or p e r s o n ( s) \nr e s p o n s i b le for p l a c i ng t h em on the m a r k et m u st I n f o rm the \nc o m p e t e nt a u t h o r i t i es of t he a d d r e ss of t h e ir r e g i s t e r ed \np l a ce of b u s i n e ss and the c a t e g o ry of d e v i c es c o n c e r n e d. T h is n o t i f i c a t i on e n a b l es the M e m b er S t a t es to h a ve b e t t er \nc o n t r ol of t he d e v i c es in q u e s t i on w h i ch a re m a r k e t ed in \nt h e ir t e r r i t o ry a n d, if n e c e s s a r y, to t a ke a p p r o p r i a te \nm e a s u r es. 12 \n\nA r t i c le 15 - C l i n i c al i n v e s t i g a t i on \n\nC l i n i c al i n v e s t i g a t i o ns m ay be n e c e s s a ry in o r d er to c o n f i rm \nthat a d e v i ce f u l ly c o m p l i es w i th the e s s e n t i al \nr e q u i r e m e n t s. T he c o m p e t e nt a u t h o r i t i es of e a ch M e m b er S t a te \nin w h i ch t he i n v e s t i g a t i o ns a re c a r r i ed o ut m u st be a b le to \ni n t e r v e n e, if n e c e s s a r y, to p r o t e ct the h e a l th of p a t i e n ts \nand p u b l ic o r d e r. A r t i c le 1 4, p a r a g r a ph 2, lays d o wn a t a c it \na p p r o v al p r o c e d u re for i m p l a n t a b le and o t h er d e v i c es in \nC l a ss I I I. T he r i g ht of i n t e r v e n t i on of the c o m p e t e nt a u t h o r i t i es is \nc e n t r ed on c o n s i d e r a t i o ns of p u b l ic h e a l th a nd p u b l ic o r d e r. For t h is r e a s o n, i n t e r v e n t i on by the a u t h o r i t i es d o es not \ni n c l u de a p r e l i m i n a ry e v a l u a t i on of o t h er a s p e c ts w h i ch a re \nt he s u b j e ct of the c o n f o r m i ty a s s e s s m e nt p r o c e d u r e s. T he \nr o le of an e t h i cs c o m m i t t ee in t h is c o n t e xt is to e v a l u a te \nt he a c c e p t a b i l i ty of the p l an of i n v e s t i g a t i o ns f r om t he \nv i e w p o i nt of p a t i e nt h e a l th and e t h i c al c o n s i d e r a t i o n s. T he c o m p e t e nt a u t h o r i t i es a re not b o u nd by t he o p i n i on \ne x p r e s s ed by an e t h i cs c o m m i t t e e. H o w e v e r, s u ch an o p i n i on \nm ay m a ke it e a s i er for t h em to e x a m i ne the f i l e. 1 3. A r t i c l es 16 to 19 - N o t i f i ed bodies,, EC m a rk \n\nT h e se a re A r t i c l es t y p i c al of t he new a p p r o a ch d i r e c t i v es \n\n\f- 12 -\n\n1 4. A r t i c le 20 - C o n f i d e n t i a l i ty \n\nT he o b s e r v a n ce of c o n f i d e n t i a l i ty is e s s e n t i al for t he \np r o t e c t i on of s p e c i f ic d a ta and b e c a u se of t he e c o n o m ic \nimpact of t he p r o c e d u r es for the p a r t i es c o n c e r n e d. 1 5. A r t i c le 21 - G u i d e l i n es \n\nT he d o c u m e n ts r e f e r r ed to in the g u i d e l i n es a re b a s ed on the \np r a c t i ce f o l l o w ed w i th r e g a rd to m e d i c i n al p r o d u c ts as set \no ut in D i r e c t i ve 8 9 / 3 4 1 / E E C. T he g u i d e l i n es m ay p r o v i de \nu s e f ul i n f o r m a t i on for the a p p l i c a t i on of the d i r e c t i v e, \na l t h o u gh t h ey do not t h e m s e l v es h a ve a ny legal f o r c e. T h ey \nw i ll c o v er a s p e c ts that a re not d e a lt w i th in h a r m o n i z ed \ns t a n d a r d s. 16 \n\nA r t i c le 22 - R e p e al and a m e n d m e nt of D i r e c t i v es \n\nD i r e c t i ve 7 6 / 7 6 4 / E EC c o v e rs mer cur y - i n - gI a ss t h e r m o m e t e r s. It is an o p t i o n al D i r e c t i v e. T he p r o d u c ts and f e a t u r es \nc o n c e r n ed a re c o v e r ed by the s c o pe of t h is d i r e c t i v e. T he a m e n d m e nt of D i r e c t i ve 8 4 / 5 3 9 / E EC r e s t r i c ts its s c o pe to \ne l e c t r o - m e d i c al e q u i p m e nt u s ed in v e t e r i n a ry m e d i c i n e. E q u i p m e nt u s ed in h u m an m e d i c i ne is c o v e r ed by t h is \np r o p o sa I. T he p u r p o se of a m e n d i ng D i r e c t i ve 9 0 / 3 8 5 / E EC is to a dd to \nthat D i r e c t i ve t he g e n e r al p r o v i s i o ns in t h is p r o p o s al so as \nto a p p ly t h em to all m e d i c al d e v i c e s. T he e x i s t i ng \np r o v i s i o ns of D i r e c t i ve 9 0 / 3 8 5 / E EC a re not a f f e c t e d. T he \na m e n d m e n ts w i ll t h e r e f o re not h a ve any e f f e ct on t he \nt r a n s p o s i t i on of the a b o v e m e n t i o n ed D i r e c t i v e. 1 7. A r t i c le 23 - I m p l e m e n t a t i o n, t r a n s i t i o n al p r o v i s i o ns \n\nA r t i c le 2 3, p a r a g r a ph 4, p r o v i d es for the o p t i o n al \na p p l i c a t i on of t he d i r e c t i ve up to J u ne 1 9 97 to m e d i c al \nd e v i c es w h i ch m u st u n d e r go c e r t i f i c a t i on by a t h i rd p a r t y. T h is p e r i od is n e c e s s a ry in o r d er to a v o id t he a d d i t i o n al \nc e r t i f i c a t i on w o r k l o ad w h i ch w o u ld a r i se w i th a s h o r t er \nt r a n s i t i o n al p e r i o d. To a v o id the u n n e c e s s a ry r e p e t i t i on of \nt e s ts a nd v e r i f i c a t i o n s, A r t i c le 2 3, p a r a g r a ph 3, s t a t es \nt h at t he n o t i f i ed b o d i es m u st t a ke a c c o u nt of t he r e s u l ts of \nt e s ts a nd v e r i f i c a t i o ns a l r e a dy c a r r i ed out u n d er p r e \ne x i s t i ng n a t i o n al r e g u l a t i o n s. - 13 -\n\n1 8. A n n ex 1 - E s s e n t i al r e q u i r e m e n ts \n\nT h is A n n ex is l a r g e ly b a s ed on D i r e c t i ve 9 0 / 3 8 5 / E E C. 1 9. A n n ex 8 - P r o c e d u r es for d e v i c es for s p e c i al p u r p o s es \n\nT he p r o c e d u r es and s t a t e m e n ts r e f e r r ed to in t h is A n n ex \na p p ly to c u s t o m - m a de d e v i c es and d e v i c es i n t e n d ed for \nc l i n i c al i n v e s t i g a t i o n s. a d o p t ed in the C o u n c il D i r e c t i ve r e l a t i ng to a c t i ve \ni m p l a n t a b le m e d i c al d e v i c e s. T h ey are b a s ed on t he s o l u t i on \n\n2 0. A n n ex 9 - C l a s s i f i c a t i on r u l es \n\nT h is A n n ex lays d o wn the r u l es for the c l a s s i f i c a t i on of \nm e d i c al d e v i c es for the a p p l i c a t i on of the c o n f o r m i ty \na s s e s s m e nt p r o c e d u r e s. T he c o n c e pt of c l a s s i f i c a t i on is \ne s s e n t i a l ly b a s ed on the v u l n e r a b i l i ty of the h u m an b o dy \nf o l l o w i ng the u se of a m e d i c al d e v i c e. a c c o u nt of the c o n s e q u e n c es of f u n c t i o n al d e f e c ts in m e d i c al \nd e v i c e s. a re as f o i l o w s: \n\nT he b a s ic c r i t e r ia for the c l a s s i f i c a t i on r u l es \n\nIt a l so t a k es \n\nc o n t a ct or i n t e r a c t i on of a d e v i ce w i th the h u m an b o d y; \nc o n t a ct w i th i n j u r ed skin-, \nthe i n v a s i ve n a t u re of a d e v i ce w i th r e g a rd to t he \no r i f i c es of the h u m an b o dy or of a s u r g i c al d e v i c e; \ni m p l a n t a t i on of a d e v i ce in the b o d y; \nc o n t a ct w i th v i t al o r g a ns ( h e a r t, c e n t r al n e r v o us \ns y s t e m) ; \nthe d e l i v e ry of e n e r gy or s u b s t a n c es into or o n to the \nb o dy. On the a b o ve b a s i s, d e v i c es w h i ch do not e n t er into c o n t a ct \nor i n t e r a ct w i th the b o dy a re g e n e r a l ly c l a s s i f i ed in C l a ss \nI. D e v i c es w h i ch a re i n v a s i ve or i m p l a n t a b le or w h i ch i n t e r a ct \nw i th the b o dy a re l a r g e ly ( a p a rt from c e r t a in p a r t i c u l ar \na s p e c t s) in C l a ss Ma or \n\nM b. - 14 -\n\nA s m a ll n u m b er of d e v i c es c o n c e r n i ng in p a r t i c u l ar the \nf u n c t i o ns of v i t al o r g a ns a re in C l a ss I I I. D e v i c es w h i ch \na re a c t i v a t ed by an e n e r gy s o u r ce and w h i ch in p r i n c i p le \ns h o u ld be in C l a ss III a re a l r e a dy c o v e r ed by the D i r e c t i ve \nr e l a t i ng to a c t i ve i m p l a n t a b le m e d i c al d e v i c e s. T he \np r o v i s i o ns of that D i r e c t i ve c o r r e s p o nd to t h o se laid d o wn \nfor CI a ss I I I d ev i c e s. 21 \n\nA n n ex 10 - C l i n i c al e v a l u a t i on \n\nA n n ex 10 h as b e en a d o p t ed f r om the D i r e c t i ve r e l a t i ng to \na c t i ve i m p l a n t a b le m e d i c al d e v i c e s. It s p e c i f i es the s u b j e ct \nof t he c l i n i c al d a ta and the p r o c e d u r es to be f o l l o w ed for \no b t a i n i ng the d a t a. C l i n i c al e v a l u a t i on is c a r r i ed out u n d er \nt he m a n u f a c t u r e r 's r e s p o n s i b i l i t y. It m ay be a f e a t u re \nr e q u i r ed in the t e c h n i c al d o c u m e n t a t i on r e f e r r ed to in the \nc o n f o r m i ty a s s e s s m e nt p r o c e d u r e s. c o n t a i n ed in t h is A n n ex w i ll a v o id r e p e t i t i on of the s a me \nc l i n i c al i n v e s t i g a t i o ns in m o re t h an o ne M e m b er S t a t e. T he h a r m o n i z ed p r o v i s i o ns \n\n2 2. A n n e x es 11 a nd 12 - M i n i m um c r i t e r ia for the n o t i f i ed \nbod i es. EC m a rk \n\nT h e se a re A n n e x es t y p i c al of the n ew a p p r o a ch d i r e c t i v e s. - 15 -\n\nProposal for a \n\nCOUNCIL DIRECTIVE \n\nconcerning medical devices \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES \n\nHaving regard to the Treaty establishing the European Economic Community, \n\nand in particular Article 100a thereof, \n\nHaving regard to the proposal from the Commission^), \n\nIn cooperation with the European Par Iiament^2), \n\nHaving regard to the opinion of the Economic and Social Committee^3), \n\nWhereas measures should be adopted for the progressive establishment of the \n\ninternal market; whereas the internal market is an area without internal \n\nfrontiers in which the free movement of goods, persons, services and \n\ncapital is ensured; \n\nWhereas the content and scope of the laws, regulations and administrative \n\nprovisions in force in the Member States with regard to the safety, health \n\nprotection and performance characteristics of medical devices are \n\ndifferent; whereas the certification and inspection procedures for such \n\ndevices differ from one Member State to another; whereas such disparities \n\nconstitute barriers to trade within the Community-, \n\nWhereas the national provisions for the safety and health protection of \n\npatients, users and, where appropriate, other persons, with regard to the \n\nuse of medical devices should be harmonized in order to guarantee the free \n\nmovement of such devices within the internal market; \n\n(1) OJ No C \n(2) OJ No C \n(3) OJ No C \n\n\f- 16 -\n\nWhereas the harmonized provisions must be distinguished from the measures \n\nadopted by the Member States to manage the funding of public health and \n\nsickness insurance schemes relating directly or Indirectly to such devices; \n\nwhereas, therefore, these provisions do not affect the ability of the \n\nMember States to implement the abovementioned measures provided Community \n\nlaw is complied with; \n\nWhereas medical devices should provide patients, users and third parties \n\nwith a high level of protection and attain the performance levels \n\nattributed to them by the manufacturer; whereas, therefore, the \n\nmaintenance or improvement of the level of protection attained in the \n\nMember States is one of the essential objectives of this Directive; \n\nWhereas certain medical devices are intended to administer medicinal \n\nproducts \n\nwithin \n\nthe meaning \n\nof \n\nCouncil \n\nDirective 65/65/EEC of \n\n26 January 1965 on the approximation of provisions laid down by law, \n\nregulation or administrative action relating to proprietary medicinal \n\nproducts^4), as last amended by Directive 89/381/EEC^5^; whereas, in \n\nsuch cases the placing of the medicinal product on the market is governed \n\nby Directive 65/65/EEC; whereas a distinction must be drawn between the \n\nabovementioned devices and medical devices incorporating, \n\ninter \n\nalia, \n\nsubstances which, if used separately, may be considered to be a medicinal \n\nsubstance within the meaning of Directive 65/65/EEC; whereas, in such \n\ncases, if the substances are incorporated in the medical devices to help \n\nthem operate, the placing of the devices on the market is governed by this \n\nDirective; whereas, in this context, in the event of the bioavailability \n\nof such substances, the safety, quality and usefulness of the substances \n\nmust be verified by analogy with the appropriate methods specified in \n\nCouncil Directive 75/318/EEC of 20 May 1975 on the approximation of the \n\nlaws of the Member States relating to analytical, pharmaco-toxicological \n\nand clinical standards and protocols in respect of the testing of \n\nproprietary medicinal \n\nproducts*6^, as last amended by Directive \n\n89/341/EEC<7), \n\n(4) OJ No L 22, 9. 2. 1965, p. 369/65. (5) OJ No L 181, 28. 6. 1989, p. 44. (6) OJ No L 147, 9. 6. 1975, p. 1. (7) OJ No L 142, 25. 5. 1989, p. 11. - 17 -\n\nWhereas, in accordance with the principles set out in the Council \n\nResolution of 7 May 1985 concerning a new approach to technical \n\nharmonization and standardization<8), rules regarding the design and \n\nmanufacture of medical devices must be confined to the provisions required \n\nto meet the essential requirements; whereas, because they are essential, \n\nsuch requirements should replace the corresponding national provisions; \n\nwhereas the essential requirements should be applied with discrimination to \n\ntake account of the technological level existing at the time of design and \n\nof technical and economic considerations; \n\nWhereas Council Directive 90/385/EEC of 20 June 1990 on the approximation \n\nof the laws of the Member States relating to active implantable medical \n\ndevices^9) is the first case of application of the new approach to the \n\nfield of medical devices; whereas in the interest of uniform Community \n\nrules applicable to all medical devices, this Directive is based largely on \n\nthe provisions of Directive 90/385/EEC; whereas, for the same reasons, \n\nDirective 90/385/EEC must be amended to insert the general provisions laid \n\ndown in this D i rect i ve; \n\nWhereas the electromagnetic compatibility aspects form an integral part of \n\nthe safety of medical devices; whereas this Directive should contain \n\nspecific rules on this subject with regard to Council Directive 89/336/EEC \n\nof 3 May 1989 on the approximation of the laws of the Member States \n\nrelating to electromagmetic compatibiIity(1\u00b0), as amended by Directive \n\n91/263/EEC<1D \n\nWhereas this Directive should include requirements regarding the design and \n\nmanufacture of devices emitting ionizing radiation-, whereas this Directive \n\ndoes \n\nnot \n\naffect \n\nthe \n\nauthorization \n\nrequired \n\nby \n\nCouncil \n\nDirective 80/836/Euratom of 15 July 1980 amending the Directives laying \n\ndown the basic safety standards for the health protection of the general \n\npublic and workers against the dangers of ionizing radi\u00e2tion^12), as \n\namended by Directive 84/467/Euratom(13), nor application of Council \n\nDirective 84/446/Euratom of 3 September 1984 laying down basic measures for \n\n(8) OJ No C 136, 4. 6. 1985, p. 1. (9) OJ No L 189, 20. 7. 1990, p. 17. (10) OJ No L 139, 23. 5. 1989, p. 19. (11) OJ No L 128, 23. 5. 1991, p. 1. (12) OJ No L 246, 17. 9. 1980, p. 1. (13) 0J No L 265, 5. 10. 1984, p. 4. - 18 -\n\nthe radiation protection of persons undergoing medical examination or \n\ntreatmentC14). whereas Council Directive 89/391/EEC of 12 June 1989 on the \n\nintroduction of measures to encourage improvements in the safety and health \n\nof workers at work^15) and the specific directives on the same subject \n\nshould continue to apply; \n\nWhereas this Directive does not affect Council Directive 76/768/EEC of \n\n27 July 1976 on the approximation of the laws of the Member States relating \n\nto cosmetic products(16), as last amended by Direct ive 91/184/EEC(17) -, \n\nwhereas the assessment whether a product is subject to the abovementioned \n\nDirective or to this Directive must take account, in particular, of the \n\nintended purpose of the product in question and of the place of \n\napplicat ion; \n\nWhereas, in order to demonstrate conformity with these essential \n\nrequirements and to enable conformity to be verified, it is desirable to \n\nhave harmonized European standards to protect against the risks associated \n\nwith the design, manufacture and packaging of medical devices-, whereas \n\nsuch harmonized European standards are drawn up by private-1 aw bodies and \n\nshould retain their status as non-mandatory texts-, whereas, to this end, \n\nthe European Committee for Standardization (CEN) and the European Committee \n\nfor Electrotechnical Standardization (CENELEC) are recognized as the \n\ncompetent bodies for the adoption of harmonized standards in accordance \n\nwith the general guidelines on cooperation between the Commission and these \n\ntwo bodies signed on 13 November 1984; \n\nWhereas, for the purpose of this Directive, a harmonized standard is a \n\ntechnical specification (European standard or harmonization document) \n\nadopted, on a mandate from the Commission, by either or both of these \n\nbodies in accordance with Council Directive 83/189/EEC of 28 March 1983 \n\nlaying down a procedure for the provision of information in the field of \n\ntechnical standards and r\u00e9gul\u00e2tions^18), as last amended by Commission \n\nDecision 90/230/EEC^19), and pursuant to the abovementioned general \n\nguidelines; whereas with regard to possible amendment of the harmonized \n\nstandards, the Commission should be assisted by the Committee set up under \n\n(14) OJ No L 265, 5. 10. 1984, p. 1. (15) OJ No L 183, 29. 6. 1989, p. 1. (16) OJ No L 262, 27. 9. 1976, p. 169 \n(17) OJ No L 91, 12. 4. 1991, p. 59. (18) OJ No L 109, 26. 4. 1983, p. 8. (19) OJ No L 128, 18. 5. 1990, p. 15. (4) \n\n\f- 19 -\n\nDirective 83/189/EEC-, whereas the measures to be taken must be defined in \n\nline with procedure I, as laid down in Council Decision 87/373/EEC^2 0); \n\nwhereas, for specific fields, what already exists in the form of European \n\nPharmacopoeia monographs should be incorporated within the framework of \n\nthis Directive; whereas, \n\ntherefore, several \n\nEuropean \n\nPharmacopoeia \n\nmonographs may be considered equal to the abovementioned harmonized \n\nstandards; \n\nWhereas, in Decision 90/683/EEC of 13 December 1990 concerning the modules \n\nfor the various phases of the conformity assessment procedures which are \nintended to be used in the technical harmonization d i r e c t i v e s ^2Dt the \n\nCouncil has \n\nlaid down harmonized conformity assessment \n\nprocedures; \n\nwhereas the application of these modules to medical devices enables the \n\nresponsibility of manufacturers and certification bodies to be determined \n\nduring conformity assessment procedures on the basis of the type of devices \n\nconcerned; whereas the details added to these modules are justified by the \n\nnature of the verification required for medical devices-, \n\nWhereas it is necessary, essentially for the purpose of the conformity \n\nassessment procedures, to group the devices into four product classes; \n\nwhereas the classification rules are based on the vulnerability of the \n\nhuman body taking account of the potential risks associated with the \n\ntechnical design and manufacture of the devices; whereas the conformity \n\nassessment procedures for Class I devices can be carried out, as a general \n\nrule, under the sole responsibility of the manufacturers in view of the low \n\nlevel of vulnerability associated with these products; whereas, for \n\nClass lia devices, the intervention of a certification body (notified body) \n\nshould be compulsory at the production stage; whereas, for devices falling \n\nwithin Classes lib and III which, in case of malfunction, constitute a high \n\nrisk potential, inspection by a notified body is required with regard to \n\nthe design and manufacture of the devices; whereas Class III is set aside \n\nfor the most critical devices for which explicit prior authorization with \n\nregard to conformity is required for them to be placed on the market; \n\n(20) OJ No L 197, 18. 7. 1987, p. 33. (21) OJ No L 380, 31. 12. 1990, p. 13 \n\n\f- 20 -\n\nWhereas in cases where the conformity of the devices can be assessed under \n\nthe responsibility of the manufacturer the competent authorities must be \n\nable, particularly in emergencies, to contact a person responsible for \n\nplacing the device on the market and established in the Community, whether \n\nthe manufacturer or another person established in the Community and \n\ndesignated by the manufacturer for the purpose-, \n\nWhereas medical devices should, as a general rule, bear the EC mark to \n\nindicate their conformity with the provisions of this Directive to enable \n\nthem to move freely within the Community and to be put into service in \n\naccordance with their intended purpose; \n\nWhereas, in the fight against AIDS and in the light of the conclusions of \n\nthe Council adopted on 16 May 1989 regarding future activities on AIDS \n\nprevention and control at Community level^2 2), medical devices used for \n\nprotection against the HIV virus must afford a high level of protection; \n\nwhereas the design and manufacture of such products should be verified by a \n\nnot i f i ed body -, \n\nWhereas the classification rules generally enable medical devices to be \n\nappropriately classified; whereas, in view of the diverse nature of the \n\ndevices and technological progress in this field, steps must be taken to \n\ninclude amongst the implementing powers conferred on the Commission the \n\ndecisions to be taken with regard to the proper classification or \n\nreclassification of the devices or, where appropriate, the adjustment of \n\nthe classification rules themselves; whereas since these issues are \n\nclosely connected with the protection of health, it is appropriate that \n\nthese decisions should come under procedure lll(a), as provided for in \n\nDecision 87/373/EEC; \n\nWhereas it is appropriate that the Member States, as provided for by \n\nArticle 100a of the Treaty, may take temporary measures to limit or \n\nprohibit the placing on the market and the use of medical devices in cases \n\nwhere they present a particular risk to the health of persons, provided \n\nthat the measures are subject to a Community control procedure-, \n\n(22) OJ No C 185, 22. 7. 1989, p. 8. - 21 -\n\nWhereas the confirmation of compliance with the essential requirements may \n\nmean that clinical \n\ninvestigations have to be carried out under the \n\nresponsibility of the manufacturer; whereas, for the purpose of carrying \n\nout the clinical investigations, appropriate means have to be specified for \n\nthe protection of public health and public order; \n\nWhereas the application of some provisions of this Directive must be \n\nfacilitated by means of guidelines published by the Commission; \n\nWhereas the protection of health and the associated controls may be made \n\nmore effective by means of a medical device vigilance system at Community \n\nI eve I ; \n\nWhereas this Directive covers the medical devices referred to in Council \n\nDirective 76/764/EEC of 27 July 1976 on the approximation of the laws of \n\nthe \n\nMember \n\nStates \n\non \n\nclinical \n\nmercury-in-glass, \n\nmaximum \n\nreading \n\nthermometers^2 3^, as last amended by Directive 8 4 / 4 1 4 / E E C ^2 4); whereas \n\nthe abovementioned Directive must therefore be repealed; whereas for the \n\nsame reasons Council Directive 84/539/EEC of 17 September 1984 on the \n\napproximation of the laws of the Member States relating to electro-medical \n\nequipment used in human or veterinary medicine^2 5) must be amended, \n\nHAS ADOPTED THIS DIRECTIVE: \n\nArticle 1 \n\nDefinitions, scope \n\n1. This Directive shall apply to medical devices. It also covers the \n\naccessories to which the provisions for medical devices apply. 2. For the purposes of this Directive, the following definitions shall \n\napply: \n\n(23) OJ No L 262, 27. 9. 1976, p. 139. (24) OJ No L 228, 25. 8. 1984, p. 25. (25) OJ No L 300, 19. 11. 1984, p. 179 \n\n\f- 22 -\n\n(a) \n\n\"medical device\" (hereinafter referred to as \"devices\") means any \n\ninstrument, apparatus, appliance, material \n\nor other \n\narticle, \n\nincluding software, whether used alone or in combination, intended \n\nby the manufacturer to be used on human beings solely or principally \n\nfor the purpose of: \n\ndiagnosis, prevention, monitoring, treatment or alleviation of \n\ndisease, injury or handicap, \n\ninvestigation, replacement or modification of the anatomy or \n\nof a physiological process, \n\ncontrol of conception, \n\nand which does not achieve its principal intended action in or on \n\nthe human body by pharmacological, immunological or metabolic means, \n\nbut which may be assisted in its function by such means. (b) \n\n\"accessory\" means an article which, while not a device, is required, \n\naccording to the intended purpose attributed to it by the \n\nmanufacturer, to enable a device to be used as specified. (c) \n\n\"device used for \n\nin vitro \n\ndiagnosis\" means any device which is a \n\nreagent, reagent product, kit, instrument, equipment or system, \n\nwhether used alone or in combination, intended by the manufacturer \n\nto be used solely or principally \n\nin vitro \n\nfor the examination of \n\nsubstances derived from the human body with a view to providing \n\ninformation for the detection, diagnosis, control or treatment of a \n\nphysiological state, of a state of health or disease, or of a \n\ncongen i ta I abnormaI i ty. (d) \n\n\"custom-made \n\ndevice\" means any device specifically made \n\nin \n\naccordance with a duly qualified medical practitioner's written \n\nprescription which gives, under his responsibility, specific design \n\ncharacteristics and is intended to be used only for an individual \n\nnamed pat ient. The abovement ioned prescription may also be made out by any other \n\nperson authorized by virtue of his professional qualifications to do \n\nso. - 23 -\n\nMass-produced devices which need to be adapted to meet the specific \n\nrequirements of the medical practitioner or any other professional \n\nuser are not considered to be custom-made devices. (e) \n\n\"device intended for clinical investigation\" means any device \n\nintended for use by a duly qualified medical practitioner when \n\nconducting investigations as referred to in point 2. 1 of Annex 10 in \n\nan adequate human clinical environment. For the purpose of conducting clinical investigation, any other \n\nperson who, by virtue of his professional qualifications, is \n\nauthorized to carry out such investigation shall be accepted as \n\nequivalent to a duly qualified medical specialist. (f) \n\n\"implantable device\" means any device which is intended: \n\nto be totally or partially introduced into the human body or a \n\nnatural or if ice or \n\nto replace an epithelial surface or the surface of the eye \n\nby surgical intervention, which is intended to remain after the \n\nprocedure for at least 30 days, and which can only be removed by \n\nmedical or surgical Intervention. (g) \n\n\"manufacturer\" means the natural or legal person with overall \n\nresponsibility for the design, manufacture, packaging and labelling \n\nof a device before it is placed on the market on his own behalf, \n\nregardless of whether these operations are carried out by that \n\nperson himself or on his behalf by a third party. The natural or legal person who assembles, packages, processes \n\nand/or labels one or more ready-made products and/or assigns to them \n\ntheir intended purpose as a device with a view to their being placed \n\non the market on his own behalf is also considered to be a \n\nmanufacturer. This sub-paragraph does not apply to the person who, \n\nwhile not a manufacturer \n\nwithin the meaning of the first \n\nsub-paragraph, assembles or adapts devices already on the market to \n\ntheir intended purpose for an individual patient. - 24 -\n\n(h) \n\n\"intended purpose\" means the use for which the device is intended \n\nand for which it is suited according to the data supplied by the \n\nmanufacturer on the labelling, in the instructions and/or in \n\npromotional materials. (i) \n\n\"placing on the market\" means the first making available in return \n\nfor payment or free of charge of a device other than a device \n\nintended for clinical investigation, with a view to distribution \n\nand/or use on the Community market, regardless of whether it is new \n\nor fully refurbished. (j) \n\n\"putting into service\" means the stage when a device is ready for \n\nuse for the first time on the Community market for its intended \n\npurpose. (k) \n\n\"bioavailability\" means the release of a substance into or onto the \n\nhuman body in such a way that the interaction with the body can \n\nreasonably be detected. 3. Where a device is intended to administer a substance defined as a \n\nmedicinal \n\nproduct \n\nwithin \n\nthe \n\nmeaning \n\nArticle 1 \n\nof \n\nDirective 65/65/EEC, that substance shall be subject to the \n\nmarketing authorization system provided for in that Directive. 4. Where a device incorporates, as an integral part, a substance which, \n\nif used separately, may be considered to be a medicinal product \n\nwithin the meaning of Article 1 of Directive 65/65/EEC, that device \n\nmust be assessed and authorized in accordance with this Directive. 5. This Directive does not apply to: \n\n(a) \n\ndevices used for in vitro diagnosis, \n\n(b) active implantable devices covered by Directive 90/385/EEC. 6. This Directive is a specific directive within the meaning of \n\nArticle 2(2) of Directive 89/336/EEC. 7. This \n\nDirective \n\ndoes \n\nnot \n\naffect \n\nthe \n\napplication \n\nof \n\nDirective 80/836/Euratom, nor of Directive 84/466/Euratom. - 25 -\n\n8. This \n\nDirective \n\ndoes \n\nnot \n\naffect \n\nthe \n\napplication \n\nof \n\nDirective 76/768/EEC. The assessment whether a product is subject \n\nto the abovementioned Directive or to this Directive shall take \n\naccount, in particular, of the intended purpose of the product in \n\nquestion and of the place of application. Art i cle 2 \n\nPlacing on the market and putting into service \n\nMember States shall take all necessary steps to ensure that devices may be \n\nplaced on the market and put into service only if they do not compromise \n\nthe safety and health of patients, users and, where applicable, other \n\npersons when properly installed, maintained and used in accordance with \n\ntheir intended purpose. Art i cle 3 \n\nEssential reguirements \n\nThe devices must meet the essential requirements set out in Annex 1 which \n\napply to them, taking account of the intended purpose of the devices \n\nconcerned. Art i cle 4 \n\nFree movement, devices intended for special purposes \n\n1. Member States shall not create any obstacles to the placing on the \n\nmarket or the putting into service within their territory of devices \n\nbear ing the EC mark. 2. Member States shall not create any obstacles to: \n\ndevices \n\nintended \n\nfor clinical \n\ninvestigation being \n\nmade \n\navailable to medical specialists or authorized persons for \n\nthat purpose if they meet the conditions laid down in \n\nArticle 15 and in Annex 8. - 26 -\n\ncustom-made devices being placed on the market and put into \n\nservice if they meet the conditions laid down in Article 11 in \n\ncombination with Annex 8-, Class M a, lib and III devices shall \n\nbe accompanied by the statement referred to in Annex 8. These devices shall not bear the EC mark. 3. At trade fairs, exhibitions, demonstrations, etc. Member States \n\nshall not create any obstacles to the showing of devices which do \n\nnot conform to this Directive, provided that a visible sign clearly \n\nindicates that such devices cannot be marketed or put into service \n\nuntil they have been made to comply. 4. Member States may require the information referred to in points 13. 3 \n\nand 13. 6 of Annex 1 to be in their national language(s) when a \n\ndevice reaches the final user, regardless of whether it is for \n\nprofessional or other use. Art icle 5 \n\nReference to standards \n\n1. Member \n\nStates \n\nshall \n\npresume \n\ncompliance \n\nwith \n\nthe \n\nessential \n\nrequirements referred to in Article 3 in respect of devices which \n\nare in conformity with the relevant provisions of the harmonized \n\nstandards, the references of which have been published in the \n\nOfficial Journal of the European Communities. Member States shall \n\npublish the references of the national standards which transpose the \n\nabovementioned harmonized standards into national law. 2. For the purposes of this Directive, reference to harmonized \n\nstandards also includes the monographs of the European Pharmacopoeia \n\non surgical sutures and on interaction between medicinal products \n\nand materials used as containers for devices, the references of \n\nwhich have been published in the Official Journal of the European \n\nCommun i t i es. - 27 -\n\n3. Where the Commission, whether on its own initiative or at the \n\nrequest of one of the Member States, considers that the harmonized \n\nstandards do not entirely meet the essential requirements referred \n\nto in Article 3, the measures to be taken by the Member States with \n\nregard to these standards and the publication referred to in \n\nparagraph 1 of this Article shall be adopted by the procedure \n\ndefined in Article 6 ( 2 ). Article 6 \n\nCommittee on Standards and Technical Regulations \n\n1. The Commission shall be assisted by the committee set up by \n\nArticle 5 of Directive 83/189/EEC. 2. The representative of the Commission shall submit to the committee a \n\ndraft of the measures to be taken. The committee shall deliver its \n\nopinion on the draft, within a time limit which the chairman may lay \n\ndown according to the urgency of the matter, if necessary by taking \n\na vote. The opinion shall be recorded in the minutes-, in addition, each \n\nMember State shall have the right to ask to have its position \n\nrecorded in the minutes. The Commission shall take the utmost account of the opinion \n\ndelivered by the committee. It shall inform the committee of the \n\nmanner in which its opinion has been taken into account. Art icle 7 \n\nCommittee on Medical Devices \n\n1. The Commission shall be assisted by the committee set up by \n\nArticle 6(2) of Directive 90/385/EEC. - 28 -\n\n2. The representative of the Commission shall submit to the committee a \n\ndraft of the measures to be taken. The committee shall deliver its \n\nopinion on the draft within a time limit which the chairman may lay \n\ndown according to the urgency of the matter. The opinion shall be \n\ndelivered by the majority laid down in Article 148(2) of the Treaty \n\nin the case of decisions which the Council is required to adopt on a \n\nproposal from the Commission. The votes of the representatives of \n\nthe Member States within the committee shall be weighted in the \n\nmanner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in \n\naccordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of \n\nthe committee, or if no opinion is delivered, the Commission shall, \n\nwithout delay, submit to the Council a proposal relating to the \n\nmeasures to be taken. The Council shall act by a qualified \n\nmajor ity. If, on the expiry of a period of three months from the date of \n\nreferral to the Council, the Council has not acted, the proposed \n\nmeasures shall be adopted by the Commission. 3. The committee may examine any question connected with implement ion \n\nof this Direct ive. Art icle 8 \n\nSafeguard clause \n\n1. Where a Member State ascertains that the devices, when correctly \n\ninstalled, maintained and used for their intended purpose, may \n\ncompromise the health and/or safety of patients, users or, where \n\napplicable, other persons, it shall take all appropriate interim \n\nmeasures to withdraw such devices from the market or prohibit or \n\nrestrict their being placed on the market or put into service. The Member State shall immediately inform the Commission of any such \n\nmeasures, \n\nindicating \n\nthe reasons for \n\nits decision \n\nand, \n\nin \n\nparticular, whether non-compliance with this Directive is due to: \n\n\f- 29 -\n\n(a) failure to meet the essential requirements referred to in \n\nArt icle 3; \n\n(b) \n\nincorrect application of the standards referred to in \n\nArticle 5, in so far it is claimed that the standards have \n\nbeen applied; \n\n(c) shortcomings in the standards themselves. These measures are applicable until the entry into force of the act \n\nprovided for in paragraph 2. 2. The measures adopted under paragraph 1 shall be confirmed and \n\nextended, possibly amended, to the whole Community or repealed by an \n\nact of the Commission. However, where the measures were adopted under paragraph 1 on the \n\nground of a shortcoming in the standards provided for in Article 5, \n\nthe procedure laid down in Article 6(2) is applicable. 3. Where a non-complying device bears the EC mark, the competent \n\nMember State shall take appropriate action against whomsoever has \n\naffixed the mark and shall inform the Commission and the other \n\nMember States thereof. 4. The Commission shall ensure that the Member States are kept informed \n\nof the progress and outcome of this procedure. Art icle 9 \n\nClassification \n\n1. Devices shall be divided into Classes I, lia, Mb and III. Classification shall be carried out in accordance with the \n\nclassification rules set out in Annex 9. - 30 -\n\n2. Where there is doubt over the classification resulting from \n\napplication of the rules contained in Annex 9, the manufacturer or \n\nhis authorized representative established in the Community may ask \n\nthe competent authorities to take a decision. In the event of a \n\ndispute between the manufacturer and the notified body concerned \n\ndefined in Article 16 resulting from the application of the \n\nabovementioned rules, the latter shall refer the matter to the \n\ncompetent authorities who will reach a decision. 3. The classification rules set out in Annex 9 may be adapted in \n\naccordance with the procedure referred to in Article 7(2) in the \n\nlight of technical progress and any information which becomes \n\navailable under the information system provided for in Article 10. Art icle 10 \n\nInformation on incidents occurring following placing \n\nof devices on the market \n\n1. Member States shall take the necessary steps to ensure that any \n\ninformation brought to their knowledge, in accordance with the \n\nprovisions of this Directive, regarding the incidents mentioned \n\nbelow involving a Class M a, Mb or III device is recorded and \n\nevaluated in a centralized manner: \n\n(a) \n\nany deterioration in the characteristics and/or performance of \n\na device, as well as any inaccuracies in the labelling or the \n\ninstruction leaflet which might lead to or might have led to \n\nthe death of a patient or user or to a serious deterioration \n\nin his state of health; \n\n(b) \n\nany technical or medical reason connected with the device \n\nleading to systematic recall of devices of the same type by \n\nthe manufacturer. - 31 -\n\n2. Where a Member State obliges medical practitioners or the medical \n\ninstitutions to inform the competent authorities of any incidents \n\nreferred to in paragraph 1, it shall take the necessary steps to \n\nensure that the manufacturer of the device concerned, or his \n\nauthorized representative established in the Community, is also \n\ninformed of the incident. 3. After carrying out an assessment, if possible together with the \n\nmanufacturer, Member States shall, without prejudice to Article 8, \n\nimmediately inform the Commission and the other Member States of the \n\nincidents referred to in paragraph 1 for which relevant measures \n\nhave been taken or are contemplated. 4. The Commission shall adopt the necessary measures concerning the \n\nfunctioning of the information system referred to in paragraphs 1, 2 \n\nand 3 and the presentation of information. Article 11 \n\nConformity assessment procedures \n\n1. In the case of devices failing within Class III, other than devices \n\nwhich are custom-made or intended for clinical investigations, the \n\nmanufacturer shall, in order to affix the EC mark, either: \n\n(a) \n\nfollow the procedure relating to the EC declaration of \n\nconformity set out in Annex 2 (full quality guarantee), or \n\n(b) \n\nfollow the procedure relating to EC type-examination set out \n\nin Annex 3, coupled with: \n\n(i) the procedure relating to EC verification set out in \n\nAnnex 4, or \n\n(ii) the procedure relating to the EC declaration of \n\nconformity set out \n\nin Annex 5 (production quality \n\nguarantee). - 32 -\n\n2. In the case of devices falling within Class M a, other than devices \n\nwhich are custom-made or intended for clinical investigations, the \n\nmanufacturer shall, in order to affix the EC mark, follow the \n\nprocedure relating to the EC declaration of conformity set out in \n\nAnnex 7, coupled with either: \n\n(a) the procedure relating to EC verification set out in Annex 4, \n\nor \n\n(b) the procedure relating to the EC declaration of conformity set \n\nout in Annex 5 (production quality guarantee), or \n\n(c) the procedure relating to the EC declaration of conformity set \n\nout in Annex 6 (product quality guarantee). Instead of applying these procedures, the manufacturer may also \n\nfollow the procedure referred to in paragraph 3(a). 3. In the case of devices falling within Class lib, other than devices \n\nwhich are custom-made or intended for clinical investigations, the \n\nmanufacturer shall, in order to affix the EC mark, either: \n\n(a) follow the procedure relating to the EC declaration of \n\nconformity set out in Annex 2 (full quality guarantee); in \n\nthis case, point 4 of Annex 2 is not applicable-, or \n\n(b) follow the procedure relating to EC type-examination set out \n\nin Annex 3, coupled with: \n\n(i) the procedure relating to EC verification set out in \n\nAnnex 4, or \n\n(ii) the procedure relating to the EC declaration of \n\nconformity set out in Annex 5 (production quality \n\nguarantee), or \n\n( M i) \n\nthe procedure relating to the EC declaration of \n\nconformity set out in Annex 6 (product quality \n\nguarantee). - 33 -\n\n4. In the case of devices falling within Class I, other than devices \n\nwhich are custom-made or intended for clinical investigations, the \n\nmanufacturer shall follow the procedure referred to in Annex 7 and \n\ndraw up the EC declaration of conformity required before placing the \n\ndevice on the market. 5. In the case of custom-made devices, the manufacturer shall follow \n\nthe procedure referred to in Annex 8 and draw up the statement set \n\nout in that Annex before placing each device on the market. 6. During the conformity assessment procedure for a device, the \n\nmanufacturer and/or the notified body shall take account of the \n\nresults of any assessment and verification operations which, where \n\nappropriate, have been carried out in accordance with this Directive \n\nat an intermediate stage of manufacture. 7. The manufacturer \n\nmay \n\ninstruct \n\nhis authorized \n\nrepresentative \n\nestablished in the Community to initiate the procedures provided for \n\nin Annexes 3, 4, 7 and 8. 8. Where the conformity assessment procedure involves the intervention \n\nof \n\na notified \n\nbody, \n\nthe manufacturer, \n\nor \n\nhis \n\nauthorized \n\nrepresentative established in the Community, may apply to a body of \n\nhis choice within the framework of the tasks for which the body has \n\nbeen not i f ied. 9. Decisions taken by the notified bodies in accordance with Annexes 2 \n\nand 3 shall be valid for a maximum of five years and may be extended \n\non application for further periods of five years. 10. The records and correspondence relating to the procedures referred \n\nto in paragraphs 1 to 5 shall be in an official language of the \n\nMember State in which the procedures are carried out or in a \n\nlanguage acceptable to the notified body. - 34 -\n\nArt icle 12 \n\nAssembly and sterilization \n\nAny natural or legal person who assembles devices bearing the EC \n\nmark for their intended purpose and within the limits of use \n\nspecified by their manufacturers with regard to their compatibility \n\nwith other devices in order to put them on the market in the form of \n\na system, kit or operation pack shall draw up a declaration in which \n\nhe states that: \n\n(a) \n\nhe has verified the mutual compatibility of the devices which \n\nmake up the system, kit or operation pack in accordance with \n\nthe manufacturers' instructions and that assembly has been \n\ncarried out in accordance with these instructions; \n\n(b) \n\nthe system, kit or operation pack has, where applicable, been \n\npackaged in accordance with the manufacturers' instructions or \n\nthe limits applicable to the various devices; \n\n(c) \n\nall of the activities referred to in (a) and (b) are subjected \n\nto appropriate methods of control and inspection. Any such system, kit or operation pack shall not bear any additional \n\nEC mark. It shall be accompanied by the information referred to in \n\npoint \n\n13 of Annex 1 which \n\nincludes, where appropriate, the \n\ninformation supplied by the manufacturers of the devices which have \n\nbeen assembled. Any natural or legal person who, in the framework of an activity \n\nreferred to paragraph 1, sterilizes devices bearing the EC mark, \n\nshall, at his choice, follow one of the procedures referred to in \n\nAnnex 4 or 5. The application of the abovementioned Annexes and the \n\nintervention of the notified body are limited to the aspects of the \n\nprocedure relating to the obtaining of sterility. The person shall \n\ndraw up a declaration stating that sterilization has been carried \n\nout in accordance with the manufacturer's instructions. (6) \n\n\f- 35 -\n\n3. This Article does not apply if one of the devices concerned does not \n\nbear the EC mark or if the EC mark for one of the devices has been \n\naffixed for a different intended purpose. Article 13 \n\nDecisions with regard to classification, derogation clause \n\n1. Where a Member State considers that \n\n(a) application of the classification rules set out in Annex 9 \n\nrequires a decision with regard to the classification of a \n\ngiven device or family of devices, or \n\n(b) a given device or family of devices should be classified, by \n\nway of derogation from the provisions of Annex 9, in another \n\nclass, or \n\n(c) the conformity of a device or family of devices should be \n\nestablished, by way of derogation from the provisions of \n\nArticle 11, by applying solely one of the given procedures \n\nchosen from among those referred to in Article 11, \n\nit shall submit a duly substantiated request to the Commission and \n\nask it to take the necessary measures. Where appropriate, these \n\nmeasures shall be adopted in accordance with the procedure referred \n\nto in Article 7(2). 2. The Commission shall inform the Member States of the measures taken \n\nand, where appropriate, publish the relevant parts of these measures \n\nin the Official Journal of the European Communities. - 36 -\n\nArticle 14 \n\nRegistration of persons responsible for placing devices on the market \n\n1. Any manufacturer who, on his own behalf, places devices on the \n\nmarket \n\nin accordance with \n\nthe procedures \n\nreferred \n\nto \n\nin \n\nArticle 11(4) and (5) shall inform the competent authorities of the \n\nMember State in which he has his registered place of business of the \n\naddress of the registered place of business and the category of \n\ndevices concerned. 2. Where a manufacturer who places devices referred to in paragraph 1 \n\non the market on his own behalf does not have a registered place of \n\nbusiness in a Member State, he shall designate the person(s) \n\nresponsible for marketing them and established in the Community. These persons shall \n\ninform the competent authorities of the \n\nMember State in which they have their registered place of business \n\nof the address of the registered place of business and the category \n\nof devices concerned. 3. The Member States shall on request inform the other Member States \n\nand the Commission of the details referred to in paragraphs 1 and 2. Art icle 15 \n\nClinical investigation \n\n1. In the case of devices falling within Classes I, Ma and Mb which \n\nare intended for clinical investigations, the manufacturer, or his \n\nauthorized representative established in the Community, shall follow \n\nthe procedure referred to in Annex 8 and keep the statement \n\nconcerned at the disposal of the competent authorities. 2. In the case of devices falling within Class III and implantable \n\ndevices falling within Classes Ma or Mb intended for clinical \n\ninvestigations, the manufacturer, or his authorized representative \n\nestablished in the Community, shall follow the procedure referred to \n\nin Annex 8 and, at least 45 days before the commencement of the \n\ninvestigations, \n\nsubmit \n\nthe \n\nstatement \n\nreferred \n\nto \n\nin \n\nthe \n\nabovementioned \n\nAnnex \n\nto \n\nthe \n\ncompetent \n\nauthorities \n\nof \n\nthe \n\nMember State in which the investigations are to be conducted. - 37 -\n\nThe manufacturer may commence the relevant clinical investigations \n\nat the end of a period of 45 days after notification, unless the \n\ncompetent authorities have notified him within that period of a \n\ndecision to the contrary based on considerations of public health or \n\npub Iic order. 3. The clinical investigations must be conducted in conformity with the \n\nprovisions of Annex 10. The provisions of Annex 10 shall be \n\nadjusted in accordance with the procedure laid down in Article 7 ( 2 ). 4. The Member States shall, if necessary, take the appropriate steps to \n\nensure public health and public order. 5. The manufacturer or his authorized representative established in the \n\nCommunity shall keep the report referred to in point 2. 3. 7 of \n\nAnnex 10 at the disposal of the competent authorities. 6. The provisions of paragraphs 1 and 2 do not apply where the clinical \n\ninvestigations are conducted using devices which are authorized in \n\naccordance with Article 11 to bear the EC mark unless the aim of \n\nthese investigations is to use the devices for a purpose other than \n\nthat referred to in the relevant conformity assessment procedure. The relevant provisions of Annex 10 remain applicable. Article 16 \n\nNot if led bodies \n\n1. The Member States shall notify the other Member States and the \n\nCommission of the bodies which they have designated for carrying out \n\nthe tasks pertaining to the procedures referred to in Articles 11 \n\nand 18 and the specific tasks for which the bodies have been \n\ndesignated. In this Directive, these bodies are referred to as \n\n\"not ified bodies\". The Commission shall allocate an identification number to these \n\nbodies and inform them and the Member States of it. It shall \n\npublish a \n\nlist of the notified bodies, together with \n\nthe \n\nidentification numbers it has allocated to them and the tasks for \n\nwhich they have been notified, in the Official Journal of the \n\nEuropean Communities. It shall ensure that the list is kept up to \n\ndate. 38 -\n\n2. Member States shall apply the minimum criteria set out in Annex 11 \n\nfor the designation of bodies. Bodies that meet the criteria laid \n\ndown in the relevant harmonized standards shall be presumed to meet \n\nthe relevant minimum criteria. 3. A Member State that has notified a body shall withdraw that \n\nnotification if it finds that the body no longer meets the criteria \n\nreferred to in paragraph 2. It shall immediately inform the other \n\nMember States and the Commission thereof. 4. The notified \n\nbody and \n\nthe manufacturer, or \n\nhis \n\nauthorized \n\nrepresentative established in the Community, shall lay down, by \n\ncommon accord, the time limits for completion of the assessment and \n\nverification operations referred to in Annexes 2 to 6. Article 17 \n\nEC marking \n\n1. Devices, other than devices which are custom-made or intended for \n\nclinical \n\ninvestigations, \n\nconsidered \n\nto \n\nmeet \n\nthe \n\nessential \n\nrequirements referred to in Article 3 must bear the EC mark of \n\nconformity when they are placed on the market. 2. The EC mark of conformity, as shown in Annex 12, must appear in a \n\nvisible, legible and indelible form on the device, where practicable \n\nand appropriate, and/or on the sales packaging and the instruction \n\nleaflet. It shall be accompanied by the identification number of the notified \n\nbody responsible for implementation of the procedures set out in \n\nAnnexes 2, 4, 5 and 6 and the last two digits of the year in which \n\nthe mark was affixed. 3. In the event of a significant change in the intended purpose of a \n\ndevice, the EC mark may be affixed only if the manufacturer or, \n\nwhere appropriate, his authorized representative established in the \n\nCommunity, has followed the applicable procedures in accordance with \n\nArticle 11. 4. It is prohibited to affix marks which may be confused with the EC \n\nmark of conformity. - 39 -\n\nArticle 18 \n\nObligations of the notified body in the case of a wrongly affixed mark \n\nWhere it is found that the EC mark has been wrongly affixed, the notified \n\nbody which carried out the assessment of conformity shall take appropriate \n\nmeasures and forthwith inform the competent Member State thereof. The \n\ncompetent Member State shall inform the other Member States and the \n\nCommission thereof. Article 19 \n\nDecisions in respect of refusal or restriction \n\n1. Any decision taken pursuant to this Directive: \n\n(a) \n\nto refuse or restrict the placing on the market or the putting \n\ninto service of a device or the carrying out of clinical \n\ninvestigations, or \n\n(b) \n\nto withdraw devices from the market, \n\nshall state the exact grounds on which it is based. Such decisions \n\nshall be notified without delay to the party concerned, who shall at \n\nthe same time be informed of the remedies available to him under the \n\nnational law in force in the Member State in question and of the \n\ntime limits to which such remedies are subject. 2. In the event of a decision to withdraw devices from the market, the \n\nmanufacturer, or his authorized representative established in the \n\nCommunity, shall have an opportunity to put forward his viewpoint in \n\nadvance, unless such consultation is not possible because of the \n\nurgency of the measure to be taken. - 40 -\n\nArticle 20 \n\nConfident iality \n\nWithout prejudice to the existing national provisions and practices on \n\nmedical secrets, Member States shall ensure that all the parties involved \n\nin the application of this Directive are bound to observe confidentiality \n\nwith regard to all information obtained in carrying out their tasks. This \n\ndoes not affect the obligations of Member States and notified bodies with \n\nregard to mutual information and the dissemination of warnings, nor the \n\nobligations of the persons concerned to provide information under criminal \n\nlaw. Article 21 \n\nGuide!ines \n\nThe Commission shall adopt the necessary guidelines for the uniform \n\napplication of this Directive in respect in particular of: \n\n(a) the scope of the Directive, \n\n(b) the classification of devices, \n\n(c) the conformity assessment procedures. The Commission shall publish these guidelines in the Official Journal of \n\nthe European Communities. Article 22 \n\nRepeal and amendment of Directives \n\n1. Directive 76/764/EEC \n\nis hereby repealed with effect \n\nfrom \n\n1 July 1994. 2. In the title and Article 1 of Directive 84/539/EEC, the words \n\n\"human or\" are deleted. - 41 -\n\n3. The \n\nfollowing \n\nparagraph \n\n6 \n\nis \n\nadded \n\nto \n\nArticle 1 \n\nof \n\nDirective 90/385/EEC: \n\n\"6. The \n\nfollowing \n\nprovisions \n\nof \n\nCouncil \n\nDirective. /. /EEC^2 6) [on medical \n\ndevices] also apply \n\nto \n\nactive \n\nimplantable \n\nmedical \n\ndevices: Article 1(2)(g) \n\nand ( i ); Article 11(6), (8) and ( 9 ); Article 13(1)(c) \n\ncoupled with Article 7; Article 17(3); Article 19(2); \n\nArticle 21 points (a) and (c) of the first paragraph. \" \n\nArt icle 23 \n\nImplementation, transitional provisions \n\n1. Member States shall adopt and publish the laws, regulations and \n\nadministrative provisions necessary to comply with this Directive \n\nnot later than 31 December 1993. They shall immediately inform the \n\nCommission thereof. The standing committee referred to in Article 7 may assume its \n\ntasks from the date of notification of this Directive. The Member \n\nStates may take the measures referred to in Article 16 within six \n\nmonths of notification of this Directive. When Member States adopt these provisions, these shall contain a \n\nreference to this Directive or shall be accompanied by such a \n\nreference \n\nat \n\nthe \n\ntime \n\nof \n\ntheir official \n\npublication. The \n\nprocedure for such reference shall be adopted by Member States. Member States shall \n\napply these provisions with effect \n\nfrom \n\n1 July 1994. 2. Member States shall communicate to the Commission the texts of the \n\nprovisions of national law which they adopt in the field covered by \n\nthis Direct ive. (26) \n\n\f- 42 -\n\n3. Member States shall take the necessary action to ensure that the \n\nnotified bodies which are responsible pursuant to Article 11(1) to \n\n(4) for the assessment of the conformity of devices already placed \n\non the market prior to the implementation of this Directive take \n\naccount of the results of tests and verifications already carried \n\nout under pre-existing national law in respect of such devices and \n\nof any other relevant information regarding the characteristics and \n\nperformance of such devices. 4. In the case of devices which, for the purposes of this Directive, \n\nmust be the subject of one of the procedures referred to in Annexes \n\n2 to 6, Member States shall accept the placing on the market and \n\nputting into service of devices which conform to the rules in force \n\nin their territory on 30 June 1994 during the period up to \n\n30 June 1997. In the case of other devices lawfully placed on the \n\nmarket before 30 June 1994, Member States shall accept their being \n\nput into service during the period up to 30 June 1995. In the case of devices which have been subjected to EEC pattern \n\napproval in accordance with Directive 76/764/EEC, Member States \n\nshall accept their being placed on the market and put into service \n\nduring the period up to 30 June 2004. Article 24 \n\nThis Directive is addressed to the Member States. Done at Brussels, \n\nFor the Council \n\nThe President \n\n(7) \n\n\f- 43 -\n\nANNEX 1 \n\nESSENTIAL REQUIREMENTS \n\n>\u2022 General requirements \n\n1. The devices must be designed and manufactured in such a way that, \n\nwhen used under the conditions and for the purposes intended, they \n\nwill not compromise the clinical condition or the safety of the \n\npatients, users and, where applicable, other persons. The risks \n\nassociated with the devices must be reduced to an acceptable level \n\ncompatible with a high level of protection of health and safety. 2. The solutions adopted by the manufacturer for the design and \n\nconstruction of the devices must conform to safety principles, \n\ntaking account of the generally acknowledged state of the art. 3. The devices must achieve the performances intended by the \n\nmanufacturer, i. e. be designed and manufactured in such a way that \n\nthey are suitable for one or more of the functions referred to in \n\nArticle 1(2)(a), as specified by the manufacturer. 4. The characteristics and performances referred to in Sections 1 and 3 \n\nmust not be adversely affected to such a degree that the clinical \n\ncondition and safety of the patients and, where applicable, of other \n\npersons are compromised during the lifetime of the device as \n\nindicated by the manufacturer, when the device is subjected to the \n\nstresses which can occur during normal conditions of use. 5. The devices must be designed, manufactured and packed in such a way \n\nthat their characteristics and performances during their intended \n\nuse are not adversely affected in the storage and transport \n\nconditions (temperature, humidity, etc. ) laid down by the \n\nmanufacturer. 6. Any undesirable side-effects must constitute acceptable risks when \n\nweighed against the performances intended. II. Requirements regarding design and construction \n\n- 44 -\n\n7. Chemical and Physical properties \n\n7. 1 \n\nThe devices must be designed and manufactured in such a way as to \n\nguarantee the characteristics and performances referred to in \n\nSection I on the \"General requirements\". Particular attention must \n\nbe paid to: \n\nthe choice of materials used, particularly as regards toxicity \n\nand, where appropriate, flammabiIity; \n\nthe compatibility between the materials used and biological \n\ntissues, cells and body fluids, taking account of the intended \n\npurpose of the device. 7. 2 \n\nThe devices must be designed, manufactured and packed in such a way \n\nas to minimize the risk posed by contaminants and residues to the \n\npersons involved in the transport, storage and use of the devices \n\nand to the patients, taking account of the intended purpose of the \n\nproduct. Particular attention must be paid to the tissues exposed \n\nand to the duration and frequency of exposure. 7. 3 \n\nThe devices must be designed and manufactured in such a way that \n\nthey can be used completely safely with the materials, substances \n\nand gases with which they enter into contact during normal use or \n\nroutine treatment. 7. 4 \n\nWhere a device incorporates, as an integral part, a substance which, \n\nif used separately, may be considered to be a medicinal product, as \n\ndefined in Article 1 of Directive 65/65/EEC, and whose action in \n\ncombination with the device can result in its bioavailability, the \n\nsafety, quality and usefulness of the substance must be verified, \n\ntaking account of the intended purpose of the device, by analogy \n\nwith the appropriate methods specified in Directive 75/318/EEC, as \n\nlast amended by Directive 89/341/EEC. 7. 5 \n\nThe devices must be designed and manufactured in such a way as to \n\nminimize the health risks posed by substances leaking from the \n\ndevice dur ing use. 8. Infection and microbial contamination \n\n- 45 -\n\n8. 1 \n\nThe devices and manufacturing processes must be designed in such a \n\nway as to minimize the risk of infection to the patient. The design \n\nmust \n\nallow \n\neasy \n\nhandling \n\nand, \n\nwhere \n\nnecessary, \n\nminimize \n\ncontamination of the device by the patient or vice versa during use. 8. 2 \n\nWhere a device incorporates animal or human tissues, the risks of \n\ncross-infect ion must be minimized by selecting appropriate tissues \n\nand \n\nusing \n\nappropriate \n\ninactivation, \n\nconservation \n\nand \n\ntest \n\nprocedures. 8. 3 \n\nSterile devices must be designed, manufactured and packed in a \n\nnon-reusable pack and/or according to appropriate procedures to \n\nensure that they are sterile when placed on the market and remain \n\nsterile, under the storage and transport conditions laid down, until \n\nthe protective packaging is damaged or opened. 8. 4 \n\nDevices \n\nlabelled sterile must \n\nhave been sterilized \n\nby an \n\nappropriate, validated method. 8. 5 \n\nPackaging systems for non-sterile devices must keep the product \n\nwithout deterioration at the level of cleanliness stipulated and, if \n\nthe devices are to be sterilized prior to use, minimize the risk of \n\nmicrobial contamination. 8. 6 \n\nThe packs and/or label of the device must distinguish between \n\nidentical or similar products sold in both sterile and non-sterile \n\npackaging. 9. Construction and environmental properties \n\n9. 1 \n\nIf the device is intended for use in combination with other devices \n\nor equipment, the connection system must be safe and must not impair \n\nthe specified performances of the devices. Any restrictions on use \n\nmust be indicated on the label or in the instruction leaflet. 9. 2 \n\nDevices must be designed and manufactured in such a way as to remove \n\nor minimize as far as possible: \n\n- 46 -\n\nthe risk of injury, in connection with their physical, \n\nincluding dimensional features; \n\nrisks connected with reasonably foreseeable environmental \n\nconditions, such as magnetic fields, external electrical \n\ninfluences, electrostatic discharge, pressure or variations in \n\npressure and acceleration; \n\nthe risks of interference with other devices normally required \n\nfor the investigations or for the treatment given; \n\nrisks possibly arising from lack of maintenance and \n\ncalibration, including: \n\nageing of the materials used, \n\nloss of accuracy of any measuring or control mechanism. 9. 3 \n\nDevices must be designed and manufactured in such a way as to \n\nminimize the risks of fire or explosion during normal use and in \n\nfailsafe condition. Particular attention must be paid to devices \n\nwhich must be exposed to or used in association with flammable \n\nsubstances or substances which could cause combustion. 10. Devices with a measuring function \n\n10. 1 \n\nDevices with a measuring function must be designed and manufactured \n\nin such a way as to provide sufficient accuracy and stability as \n\nspecified by the manufacturer, taking account of the intended \n\npurpose of the device. 10. 2 The units on the measurement, monitoring and display scale must be \n\ndesigned in line with ergonomie principles, taking account of the \n\nintended purpose of the device. 10. 3 The measurements made by devices with a measuring function must be \n\nexpressed in legal units conforming to the provisions of Council \n\nDirective 80/181/EEC(1), \n\nas \n\nlast \n\namended \n\nby \n\nDirective \n\n89/617/EEC<2>. (1) OJ No L 39, 15. 2. 1980, p. 40. (2) OJ No L 357, 7. 12. 1989, p. 28. 11. Protection against radi\u00e2t Ion \n\n_ 47 -\n\n11. 1 \n\nThe devices must be designed and constructed in such a way that the \n\nradiation emitted will not attain dangerous levels. Where emission \n\nof dangerous levels of radiation is necessary for a specific medical \n\npurpose considered to outweigh the risks inherent in the emissions, \n\nit must be possible for the user to control the emissions. 11. 2 \n\nDevices emitting ionizing radiation must be designed and constructed \n\nin such a way as: \n\n(a) \n\nto ensure that the quantity and quality of radiation emitted \n\ncan be adjusted and controlled; \n\n(b) \n\nto reduce exposure of the user at work and all unnecessary \n\nexposure of the patient. 11. 3 \n\nThe operating instructions for devices emitting radiation must give \n\ndetailed information on the nature of the devices, means of \n\nprotecting the patient and user and on ways of avoiding mishandling \n\nand the risks inherent in installation. 11. 4 \n\nDevices emitting radiation must be designed and manufactured in such \n\na way as to reduce unnecessary exposure of the patient and of the \n\nuser as far as possible. 11. 5 \n\nInstruments, apparatus or appliances emitting radiation must be \n\nfitted with visual displays and/or audible warnings of radiation \n\nemissions. 12- \n\nRequirements for medical devices connected to or equipped with an \n\nenergy source \n\n12. 1 \n\nDevices depending on software must be designed in such a way as to \n\nminimize the risks arising from errors in the program. 12. 2 \n\nDevices where the safety of the patients depends on an internal \n\npower supply must be equipped with a means of determining the state \n\nof the power supply. - 48 -\n\n12. 3 Devices where the safety of the patients depends on an external \n\npower supply must include an alarm system to signal any power \n\nfailure. 12. 4 Devices intended to monitor one or more clinical parameters of a \n\npatient shall be equipped with appropriate alarm systems to alert \n\nthe user of situations which could lead to death or severe \n\ndeterioration of the patient's state of health. 12. 5 The devices must be designed and manufactured in such a way as to \n\nminimize the risks of creating electromagnetic fields which could \n\nimpair the operation of other devices or equipment in the vicinity. 12-6 Protection against electrical risks \n\nThe devices must be designed and manufactured in such a way as to \n\navoid, as far as possible, the risk of electric shocks during normal \n\nuse and \n\nn single fault condition, provided the devices are \n\ninstalled correctly. 12. 7 Protection against mechanical and thermal risks \n\n12. 7. 1 The devices must be designed and manufactured in such a way as to \n\nprotect the patient and user against mechanical risks connected \n\nwith, for example, resistance, stability and moving parts. 12. 7. 2 The devices must be designed and manufactured in such a way as to \n\nreduce to the lowest possible level the risks arising from vibration \n\ngenerated by the devices, taking account of technical progress and \n\nof the means available for limiting vibrations, particularly at \n\nsource, unless the vibrations are part of the specified performance. 12. 7. 3 The devices must be designed and manufactured in such a way as to \n\nreduce to the lowest possible level the risks arising from the noise \n\nemitted, taking account of technical progress and of the means \n\navailable to reduce noise, particularly at source, unless the noise \n\nemitted is part of the specified performance. - 49 -\n\n12. 7. 4 The terminals and connectors to the electricity, gas or hydraulic \n\nand pneumatic energy supplies which the user has to handle must be \n\ndesigned and constructed in such a way as to minimize all possible \n\nrisks. 12. 7. 5 Accessible parts of the devices and their surroundings must not \n\nattain potentially dangerous temperatures under normal use. 12. 8 \n\nProtection against the risks posed to the patient by energy supplies \n\nor substances \n\n12. 8. 1 Devices for supplying the patient with energy or substances must be \n\ndesigned and constructed in such a way that the flow rate can be set \n\nand maintained accurately enough to guarantee the safety of the \n\npatient and of the user. 12. 8. 2 Devices must be fitted with an interlock and/or alarm system to \n\nprevent and/or indicate any inadequacies in the flow rate which \n\ncould pose a danger. 12. 9 \n\nThe function of the controls and visual displays must be clearly \n\nspecified on the devices. 13. Information supplied by the manufacturer \n\n13. 1 \n\nEach device must be accompanied by the information needed to use it \n\nsafely and to identify the manufacturer, taking account of the \n\ntraining and knowledge of the potential users. This information comprises the details on the label and the data in \n\nthe instruction leaflet. As far as practicable and appropriate, the information needed to use \n\nthe device safely must be set out on the device itself and/or on the \n\npackaging for each unit or, where appropriate, on the sales \n\npackaging. If individual packaging of each unit is not practicable, \n\nthe information must be set out in the leaflet supplied with one or \n\nmore devices. - 50 -\n\nAn instruction leaflet must be included in the packaging for every \n\ndevice. By way of exception, no such instruction leaflet is needed for \n\ndevices in Class I or Class Ma if they can be used completely \n\nsafely without any such instructions. 13. 2 Where appropriate, this information should take the form of symbols. Any symbols and identification colours used must conform to the \n\nharmonized standards. In areas for which no standards exist, the \n\nsymbols and colours must be described in the documentation supplied \n\nwith the device. 13. 3 The label must bear the following particulars: \n\n(a) the name or trade name and address of the manufacturer; \n\n(b) the details strictly necessary for the user to identify the \n\ndevice and the contents of the packaging-, \n\n(c) where appropriate, the word \"STERILE\"; \n\n(d) where appropriate, the batch code, preceded by the word \"LOT\", \n\nor the serial number; \n\n(e) where appropriate, an indication of the time limit for \n\ncompletely safe use, expressed as the year and month; \n\n(f) where appropriate, an indication that the device is for single \n\nuse; \n\n(g) \n\nif the device is custom-made, the words \"custom-made device\"; \n\n(h) \n\nif the device is intended for clinical investigations, the \n\nwords \"exclusively for clinical investigations\"; \n\n(i) any special storage and/or handling conditions; \n\n(j) any special operating instructions; \n\n(k) any warnings and/or precautions to take. (8) \n\n\f- 51 -\n\n13. 4 \n\nIf the intended purpose of the device is not obvious to the user, \n\nthe manufacturer must clearly state it on the label and in the \n\ninstruction leaflet. 13. 5 Wherever reasonable and practicable, the devices and detachable \n\ncomponents must be identified, where appropriate in terms of \n\nbatches, to allow all appropriate action to detect any potential \n\nrisk posed by the devices and detachable components. 13. 6 Where appropriate, the instruction leaflet must contain the \n\nfollowing particulars: \n\n(a) for devices \n\nin Class Mb or Class III the year of \n\nauthorization to affix the EC mark; \n\n(b) the details referred to in Section 13. 3, with the exception of \n\npoints (d) and (e); \n\n(c) the performances referred to in Section 3 and any undesirable \n\nside-effects; \n\n(d) \n\nif the device must be installed with or connected to other \n\nmedical devices or equipment in order to operate as required \n\nfor \n\nits intended purpose, sufficient details of its \n\ncharacteristics to identify the correct devices or equipment \n\nto use in order to obtain a safe combination; \n\n(e) all the information needed to verify whether the device is \n\nproperly installed and can operate correctly and safely, plus \n\ndetails of the nature and frequency of the maintenance needed \n\nto ensure that the devices operate properly and safely at all \n\nt imes-, \n\n(f) where appropriate, information to avoid certain risks in \n\nconnection with implantation of the device-, \n\n(g) \n\ninformation regarding the risks of reciprocal interference \n\nposed by the presence of the device during specific \n\ninvestigations or treatment; \n\n\f- 52 -\n\n(h) \n\nthe necessary Instructions in the event of damage to the \n\nsterile \n\npackaging \n\nand, \n\nwhere \n\nappropriate, \n\ndetails \n\nof \n\nappropriate methods of resteriIization; \n\n(I) \n\nif the device is reusable, information on the appropriate \n\nprocesses to allow reuse, including cleaning, disinfection, \n\npackaging and, where appropriate, resteriMzation, and any \n\nrestriction on the number of reuses; \n\n(J) \n\ndetails of any further treatment or handling needed before the \n\ndevice can be used (for example, sterilization, final \n\nassembly, etc. ); \n\n(k) \n\nin the case of devices emitting radiation for medical \n\npurposes, details of \n\nthe nature, type, \n\nintensity \n\nand \n\ndistribution of this radiation. The instruction leaflet must also include details allowing the \n\nmedical staff to brief the patient on any contra-indications \n\nand any precautions to be taken. These details should cover \n\nin part icular: \n\n(I) \n\nprecautions to be taken in the event of changes in the \n\nperformance of the device; \n\n(m) \n\nprecautions to be taken as regards exposure, in reasonably \n\nforeseeable environmental conditions, to magnetic fields, \n\nexternal \n\nelectrical \n\ninfluences, electrostatic \n\ndischarge, \n\npressure or variations in pressure, acceleration, thermal \n\nignition sources, etc. ; \n\n(n) \n\nadequate information regarding the medicinal products which \n\nthe device in question is designed to administer; \n\n(o) \n\nprecautions to be taken against any special, unusual risks \n\nrelated to the disposal of the device. - 53 -\n\nANNEX 2 \n\nE\u00c7 pEgARATIQN QF CQNFQRMITY \n\n(FUU, QUAIITY ASSURANCE SYSTEM) \n\n1. The manufacturer shall apply the quality system approved for the \n\ndesign, manufacture and final inspection of the products concerned, \n\nas specified in Sections 3 and 4, and shall be subject to the EC \n\nsurveillance specified in Section 5. 2. The declaration of conformity \n\nis the procedure whereby the \n\nmanufacturer who fulfils the obligations imposed by Section 1 \n\nensures and declares that the products concerned meet the provisions \n\nof this Directive which apply to them. The manufacturer shall affix the EC mark in accordance with \n\nArticle 17 and shall draw up a written declaration of conformity. This declaration shall cover a given number of identified specimens \n\nof the products manufactured and shall be kept by the manufacturer. The EC mark shall be accompanied by the identification number of the \n\nnotified body which performs the tasks referred to in this Annex. 3. Qua Iity system \n\n3. 1 \n\nThe manufacturer shall lodge an application for assessment of his \n\nquality system with a notified body. The application shall include: \n\nthe name and address of the manufacturer; \n\nall the relevant information on the product or product \n\ncategory covered by the procedure; \n\na written declaration that no application has been lodged with \n\nany other notified body for the same products; \n\nthe documentation on the quality system-, \n\nan undertaking to fulfil the obligations imposed by the \n\nquality system approved; \n\nan undertaking to keep the approved quality system adequate \n\nand ef f icacious-, \n\n\f- 54 -\n\nan undertaking by the manufacturer to institute and keep \n\nupdated \n\na \n\npost-marketing \n\nsurveillance \n\nsystem. This \n\nundertaking shall include an obligation for the manufacturer \n\nto notify the competent authorities of the following incidents \n\nimmediately on learning of them: \n\n(i) any \n\ndeterioration \n\nin the characteristics \n\nand/or \n\nperformances of a device, as well as any inaccuracies in \n\nthe instruction leaflet which might lead to or might have \n\nled to the death of a patient or user or to a serious \n\ndeterioration in their state of health-, \n\n(ii) any technical or medical reason connected with the device \n\nleading to recall of devices of the same type by the \n\nmanufacturer. 3. 2 \n\nApplication of the quality system must ensure that the products \n\nconform to the provisions of this Directive which apply to them at \n\nevery stage, from design to final inspection. All the elements, \n\nrequirements and provisions adopted by the manufacturer for his \n\nquality system shall be documented in a systematic and orderly \n\nmanner in the form of written policies and procedures. This quality \n\nsystem documentation must permit uniform interpretation of the \n\nquality policies and procedures such as quality programmes, quality \n\nplans, quality manuals and quality records. It shall include in particular an adequate description of: \n\n(a) the manufacturer's quality objectives; \n\n(b) the organization of the business and in particular: \n\nthe organizational structures, the responsibilities of \n\nthe managerial staff and their organizational authority \n\nwhere quality of design and manufacture of the products \n\nis concerned; \n\n\f- 55 -\n\nthe methods of monitoring the efficient operation of the \n\nquality system and in particular its ability to achieve \n\nthe desired quality of design and of product, including \n\ncontrol of products which fail to conform; \n\n(c) \n\nthe procedures for monitoring and verifying the design of the \n\nproducts and in particular: \n\na general description of the product, including any \n\nvar iants planned; \n\nthe design specifications, including the standards which \n\nwill be applied and a description of the solutions \n\nadopted to fulfil the essential requirements which apply \n\nto the products if the standards referred to in Article 5 \n\nare not applied in fui I ; \n\nthe techniques used to control and verify the design and \n\nthe processes and systematic measures which will be used \n\nwhen the products are being designed; \n\nif the device is to be connected to other device(s) in \n\norder to operate as intended, proof must be provided that \n\nit conforms to the essential requirements when connected \n\nto any \n\nsuch \n\ndevice(s) having \n\nthe \n\ncharacteristics \n\nspecified by the manufacturer-, \n\na statement \n\nindicating whether or not \n\nthe device \n\nincorporates, as an integral part, a substance as \n\nreferred to in Section 7. 4 of Annex 1 whose action in \n\ncombination \n\nwith \n\nthe \n\ndevice \n\nmay \n\nresult \n\nin \n\nits \n\nbioavailability and data on the tests conducted in this \n\nconnect ion; \n\nthe clinical data referred to in Annex 10-, \n\nthe draft label and, where appropriate, instruction \n\nleaf let ; \n\n\f- 56 -\n\n(d) \n\nthe inspection and quality assurance techniques at the \n\nmanufacturing stage and in particular: \n\nthe processes and procedures which will be used, \n\nparticularly as regards sterilization, purchasing and the \n\nrelevant documents; \n\nthe product-identification procedures drawn up and kept \n\nup to date from drawings, specifications or other \n\nrelevant documents at every stage of manufacture; \n\n(e) \n\nthe appropriate tests and trials which will be carried out \n\nbefore, during and after manufacture, the frequency with which \n\nthey will take place, and the test equipment used; it must be \n\npossible to trace back the calibration of the test equipment \n\nadequately. 3. 3 \n\nThe notified body shall audit the quality system to determine \n\nwhether it meets the requirements referred to in Section 3. 2. It \n\nshall presume that quality systems which implement the relevant \n\nharmonized standards conform to these requirements. The assessment team shall include at least one member with past \n\nexperience of \n\nassessments of \n\nthe technology \n\nconcerned. The \n\nassessment \n\nprocedure \n\nshall \n\ninclude \n\nan \n\ninspection \n\non \n\nthe \n\nmanufacturer's premises and, in duly substantiated cases, on the \n\npremises \n\nof \n\nthe \n\nmanufacturer's \n\nsuppliers \n\nto \n\ninspect \n\nthe \n\nmanufacturing processes. The decision shall be notified to the manufacturer. It shall \n\ncontain the conclusions of the inspection and a reasoned assessment. 3. 4 \n\nThe manufacturer shall inform the notified body which approved the \n\nquality system of any plan for substantial changes to the quality \n\nsystem. - 57 -\n\nThe notified body shall assess the changes proposed and shall verify \n\nwhether after these changes the quality system will still meet the \n\nrequirements referred to in Section 3. 2. It shall notify the \n\nmanufacturer of its decision. This decision shall contain the \n\nconclusions of the inspection and a reasoned assessment. 4. Examination of the design of the product \n\n4. 1 \n\nIn addition \n\nto the obligations \n\nimposed \n\nby \n\nSection 3, the \n\nmanufacturer shall lodge an application for examination of the \n\ndesign dossier relating to the product which he plans to manufacture \n\nand which falls into the category referred to in Section 3. 1. 4. 2 \n\nThe application shall \n\ndescribe \n\nthe design, manufacture \n\nand \n\nperformances of the product in question. It shall include the \n\ndocuments needed to assess whether the product conforms to the \n\nrequirements of this Directive, as referred to in Section 3. 2(c). 4. 3 \n\nThe notified body shall examine the application and, if the product \n\nconforms to the relevant provisions of this Directive, shall issue \n\nthe applicant with an EC design-examination certificate. The \n\nnotified body may require the application to be completed by further \n\ntests or proof to allow assessment of conformity with the \n\nrequirements of the Directive. The certificate shall contain the \n\nconclusions of the examination, the conditions of validity, the data \n\nneeded for identification of the approved design and, where \n\nappropriate, a description of the intended purpose of the product. 4. 4 \n\nThe applicant shall inform the notified body which issued the EC \n\ndesign-examination certificate of any significant change made to the \n\napproved design. Changes to the approved design must receive \n\nfurther approval from the notified body which issued the EC \n\ndesign-examination certificate wherever the changes could affect \n\nconformity with the essential requirements of the Directive or with \n\nthe conditions prescribed for use of the product. This additional \n\napproval \n\nshall \n\ntake the form of a supplement \n\nto the EC \n\ndesign-examination certificate. 5. Surveillance \n\n- 58 -\n\n5. 1 \n\nThe aim of surveillance is to ensure that the manufacturer duly \n\nfulfils the obligations imposed by the approved quality system. 5. 2 \n\nThe manufacturer shall authorize the notified body to carry out all \n\nthe necessary inspections and shall supply it with all relevant \n\ninformation, in particular: \n\nthe documentation on the quality system-, \n\nthe data stipulated in the part of the quality system relating \n\nto design, such as the results of analyses, calculations, \n\ntests, etc. ; \n\nthe data stipulated in the part of the quality system relating \n\nto manufacture, such as reports concerning inspections, tests, \n\ncalibration and the qualifications of the staff concerned, \n\netc. 5. 3 \n\nThe notified body shall periodically carry out appropriate \n\ninspections and assessments to make sure that the manufacturer \n\napplies the approved quality system and shall supply the \n\nmanufacturer with an assessment report. 5. 4 \n\nIn addition, the notified body may pay unannounced visits to the \n\nmanufacturer. At the time of such visits, the notified body may, \n\nwhere necessary, carry out or ask for tests in order to check that \n\nthe quality system is working properly. It shall provide the \n\nmanufacturer with an inspection report and, if a test has been \n\ncarried out, with a test report. 6. Administrative provisions \n\n6. 1 \n\nThe manufacturer shall, for a period ending at least five years \n\nafter the last product has been manufactured, keep at the disposal \n\nof the national authorities: \n\nthe declaration of conformity; \n\nthe documentation referred to in the fourth indent of \n\nSect ion 3. 1 ; \n\nthe changes referred to in Section 3. 4; \n\n\f- 59 -\n\nthe documentation referred to in Section 4. 2; and \n\nthe decisions and reports from the notified body as referred \n\nto in Sections 3. 3, 4. 3, 4. 4, 5. 3 and 5. 4. 6. 2 \n\nThe notified body shall communicate to the other notified bodies all \n\nrelevant information concerning the quality system approvals issued, \n\nrefused or withdrawn. 7. A DD I icat ion to devices in Classes Ma and Mb \n\nIn line with Article 11(2) and (3), this Annex may apply to products \n\nin Classes lia and M b, subject to the following derogations: \n\n7. 1 \n\nFor products in Class M a, by way of derogation from the final \n\nindent of Section 3. 1, the manufacturer shall undertake to notify \n\nthe competent authorities of the incidents referred to in the \n\nabovementioned indent immediately on learning of them and to \n\ninstitute and keep updated an appropriate internal system for this \n\npurpose. 7. 2 \n\nSection 4 shall not apply to products in Classes Ma and M b. - 60 -\n\nANNEX 3 \n\nEC TYPE-EXAMINATION \n\n1. EC type-examination is the procedure whereby a notified body \n\nascertains and certifies that a representative sample of the \n\nproduction covered fulfils the relevant provisions of this \n\nDirective. 2. The application for EC type-examination shall be lodged by the \n\nmanufacturer or by his authorized representative established in the \n\nCommunity with a notified body. The application shall include: \n\nthe name and address of the manufacturer and the name and \n\naddress of the authorized representative if the application is \n\nlodged by the representative; \n\nthe documentation described in Section 3 needed to assess the \n\nconformity of the representative sample of the production in \n\nquestion, hereinafter referred to as the \"type\", with the \n\nrequirements of this Directive. The applicant shall make a \n\n\"type\" available to the notified body. The notified body may \n\nrequest other samples as necessary; \n\na written declaration that no application has been lodged with \n\nany other notified body for the same type. 3. The documentation must allow an understanding of the design, the \n\nmanufacture and the performances of the product. The documentation \n\nshall contain the following items in particular: \n\na general description of the type, including any variants \n\nplanned; \n\n\f- 61 -\n\ndesign \n\ndrawings, methods of manufacture \n\nenvisaged, \n\nin \n\nparticular \n\nas \n\nregards \n\nsterilization, \n\nand \n\ndiagrams \n\nof \n\ncomponents, sub-assemblies, circuits, etc. ; \n\nthe descriptions and explanations necessary to understand the \n\nabovementioned drawings and diagrams and the operation of the \n\nproduct; \n\na list of the standards referred to in Article 5, applied in \n\nfull or in part, and descriptions of the solutions adopted to \n\nmeet the essential requirements if the standards referred to \n\nin Article 5 have not been applied in full; \n\nthe results of the design calculations, investigations, \n\ntechnical tests, etc. carried out; \n\na statement indicating whether or not the device incorporates, \n\nas an integral part, a substance as referred to in Section 7. 4 \n\nof Annex 1 whose action in combination with the device may \n\nresult in its bioavailability, and data on the tests conducted \n\nin this connect ion; \n\nthe clinical data referred to in Annex 10; \n\nthe draft label and, where appropriate, instruction leaflet. 4. The notified body shall: \n\n4. 1 \n\nexamine and assess the documentation and verify that the type has \n\nbeen manufactured in conformity with that documentation; it shall \n\nalso record the items designed in conformity with the applicable \n\nprovisions of the standards referred to in Article 5, as well as the \n\nitems not designed on the basis of the relevant provisions of the \n\nabovementioned standards; \n\n\f- 62 -\n\n4. 2 \n\ncarry out or ask for the appropriate inspections and the tests \n\nnecessary to verify whether the solutions adopted by the \n\nmanufacturer meet the essential requirements of this Directive if \n\nthe standards referred to in Article 5 have not been applied; if \n\nthe device is to be connected to other device(s) in order to operate \n\nas intended, proof must be provided that it conforms to the \n\nessential requirements when connected to any such device(s) having \n\nthe characteristics specified by the manufacturer-, \n\n4. 3 \n\ncarry out or ask for the appropriate inspections and the tests \n\nnecessary to verify whether, if the manufacturer has chosen to apply \n\nthe relevant standards, these have actually been applied; \n\n4. 4 \n\nagree with the applicant on the place where the necessary \n\ninspections and tests will be carried out. 5. If the type conforms to the provisions of this Directive, the \n\nnotified body shall issue the applicant with an EC type-examination \n\ncertificate. The certificate shall contain the name and address of \n\nthe manufacturer, the conclusions of the inspection, the conditions \n\nof validity and the data needed for identification of the type \n\napproved. The relevant parts of the documentation shall be annexed \n\nto the certificate and a copy shall be kept by the notified body. 6. The applicant shall inform the notified body which issued the EC \n\ntype-examination certificate of any significant change made to the \n\napproved product. Changes to the approved product must receive further approval from \n\nthe notified body which issued the EC type-examination certificate \n\nwherever the changes may affect conformity with the essential \n\nrequirements or with the conditions prescribed for use of the \n\nproduct. This new approval shall, where appropriate, take the form \n\nof a supplement to the initial EC type-examination certificate. 7. Administrative provisions \n\n- 63 -\n\n7. 1 \n\nEach notified body shall communicate to the other notified bodies \n\nall relevant information on EC type-examination certificates and \n\nsupplements issued, refused or withdrawn. 7. 2 \n\nOther notified bodies may obtain a copy of the EC type-examination \n\ncertificates and/or the supplements thereto. The annexes to the \n\ncertificates shall be made available to the other notified bodies on \n\nreasoned application, after informing the manufacturer. - 64 -\n\nANNEX 4 \n\nEC VERIFICATION \n\n1. EC verification is the procedure whereby the manufacturer or his \n\nauthorized representative established in the Community ensures and \n\ndeclares that the products which have been subjected to the \n\nprocedure set out in Section 4 conform to the type described in the \n\nEC type-examination certificate and meet the requirements of this \n\nDirective which apply to them. 2. The manufacturer shall take all the measures necessary for the \n\nmanufacturing process to ensure that the products conform to the \n\ntype described in the EC type-examination certificate and to the \n\nrequirements of the Directive which apply to them. Before the start \n\nof manufacture, the manufacturer shall prepare documents defining \n\nthe manufacturing process, in particular as regards sterilization \n\nwhere necessary, together with all the routine, pre-established \n\nprovisions to be implemented to ensure homogeneous production and, \n\nwhere appropriate, conformity of the products with the type \n\ndescribed in the EC type-examination certificate and with the \n\nrequirements of this Directive which apply to them. The \n\nmanufacturer shall affix the EC mark in accordance with Article 17 \n\nand shall draw up a declaration of conformity. 3. The manufacturer shall undertake to institute and keep updated a \n\npost-marketing surveillance system. This undertaking shall include \n\nan obligation for the manufacturer to notify the competent \n\nauthorities of the following incidents immediately on learning of \n\nthem: \n\n(i) any deterioration in the characteristics and/or performances \n\nof a device, as well as any inaccuracies in the instruction \n\nleaflet which might lead to or might have led to the death of \n\na patient or user or to a serious deterioration in their state \n\nof health; \n\n\f- 65 -\n\n(ii) any technical or medical reason connected with the device \n\nleading to recall of devices of the same type by the \n\nmanufacturer. 4. The notified body shall carry out the appropriate examinations and \n\ntests in order to verify the conformity of the product with the \n\nrequirements of the Directive either by examining and testing every \n\nproduct as specified in Section 5 or by examining and testing \n\nproducts on a statistical basis as specified in Section 6, at the \n\nchoice of the manufacturer. 5. Verification by examination and testing of every product \n\n5. 1 \n\nEvery product shall be examined individually and the appropriate \n\ntests defined in the relevant standard(s) referred to in Article 5 \n\nor equivalent tests shall be carried out in order to verify, where \n\nappropriate, the conformity of the products with the type described \n\nin the EC type-examination certificate and with the requirements of \n\nthe Directive which apply to them. 5. 2 \n\nThe notified body shall affix, or have affixed, its identification \n\nnumber to each approved product and shall draw up a written \n\ncertificate of conformity relating to the tests carried out. 6. Statistical verification \n\n6. 1 \n\nThe manufacturer shall present the manufactured products in the form \n\nof homogeneous batches. 6. 2 \n\nA random sample shall be taken from each batch. The products which \n\nmake up the sample shall be examined individually and the \n\nappropriate tests defined in the relevant standard(s) referred to in \n\nArticle 5 or equivalent tests shall be carried out to verify, where \n\nappropriate, the conformity of the products with the type described \n\nin the EC type-examination certificate and with the requirements of \n\nthe Directive which apply to them in order to determine whether to \n\naccept or reject the batch. - 66 -\n\n6. 3 \n\nStatistical control of products will be based on attributes, \n\nentailing a sampling system ensuring a limit quality corresponding \n\nto a probability of acceptance of 5%, with a non-conformity \n\npercentage of between 3 and 7%. The sampling method shall be \n\nestablished by the harmonized standards referred to in Article 5, \n\ntaking account of the specific nature of the product categories in \n\nquestion. 6. 4 \n\nIf the batch is accepted, the notified body shall affix, or have \n\naffixed, its identification number to each product and shall draw up \n\na written certificate of conformity relating to the tests carried \n\nout. All products in the batch may be put on the market except any \n\nin the sample which failed to conform. If a batch is rejected the competent notified body shall take \n\nappropriate measures to prevent the batch from being placed on the \n\nmarket. In the event of frequent rejection of batches, the notified \n\nbody may suspend the statistical verification. The manufacturer may, on the responsibility of the notified body, \n\naffix \n\nthe notified body's \n\nidentification number \n\nduring \n\nthe \n\nmanufacturing process. 7. Administrative provisions \n\nThe manufacturer or the manufacturer's authorized representative \n\nshall, for a period ending at least five years after the last \n\nproduct has been manufactured, keep at the disposal of the national \n\nauthor it ies: \n\nthe declaration of conformity; \n\nthe documentation referred to in Section 2; \n\nthe certificates referred to in Sections 5. 2 and 6. 4. 8. Application to devices in Class Ma \n\nIn line with Article 11(2), this Annex may apply to products in \n\nClass M a, subject to the following derogations: \n\n\f- 67 -\n\n8. 1 \n\nBy way of derogation from Sections 1 and 2, by virtue of the \n\ndeclaration of conformity the manufacturer ensures and declares that \n\nthe products in Class Ma are manufactured in conformity with the \n\ntechnical documentation referred to in Section 3 of Annex 7 and meet \n\nthe requirements of this Directive which apply to them. 8. 2 \n\nBy way of derogation from Sections 1, 2, 5 and 6, the verifications \n\nconducted by the notified body are intended to confirm the \n\nconformity of the products in Class Ma with the technical \n\ndocumentation referred to in Section 3 of Annex 7. 8. 3 \n\nBy way of derogation from Section 3, the manufacturer or the \n\nmanufacturer's authorized representative established in the European \n\nCommunity undertake to notify the competent authorities of the \n\nincidents referred to in the abovementioned Section immediately on \n\nlearning of them and to institute and keep updated an appropriate \n\ninternal system for this purpose. - 68 -\n\nANNEX 5 \n\nEC DECLARATION OF CONFORMITY \n\n(PRODUCTION QUAUTY ASSURANCE) \n\n1. The manufacturer shall apply the quality system approved for the \n\nmanufacture of the products concerned and carry out the final \n\ninspection, as specified in Section 3, and shall be subject to the \n\nEC surveillance referred to in Section 4. 2. The declaration of conformity is the part of the procedure whereby \n\nthe manufacturer who fulfils the obligations imposed by Section 1 \n\nensures and declares that the products concerned conform to the type \n\ndescribed in the EC type-examination certificate and meet the \n\nprovisions of this Directive which apply to them. The manufacturer shall affix the CE mark in accordance with \n\nArticle 17 and shall draw up a written declaration of conformity. This declaration shall cover a given number of identified specimens \n\nof the products manufactured and shall be kept by the manufacturer. The CE mark shall be accompanied by the identification number of the \n\nnotified body which performs the tasks referred to in this Annex. 3- \n\nQua Iitv system \n\n3. 1 \n\nThe manufacturer shall lodge an application for assessment of his \n\nquality system with a notified body. The application shall include: \n\nthe name and address of the manufacturer; \n\nall the relevant information on the product or product \n\ncategory covered by the procedure; \n\na written declaration that no application has been lodged with \n\nany other notified body for the same products-, \n\n\f- 69 -\n\nthe documentation on the quality system; \n\nan undertaking to fulfil the obligations imposed by the \n\nquality system approved; \n\nan undertaking to keep the approved quality system adequate \n\nand efficacious; \n\nwhere appropriate, the technical documentation on the types \n\napproved and a copy of the EC type-examination certificates; \n\nan undertaking by the manufacturer to institute and keep \n\nupdated \n\na \n\npost-marketing \n\nsurveillance \n\nsystem. This \n\nundertaking shall include an obligation for the manufacturer \n\nto notify the competent authorities of the following incidents \n\nimmediately on learning of them: \n\n(i) any \n\ndeterioration \n\nin \n\nthe \n\ncharacteristics \n\nand/or \n\nperformances of a device, as well as any inaccuracies in \n\nthe instruction?leaflet which might lead to or might have \n\nled to the death of a patient or user or to a serious \n\ndeterioration in their state of health; \n\n(ii) any technical or medical reason connected with the device \n\nleading to recall of devices of the same type by the \n\nmanufacturer. 3. 2 \n\nApplication of the quality system must ensure that the products \n\nconform \n\nto \n\nthe \n\ntype described \n\nin the \n\nEC \n\ntype-examination \n\ncertificate. AM the elements, requirements and provisions adopted \n\nby the manufacturer for his quality system shall be documented in a \n\nsystematic and orderly manner in the form of written policies and \n\nprocedures. This quality system documentation must permit uniform \n\ninterpretation of the quality policies and procedures such as \n\nquality programmes, quality plans, quality manuals and quality \n\nrecords. It shall include in particular an adequate description of: \n\n- 70 -\n\n(a) the manufacturer's quality objectives; \n\n(b) the organization of the business and in particular: \n\nthe organizational structures, the responsibilities of \n\nthe managerial staff and their organizational authority \n\nwhere manufacture of the products is concerned; \n\nthe methods of monitoring the efficient operation of the \n\nquality system and in particular its ability to achieve \n\nthe desired quality of product, including control of \n\nproducts which fail to conform; \n\n(c) the inspection and quality assurance techniques at the \n\nmanufacturing stage and in particular: \n\nthe processes and procedures which will be used, \n\nparticularly as regards sterilization, purchasing and the \n\nrelevant documents; \n\nthe product-identification procedures drawn up and kept \n\nup to date from drawings, specifications or other \n\nrelevant documents at every stage of manufacture-, \n\n(d) the appropriate tests and trials which will be carried out \n\nbefore, during and after manufacture, the frequency with which \n\nthey will take place, and the test equipment used; it must be \n\npossible to trace back the calibration of the test equipment \n\nadequately. 3. 3 \n\nThe notified body shall audit the quality system to determine \n\nwhether it meets the requirements referred to in Section 3. 2. It \n\nshall presume that quality systems which implement the relevant \n\nharmonized standards conform to these requirements. - 71 -\n\nThe assessment team shall include at least one member with past \n\nexperience of assessments of the technology concerned. The \n\nassessment \n\nprocedure shall \n\ninclude an \n\ninspection on the \n\nmanufacturer's premises and, in duly substantiated cases, on the \n\npremises of \n\nthe manufacturer's suppliers to \n\ninspect \n\nthe \n\nmanufacturing processes. The decision shall be notified to the manufacturer after the final \n\ninspection. It shall contain the conclusions of the inspection and \n\na reasoned assessment. 3. 4 \n\nThe manufacturer shall inform the notified body which approved the \n\nquality system of any plan for substantial changes to the quality \n\nsystem. The notified body shall assess the changes proposed and shall verify \n\nwhether after these changes the quality system will still meet the \n\nrequirements referred to in Section 3. 2. After receiving the \n\nabovementioned information it shall notify the manufacturer of its \n\ndecision. This decision shall contain the conclusions of the \n\ninspection and a reasoned assessment. 4. SurveiI lance \n\n4. 1 \n\nThe aim of surveillance is to ensure that the manufacturer duly \n\nfulfils the obligations imposed by the approved quality system. 4. 2 \n\nThe manufacturer shall authorize the notified body to carry out all \n\nthe necessary inspections and shall supply it with all relevant \n\ninformation, in particular: \n\nthe documentation on the quality system-, \n\nthe data stipulated in the part of the quality system relating \n\nto manufacture, such as reports concerning inspections, tests, \n\ncalibration and the qualifications of the staff concerned, \n\netc. - 72 -\n\n4. 3 \n\nThe notified body shall periodically carry out appropriate \n\ninspections and assessments to make sure that the manufacturer \n\napplies the approved quality system and shall supply the \n\nmanufacturer with an assessment report. 4. 4 \n\nIn addition, the notified body may pay unannounced visits to the \n\nmanufacturer. At the time of such visits, the notified body may, \n\nwhere necessary, carry out or ask for tests in order to check that \n\nthe quality system is working properly. It shall provide the \n\nmanufacturer with an inspection report and, if a test has been \n\ncarried out, with a test report. 5. Administrative provisions \n\n5. 1 \n\nThe manufacturer shall, for a period ending at least five years \n\nafter the last product has been manufactured, keep at the disposal \n\nof the national authorities: \n\nthe declaration of conformity; \n\nthe documentation referred to in the fourth indent of \n\nSect ion 3. 1 ; \n\nthe changes referred to in Section 3. 4; \n\nthe documentation referred to in the seventh indent of \n\nSect ion 3. 1 -, and \n\nthe decisions and reports from the notified body as referred \n\nto in Sections 4. 3 and 4. 4. 5. 2 \n\nThe notified body shall communicate to the other notified bodies all \n\nrelevant information concerning the quality system approvals issued, \n\nrefused or withdrawn. 6. Application to devices in Class Ma \n\nIn line with Article 11(2), this Annex may apply to products in \n\nClass M a, subject to these derogations: \n\n\f- 73 -\n\n6. 1 \n\nBy way of derogation from Sections 2, 3. 1 and 3. 2, by virtue of the \n\ndeclaration of conformity the manufacturer ensures and declares that \n\nthe products in Class Ma are manufactured in conformity with the \n\ntechnical documentation referred to in Section 3 of Annex 7 and meet \n\nthe requirements of this Directive which apply to them. 6. 2 \n\nBy way of derogation from the final indent of Section 3. 1, the \n\nmanufacturer shall undertake to notify the competent authorities of \n\nthe incidents referred to in the abovementioned indent immediately \n\non learning of them and to institute and keep updated an appropriate \n\ninternal system for this purpose. - 74 -\n\nANNEX 6 \n\nEC DECLARATION OF CONFORMITY \n\n(PRODUCT QUALITY ASSURANCE) \n\n1. The manufacturer shall apply the quality system approved for the \n\nfinal inspection and testing of the product, as specified in Section \n\n3, and shall be subject to the surveillance referred to in Section \n\n4. 2. The declaration of conformity is the part of the procedure whereby \n\nthe manufacturer who fulfils the obligations imposed by Section 1 \n\nensures and declares that the products concerned conform to the type \n\ndescribed in the EC type-examination certificate and meet the \n\nprovisions of this Directive which apply to them. The manufacturer shall affix the EC mark in accordance with \n\nArticle 17 and shall draw up a written declaration of conformity. This declaration shall cover a given number of identified specimens \n\nof the products manufactured and shall be kept by the manufacturer. The CE mark shall be accompanied by the identification number of the \n\nnotified body which performs the tasks referred to in this Annex. 3. Qua Iity system \n\n3. 1 \n\nThe manufacturer shall lodge an application for assessment of his \n\nquality system with a notified body. The application shall include: \n\nthe name and address of the manufacturer; \n\nall the relevant information on the product or product \n\ncategory covered by the procedure-, \n\na written declaration that no application has been lodged with \n\nany other notified body for the same products; \n\n\f- 75 -\n\nthe documentation on the quality system; \n\nan undertaking to fulfil the obligations imposed by the \n\nquality system approved; \n\nan undertaking to keep the approved quality system adequate \n\nand efficacious; \n\nwhere appropriate, the technical documentation on the types \n\napproved and a copy of the EC type-examination certificates; \n\nan undertaking by the manufacturer to notify the competent \n\nauthorities of the following incidents immediately on learning \n\nof them: \n\n(i) any \n\ndeterioration \n\nin \n\nthe \n\ncharacteristics \n\nand/or \n\nperformances of a device, as well as any inaccuracies in \n\nthe instruction leaflet which might lead to or might have \n\nled to the death of a patient or user or to a serious \n\ndeterioration in their state of health; \n\n(ii) any technical or medical reason connected with the device \n\nleading to recall of devices of the same type by the \n\nmanufacturer. 3. 2 \n\nUnder the quality system, each product shall be examined and the \n\nappropriate tests defined in the relevant standard(s) referred to in \n\nArticle 5 or equivalent tests shall be carried out to ensure that \n\nthe \n\nproducts \n\nconform \n\nto \n\nthe \n\ntype \n\ndescribed \n\nin \n\nthe \n\nEC \n\ntype-examination certificate and fulfil the provisions of this \n\nDirective which apply to them. All the elements, requirements and \n\nprovisions adopted by the manufacturer shall be documented in a \n\nsystematic and orderly manner in the form of written measures, \n\nprocedures and instructions. This quality system documentation must \n\npermit uniform interpretation of the quality programmes, quality \n\nplans, quality manuals and quality records. It shall include in particular an adequate description of: \n\n- 76 -\n\nthe quality objectives and the organizational structure, \n\nresponsibilities and powers of the managerial staff with \n\nregard to product quality; \n\nthe examinations and tests that will be carried out after \n\nmanufacture; it must be possible to trace back the \n\ncalibration of the test equipment adequately; \n\nthe methods of monitoring the efficient operation of the \n\nqua Iity system; \n\nthe quality records, such as reports concerning inspections, \n\ntests, calibration and the qualifications of the staff \n\nconcerned, etc. 3. 3 \n\nThe notified body shall audit the quality system to determine \n\nwhether it meets the requirements referred to in Section 3. 2. It \n\nshall presume that quality systems which implement the relevant \n\nharmonized standards conform to these requirements. The assessment team shall include at least one member with past \n\nexperience of assessments of the technology concerned. The \n\nassessment \n\nprocedure shall \n\ninclude an \n\ninspection on the \n\nmanufacturer's premises and, in duly substantiated cases, on the \n\npremises of \n\nthe manufacturer's suppliers \n\nto \n\ninspect \n\nthe \n\nmanufacturing processes. The decision shall be notified to the manufacturer. It shall \n\ncontain the conclusions of the inspection and a reasoned assessment. 3. 4 \n\nThe manufacturer shall inform the notified body which approved the \n\nquality system of any plan for substantial changes to the quality \n\nsystem. The notified body shall assess the changes proposed and shall verify \n\nwhether after these changes the quality system will still meet the \n\nrequirements referred to in Section 3. 2. After receiving the \n\nabovementioned information it shall notify the manufacturer of its \n\ndecision. This decision shall contain the conclusions of the \n\ninspection and a reasoned assessment. 4. Survelllance \n\n- 77 -\n\n4. 1 \n\nThe aim of surveillance Is to ensure that the manufacturer duly \n\nfulfils the obligations imposed by the approved quality system. 4. 2 \n\nThe manufacturer shall allow the notified body entrance for \n\ninspection purposes to the inspection, testing and storage locations \n\nand shall supply it with all relevant information, in particular: \n\nthe documentation on the quality system; \n\nthe technical documentation; \n\nthe quality records, such as reports concerning inspections, \n\ntests, calibration and the qualifications of the staff \n\nconcerned, etc. 4. 3 \n\nThe notified body shall periodically carry out appropriate \n\ninspections and assessments to make sure that the manufacturer \n\napplies the quality system and shall supply the manufacturer with an \n\nassessment report. 4. 4 \n\nIn addition, the notified body may pay unannounced visits to the \n\nmanufacturer. At the time of such visits, the notified body may, \n\nwhere necessary, carry out or ask for tests in order to check that \n\nthe quality system is working properly and that the production \n\nconforms to the requirements of the Directive which apply to it. To \n\nthis end, an adequate sample of the final products, taken on site by \n\nthe notified body, shall be examined and the appropriate tests \n\ndefined in the relevant standard(s) referred to in Article 5 or \n\nequivalent tests shall be carried out. Where one or more of the \n\nsamples fails to conform, the notified body shall take the \n\nappropriate measures. It shall provide the manufacturer with an \n\ninspection report and, if a test has been carried out, with a test \n\nreport. 5. Administrative provisions \n\n- 78 -\n\n5. 1 \n\nThe manufacturer shall, for a period ending at least five years \n\nafter the last product has been manufactured, keep at the disposal \n\nof the national authorities: \n\nthe declaration of conformity; \n\nthe documentation referred to in the seventh indent of \n\nSection 3. 1 -, \n\nthe changes referred to in Section 3. 4; and \n\nthe decisions and reports from the notified body as referred \n\nto in the final indent of Section 3. 4 and in Sections 4. 3 and \n\n4. 4. 5. 2 \n\nThe notified body shall communicate to the other notified bodies all \n\nrelevant information concerning the quality system approvals issued, \n\nrefused or withdrawn. 6. Application to devices in Class Ma \n\nIn line with Article 11(2), this Annex may apply to products in \n\nClass M a, subject to this derogation: \n\n6. 1 \n\nBy way of derogation from Sections 2, 3. 1 and 3. 2, by virtue of the \n\ndeclaration of conformity the manufacturer ensures and declares that \n\nthe products in Class Ma are manufactured in conformity with the \n\ntechnical documentation referred to in Section 3 of Annex 7 and meet \n\nthe requirements of this Directive which apply to them. - 79 -\n\nANNEX 7 \n\nEC DECLARATION OF CONFORMITY \n\n1. The EC declaration of conformity is the procedure whereby the \n\nmanufacturer or his authorized representative established in the \n\nCommunity who fulfils the obligations imposed by Section 2 and, in \n\nthe case of sterile products and measuring devices, the obligations \n\nimposed by Section 5 ensures and declares that the products \n\nconcerned meet the provisions of this Directive which apply to them. The manufacturer may affix the CE mark to each product in accordance \n\nwith Article 17. The manufacturer shall draw up a written \n\ndeclaration of conformity. 2. The manufacturer shall establish the technical documentation \n\ndescribed \n\nin Section 3. The manufacturer or his authorized \n\nrepresentative established in the Community shall keep this \n\ndocumentation, including the declaration of conformity, at the \n\ndisposal of the national authorities for inspection purposes for a \n\nperiod ending at least five years after the last product has been \n\nmanufactured. Where neither the manufacturer nor his authorized representative are \n\nestablished in the Community, this obligation to keep the technical \n\ndocumentation available shall be the responsibility of the person \n\nwho places the product on the Community market. 3. The technical documentation must allow assessment of the conformity \n\nof the product with the requirements of the Directive. It shall \n\ninclude in particular: \n\na general description of the product, including any variants \n\nplanned; \n\ndesign drawings, methods of manufacture envisaged and diagrams \n\nof components, sub-assemblies, circuits, etc. ; \n\n\f- 80 -\n\nthe descriptions and explanations necessary to understand the \n\nabovementioned drawings and diagrams and the operation of the \n\nproduct ; \n\na list of the standards referred to in Article 5, applied in \n\nfull or in part, and descriptions of the solutions adopted to \n\nmeet the essential requirements of the Directive if the \n\nstandards referred to in Article 5 have not been applied in \n\nfull ; \n\nin the case of sterile products, a description of the methods \n\nused; \n\nthe results of the design calculations and of the inspections \n\ncarried out, etc. if the device is to be connected to other \n\ndevice(s) in order to operate as intended, proof must be \n\nprovided that it conforms to the essential requirements when \n\nconnected to any such device(s) having the characteristics \n\nspecified by the manufacturer; \n\nthe test reports and, where appropriate, clinical data. 4. The manufacturer shall take all the measures necessary for the \n\nmanufacturing process to ensure that the products manufactured \n\nconform to the technical documentation referred to in Section 3 and \n\nto the requirements of the Directive which apply to them. 5. In the case of products placed on the market in sterile condition \n\nand of measuring devices, the manufacturer must observe not only the \n\nprovisions laid down in this Annex but also one of the procedures \n\nreferred to in Annexes 4, 5 or 6. Application of the abovementioned \n\nAnnexes and the intervention by the notified body shall be limited \n\nto: \n\nin the case of sterile products, only the aspects of \n\nmanufacture concerned with obtaining sterile conditions; \n\nin the case of measuring devices, only the aspects of \n\nmanufacture concerned with the conformity of the products with \n\nthe metrological requirements. Section 6. 1 of this Annex shall apply. 6. Application to devices in Class Ma \n\n- 81 -\n\nIn line with Article 11(2), this Annex may apply to products in \n\nClass M a, subject to this derogation: \n\n6. 1 \n\nWhere this Annex is applied in conjunction with the procedure \n\nreferred to in Annex 4, 5 or 6, the declaration of conformity \n\nreferred to in Section 1 of this Annex and the declaration of \n\nconformity referred to in the other abovementioned Annexes shall \n\nform a single declaration. As regards the declaration based on this \n\nAnnex, the manufacturer shall ensure and declare that the product \n\ndesign meets the provisions of this Directive which apply to it. - 82 -\n\nANNEX 8 \n\nSTATEMENT CONCERNING DEVICES \n\nFOR SPECIAL PURPOSES \n\n1. For custom-made devices or for devices intended for clinical \n\ninvestigations the manufacturer or his authorized representative \n\nestablished in the Community shall draw up the statement containing \n\nthe information stipulated in Section 2. 2. The statement shall contain the following information: \n\n2. 1 \n\nFor custom-made devices: \n\ndata allowing identification of the device in question; \n\na statement that the device is intended for exclusive use by a \n\nparticular patient, together with the name of the patient; \n\nthe name of the medical specialist or other authorized person \n\nwho made out the prescription and, where applicable, the name \n\nof the clinic concerned; \n\nthe particular features of the device as specified in the \n\nrelevant medical prescription; \n\na statement that the device in question conforms to the \n\nessential requirements set out in Annex 1 and, where \n\napplicable, indicating which essential requirements have not \n\nbeen fully met, together with the grounds. 2. 2 \n\nFor devices intended for the clinical investigations covered by \n\nAnnex 10: \n\ndata allowing identification of the device in question-, \n\nan investigation plan stating in particular the purpose, scope \n\nand number of devices concerned; \n\nthe opinion of the Ethics Committee concerned and details of \n\nthe aspects covered by its opinion-, \n\n\f- 83 -\n\nthe name of the medical specialist or other authorized person \n\nand of the institution responsible for the Investigations; \n\nthe place, starting date and scheduled duration for the \n\ninvest igat ions; \n\na statement that the device in question conforms to the \n\nessential requirements apart from the aspects covered by the \n\ninvestigations and that, with regard to these aspects, every \n\nprecaution has been taken to protect the health and safety of \n\nthe pat ient. 3. The manufacturer shall also undertake to keep available for the \n\ncompetent national authorities: \n\n3. 1 \n\nFor custom-made devices, documentation allowing an understanding of \n\nthe design, manufacture and performances of the product, including \n\nthe expected performances, so as to allow assessment of conformity \n\nwith the requirements of this Directive. The manufacturer shall take all the measures necessary for the \n\nmanufacturing process to ensure that the products manufactured \n\nconform to the documentation mentioned in the first paragraph. 3. 2 \n\nFor devices intended for clinical investigations, the documentation \n\nshalI contain: \n\na general description of the product; \n\ndesign drawings, methods of manufacture envisaged, in \n\nparticular \n\nas regards sterilization, and diagrams of \n\ncomponents, sub-assemblies, circuits, etc. -, \n\nthe descriptions and explanations necessary to understand the \n\nabovementioned drawings and diagrams and the operation of the \n\nproduct ; \n\na list of the standards referred to in Article 5, applied in \n\nfull or in part, and descriptions of the solutions adopted to \n\nmeet the essential requirements of this Directive if the \n\nstandards referred to in Article 5 have not been applied; \n\nthe results of the design calculations, and of the inspections \n\nand technical tests carried out, etc. - 84 -\n\nThe manufacturer shall take all the measures necessary for the \n\nmanufacturing process to ensure that the products manufactured \n\nconform to the documentation referred to In the first paragraph of \n\nthis Sect ion. The manufacturer may authorize the assessment, or audit where \n\nnecessary, of the effectiveness of these measures. - 85 -\n\nANNEX 9 \n\nCLASSIFICATION CRITERIA \n\nI. CLASSIFICATION P U US \n\n1. Non-invasive devices \n\n1. 1 \n\nRule 1 \n\nAll non-invasive devices are in Class I, unless one of the rules set \n\nout hereinafter applies. 1. 2 \n\nRule 2 \n\nAll non-invasive devices intended for channelling or storing blood, \n\nbody liquids or tissues, liquids or gases for the purpose of \n\neventual infusion, administration or introduction into the body are \n\nin Class lia: \n\nif they are connected to an active medical device in Class Ma \n\nor a higher class; \n\nif they are used for storing blood or other body liquids or \n\nt i ssues. in all other cases they are in Class I. 1. 3 \n\nRule 3 \n\nAM non-invasive devices intended for modifying the biological or \n\nchemical composition of blood, other body liquids or other liquids \n\nintended for infusion into the body are in Class lib, unless the \n\ntreatment consists of filtration, centrifugation or exchanges of \n\ngas, heat or solute, in which case they are in Class M a. 1. 4 \n\nRule 4 \n\n- 86 -\n\nAll non-invasive devices which come into contact with injured skin \n\nare in Class I if they are intended to be used as a mechanical \n\nbarrier, for compression, for the absorption of exudates or for \n\nmoisture permeability. They are in Class Mb if they are intended to be used principally \n\nfor third-degree burns or other skin injuries of comparable degree. In all other cases they are In Class M a. 2. Invasive devices \n\n2. 1 \n\nRule 5 \n\nAll invasive devices with respect to body orifices, other than \n\nsurgically \n\ninvasive devices and which are not \n\nintended for \n\nconnection to an active medical device: \n\nare in Class I If they are intended for transient use; \n\nare in Class Ma if they are intended for short-term use, \n\nexcept If they are used in the oral cavity as far as the \n\npharynx, in the anterior nostrils or the external ear canal up \n\nto the ear drum, in which case they are in Class I; \n\nare in Class Ma if they are intended for long-term use. All Invasive devices with respect to body orifices, other than \n\nsurgically invasive devices intended for connection to an \n\nactive medical device in Class Ma or a higher class, are in \n\nClass M a. 2. 2 \n\nRule 6 \n\nAll surgically invasive devices intended for transient use are in \n\nClass Ma unless they are: \n\n\f- 87 -\n\nintended to diagnose, monitor or correct a defect of the heart \n\nor of the central circulatory system through direct contact \n\nwith these parts of the body, in which case they are in \n\nClass 111; \n\nreusable surgical instruments, in which case they are in \n\nClass I. 2. 3 \n\nRule 7 \n\nAll surgically invasive devices intended for short-term use are in \n\nClass Ma unless they are intended: \n\neither to diagnose, monitor or correct a defect of the heart \n\nor of the central circulatory system through direct contact \n\nwith these parts of the body, in which case they are in \n\nClass I I I ; \n\nor for use in direct contact with the central nervous system, \n\nin which case they are in Class III. 2. 4 \n\nRule 8 \n\nAll implantable devices and long-term surgically invasive devices \n\nare in Class lib unless they are intended: \n\nto be placed in the teeth, in which case they are in \n\nCI ass 11 a ; \n\nto be used in direct contact with the heart, the central \n\ncirculatory system or the central nervous system, in which \n\ncase they are in Class III; \n\nto undergo chemical change in the body, to be biologically \n\nactive, to be wholly or mainly absorbed, to supply energy in \n\nthe form of ionizing radiation or to administer medicines, in \n\nwhich case they are in Class III, except if the devices are \n\nplaced in the teeth. - 88 -\n\n3. Act ive devices \n\n3. 1 \n\nRule 9 \n\nAll active therapeutical devices intended to supply energy or to \n\nadminister, sample or exchange substances are in Class Ma unless \n\nthey are intended: \n\nto administer potentially dangerous levels or forms of energy \n\nto the human body, taking account of the part of the body \n\nabsorbing the energy and/or the density of the energy; \n\nto administer or exchange medicines, body liquids or other \n\nsubstances in a potentially dangerous way, taking account of \n\nthe nature of the substances administered and of the part of \n\nthe body concerned, or in such a way that the exchange or flow \n\ncannot be controlled by the patient. In these cases, the devices are in Class M b. All active \n\ndevices intended to control and monitor the performance of \n\nactive therapeutical devices in Class I lb or intended directly \n\nto influence the performance of such devices are in Class M b. 3. 2 \n\nRule 10 \n\nAll active devices intended for diagnosis are in Class M a: \n\nif they are intended to supply energy which will be absorbed \n\nby the human body, except for devices used to illuminate the \n\npatient's body, in the visible spectrum; \n\nif they are intended primarily to allow direct diagnosis of \n\nvital physiological processes in a situation posing an \n\nimmediate danger to the patient's life. 3. 3 \n\nRule 11 \n\nAll other active devices are in Class I. - 89 -\n\nSpecial rules \n\n4. 1 \n\nRule 12 \n\nAll devices incorporating, as an integral part, a substance which, \n\nif used separately, can be considered to be a medicinal product, as \n\ndefined in Article 1 of Directive 65/65/EEC, and whose action in \n\ncombination with the devices can result in its bioavailability, are \n\nin Class III. 4. 2 \n\nRule 13 \n\nAll devices used for contraception or the prevention of the \n\ntransmission of a viral disease by sexual contact are in Class M b. II. DEFINITIONS AND IMPLEMENTING RULES \n\n- 90 -\n\n1. DEFINITIONS FOR THE CLASSIFICATION RULES \n\n1. 1 \n\nPujatlon \n\nTransient Normally intended for continuous use for less than 60 \n\nminutes. Short term \n\nNormally intended for continuous use for not more \n\nthan 30 days. Long term \n\nNormally intended for continuous use for more than \n\n30 days. 1. 2 \n\nInvasive devices \n\nInvasive device A device which, in whole or in part, penetrates \n\ninside the body, either through a body orifice or \n\nthrough the surface of the body. Body orifice \n\nAny natural opening in the body, including the \n\nexternal surface of the eyeball, or any permanent \n\nartificial opening, such as a stoma. Surgically Invasive \n\ndevice \n\nA device which penetrates inside the body through \n\nthe surface of the body, with the aid or in the \n\ncontext of a surgical operation. 1-3 \n\nReusable surgical \n\ninstrument \n\nInstrument intended for a surgical operation such as \n\ncutting, drilling, sawing, scratching, retracting or \n\nclipping without connection to any other medical \n\ndevice and which can be used in several different \n\noperations. 1. 4 \n\nActive medical \n\n- 91 -\n\ndevice \n\nAny medical device connected to or equipped with a \n\nsource of electrical energy or any source of power \n\nother than that directly generated by the human body \n\nor gravity and which acts by converting this energy. Medical \n\ndevices \n\nintended \n\nto transmit \n\nenergy, \n\nsubstances or other elements between an active \n\nmedical \n\ndevice and the patient, without \n\nany \n\nsignificant change, are not considered to be active \n\nmedical devices. 1. 5 \n\nActive therapeutical \n\ndevice \n\nAny active medical device, whether used alone or in \n\ncombination with other medical devices, to support, \n\nmodify or replace biological functions or structures \n\nwith a view to treatment or alleviation of an \n\nillness, injury or handicap. 1-6 \n\nActive device for \n\nd i aonos i s \n\nAny active medical device, whether used alone or in \n\ncombination with other medical devices, to supply \n\ninformation for detecting, diagnosing, monitoring or \n\ntreating physiological conditions, states of health, \n\nillnesses or congenital deformities. 1. 7 \n\nCentral circulatory \n\nsystem \n\nThe following vessels: \n\narteriae pulmonales, aorta ascendens, arteriae \n\ncoronariae, \n\narteria \n\ncarotis \n\ncommunis, \n\narteria \n\ncarotis externa, arteria carotis interna, arteriae \n\ncerebrates, truncus brachiocephalicus, venae cordis, \n\nvenae pulmonales, vena cava superior, vena cava \n\ninferior. 1. 8 \n\nCentral nervous \n\nsystem \n\nBrain and spinal cord. 2. IMPLEMENTING RULES \n\n- 92 -\n\n2. 1 \n\nApplication of the classification rules shall be governed by the \n\nintended purpose of the devices. 2. 2 \n\nif the device is intended to be used in combination with another \n\ndevice, the classification rules shall apply separately to each of \n\nthe devices. 2. 3 \n\nif the device is not intended to be used solely or principally in a \n\nspecific part of the body, it must be considered and classified on \n\nthe basis of the most critical use. 2. 4 \n\nIf two rules apply to the same device, based on the performance \n\nspecified for the device by the manufacturer, the rule resulting in \n\nthe higher classification shall apply. - 93 -\n\nANNEX 10 \n\nCLINICAL EVALUATION \n\n1. General provisions \n\n1. 1 \n\nAs a general rule, confirmation of conformity with the requirements \n\nconcerning the characteristics and performances referred to in \n\nSection 1 of Annex 1 under the normal conditions of use of the \n\ndevice and the evaluation of the undesirable side-effects must be \n\nbased on clinical data in the case of implantable devices, devices \n\nin Class III and, where Justified, other devices. Taking account of \n\nany relevant harmonized standards, where appropriate, the adequacy \n\nof the clinical data shall be based on: \n\n1. 1. 1 either a compilation of the relevant scientific literature currently \n\navailable on the intended purpose of the device and the techniques \n\nemployed as well as, if appropriate, a written report containing a \n\ncritical evaluation of this compilation; \n\n1. 1. 2 or the results of all the clinical investigations made, including \n\nthose carried out in conformity with Section 2. 1. 2 \n\nAll the data must remain confidential, in conformity with the \n\nprovisions of Article 20. 2. Clinical investigation \n\n2. 1 \n\nObjectives \n\nThe objectives of clinical investigation are: \n\nto verify that, under normal conditions of use, the \n\nperformances of the devices conform to those referred to in \n\nSection 3 of Annex 1; and \n\nto determine any undesirable side-effects, under normal \n\nconditions of use, and assess whether they are risks when \n\nweighed against the intended performance of the device. 2. 2 \n\nEthical considerations \n\n- 94 -\n\nClinical investigations shall be carried out in accordance with the \n\nHelsinki Declaration adopted by the 18th World Medical Assembly in \n\nHelsinki, Finland, in 1964, as last amended by the 41st World \n\nMedical Assembly in Hong Kong in 1989. It is mandatory that all \n\nmeasures relating to the protection of human subjects are carried \n\nout in the spirit of the Helsinki Declaration. This shall include \n\nevery step in the clinical investigation from first consideration of \n\nthe need and Justification of the study to publication of the \n\nresults. 2. 3 \n\nMethods \n\n2. 3. 1 Clinical investigations shall be performed on the basis of an \n\nappropriate plan of investigation corresponding to the state of the \n\nart and defined in such a way as to confirm or refute the \n\nmanufacturer's claims for the device-, these investigations shall \n\ninclude an adequate number of observations to guarantee the \n\nscientific validity of the conclusions. 2. 3. 2 The procedures used to perform the investigations shall be \n\nappropriate to the device under examination. 2. 3. 3 Clinical investigations shall be performed in circumstances similar \n\nto the normal conditions of use of the device. 2. 3. 4 All the appropriate features, including those involving the safety \n\nand performances of the device, and its effect on patients shall be \n\nexamined. 2. 3. 5 All adverse incidents shall be fully recorded. 2. 3. 6 The Investigations shall be performed under the responsibility of a \n\nmedical specialist or another authorized qualified person in an \n\nappropriate environment. The medical specialist or other authorized person shall have access \n\nto the technical and clinical data regarding the device. - 95 -\n\n2. 3. 7 The written report, signed by the medical specialist or other \n\nauthorized person responsible, shall contain a critical evaluation \n\nof all the data collected during the clinical investigation. - 96 -\n\nANNEX 11 \n\nMINIMUM CRITERIA FOR THE DESIGNATION OF \n\nNOTIFIED INSPECTION BODIES \n\n1. The notified body, its Director and the assessment and verification \n\nstaff shall not be the designer, manufacturer, supplier, installer \n\nor user of the devices which they inspect, nor the authorized \n\nrepresentative of any of these persons. They may not be directly \n\ninvolved in the design, construction, marketing or maintenance of \n\nthe devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical \n\ninformation between the manufacturer and the body. 2. The inspection body and its staff must carry out the assessment and \n\nverification operations with the highest degree of professional \n\nintegrity and the requisite competence in the field of medical \n\ndevices and must be free from all pressures and inducements, \n\nparticularly financial, which might influence their judgment or the \n\nresults of the inspection, especially from persons or groups of \n\npersons with an interest in the results of the verifications. Should the notified body subcontract specific tasks connected with \n\nthe establishment and verification of the facts, it must first \n\nensure that the subcontractor meets the provisions of the Directive \n\nand, In particular, of this Annex. The notified body shall keep at \n\nthe disposal of the national authorities the relevant documents \n\nassessing the subcontractor's qualifications and the work carried \n\nout by the subcontractor under this Directive. 3. The notified body must be able to carry out all the tasks assigned \n\nto such bodies by one of Annexes 2 to 6 and for which it has been \n\nnotified, whether these tasks are carried out by the body itself or \n\non its responsibility. In particular, it must have the necessary \n\nstaff and possess the facilities needed to perform properly the \n\ntechnical and administrative tasks entailed in assessment and \n\nverification. It must also have access to the equipment necessary \n\nfor the verifications required. 4. The inspection staff must have: \n\n- 97 -\n\nsound vocational training covering all the assessment and \n\nverification \n\noperations \n\nfor which \n\nthe body \n\nhas been \n\ndesignated; \n\nsatisfactory knowledge of the rules on the inspections which \n\nthey carry out and adequate experience of such inspections; \n\nthe ability required to draw up the certificates, records and \n\nreports to demonstrate that the inspections have been carried \n\nout. 5. The impartiality of the inspection staff must be guaranteed. Their \n\nremuneration must not depend on the number of inspections carried \n\nout, nor on the results of the inspections. 6. The body must take out civil liability insurance, unless liability \n\nis assumed by the State under the national law or the Member State \n\nitself carries out the inspections directly. 7. The staff of the inspection body are bound to observe professional \n\nsecrecy with regard to all information gained in the course of their \n\nduties (except vis-\u00e0-vis the competent administrative authorities of \n\nthe State in which their activities are carried out) under this \n\nDirective or any provision of national law putting it into effect. - 98 -\n\nANNEX 12 \n\nCE MARK OF CONFORMITY \n\n\f- 99 \n\nFICHE FINANCIERE \n\nVOLET 1 : IMPLICATIONS FINANCIERES \n\n1. Int itul\u00e9 de I'act Ion \n\nProposition de directive concernant le rapprochement des \nl\u00e9gislations des Etats membres relatives aux dispositifs \nm\u00e9d i eaux. 2. Lignes budg\u00e9taires concern\u00e9es \n\narticle B 5-300 \n\n: actions relatives \u00e0 l'ach\u00e8vement du \n\nMarch\u00e9 Int\u00e9rieur, d\u00e9penses \nop\u00e9r\u00e2t ionneII es \n\narticle B 8-530 \n\n: actions relatives \u00e0 l'ach\u00e8vement du \n\nMarch\u00e9 Int\u00e9rieur, d\u00e9penses d'appui et de \nsout i en. 3. Base l\u00e9ga I e \n\nArticle 100A du Trait\u00e9 CEE \n\n4. Description de l'action \n\n4. 1. Ach\u00e8vement du March\u00e9 Int\u00e9rieur dans le secteur des \n\ndispositifs m\u00e9dicaux; am\u00e9lioration de la protection de \nla sant\u00e9 et de la s\u00e9curit\u00e9 des patients et des \nut i Ii sateurs. En suivant les principes de la Nouvelle A p p r o c h e, la \ndirective harmonise les exigences et les proc\u00e9dures \nd'\u00e9valuation de conformit\u00e9 auxquelles doivent r\u00e9pondre \nles dispositifs m\u00e9dicaux lors de leur mise sur le march\u00e9 \net de leur mise en service. La mise en oeuvre efficace \nimplique aupr\u00e8s de la Commission, des Etats membres et \ndes organismes europ\u00e9ens de normalisation CEN/CENELEC \ndes activit\u00e9s dans les domaines suivants -. \u00e9tablissement des normes harmonis\u00e9es par le \nCEN/CENELEC facilitant la preuve de la conformit\u00e9 aux \nexigences essentielles de la d i r e c t i v e, \nmise en place par les Etats membres d'une \ninfrastructure d'autorit\u00e9s comp\u00e9tentes assurant le \ncontr\u00f4le du respect de la directive ainsi que la \nd\u00e9signation par les Etats membres des organismes de \ncertification charg\u00e9s de l'\u00e9valuation de la \nconform i t\u00e9, \n\n\f- 100 -\n\n\u00e9 t ab I i s s e m e nt \np e r m e t t a nt au \nde p r o t e ct ion \ni n t e r v e n us av \n\u00e9 I a b o r a ti on p \nu t i l es \u00e0 I'a p \np o r t a nt sur s \nc I a ss i f i cat io \ng e st i on des p \nd es d i spos i t i \ns a u v e g a r de im \nd es e x p er ts , \nm i se en pi ace \np o r t a nt sur I \nc l a s s i f i c a t io \nc a d re du syst \n\net g e s t i on d'un s y s t \u00e8 me d ' a l e r te \n\nx E t a ts m e m b r es de p r e n d re d es m e s u r es \n\ns u i te \u00e0 d es i n c i d e n ts i n d \u00e9 s i r a b l es \n\nec des d i s p os i t i f s, \nar la C o m m i s s i on des l i g n es d i r e c t r i c es \np l i c a t i on u n i f o r me de la d i r e c t i ve \non champ d ' a p p l i c a t i on a i n si q ue sur la \nn des d i s p os i t i f s, \nr o c \u00e9 d u r es c o n c e r n a nt la c l a s s i f i c a t i on \nfs et l ' a p p l i c a t i on de la c l a u se de \np l i q u a nt le r e c o u rs \u00e0 l ' a v is t e c h n i q ue \n\nd ' u ne b a se e u r o p \u00e9 e n ne de d o n n \u00e9 es \na c e r t i f i c a t i on des d i s p o s i t i f s, la \nn et les i n c i d e n ts n o t i f i \u00e9s d a ns le \n\u00e8me d ' a l e r t e. 4. 2. D u r \u00e9e : e n v i r on 4-5 a n s; a c t i on p o n c t u e l l e. Le m o n t a nt \nd es c r \u00e9 d i ts a l l o u \u00e9s pour c e t te a c t i on s e ra t o u t e f o is \nd \u00e9 t e r m i n\u00e9 c h a q ue a n n \u00e9e en f o n c t i on des t r a v a ux r e s t a nt \u00e0 \nef f e c t u e r. 4. 3. P o p u l a t i on c o n c e r n \u00e9e : p o t e n t i e l l e m e n t, l ' e n s e m b le de la \np o p u l a t i on c o m m u n a u t a i re et des p a ys t i e r s. C l a s s i f i c a t i on des d \u00e9 p e n s es \n\n5. 1. D \u00e9 p e n s es non o b l i g a t o i r es \n\n5. 2. B 5 - 3 00 : c r \u00e9 d i ts d i s s o c i \u00e9s. B 8 - 5 30 : c r \u00e9 d i ts non d i s s o c i \u00e9s \n\nN a t u re d es d \u00e9 p e n s es \n\nL ' \u00e9 l a b o r a t i on des n o r m es h a r m o n i s \u00e9 es par le C E N / C E N E L EC est \nc o u v e r te par une c o n t r i b u t i on f i n a n c i \u00e8 re de la C o m m u n a u t\u00e9 et \nl'AELE (part du f i n a n c e m e nt i n c o m b a nt \u00e0 la CE. - 8 6 %, \u00e0 \nl'AELE : 1 4 % ). Les f r a is r e s t a nt s e r o nt c o u v e r ts par les \no r g a n i s m es de n o r m a l i s a t i on et les p a r t i es c o n c e r n \u00e9 es \n( i n d u s t r i e, o r g a n i s m es de c e r t i f i c a t i on e t c ). Le f i n a n c e m e nt sera o c t r o y\u00e9 m o y e n n a nt des b o ns de c o m m a n de \np a s s \u00e9s en v e r tu du c o n t r a t - c a d re du 4 ao\u00fbt 1 9 89 s i g n\u00e9 a v ec le \nC E N / C E N E L E C. La m i se en p l a ce d'une base de d o n n \u00e9 es n \u00e9 c e s s i t e ra un \nf i n a n c e m e nt s o us forme d ' \u00e9 t u de de f a i s a b i l i t\u00e9 et de p r e s t a t i on \nde s e r v i c es au c o u rs de la p h a se de d \u00e9 m a r r a g e. La f o u r n i t u re des a v is t e c h n i q u es n \u00e9 c e s s a i r es en vue des \nq u e s t i o ns s p \u00e9 c i f i q u es d a ns le c a d re de la g e s t i on c o u r a n te \ns e ra f i n a n c \u00e9e par des c o n t r a ts d ' \u00e9 t u de et de p r e s t a t i on de \ns e r v i c e. - 101 -\n\n7. Incidence financi\u00e8re sur les cr\u00e9dits d'intervention (partie B \ndu b u d g e t) \n\na) \u00e9laboration des normes europ\u00e9ennes (CD) \n\n1. M o de de calcul \n\nLe financement sera d\u00e9termin\u00e9 en fonction des travaux \u00e0 \nconfier aux contractants. Il sera calcul\u00e9 sur la base de \nl'unit\u00e9 \"homme/mois\", qui s'\u00e9l\u00e8ve actuellement \u00e0 \n8. 000 ECU. Le nombre de normes harmonis\u00e9es n\u00e9cessaires jusqu'\u00e0 fin \n1996 est de 300. La contribution de la Commission est \nestim\u00e9e \u00e0 6,25 hommes/mois par norme; \nFrais totaux : 1. 875 hommes/mois, soit 15 mio ECU \n\n2. L'\u00e9ch\u00e9ancier indicatif des cr\u00e9dits pourrait \u00eatre le \n\nsu i vant : \n\nCr\u00e9dits d'engagement \n\n(1. 000 ECU) \n\nCr\u00e9dits de pa i ement \n(1. 000 ECU) \n\n1992 \n1993 \n1994 \n1995 \n1996 \n\n1. 5 00 \n4. 0 00 \n5. 0 00 \n4. 5 00 \np. m. 15. 000 \n\n1. 000 \n2. 000 \n4. 000 \n5. 000 \n3. 000 \n\n15. 000 \n\nLe niveau des cr\u00e9dits \u00e0 partir de 1992 sera fix\u00e9 par la \nproc\u00e9dure budg\u00e9taire annuelle dans le cadre des \ncontraintes fix\u00e9es par les Perspectives financi\u00e8res \npost 9 2. Pour 1992, le montant global (mini-budgets compris) est \ninclus dans le chiffre total des d\u00e9penses de -\nNotification, reconnaissance mutuelle, harmonisation des \nl\u00e9gislations techniques, normalisation et rectification \net essais (33. 153. 000) de la fiche financi\u00e8re globale \ndes postes B5-300 et B 8 - 5 3 0. b) autres mesures financ\u00e9es par le mini-budget \n\nconform\u00e9ment \u00e0 la d\u00e9cision de la Commission du 22. 5. 1990 \nsur les mini-budgets \n\nfrais d'experts : 450 \u00e0 500 ECU par expert, par Jour \n\n1992 \n1993 \n1994 \n1995 \n1996 \n\n30 x 450 ECU \n30 X 450 ECU \n30 x 450 ECU \n20 x 500 ECU \n20 x 500 ECU \n\nECU \n\n13 \n13 \n13 \n10 \n10 \n\n500 \n500 \n500 \n000 \n000 \n\nTOTAL (1992-1996) \n\n60. 500 \n\n\f- 102 -\n\nfrais pour la mise en place et le d\u00e9marrage de la base \nde donn\u00e9es, \u00e0 r\u00e9partir en trois tranches sur les ann\u00e9es \n1992 \u00e0 1994 : \n\n* 1992 \n* 1993 \n* 1994 \n\nECU \n\n200. 000 \n200. 000 \n100. 000 \n\n500. 000 \n\nTOTAL (1992-1994) \n\n8. D i s p o s i t i o ns anti-fraude pr\u00e9vues dans la p r o p o s i t i on d'action? \n\nLe c o n t r a t - c a d re vis\u00e9 sous le point 6. pr\u00e9voit un \n\u00e9chelonnement des paiements en fonction des p r o g r \u00e8s des \nt r a v a u x, ainsi que la possibilit\u00e9 d'un audit par la Commission \nou la Cour des Comptes. VOLET 2 : D E P E N S ES ADM INSTRATIVES (partie A du b u d g e t) \n\nL'action propos\u00e9e implique une augmentation du personnel statutaire \naffect\u00e9 \u00e0 la gestion de la directive. Les proc\u00e9dures d\u00e9cisionnelles \nportant sur la classification des dispositifs et sur la clause de \ns a u v e g a r d e, le suivi de la normalisation europ\u00e9enne pr\u00e9supposent \nl'existence d'effectifs pouvant \u00e9tablir des analyses et avis \ntechnico-Juridiques et en organiser la gestion a d m i n i s t r a t i v e. Les besoins en personnel sont \u00e0 pourvoir, soit par voie de \nred\u00e9ploiement interne, soit par d\u00e9cision de la C o m m i s s i on \nallocation ressources dans le cadre de la proc\u00e9dure b u d g \u00e9 t a i r e, \nsont e s t i m \u00e9 s, pour l'unit\u00e9 III. D. 4, \u00e0 partir de 1992 \u00e0 : \n\nI Is \n\n- 1 A \n- 1 B \n\nsoit environ 200. 000 ECU, \u00e0 raison de 100. 000 ECU en m o y e n ne par \npersonne et par an. VOLET 3 : E L E M E N TS D'ANALYSE COUT-EFFICACITE \n\n1. O b j e c t i fs et coh\u00e9rence avec ia programmation f i n a n c i \u00e8 re \n\nLa d i r e c t i ve de type Nouvelle Approche s'inscrit dans le cadre \nde l'ach\u00e8vement du March\u00e9 Int\u00e9rieur. Le renvoi aux normes \nh a r m o n i s \u00e9 es fait partie de l'action pluriannuelle de la \nC o m m i s s i on qui consiste \u00e0 soutenir le renforcement et \nl'\u00e9largissement de la normalisation e u r o p \u00e9 e n n e. L'action est pr\u00e9vue dans la programmation financi\u00e8re de la \nDG III. - 103 -\n\n2. Justification de l'action \n\nLes divergences dans les syst\u00e8mes nationaux en ce qui concerne \nles exigences pour les produits et les proc\u00e9dures relatives \u00e0 \nla mise sur le march\u00e9 entra\u00eenent un gaspillage \u00e9norme de \nressources humaines et financi\u00e8res \u00e0 charge des fabricants et \ndes Etats m e m b r e s. Les proc\u00e9dures communautaires permettront d'\u00e9viter la \nr\u00e9p\u00e9tition multiple des proc\u00e9dures visant le m\u00eame objet. De \nplus, les exigences harmonis\u00e9es permettront \u00e0 l'industrie de \nr\u00e9aliser des \u00e9conomies sur le prix par unit\u00e9 de production, ce \nqui pourra m\u00eame avoir un effet b\u00e9n\u00e9fique sur les d\u00e9penses \u00e0 \ncharge des syst\u00e8mes de sant\u00e9 publique. Quant \u00e0 l'harmonisation des normes, l'action vise \u00e0 mettre en \ncommun les ressources et, de ce fait, \u00e0 \u00e9viter la \nmultiplication des d\u00e9penses pour l'ensemble des Etats membres. Globalement, les ressources requises \u00e0 imposer au budget \ncommunautaire ne repr\u00e9sentent qu'une part mineure par rapport \n\u00e0 la totalit\u00e9 des ressources qui, de la part des Etats membres \net des parties concern\u00e9es, seront allou\u00e9es dans la suite de \nl'action au b\u00e9n\u00e9fice commun. 3. Suivi et \u00e9valuation de l'action \n\n3. 1. I n d i c a t i on d es performances : \n\ndegr\u00e9 d'harmonisation au plan de la normalisation \n(nombre de n o r m e s ), \nnombre de certifications effectu\u00e9es, \nnombre de rapports notifi\u00e9s sur des incidents \ni nd\u00e9s i rabI es , \nnombre de proc\u00e9dures de clause de s a u v e g a r d e. 3. 2. M o d a l i t \u00e9s d es \u00e9valuations : \n\nrapports d'\u00e9tat des progr\u00e8s p\u00e9riodiques sur la \nnormalisation dans le cadre de la directive du \nConseil 83/189/CEE ayant au minimum un caract\u00e8re \nannue I ; \n\u00e9changes de vues dans un Comit\u00e9 sectoriel \n\"dispositifs m\u00e9dicaux\". 3. 3. P r i n c i p a ux facteurs d'incertitude : \n\nla d\u00e9signation des organismes de certification par \nles Etats membres se fait sur une base facultative et \nde mani\u00e8re d\u00e9centralis\u00e9e, \nl'assurance d'une application homog\u00e8ne d'un tel \nsyst\u00e8me pr\u00e9suppose, aussi bien aupr\u00e8s des Etats \nmembres que sur le plan communautaire, la \ndisponibilit\u00e9 d'interfaces assurant le fonctionnement \ndes p r o c \u00e9 d u r e s. - 104 -\n\nF i c he d ' \u00e9 v a l u a t i on d ' i m p a ct \n\nImpact de la p r o p o s i t i on sur les e n t r e p r i s es e t, en \np a r t i c u l i e r, sur les p e t i t es et m o y e n n es e n t r e p r i s es \n\nT I T RE DE LA P R O P O S I T I ON \n\nP r o p o s i t i on de d i r e c t i ve c o n c e r n a nt le r a p p r o c h e m e nt d es \nl \u00e9 g i s l a t i o ns d es E t a ts m e m b r es r e l a t i v es aux d i s p o s i t i fs \nm \u00e9d i e a u x. N U M E RO DE R E F E R E N CE DU D O C U M E NT \n\n2 1 2 1. 21 \n\nLA P R O P O S I T I ON. 1. C o m p te t e nu du p r i n c i pe de s u b s i d i a r i t\u00e9 , p o u r q u oi une \nl \u00e9 g i s l a t i on c o n m u n a u t ai re e s t - e l le n \u00e9 c e s s a i re d a ns ce \nd o m a i ne et q u e ls sont ses p r i n c i p a ux o b j e c t i f s? \n\nL es r \u00e9 g l e m e n t a t i o ns n a t i o n a l es r e l a t i v es \u00e0 la m i se sur le \nm a r c h\u00e9 et la m i se en s e r v i ce d es d i s p o s i t i fs m \u00e9 d i c a ux \np r \u00e9 s e n t e nt un tel d e g r\u00e9 de d i v e r g e n c es s u b s t a n t i e l l e s, \nq u ' u ne libre c i r c u l a t i on d a ns la C o m m u n a u t\u00e9 n ' e st p as \na s s u r \u00e9 e. L ' h a r m o n i s a t i on d es e x i g e n c es et d es p r o c \u00e9 d u r es \nd ' \u00e9 v a l u a t i on de la c o n f o r m i t\u00e9 a u x q u e l l es d o i v e nt r \u00e9 p o n d re \nles d i s p o s i t i fs m \u00e9 d i c a ux p o ur a s s u r er la p r o t e c t i on d es \np a t i e n t s, u t i l i s a t e u rs et t i e rs e s t, d \u00e8s l o r s, le seul m o y en \np o ur a c h e v er le m a r c h\u00e9 i n t \u00e9 r i e ur d a ns ce s e c t e u r. I M P A CT S UR L ES E N T R E P R I S ES \n\n2. Qui s e ra a f f e c t\u00e9 par la p r o p o s i t i o n? \n\ns e c t e u rs d ' e n t r e p r i s es : tout f a b r i c a nt de d i s p o s i t i fs \nm \u00e9 d i c a ux (\u00e0 l ' e x c e p t i on d es d i s p o s i t i fs \na c t i f s, t e ls que d es s t i m u l a t e u rs c a r d i a q u es a i n si q ue \nd es d i s p o s i t i fs d e s t i n \u00e9s au d i a g n o s t ic \ne x e m p l es : a p p a r e i ls \u00e9 l e c t r o m \u00e9 d i c a u x, p r o d u i ts \u00e0 u s a ge \nu n i q u e, m a t \u00e9 r i a ux et p r o t h \u00e8 s es d e n t a i r e s, p r o t h \u00e8 s es \no r t h o p \u00e9 d i q u e s, i n s t r u m e n t s, e tc \n\ni m p l a n t a b l es \n\ni n - v i t r o ), \n\nt a i l l es d es e n t r e p r i s es : t o u te t a i l l e, y c o m p r is les \nm u l t i n a t i o n a l es et le. s PME \n\nz o n es g \u00e9 o g r a p h i q u es p a r t i c u l i \u00e8 r es d ' i m p l a n t a t i on : a u c u ne \n\n\f- 105 -\n\nQ u e l l es m e s u r es les e n t r e p r i s es d e v r o n t -e I I es p r e n d re pour \nse c o n f o r m er \u00e0 la p r o p o s i t i o n? \n\nA p a r t ir de l ' a p p l i c a t i on t o t a le de la d i r e c t i v e, c ' e s t - \u00e0-\nd i re le 1er J u i l l et 1 9 97 : \n\nla c o n c e p t i on et la f a b r i c a t i on d es p r o d u i ts d e v r o nt \nr \u00e9 p o n d re aux e x i g e n c es de la d i r e c t i v e, \nles f a b r i c a n ts ou l e u rs m a n d a t a i r es d e v r o nt s u i v re les \np r o c \u00e9 d u r es d ' \u00e9 v a l u a t i on de c o n f o r m i t\u00e9 p r \u00e9 v u e s. Au c o u rs d ' u ne p \u00e9 r i o de de t r o is a ns \u00e0 p a r t ir de la p r e m i \u00e8 re \na p p l i c a t i on de la d i r e c t i ve ( e n t re J u in 1 9 94 et J u in 1 9 9 7 ), \nles f a b r i c a n ts p o u r r o n t, soit c o n t i n u er \u00e0 a p p l i q u er les \nl \u00e9 g i s l a t i o ns n a t i o n a l es p r \u00e9 e x i s t a n t e s, s o it se c o n f o r m er au \nr\u00e9g ime h a r m on i s e. Q u a nt aux p r o c \u00e9 d u r es d ' \u00e9 v a l u a t i on de c o n f o r m i t \u00e9, les \nf a b r i c a n ts p o u r r o nt c h o i s i r, en c as d ' i n t e r v e n t i on d ' u ne \nt i e r ce p a r t i e, e n t re t r o is ou q u a t re p r o c \u00e9 d u r es \na l t e r n a t i v e m e nt a p p l i c a b l e s. L es d i s p o s i t i o ns t r a n s i t o i r es a i n si q ue le c h o ix p o ur les \nf a b r i c a n ts e n t re p l u s i e u rs p r o c \u00e9 d u r es d ' \u00e9 v a l u a t i on de la \nc o n f o r m i t\u00e9 d e v r o nt f a c i l i t er la t r a n s i t i on v e rs le r \u00e9 g i me \nh a r m on i s e. Q u e ls e f f e ts \u00e9 c o n o m i q u es \nd ' a v o i r? \n\na p r o p o s i t i on e s t - e l le s u s c e p t i b le \n\nsur I ' e m p lo i : a u c un e f f et s i g n i f i c a t if n ' e st e s c o m p t \u00e9. s ur les i n v e s t i s s e m e n ts et la c r \u00e9 a t i on de n o u v e l l es \ne nt r e p ri s es : la d i r e c t i ve peut a v o ir c o m me e f f e t, \nn o t a m m e nt en ce qui c o n c e r ne les d i s p o s i t i fs m \u00e9 d i c a ux \np r \u00e9 s e n t a nt un r i s q ue \u00e9 l e v \u00e9, q u ' u ne p a r t ie d es e n t r e p r i s es \nd o i v e nt a d a p t er l e u rs p r o c \u00e9 d \u00e9s de f a b r i c a t i o n, de s o r te \u00e0 \np e r m e t t re u ne q u a l i t\u00e9 de p r o d u c t i on \u00e9 l e v \u00e9e et c o n s t a n t e. O r, c es i n v e s t i s s e m e n ts r e n f o r c e r o nt la c o m p \u00e9 t i t i v i t\u00e9 d es \ne nt r e pr i s e s. s ur la c o m p \u00e9 t i t i v i t\u00e9 d es e n t r e p r i s es : l ' a c t i on p r o p o s \u00e9e \nf a c i l i t e ra l ' a c c \u00e8s \u00e0 un m a r c h\u00e9 de d i m e n s i on \nc o m m u n a u t a i r e. C e t te p e r s p e c t i ve o u v r i ra de n o u v e a ux \nh o r i z o ns aux e n t r e p r i s es de t a i l le p l us m o d e s te qui ne \nd i s p o s e nt p as de f i l i a l es d a ns c h a q ue E t at m e m b re p o ur \nt r a i t er d i r e c t e m e nt a v ec les a u t o r i t \u00e9s n a t i o n a l es \nc o m p \u00e9 t e n t e s. Il faut \u00e9 g a l e m e nt s o u l i g n er q ue les \ne n t r e p r i s es d e v r o n t, de ce f a i t, f a i re f a ce \u00e0 u ne \ni n t e n s i f i c a t i on de la c o n c u r r e n c e. La p r o p o s i t i on c o n t i e n t - e l le des m e s u r es v i s a nt \u00e0 t e n ir \nc o m p te de la s i t u a t i on s p \u00e9 c i f i q ue des p e t i t es et m o y e n n es \ne n t r e pr i s e s? \n\nNon \n\n\f- 106 -\n\nCONSULTATION \n\nPour pr\u00e9parer cette proposition, la Commission a o r g a n i s \u00e9, depuis \n1989, au moins cinq r\u00e9unions rassemblant les experts \ngouvernementaux et les f\u00e9d\u00e9rations professionnelles. De p l u s, de \nmultiples r\u00e9unions bilat\u00e9rales avec les f\u00e9d\u00e9rations sur des \naspects sp\u00e9cifiques ont eu lieu. Ont \u00e9t\u00e9 consult\u00e9es : \n\nles associations europ\u00e9ennes de l'industrie des dispositifs \nm\u00e9d i eaux , \nles associations des utilisateurs, notamment des m \u00e9 d e c i ns et \ndes p h a r m a c i e n s. La Commission a, dans une large mesure, tenu compte des \ncommentaires re\u00e7us lors de la consultation. Les milieux \nint\u00e9ress\u00e9s, y compris les f\u00e9d\u00e9rations industrielles, ont \nprincipalement support\u00e9 l'approche suivie dans la p r o p o s i t i o n. ISSN 0254-1475 \n\nCOM(91) 287 final \n\nDOCUMENTS \n\nEN \n\n06 \n\nCatalogue number : CB-CO-91-356-EN-C \n\nISBN 92-77-74963-6 \n\nOffice for Official Publications of the European Communities \n\nLr29SS Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/da2ac9a4-6391-49e7-ab27-3de232274ab7", "title": "Commission Regulation (EEC) No 2530/91 of 23 August 1991 re-establishing the levying of customs duties on products falling within CN code 4203, originating in Pakistan and India, to which the preferential tariff arrangements set out in Council Regulation (EEC) No 3831/90 apply", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-23", "subjects": "India,Pakistan,restoration of customs duties,textile product", "workIds": "celex:31991R2530,oj:JOL_1991_236_R_0010_026", "eurovoc_concepts": ["India", "Pakistan", "restoration of customs duties", "textile product"], "url": "http://publications.europa.eu/resource/cellar/da2ac9a4-6391-49e7-ab27-3de232274ab7", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/aac39b0f-3c3c-48b2-86b4-bc487ab02cf1", "title": "Commission Regulation (EEC) No 2531/91 of 23 August 1991 re-establishing the levying of customs duties applicable to the products falling within CN code 2850 00 70, originating in Argentina, to which the preferential tariff arrangements of Council Regulation (EEC) No 3831/90 apply", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-23", "subjects": "generalised preferences,metal product,restoration of customs duties", "workIds": "celex:31991R2531,oj:JOL_1991_236_R_0011_027", "eurovoc_concepts": ["generalised preferences", "metal product", "restoration of customs duties"], "url": "http://publications.europa.eu/resource/cellar/aac39b0f-3c3c-48b2-86b4-bc487ab02cf1", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/2a319d14-6a54-4a0a-b41a-300aeeb6b99c", "title": "Commission Regulation (EEC) No 2535/91 of 22 August 1991 amending Regulation (EEC) No 863/91 on the special sale of intervention butter for export to the Soviet Union and amending Regulation (EEC) No 569/88", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-22", "subjects": "USSR,award of contract,butter,intervention stock,sale", "workIds": "celex:31991R2535,oj:JOL_1991_236_R_0018_031", "eurovoc_concepts": ["USSR", "award of contract", "butter", "intervention stock", "sale"], "url": "http://publications.europa.eu/resource/cellar/2a319d14-6a54-4a0a-b41a-300aeeb6b99c", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/f7908a32-cfe3-45da-8c63-b4e43330cc7c", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) AMENDING REGULATION ( EEC ) NO 3905/88 AND REPEALING THE DEFINITIVE ANTI-DUMPING DUTY IMPOSED ON IMPORTS INTO THE COMMUNITY OF POLYESTER YARN ORIGINATING IN MEXICO", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-21", "subjects": "Mexico,anti-dumping duty,dumping,plastics", "workIds": "celex:51991PC0327,comnat:COM_1991_0327_FIN", "eurovoc_concepts": ["Mexico", "anti-dumping duty", "dumping", "plastics"], "url": "http://publications.europa.eu/resource/cellar/f7908a32-cfe3-45da-8c63-b4e43330cc7c", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 327 f i n al \n\nBrussels, 21 August 1991 \n\nProposal \n\nfor a \n\nCOUNCIL REGULATION \n\n(EEC) \n\na m e n d i ng R e g u l a t i on \n\nr e p e a l i ng \n\ni m p o s ed on \nof p o l y e s t er \n\nt he d e f i n i t i ve \ni m p o r ts \ny a rn o r i g i n a t i ng \n\ni n to \n\nt he C o m m u n i ty \n\nin M e x i c o. ( E E C) N * 3 9 0 5 / 88 \na n t i - d u m p i ng \n\na nd \nd u ty \n\n(presented by the Commission) \n\ns'fll ;. I\" \u00bb,\u00bb*;\u00a3**& \n\n\fEXPLANATORY MEMORANDUM \n\n1. Following a request lodged in September 1990 by several exporters \n\nfrom Mexico, the Commission announced, in November 1990, the \n\ninitiation of a review of anti-dumping measures concerning imports \n\nof polyester yarn originating in Mexico, in accordance with Article \n\n14 of Council Regulation (EEC) N' 2423/88, and commenced an \n\ninvest igat ion. 2. The measures under review were anti-dumping duties of 15. 8% on non-\n\ntextured partially oriented filament yarn (POY) and anti-dumping \n\nduties ranging from 5. 8% to 26. 7% on textured polyester yarn \n\nfilament (PTY), imposed by Council Regulation (EEC) N* 3905/88. This \n\nregulation also imposed duties on polyester yarn from South Korea, \n\nTaiwan and Turkey, which are not part of the present case. 3. a) \n\nIn calculating dumping, normal value has been established on \n\nthe basis of the price actually paid or payable for the product \n\nsold on the domestic market. In the case of two exporters, \n\ndomestic price was consistently and substantially below cost of \n\nproduction during the investigation period. In these cases, \n\nnormal value was based on cost of production plus domestic \n\nprofit from other exporters. Export prices were based on the \n\nprice paid or payable for the product exported to the \n\nCommunity. b) Normal values (calculated on a monthly average bases) and \n\nexport prices (brought to ex-factory level) were compared for \n\nthe corresponding month on a transaction-by-transaction basis. With the exception of one exporter of PTY, whose dumping margin \n\n(0. 53%) is, according to a consistent practice cf the \n\nCommission, considered to be de minimis, no dumping wa~ found \n\nas regards imports of PTY and POY originating in Mexico. - 2 -\n\nThe investigation has therefore demonstrated that imports of \n\npolyester yarn originating in Mexico are no longer being dumped. The Council notes that this absence of dumping, in the presence of a \n\nsignificant volume of imports, has come about as a result of a \n\ndurable change in the behaviour of the exporters, notably in the \n\narea of pricing policy. In view of these changed circumstances, it is proposed that the \n\ndefinitive anti-dumping duty imposed by Regulation (EEC) N' 3905/88 \n\non imports originating in Mexico be repealed. The provisions of \n\nRegulation (EEC) N* 3905/88 which relate to imports of the same \n\nproduct originating in South Korea, Taiwan and Turkey should remain \n\nunchanged. Furthermore, it should be noted that this amendment, \n\nwhich relates only to imports originating in Mexico, has no effect \n\non the date on which the definitive anti-dumping duty imposed on \n\nimports of polyester yarn originating in South Korea, Taiwan and \n\nTurkey shall lapse. This date continues to be based on the date of \n\nentry into force of Regulation (EEC) N\" 3905/88. -4* fei\u00ab> \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, \n\nHaving regard to Council Regulation (EEC) N\" 2423/88 of 11 July 1988 on \n\nprotection against dumped or subsidized imports from countries not \n\nmembers of the European Economic Community*1) and in particular \n\nArt icle 14 thereof, \n\nHaving regard to the proposal submitted by the Commission after \n\nconsultations within the Advisory Committee as provided for under the \n\nabove R\u00e9gul\u00e2t ion, \n\nWhereas, \n\nA. PROCEDURE \n\nIn November 1990 the Commission announced by a notice published in \n\nthe Official Journal of the European Commun!ties<2) the \n\ninitiation of a review of anti-dumping measures concerning imports \n\nof polyester yarn originating in Mexico, in accordance with \n\nArticle 14 of Regulation (EEC) N\" 2423/88 and commenced an \n\ninvestigation. The measures in question consisted of definitive \n\nduties on imports of polyester yarn originating in Mexico imposed \n\nby Council Regulation (EEC) N' 3905/88*3>. (1) OJ N- L 209 2/08/1988, p. 1 \n(2) OJ N\" C 289 17/11/1990, p. 7. (3) OJ N* L 347 16/12/1988, p. 10. - 3 -\n\n2. The proceeding was initiated as a result of a request lodged in \n\nSeptember 1990 by several exporters in Mexico. The request \n\nalleged changed circumstances since the imposition of the \n\ndefinitive anti-dumping duty. In particular, it was alleged that \n\nimports of polyester yarn from Mexico to the Community were now \n\nbeing made at non-dumped prices. The evidence contained in this \n\nrequest was considered sufficient to justify opening a proceeding. 3. The Commission officially advised the exporters known to be \n\nconcerned, the representatives of the exporting country and the \n\ncomplainant in the original proceeding, the Comit\u00e9 International \n\nde la Rayonne et des Fibres Synth\u00e9tiques (CIRFS) representing the \n\nCommunity industry, and gave the parties concerned the opportunity \n\nto make their views known in writing and to request a hearing. 4. The exporters and CIRFS made their views known in writing. 5. The Commission sought and verified all information it deemed \n\nnecessary for the purposes of this proceeding and carried out \n\ninvestigations at the premises of the following Mexican \n\nproducers/exporters: \n\nFibras Quimicas SA, Monterrey, Mexico \n\nNylon de Mexico SA, Monterrey, Mexico \n\nKimex SA, Mexico City \n\nFibras Sinteticas SA, Mexico City \n\nCelanese Mexicana SA, Mexico City \n\n6. The investigation of dumping covered the period 1 January 1990 to \n\n30 September 1990 (the investigation period). - 4 -\n\nB. PRODUCTS UNDER CONSIDERATION \n\n(i) Definition of products \n\n7. The products concerned are non-textured partially oriented \n\nfilament yarn (POY), falling within CN Code 5402 42 00, and \n\ntextured polyester yarn filament (PTY), falling within CN Codes \n\n5402 33 10 and 5402 33 90. (ii) Description of products \n\n8. POY is used to produce PTY and other types of yarn. PTY of \n\nvarying quality is produced, and there are several different \n\ntypes. 9. Three qualities of PTY are produced \n\n1st Quality: Mechanically perfect, guaranteed for dyeing \n\n2nd Quality: Mechanically perfect, not guaranteed for dyeing \n\n(\"whites only\") \n\n3rd Quality: Lower quality yarn \n\nThe proportion of each quality produced depends on the efficiency \n\nof the production process. The exporters are producing all three \n\nqua I it ies of PTY. - 5 -\n\n10. There are different types of PTY. The relative thickness and \n\nweight of PTY is expressed in units of 1 dtex, which is equal to \n\nthe weight in grams of 10. 000 metres of yarn. (It is also \n\nsometimes expressed in denier, of which 1. 1 equals 1 dtex). Therefore the yarn becomes finer as the number of dtex becomes \n\nsmaller. Furthermore, every type of yarn contains a certain \n\nnumber of constituent filaments, given a certain dtex. The \n\ngreater the number of filaments, the greater is the value of the \n\nyarn. C. DUMPING \n\n(I) Normal value \n\n11. Normal value was calculated separately for each month (in view of \n\nthe high inflation rate in Mexico) and for each different type and \n\nquality of yarn. (Recitals 10 and 11). 12. In general, normal value was established on the basis of the price \n\nactually paid or payable for the product sold on the domestic \n\nmarket. 13. In the case of two exporters, domestic price was consistently and \n\nsubstantially below cost of production during the investigation \n\nperiod. In these cases it was considered appropriate to establish \n\na constructed normal value in accordance with Article 2(3)(b)(ii) \n\nof Regulation (EEC) n\" 2423/88 using these companies' costs of \n\nproduction plus a profit (6%), equivalent to that realised by \n\nother Mexican exporters on profitable sales in the domestic \n\nmarket, which was considered to be a reasonable level of profit. - 6 -\n\n(il) Export price \n\n14. Export prices were determined on the basis of the price actually \n\npaid or payable for the product exported to the Community. (i i i) Comparison \n\n15. The normal value per type and quality (calculated on a monthly \n\naverage basis) was compared with export prices of the same type \n\nand quality for the corresponding month on a transaction-by-\n\ntransaction basis. Requests for allowances were accepted with \n\nregard to differences affecting price comparability and bearing a \n\ndirect relationship to the sales under consideration and for which \n\nsatisfactory evidence was submitted. All comparisons were made at \n\nthe ex-factory level. (iv) Dumping margins \n\n16. With the exception of one exporter of PTY, whose dumping margin \n\n(0. 53%) is, according to the consistent practice of the \n\nCommission, considered to be de minimis, no dumping was found as \n\nregards imports of PTY and POY originating in Mexico. 17. The Council confirms the conclusions of the Commission relating to \n\ndump i ng. - 7 -\n\nC. CONCLUSION \n\n(i) Repeal of ant I-dumping measures \n\n18. The investigation has demonstrated that imports of polyester yarn \n\nfrom Mexico are no longer being dumped. The Council notes that \n\nthis absence of dumping, in the presence of a significant volume \n\nof imports, has continued over a substantial period and has been \n\nrepeated on export markets outside the Community. The Council \n\ntherefore concludes that there has been a durable change in the \n\nbehaviour of the Mexican exporters, particularly in the area of \n\npricing policy. In view of these changed circumstances, the \n\nCouncil considers that the anti-dumping measures concerning \n\nimports of polyester yarn originating in Mexico are now neither \n\njustified nor necessary and should therefore be repealed. 19. The exporters and the complainant requested, and were granted, the \n\nopportunity to be heard by the Commission. At their request, the exporters and the complainant were also \n\ninformed of the essential facts and considerations on the basis of \n\nwhich it was proposed to recommend the repeal of the ant I-dumping \n\nmeasures, concerning imports of polyester yarns originating in \n\nMex i co. The parties were granted a period within which to make \n\nrepresentation on any of the above matters subsequent to \n\ndisclosure. Where appropriate, their comments were taken into \n\nconsid\u00e9r\u00e2t ion. - 8 -\n\n20. Since the imports orginating in South Korea, Taiwan and Turkey \n\nwere of such importance that they have to be considered to have by \n\nthemselves cumulatively caused material injury during the original \n\ninvestigation period, the repeal of the anti-dumping measures \n\nconcerning imports of polyester yarn originating in Mexico cannot \n\nhave any effect on the continuing validity of the anti-dumping \n\nmeasures imposed on imports of the same product originating in \n\nSouth Korea, Taiwan and Turkey. (ii) Amendment to Regulation 3905/88 \n\n21. Regulation (EEC) N\" 3905/88 relating to imports of polyester yarn \n\noriginating in Mexico, South Korea, Taiwan and Turkey, should \n\naccordingly be amended in order to repeal the definitive anti \n\ndumping duty imposed by that regulation on imports originating in \n\nMex ico. 22. The provisions of Regulation (EEC) N* 3905/88 which relate to \n\nimports of the same product originating in South Korea, Taiwan and \n\nTurkey should remain unchanged. 23. This amendment, which relates only to imports originating in \n\nMexico, should have no effect on the expiry of the definitive \n\nanti-dumping duty imposed on imports of polyester yarn originating \n\nin South Korea, Taiwan and Turkey. The prospective date on which the measures concerning these \n\ncountries shall lapse should continue to be based on the date of \n\nentry into force of Regulation (EEC) n* 3905/88, \n\n\f- 9 -\n\nHAS ADOPTED THIS REGULATION \n\nARTICLE I \n\nArticle 1 (1) of Regulation (EEC) N\" 3905/88 is hereby amended to \n\nexclude the reference to \"Mexico\". Article 1 (2) of Regulation (EEC) N* 3905/88 Is hereby amended to \n\nexclude the following paragraph: \n\n- \"15. 8% for POY originating in Mexico excluding yarn produced and \n\nsold for export to the Community by Celanese Mexicana SA, Mexico \n\nCity, which shall not be subject to such a duty;\" \n\nARTICLE 2 \n\nArticle 2 (1) of Regulation (EEC) N' 3905/88 is hereby amended to \n\nexclude the reference to \"Mexico\". Article 2 (2) of Regulation (EEC) N' 3905/88 is hereby amended to \n\nexclude the following paragraph: \n\n- \"26. 7% for PTY originating in Mexico. The following duties shall \n\nbe applicable to PTY produced and sold for export to the Community \n\nby the companies listed below: \n\n- Celanese Mexicana SA, Mexico City \n\n- Fibras Quimicas SA, Monterrey \n\n- Kimex SA, Mexico City \n\n15. 9% \n\n5. 8% \n\n18. 7%;\" \n\nThe remainder of Regulation (EEC) 3905/88 shall remain unchanged. - 10 \n\nARTICLE 3 \n\nThis Regulation shall enter into force on the day following its \n\npublication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels \n\nFor the CounciI \n\n\fISSN 0254-1475 \n\nCOM(91) 327 final \n\nDOCUMENTS \n\n11 02 \n\nEN \n\nCatalogue number : CB-CO-91-377-EN-C \n\nISBN 92-77-75479-6 \n\nOffice for Officiai Publications of the European Communities \n\nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/6c430860-cd08-4b66-a958-91373de4b35d", "title": "Commission Regulation (EEC) No 2505/91 of 20 August 1991 re-establishing the levying of customs duties on the products falling within CN code 2817 00 00, originating in China, to which the preferential tariff arrangements of Council Regulation (EEC) No 3831/90 apply", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-20", "subjects": "oxide,restoration of customs duties,tariff preference", "workIds": "celex:31991R2505,oj:JOL_1991_233_R_0007_024", "eurovoc_concepts": ["oxide", "restoration of customs duties", "tariff preference"], "url": "http://publications.europa.eu/resource/cellar/6c430860-cd08-4b66-a958-91373de4b35d", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/ec7b3d90-d91a-43f6-b632-18f39aaf777c", "title": "Commission Regulation (EEC) No 2507/91 of 20 August 1991 concerning the classification of certain goods in the combined nomenclature", "langIdentifier": "ENG", "mtypes": "fmx4,html,pdfa1b,print,xhtml", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-20", "subjects": "Combined Nomenclature,clothing,common customs tariff", "workIds": "celex:31991R2507,oj:JOL_1991_233_R_0009_026", "eurovoc_concepts": ["Combined Nomenclature", "clothing", "common customs tariff"], "url": "http://publications.europa.eu/resource/cellar/ec7b3d90-d91a-43f6-b632-18f39aaf777c", "lang": "eng", "formats": ["fmx4", "html", "pdfa1b", "print", "xhtml"], "text": "L_1991233EN. 01000901. xml\n\n\n\n\n\n\n\n\n\n\n22. 8. 1991\u00a0\u00a0\u00a0\n\n\nEN\n\n\nOfficial Journal of the European Communities\n\n\nL 233/9\n\n\n\n\n\nCOMMISSION REGULATION (EEC) NO 2507/91\nof 20 August 1991\nconcerning the classification of certain goods in the combined nomenclature\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Economic Community,\nHaving regard to Council Regulation (EEC) No 2658/87\u00a0(1) on the tariff and statistical nomenclature and on the Common Customs Tariff, as last amended by Regulation (EEC) No 2242/91\u00a0(2), and in particular Article 9 thereof,\nWhereas, in order to ensure uniform application of the combined nomenclature annexed to the Regulation it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation;\nWhereas Regulation (EEC) No 2658/87 has set down the general rules for the interpretation of the combined nomenclature and these rules also apply to any other nomenclature which is wholly or partly based on it or which adds any additional subdivisions to it and which is established by specific Community provisions, with a view to the application of tariff or other measures relating to trade in goods;\nWhereas, pursuant to the said general rules, the goods described in column 1 of the table annexed to the present Regulation must be classified under the appropriate CN codes indicated in column 2, by virtue of the reasons set out in column 3;\nWhereas the measures provided for in this Regulation are in accordance with the opinion of the Nomenclature Committee,\nHAS ADOPTED THIS REGULATION:\nArticle 1\nThe goods described in column 1 of the annexed table are now classified within the combined nomenclature under the appropriate CN codes indicated in column 2 of the said table. Article 2\nThis Regulation shall enter into force on the 21st day after its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 20 August 1991. For the Commission\n\nKarel VAN MIERT\n\nMember of the Commission\n\n\n\n\n\n(1)\u00a0\u00a0OJ No L 256, 7. 9. 1987, p. 1. (2)\u00a0\u00a0OJ No L 204, 27. 7. 1991, p. 21. ANNEX\n\n\n\n\n\n\n\nDescription\n\n\nClassification\n(CN code)\n\n\nReasons\n\n\n\n\n(1)\n\n\n(2)\n\n\n(3)\n\n\n\n\n\n\n\n\n\n\n1. Woven one-piece garment (100 % cotton), sleeveless, clothing both the upper part of the body and the lower part to just below the knee, enveloping each leg separately. It has inset pockets at hip level. This garment, which is cut fully from the waist, has a partial opening at the front with buttoning right over left. (See photograph No 458)\u00a0(1). 6204\u00a042\u00a000\n\n\nThe classification is determined by General Rules 1 and 6 for the interpretation of the combined nomenclature, by the wording of CN codes 6204 and 6204\u00a042\u00a000 and the Explanatory Notes to CN codes 6204\u00a041\u00a000 to 6204\u00a049\u00a090. 2. Woven one-piece garment (100 % cotton), gathered at the waist, clothing both the upper part of the body and the lower part to just above the knees, enveloping each leg separately. It has short sleeves, two inset pockets at hip level and one stitched-on breast pocket. The garment has a collar and a partial opening at the front with buttoning right over left. (See photograph No 457)\u00a0(1)\n\n\n\n\n\n\n\n6211\u00a042\u00a090\n\n\nThe classification is determined by General Rules 1 and 6 for the interpretation of the combined nomenclature and by the wording of CN codes 6211, 6211\u00a042 and 6211\u00a042\u00a090. 3. Woven one-piece garment (100 % synthetic fibres), clothing the upper part of the body and the lower part to the ankles, enveloping each leg separately, with short sleeves and with inset pockets at hip level. The garment has a collar and a partial opening at the front with buttoning right over left. This garment is accompanied by a tie belt of the same material. (See photograph No 456)\u00a0(1). 6211\u00a043\u00a090\n\n\nThe classification is determined by General Rules 1 and 6 for the interpretation of the combined nomenclature and by the wording of CN codes 6211, 6211\u00a043 and 6211\u00a043\u00a090. (1)\u00a0\u00a0Photographs are of a purely illustrative nature"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/f5d39e86-02a6-44d4-baec-f7cef0b2b1b2", "title": "Commission Regulation (EEC) No 2506/91 of 20 August 1991 re-establishing the levying of customs duties on the products falling within CN code 2827 32 00, originating in India, to which the preferential tariff arrangements of Council Regulation (EEC) No 3831/90 apply", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-20", "subjects": "India,generalised preferences,restoration of customs duties", "workIds": "celex:31991R2506,oj:JOL_1991_233_R_0008_025", "eurovoc_concepts": ["India", "generalised preferences", "restoration of customs duties"], "url": "http://publications.europa.eu/resource/cellar/f5d39e86-02a6-44d4-baec-f7cef0b2b1b2", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/35b1f9fe-fc70-492a-b0dd-3c19464803ed", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) AMENDING REGULATION ( EEC ) NO 1048/90 WITH REGARD TO THE IMPOSITION OF A DEFINITIVE ANTI-DUMPING DUTY ON IMPORTS OF SMALL SCREEN COLOUR TELEVISION RECEIVERS ORIGINATING IN THE REPUBLIC OF KOREA", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-19", "subjects": "South Korea,anti-dumping duty,dumping,import,television equipment", "workIds": "celex:51991PC0326,comnat:COM_1991_0326_FIN", "eurovoc_concepts": ["South Korea", "anti-dumping duty", "dumping", "import", "television equipment"], "url": "http://publications.europa.eu/resource/cellar/35b1f9fe-fc70-492a-b0dd-3c19464803ed", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nCOM(91>326 final \n\nBrussels, 19 August 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\n\u00abrending R\u00e9gulation (\u0152D) No 1048/90 with regard to the \nirrposition of a definitive anti-durrping duty on irrports of \n\u00abrail screen colour television receivers originating in the \nRepubl ic of Korea \n\n(presented by the Commission) \n\ni^F \n\n;*?? \n\n?#t-\n\n\fEXPLANATORY MEMORANDUM \n\n1. In April 1990 the Council imposed a definitive ant i -dumping duty on \nimports of small screen colour television receivers (SCTVs) \noriginating in the Republic of Korea, by Regulation (EEC) 1048/90. 2. In the above regulation, duties of between 10,2 % and 10,5 % were \n\nimposed on imports from three cooperating exporters. 3. The duty applicable to other Korean exporters (the general duty) who \nrefused to cooperate in the investigation, was established on the \nbasis of facts available, in accordance with Article 7(7)(b) of \nRegulation (EEC) 2423/88, at a level of 19. 6 %, with the dumping \nmargin calculated by comparing an export price based on the average \nC. I. F. unit price of imports into the Community from Korea with a \nnormal value based on the average domestic selling price of the \ncooperating Korean exporters. This method was used because of the \nactivities of one particular exporter which was known to be sending \nlarge volumes of SCTVs to the Community, often transhipped through \nthird countries, and which refused to co-operate with the Commission. 4. In November 1990 the Commission received information from the \nElectronic Industries Association of Korea (E. I. A. K. ) to the effect \nthat the non-cooperating exporter mentioned above was no longer \nexporting small screen colour television receivers to the European \nCommunity. They alleged that this changed situation removed the \njustification for the 19,6 % general duty and suggested that it \nshould be reduced to the level of the highest duty for a cooperating \ncompany (i. e. 10,5 % ). 5. In the light of this information, the Commission, in January 1991, \nopened a partial review on its own initiative, limited to question of \nwhether or not to modify the general duty. 6. The Commission's investigation showed that the exporter whose \nactivities led to the imposition of the 19. 6 % general duty is no \nlonger producing SCTVs in Korea. In addition, it was established that the quantities exported by other \nnon-cooperating exporters were extremely small, even before the \nimposition of the anti-dumping duty. \"L \n\n\f2 -\n\nIn view of these changed circumstances, the imposition an anti \ndumping duty on a different basis from that used for the cooperating \nexporters is no longer Justified, and the appropriate level for the \ngeneral duty should be highest rate of anti-dumping duty found for a \ncooperating exporter, i. e. 10. 5 %. 8. Regulation (EEC) No 1048/90 should therefore be amended to reduce the \ngeneral duty from 19. 6 % to 10. 5 %. This measure shall lapse on the \nsame day as the definitive anti-dumping measures imposed by \nRegulation (EEC) No 1048/90. 9. Of course, if the Commission becomes aware of a resumption of \nproduction of SCTVs in Korea by the exporter mentioned in \nParagraph 3, 4 and 6, it will consider reopening a new partial review \nin order to investigate the matter. Proposal for a \n\nCOUNCIL REGULATION (EEC) \n\n\u00abrending Regulation (EEC) No 1048/90 with regard to the \n\nirrposition of a definitive anti-durrping duty on irrports of \n\n\u00abrail screen colour television receivers originating in the \n\nRepubl ic of Korea \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic Community, \n\nHaving regard to Council Regulation (EEC) No 2423/88 of 11 July 1988 on \n\nprotection against dumped or subsidized imports from countries not \nmembers of the European Economic Commun!ty<1), and in particular \n\nArticle 14 thereof, \n\nHaving regard to the proposal submitted by the Commission after \n\nconsultation within the Advisory Committee as provided for under the \n\nabove Regulation. (1) OJ No L 209, 02. 08. 1988, p. 1 \n\nU \n\n\f- 2 -\n\nI. PREVIOUS PROCEDURE \n\n(a) Imposition of definitive anti-dumping duty \n\n(1) In February 1988 the Commission initiated an anti-dumping proceeding \n\nconcerning imports of small screen colour television receivers \n\n(hereafter referred to as SCTVs) originating in the Republic of \n\nKorea <2>. This followed a complaint lodged by the European \n\nAssociation of Consumer Electronic Manufacturers (E. A. C. E. M. ), \n\nrepresenting a major proportion of Community production. Following an \n\ninvestigation, a provisional anti-dumping duty was imposed by \n\nCommission Regulation (EEC) No 3232/89(3), and a definitive duty \n\nwas subsequently imposed by Council Regulation (EEC) No 1048/90(4). (b) General duty \n\n(2) In Regulation (EEC) No 1048/90, duties of between 10,2 % and 10,5 % \n\nwere imposed on imports from three cooperating exporters. (3) The duty applicable to other Korean exporters (hereafter referred to \n\nas the general duty) and in particular to one exporter who refused to \n\ncooperate in the investigation and who was known to have exported \n\nlarge quantities of the product concerned to the Community, was \n\nestablished on the basis of what were considered to be the most \n\nappropriate facts available, i. e. by comparing an export price based \n\non the average C. I. F. unit price of imports into the Community from \n\nKorea with a normal value based on the average domestic selling price \n\nof the cooperating Korean exporters. The margin thus established was \n\n19. 6%. (2) OJ No C 44, 17. 02. 1988, p. 2 \n\n(3) 0J No L 314, 28. 10. 1989, p. 1 \n\n(4) OJ No L 107, 27. 04. 1990, p. 56 \n\n\f- 3 -\n\nII\u00bb REVIEW PROCEDURE \n\n(4) in November 1990 the Commission received information from the \n\nElectronic Industries Association of Korea (E. I. A. K. ) to the effect \n\nthat the non-cooperating exporter mentioned above was no longer \n\nexporting small screen colour television receivers to the European \n\nCommunity. It was alleged that this changed situation removed the \n\nJustification for the 19,6 % general duty and suggested that it \n\nshould be reduced to the level of the highest duty imposed on imports \n\nof a cooperating exporter (i. e. 10,5 % ). (5) After consulting the Advisory Committee, the Commission decided that \n\nthere was sufficient evidence to Justify the initiation of a partial \n\nreview, limited in scope to the question of whether or not to modify \n\nthe general duty. The partial review was opened on the initiative of \n\nthe Commission, in accordance with Article 14 of Council Regulation \n\n(EEC) 2423/88, by a notice published in the Official Journal of the \nEuropean Communities*5*. (6) The Commission officially advised E. I. A. K. , the exporters who \n\ncooperated in the original Investigation, the representatives of the \n\n>-\n\nexporting country and the complainant in the original proceeding \n\n(E. A. C. E. M. ), and gave the parties concerned the opportunity to make \n\ntheir views known in writing and to request a hearing. (7) E. I. A. K. , some exporters and E. A. C. E. M. made their views known in \n\nwr i t i n g. (8) The Commission sought and verified all information it deemed to be \n\nnecessary for the purposes of this proceeding and in particular \n\nreceived and verified to the extent necessary information from \n\nE. I. A. K. (5) OJ No C 18, 26. 1. 1991, p. 3 \n\nG \n\n\f- 4 -\n\nM l. RESULTS OF THE INVESTIGATION \n\n(a) Determination of general duty in original anti-dumping investigation \n\n(9) As is stated by the Commission in Recital 33 of Regulation (EEC) \n\n3232/89 (imposing the provisional duty), for those Korean exporters \n\nwho did not make themselves known during the course of the original \n\ninvestigation, dumping was determined on the basis of what were \n\nconsidered by the Commission to be the most appropriate facts \n\navailable, in accordance with Article 7(7)(b) of Regulation (EEC) \n\nNo 2423/88. (10) For these non-cooperating exporters, the dumping margin was \n\ncalculated by comparing an export price based on the average C. I. F. unit price of imports into the Community from Korea (according to \n\n1987 Eurostat data) with a normal value based on the average \n\ndomestic selling price of the cooperating Korean exporters. The \n\nresulting dumping margin of 19. 6 % became that applicable to the \n\nnon-cooperating exporters and was imposed as the general duty, while \n\nthe imports of the three cooperating Korean exporters (Daewoo, \n\nGoldstar and Samsung) are subject to definitive anti-dumping duties \n\nof 10. 2 %, 10. 4 % and 10. 5 % respectively. (11) The major reason for not considering the highest duty imposed on \n\nimports from a cooperating exporter to be appropriate for the non-\n\ncooperating exporters was the behaviour of one \n\nparticular \n\nmanufacturer based in Korea. This company was known to be exporting \n\nlarge quantities of SCTVs to the Community, with many of them being \n\ntrans-shipped via third countries. It was approached by the \n\nCommission during its on-the-spot investigation, with the assistance \n\nof the Electronic Industries Association of Korea, with a view to \n\nsecuring its co-operation. However, the company refused to co \n\noperate. - 5 -\n\n(12) The Commission decided, and the Council confirmed, that, in these \n\ncircumstances, neither the dumping margins determined for the \n\ncooperating exporters nor the information contained in the complaint \n\nprovided the most appropriate basis for determining the margin of \n\ndumping for non-cooperating exporters. (b) Changed trade situation \n\n(13) The 19. 6 % general duty was imposed on the basis of the facts \n\navailable for the original investigation period - 1987. In view of \n\nthe information received from E. I. A. K. and other sources, it is \n\nclear that the trade situation concerning the above exporter has now \n\nchanged considerably. (i) \n\nInformation from E. I. A. K. JFr \n\n(14) According to E. I. A. K. 's internal statistics, and independent data \n\nobtained from the Korean Foreign Trade Association, both of which \n\nwere verified by the Commission, the exporter in question has not \n\nexported S C T Vs to the Community since 1988. Furthermore, its total \n\nexports from Korea of S C T Vs to all destinations in 1990 amounted to \n\nonly 3 % of the 1988 volume. (15) E. I. A. K. supplied evidence that the exporter involved had shifted \n\nits capacity away from CTV's to other electronic products. (16) The exporter, which is a member of E. I. A. K. , had supplied the \n\nAssociation with a signed declaration that it no longer planned to \n\nexport S C T Vs to the Community. Furthermore, it was established that \n\nit had converted its production facilities to the manufacture of \n\nother electronic products. f \n\n\f(ii) \n\nInformation from Korean Ministry of Trade and Industry \n\n(17) In May 1991, the Ministry of Trade and Industry of Korea certified \n\nto the Commission that the exporter had now ceased all production \n\nof SCTVs in Korea, and provided appropriate documentary evidence. (c) Imports from other non-cooperatIng exporters \n\n(18) The Commission also established that the export volumes of other \n\nnon-cooperating exporters were extremely small, even before the \n\nimposition of the anti-dumping duty. (d) Conclusion \n\n(19) In view of these changed circumstances, the Council concludes that \n\nthe situation which Justified the use of a different basis from that \n\napplied to the cooperating exporters for the purpose of imposing an \n\nanti-dumping duty no longer exists. The exporter mentioned in \n\nrecitals 13-17 has now ceased production of SCTVs in Korea and \n\ntherefore the quantities exported to the Community by non-\n\ncooperating exporters can only be very small. In these circumstances \n\nthe appropriate level for the general duty should be the highest \n\nrate of anti-dumping duty imposed on imports from a cooperating \n\nexporter i. e. 10. 5 %. (20) This rate of duty does not act as an incentive to circumvention, nor \n\nas a reward for non-cooperation, but constitutes an equitable \n\nresponse to the changed trade situation. (21) The parties were informed of the essential facts and considerations \n\nupon which the findings were based, and were granted a period within \n\nwhich to make representations to the Commission. Where appropriate, \n\ntheir comments were taken into consideration. E. A. C. E. M. requested, \n\nand was granted, an opportunity to be heard by the Commission. vith \n\nregard to its findings in this proceeding. a \n\n\f- 7 -\n\nIV. AMENDMENT TO REGULATION (EEC) No 1048/90 \n\nc \n\n(22) Article 1 of Regulation (EEC) No 1048/90 should therefore be amended \n\nto reduce the general anti-dumping duty from 19. 6 % to 10. 5 %, with \n\neffect from the date of entry into force of the present regulation. (23) This measure shall lapse on the same day as the definitive anti \n\ndumping measures imposed by Regulation (EEC) No 1048/90, \n\nHAS ADOPTED THIS REGULATION : \n\nArtl\u00c7la 1 \n\nIn Article 1 (1) of Regulation (EEC) No 1048/90 the figure \"19. 6 %\" is \nreplaced by \"10. 5 %M. The remainder of Regulation (EEC) No 1048/90 remains unchanged. Article 2 \n\nThis Regulation shall enter into force on the day following its \n\npublication in the Official Journal of the European Communities. This Regulation shall be binding in its entirely and directly applicable \n\nin a 11 Member States. '\"Lis \n\n\fISSN 0254-1475 \n\nCOM(91) 326 final \n\nDOCUMENTS \n\nEN \n\n1102 \n\nCatalogue number : CB-CO-91-373-EN-C \n\nISBN 92-77-75361-7 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/a6709791-0db2-4241-b554-843155b20f8e", "title": "PROPOSAL FOR A COUNCIL DECISION CONCERNING THE CONCLUSION OF THE AGREEMENT BETWEEN THE EUROPEAN ECONOMIC COMMUNITY OF THE ONE PART AND THE GOVERNMENT OF DENMARK AND THE HOME GOVERNMENT OF THE FAROE ISLANDS OF THE OTHER PART", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_other,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-19", "subjects": "Denmark,Faroes,agreement (EU),customs duties,trade agreement", "workIds": "celex:51991PC0323,comnat:COM_1991_0323_FIN", "eurovoc_concepts": ["Denmark", "Faroes", "agreement (EU)", "customs duties", "trade agreement"], "url": "http://publications.europa.eu/resource/cellar/a6709791-0db2-4241-b554-843155b20f8e", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 323 f i n al \n\nB r u s s e l s, 19 August 1991 \n\nProposal \n\nf or a \n\nCOUNCIL DECISION \n\nc o n c e r n i ng t he c o n c l u s i on of t he Agreement between \nt he European Economic Community of t he one p a rt \nand t he Government of Denmark and t he \nHome Government of t he Faroe I s l a n ds of t he o t h er p a rt \n\n( p r e s e n t ed by the Commission) \n\n\f\fEXPLANATORY MEMORANDUM \n\nA Council ad hoc working group was mandated on 21 March 1990 by the \n\nPermanent Representatives Committee to examine a recommendation for a \n\nCouncil decision regarding directives for negotiation concerning an \n\nagreement between the Faeroe Islands and Denmark (Doc SEC(90) 275 \n\nfinal). On 11 April 1990 the Permanent Representatives Committee gave its \n\nagreement provided that Member States would be closely associated with \n\nthe negotiations in order to take account of the fishing sector \n\nindustries. The negotiations were therefore carried out by the Commission with the \n\nassistance of Member States. The last round took place in the Faeroe Islands on 19 and 21 June 1991. Uith the negotiation sessions alternating with the holding of a \n\n113 Committee to allow Member States to be kept closely informed. The agreement was signed on 21 June. Proposal for a \n\nDraft Council Decision No \n\nof \n\nconcerning the conclusion of the Agreement between \nthe European Economic Community of the one part \nand the Government of Denmark and the \nHome Government of the Faroe Islands of the other part \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European \nEconomic Community, and in particular Article 113 \nthereof, \n\nHaving regard to the proposal from the Commission, \n\nWhereas the Agreement negotiated between the European \nEconomic Community of the one part and the Government of \nDenmark and the Home Government of the Faroe Islands, on \nthe other part should be approved, \n\nHAS ADOPTED THIS DECISION: \n\nArticle 1 \n\nThe Agreement between the European Economic Community of \nthe one part and the Government of Denmark and the Home \nGovernment of the Faroe Islands, on the other part is \nhereby approved on behalf of the Community. The text of the Agreement is attached to this Decision. Article 2 \n\nThe President of the Council shall give the notification \nprovided for in Article 38 of the Agreement (1). Done at Brussels, \n\nFor the Council \nThe President \n\n(1) The date of entry into force of the Agreement will be \npublished in the Official Journal of the European \nCommunities by the General Secretariat of the Council. A G R E E M E NT \n\nbetween the European Economic Community of the one part \nand the Government of Denmark \nand the Home Government of the Faroe Islands of the other \npart \n\nThe EUROPEAN ECONOMIC COMMUNITY, \n\nof the one part, and \n\nthe GOVERNMENT OF DENMARK AND THE HOME GOVERNMENT OF THE \nFAROE ISLANDS, \n\nof the other part, \n\nRECALLING the status of the Faroe Islands as a self-\ngoverning integral part of one of the Member States of the \nCommunity; \n\nRECALLING the resolution of the Council of 4 February 1974 \non the problems of the Faroe Islands; \n\nCONSIDERING the vital importance for the Faroe Islands of \nfisheries which constitute their essential economic \nactivity, fish and fishery products being their main export \narticles ; \n\nCONSIDERING the importance of the fisheries relationship \nlaid down in the agreement on fisheries between the parties, \nwho confirm that the trade aspects of the present agreement \nshould not affect the functioning of the fisheries agreement \nand that, consequently, the volume of the mutual fisheries \npossibilities under that agreement should continue to be \nmaintained at a satisfactory level; \n\nDESIRING to consolidate and to extend the economic relations \nexisting between the Community and the Faroe Islands and to \nensure, with due regard for fair conditions of competition, \nthe harmonious development of their commerce for the purpose \nof contributing to the work of constructing Europe; \n\nRESOLVED to this end to eliminate progressively the \nobstacles to substantially all their trade, in accordance \nwith the provisions of the General Agreement on Tariffs and \nTrade concerning the establishment of free trade areas; \n\nDECLARING their readiness to examine, in the light of any \nrelevant factor, and in particular of developments in the \nCommunity, the possibility of developing and deepening their \nrelations where it would appear to be useful in the \ninterests of their economies to extend them to fields not \ncovered by this Agreement; \n\n\fHAVE DECIDED, in pursuit of these objectives and considering \nthat no provisions of this Agreement may be interpreted as \nexempting the Contracting Parties from the obligations which \nare incumbent upon them under other international \nagreements, \n\nTO CONCLUDE THIS AGREEMENT: \n\nThe aim of this Agreement is: \n\nArticle 1 \n\n(a) \n\n(b) \n\n(c) \n\nto promote through the expansion of reciprocal \ntrade the harmonious development of economic \nrelations between the European Economic Community \nand the Faroe Islands and thus to foster in the \nCommunity and in the Faroe Islands the advance of \neconomic activity, the improvement of living and \nemployment conditions, and increased productivity \nand financial stability, \n\nto provide fair conditions of competition for \ntrade between the Contracting Parties, \n\nto contribute in this way, by the removal of \nbarriers to trade, to the harmonious development \nand expansion of world trade. Article 2 \n\nThe Agreement shall apply to products originating in the \nCommunity or the Faroe Islands: \n\n(i) which fall within Chapters 25 to 97 of the Harmonized \n\nSystem, other than those listed in Annex II to the \nTreaty establishing the European Economic Community, \nand other than those listed in Annex I; \n\n(ii) which are specified in Protocols Nos 1, 2 and 4, with \n\ndue regard to the arrangements provided for in those \nProtocols. Article 3 \n\n1. 2. No new customs duty on imports shall be introduced in \ntrade between the Community and the Faroe Islands. The Community as constituted on 31 December 1985 shall \nabolish customs duties on imports from the Faroe \nIslands on 1 January 1992. 3. The Kingdom of Spain shall reduce its customs duties \n\napplicable to the Faroe Islands in accordance with \nArticle 31 (1) and (3) of the Act of Accession. 4. The Portuguese Republic shall reduce its customs duties \napplicable to the Faroe Islands in accordance with \nArticle 190 (1) and (2) of the Act of Accession. Article 4 \n\nThe Faroe Islands shall abolish customs duties on imports \nfrom the Community on 1 January 1992, as specified in Annex \nII. Article 5 \n\n1. The provisions concerning the abolition of customs \n\nduties on imports shall apply also to import duties of \na fiscal nature. The Faroe Islands may replace an import duty of a \nfiscal nature or the fiscal element of an import duty \nby an internal tax. 2. The Faroe Islands may temporarily retain the import \nduties of a fiscal nature in existence on 1 May 1991, \nas mentioned in Annex II, part A. 3. The Faroe Islands may temporarily introduce new import \nduties of a fiscal nature and increase existing import \nduties of a fiscal nature, provided that such duties or \nduty increases respect the conditions laid down in \nArticle 19. The Faroe Islands shall notify the \nCommunity of such changes. 4. The Faroe Islands shall abolish all import duties of a \nfiscal nature in connection with the implementation of \nthe reform described in Annex II and no later than 1 \nJanuary 1993. Article 6 \n\nNo new charge having an effect equivalent to a customs duty \nshall be introduced in trade between the Community and the \nFaroe Islands. Charges having an effect equivalent to customs duties on \nimports in trade between the Community and the Faroe Islands \nshall be abolished upon the entry into force of the \nAgreement. Article 7 \n\nNo customs duty on exports or charge having equivalent \neffect shall be introduced in trade between the Community \nand the Faroe Islands. Customs duties on exports and charges having equivalent \neffect shall be abolished not later than 1 January 1992. Article 8 \n\nProtocol No 1 lays down the tariff treatment and \narrangements applicable to certain fish and fishery products \nreleased for free circulation in the Community or imported \ninto the Faroe Islands. Article 9 \n\nProtocol No 2 lays down the tariff treatment and \narrangements applicable to certain products obtained by \nprocessing agricultural products. Article 10 \n\n1. In the event of specific rules being established as a \n\nresult of the implementation of its agricultural policy \nor of any alteration of the current rules the \nContracting Party in question may adapt the \narrangements resulting from this Agreement in respect \nof the products which are the subject of those rules or \nalterations. 2. In such cases the Contracting Party in question shall \n\ntake due account of the interests of the other \nContracting Party. To this end the Contracting Parties \nmay consult each other within the Joint Committee \nprovided for in Article 30. Protocol No 3 lays down the rules of origin. Article 11 \n\n\fArticle 12 \n\nA Contracting Party which is considering the reduction of \nthe effective level of its duties or charges having \nequivalent effect applicable to third countries benefiting \nfrom most-favoured-nation treatment, or which is considering \nthe supension of their application, shall, as far as may be \npracticable, notify the Joint Committee not less than thirty \ndays before such reduction or suspension comes into effect. It shall take note of any representations by the other \nContracting Party regarding any distortions which might \nresult therefrom. Article 13 \n\n1. No new quantitative restriction on imports or measures \n\nhaving equivalent effect shall be introduced in trade \nbetween the Community and the Faroe Islands. 2. The Contracting Parties shall abolish quantitative \nrestrictions on imports and any measures having an \neffect equivalent to quantitative restrictions on \nimports not later than 1 January 1992. Article 14 \n\n1. The Community reserves the right to modify the \n\narrangements applicable to the petroleum products \nfalling within headings Nos 2710, 2711, ex 2712 \n(excluding ozokerite, lignite wax and peat wax) and \n2713 of the Combined Nomenclature upon adoption of a \ncommon definition of origin for petroleum products, \nupon adoption of decisions under the common commercial \npolicy for the products in question or upon \nestablishment of a common energy policy. In this event, the Community shall take due account of \nthe interests of the Faroe Islands; to this end it \nshall inform the Joint Committee, which shall meet \nunder the conditions set out in Article 32. The Faroe Islands reserves the right to take similar \naction should it be faced with like situations. Subject to paragraphs 1 and 2, the Agreement shall not \nprejudice the non-tariff rules applied to imports of \npetroleum products. 2. 3. 8 \n\n\fArticle 15 \n\n1. The Contracting Parties declare their readiness to \n\nfoster, so far as their agricultural policies allow, \nthe harmonious development of trade in agricultural \nproducts to which the Agreement does not apply. 2. The Contracting Parties shall apply their rules in \nveterinary, health and plant health matters in a non \ndiscriminatory fashion and shall not introduce any new \nmeasures that have the effect of unduly obstructing \ntrade. 3. The Contracting Parties shall examine, under the \n\nconditions set out in Article 33, any difficulties that \nmight arise in their trade in agricultural products and \nshall endeavour to seek appropriate solutions. Article 16 \n\nThe Home Government of the Faroe Islands shall take the \nnecessary control measures to ensure the correct application \nof the reference price fixed or to be fixed by the \nCommunity, referred to in Article 2 of Protocol No 1. The Contracting Parties shall ensure the correct application \nof the definition of the concept of \"originating products\" \nand methods of administrative cooperation, laid down in \nProtocol No 3. Article 17 \n\nProtocol No 4 lays down the special provisions applicable to \nimports of certain agricultural products other than those \nlisted in Protocol No 1. Article 18 \n\nThe Contracting Parties reaffirm their commitment to grant \neach other the most favoured nation treatment in accordance \nwith the General Agreement on Tariffs and Trade (GATT). The Agreement shall not preclude the maintenance or \nestablishment of customs unions, free trade areas or \narrangements for frontier trade, except insofar as they \nalter the trade arrangements provided for in this Agreement, \nin particular the provisions concerning rules of origin. Article 19 \n\nThe Contracting Parties shall refrain from any measure or \npractice of an internal fiscal nature establishing, whether \ndirectly or indirectly, discrimination between the products \nof one Contracting Party and like products originating in \nthe territory of the other Contracting Party. Products exported to the territory of one of the Contracting \nParties may not benefit from repayment of internal taxation \nin excess of the amount of direct or indirect taxation \nimposed on them. Article 20 \n\nPayments relating to trade in goods and the transfer of such \npayments to the Member State of the Community in which the \ncreditor is resident or to the Faroe Islands shall be free \nfrom any restrictions. Article 21 \n\nThe Agreement shall not preclude prohibitions or \nrestrictions on imports, exports or goods in transit \njustified on grounds of public morality, law and order or \npublic security, the protection of life and health of \nhumans, animals or plants, the protection of national \ntreasures of artistic, historic or archaeological value, the \nprotection of industrial and commercial property, or rules \nrelating to gold or silver. Such prohibitions or \nrestrictions must not, however, constitute a means of \narbitrary discrimination or a disguised restriction on trade \nbetween the Contracting Parties. Article 22 \n\nNothing in the Agreement shall prevent a Contracting Party \nfrom taking any measures: \n\n(a) which it considers necessary to prevent the disclosure \nof information contrary to its essential security \ninterests; \n\n(b) which relate to trade in arms, munitions or war \n\nmaterials or to research, development or production \nindispensable for defence purposes, provided that such \nmeasures do not impair the conditions of competition in \nrespect of products not intended for specifically \nmilitary purposes: \n\ni'c) which it considers essential to its own security in \n\ntime of war or serious international tension. 10 \n\n\fArticle 23 \n\n1. The Contracting Parties shall refrain from any measure \n\nlikely to jeopardize the fulfilment of the objectives \nof the Agreement. 2. They shall take any general or specific measures \nrequired to fulfil their obligations under the \nAgreement : \n\nIf either Contracting Party considers that the other \nContracting Party has failed to fulfil an obligation \nunder the Agreement, it may take appropriate measures \nunder the conditions and in accordance with the \nprocedures laid down in Article 28. Article 24 \n\n1. The following are incompatible with the proper \n\nfunctioning of the Agreement insofar as they may affect \ntrade between the Community and the Faroe Islands: \n\n(i) all agreements between undertakings, decisions by \n\nassociations of undertakings and concerted \npractices between undertakings which have as their \nobject or effect the prevention, restriction or \ndistortion of competition as regards the \nproduction of or trade in goods; \n\n(ii) abuse by one or more undertakings of a dominant \n\nposition in the territories of the Contracting \nParties as a whole or in a substantial part \nthereof ; \n\n(iii)any public aid which distorts or threatens to \ndistort competition by favouring certain \nundertakings or the production of certain goods. 2. Should a Contracting Party consider that a given \npractice is incompatible with this Article, it may take \nappropriate measures under the conditions and in \naccordance with the procedure laid down in Article 28. Article 25 \n\nWhere an increase in imports of a given product is or is \nlikely to be seriously detrimental to any production \nactivity carried on in the territory of one of the \nContracting Parties and where this increase is due to: \n\n(i) the partial or total reduction in the importing \n\nContracting Party, as provided for in the Agreement, of \ncustoms duties and charges having equivalent effect \nlevied on the product in question; and \n\n11 \n\n\f(ii) the fact that the duties or charges having equivalent \n\neffect levied by the exporting Contracting Party on \nimports of raw materials or intermediate products used \nin the manufacture of the product in question are \nsignificantly lower than the corresponding duties or \ncharges levied by the importing Contracting Party: \n\nthe Contracting Party concerned may take appropriate \nmeasures under the conditions and in accordance with the \nprocedures laid down in Article 28. Article 26 \n\nIf one of the Contracting Parties finds that dumping is \ntaking place in trade with the other Contracting Party, it \nmay take appropriate measures against this practice in \naccordance with the Agreement on Implementation of Article \nVI of the General Agreement on Tariffs and Trade, under the \nconditions and in accordance with the procedures laid down \nin Article 28. Article 27 \n\nIf serious disturbances arise in any sector of the economy \nor if difficulties arise which could bring about serious \ndeterioration in the economic situation of a region, the \nContracting Party concerned may take appropriate measures \nunder the conditions and in accordance with the procedures \nlaid down in Article 28. Article 28 \n\n1. 2. In the event of a Contracting Party subjecting imports \nof products liable to give rise to the difficulties \nreferred to in Articles 25 and 27 to an administrative \nprocedure, the purpose of which is to provide rapid \ninformation on the trend of trade flows, it shall \ninform the other Contracting Party. In the cases specified in Articles 23 to 27, before \ntaking the measures provided for therein or, in cases \nto which paragraph 3 (d) applies, as soon as possible, \nthe Contracting Party in question shall supply the \nJoint Committee with all relevant information required \nfor a thorough examination of the situation with a view \nto seeking a solution acceptable to the Contracting \nParties. In the selection of measures, priority must be given to \nthose which least disturb the functioning of the Agreement. The safeguard measures shall be notified immediately to the \nJoint Committee and shall be the subject of periodical \nconsultations within the Committee, particularly with a view \nto their abolition as soon as circumstances permit. 12 \n\n\f10 \n\n3. For the implementation of paragraph 2, the following \nprovisions shall apply: \n\n(a) As regards Article 24, either Contracting Party \n\nmay refer the matter to the Joint Committee if it \nconsiders that a given practice is incompatible \nwith the proper functioning of the Agreement \nwithin the meaning of Article 24 (1). The Contracting Parties shall provide the Joint \nCommittee with all relevant information and shall \ngive it the assistance it requires in order to \nexamine the case and, where appropriate, to \neliminate the practice objected to. If the Contracting Party in question fails to put \nan end to the practice objected to within the \nperiod fixed by the Joint Committee, or in the \nabsence of agreement in the Joint Committee within \nthree months of the matter being referred to it, \nthe Contracting Party concerned may adopt any \nsafeguard measures it considers necessary to deal \nwith the serious difficulties resulting from the \npractices in question in particular it may \nwithdraw tariff concessions. (b) As regards Article 25, the difficulties arising \n\nfrom the situation referred to in that Article \nshall be referred for examination to the Joint \nCommittee, which may take any decision needed to \nput an end to such difficulties. If the Joint Committee or the exporting \nContracting Party has not taken a decision putting \nan end to the difficulties within thirty days of \nthe matter being referred, the importing \nContracting Party is authorized to levy a \ncompensatory charge on the product imported. The compensatory charge shall be calculated \naccording to the incidence on the value of the \ngoods in question of the tariff disparities in \nrepsect of the raw materials or intermediate \nproducts incorporated therein. (c) As regards Article 26, consultation in the Joint \n\nCommittee shall take place before the Contracting \nParty concerned takes the appropriate measures. (d) Where exceptional circumstances requiring \n\nimmediate action make prior examination \nimpossible, the Contracting Party concerned may, \nin the situations specified in Article 25, 26 and \n27 and also in the case of export aids having a \ndirect and immediate incidence on trade, apply \nforthwith the precautionary measures strictly \nnecessary to remedy the situation. 13 \n\n\f11 \n\nArticle 29 \n\nWhere one or more Member States of the Community or the \nFaroe Islands is in difficulties or is seriously threatened \nwith difficulties as regards its balance of payments, the \nContracting Party concerned may take the necessary safeguard \nmeasures. It shall inform the other Contracting Party \nforthwith. Article 30 \n\n1. A Joint Committee is hereby established which shall be \n\nresponsible for the administration of the Agreement and \nshall ensure its proper implementation. For this \npurpose, it shall make recommendations and take \ndecisions in the cases provided for in the Agreement. These decisions shall be put into effect by the \nContracting Parties in accordance with their own rules. 2. For the purpose of the proper implementation of the \nAgreement the Contracting Parties shall exchange \ninformation and, at the request of either Party, shall \nhold consultations within the Joint Committee. 3. The Joint Committee shall adopt its own rules of \n\nprocedure. Article 31 \n\n1. The Joint Committee shall consist of representatives of \n\nthe Contracting Parties. 2. The Joint Committee shall act by mutual agreement. Article 32 \n\n1. 2. Each Contracting Party shall preside in turn over the \nJoint Committee, in accordance with the arrangements to \nbe laid down in its rules of procedure. The Chairman shall convene meetings of the Joint \nCommittee at least once a year in order to review the \ngeneral functioning of the Agreement. The Joint Committee shall, in addition, meet whenever \nspecial circumstances so require, at the request of either \nContracting Party, in accordance with the conditions to be \nlaid down in its rules of procedure. 14 \n\n\f12 \n\n3. In the event of modifications to the nomenclature of \nthe customs tariffs of the Contracting Parties \naffecting products referred to in this Agreement, the \nJoint Committee may adapt the tariff nomenclature of \nthese products to conform with such modifications. 4. The Joint Committee may decide to set up any working \nparty that can assist it in carrying out its duties. Article 33 \n\n1. Where a Contracting Party considers that it would be \n\nuseful in the common interest of both Contracting \nParties to develop the relations established by the \nAgreement by extending them to fields not covered \nthereby, it shall submit a reasoned request to the \nother Contracting Party. The Contracting Parties may instruct the Joint Committee to \nexamine this request and, where appropriate, to make \nrecommendations to them, particularly with a view to opening \nnegotiations. 2. The agreements resulting from the negotiations referred \nto in paragraph 1 will be subject to ratification or \napproval by the Contracting Parties in accordance with \ntheir own procedures. Article 34 \n\nAt the request of the Faroe Islands, the Community will \nconsider \n\nimproving the access possibilities for specific \nproducts ; \n\nextending its tariff concessions for Faroese fishery \nproducts to include new fish species caught by Faroese \nfishing vessels based and operating in the North \nAtlantic, or to include fishery products pertaining \nthereto not currently produced by the Faroese fishing \nindustry. These new fish species or fishery products \ncould be imported free of duty into the Community, \nsubject to the necessary quantitative limitations, \nshould the new fish species or fishery products be of ; \nsensitive nature in the Community. The Annexes and Protocols to the Agreement shall form an \nintegral part thereof. Article 35 \n\n15 \n\n\f13 \n\nArticle 36 \n\nEither Contracting Party may denounce the Agreement by \nnotifying the other Contracting Party. The Agreement shall \ncease to be in force twelve months after the date of such \nnotification. Article 37 \n\nThe Agreement shall apply, on the one hand, to the \nterritories to which the Treaty establishing the European \nEconomic Community applies upon the terms laid down in that \nTreaty and, on the other, to the territory of the Faroe \nIslands. Article 38 \n\nThis Agreement is drawn up in duplicate in the Danish, \nDutch, English, Faroese, French, German, Greek, Italian, \nPortuguese and Spanish languages, each of these texts being \nequally authentic. This Agreement will be approved by the Contracting Parties \nin accordance with their own procedures. It shall enter into force on 1 January 1992, provided that \nthe Contracting Parties have notified each other before that \ndate that the procedures necessary to this end have been \ncompleted. After this date, this Agreement shall enter into force on \nthe first day of the second month following such \nnotification. The provisions applicable on 1 January 1992 shall be applied \nupon the entry into force of this Agreement if it enters \ninto force after that date. IN WITNESS WHEREOF, the undersigned, being duly authorized \nfor this purpose, have signed this Agreement. (2) \n\n16 \n\n\fList c\"f prcc-jc:s referred to *. n Article 2 (-\u2022; c\"f :-? - = -?e^\u00bb^t \n\nANNE >. I \n\nCN c o de \n\n3502 \n\n35K10 \n\nD e s c r i ot i c^ \n\nAJbamtttS, albuminates and other albumin derivatives : \n\n- - Other \n\n- \u2014 \u2014 Dned (Tor example, in sbecs. scale*, fi4k. es. pc*Cc:) \n\nI SC It 99 \n\nOther \n\n3 9 R 90 \n\n- Otber : \n\n- \u2014 AJbumins. other thac eu albumin \n\n- \n\n- - Other : \n\n- - - \u2014 Milk aJbumin ( l a o i l b u n m; \n\n3SRMS1 \n\n3502 90 59 \n\n-\n\n-\n\n-\n\n-\n\n-\n\n-\n\n-- Dn\u00abl (for ciunplc \n\nin ibecu. icalev flilca. ponder) \n\n-- Other \n\n17 \n\n\fImplementation bv the Faroe Islands of abolition of tariffs \nand duties on goods of Community origin \n\nANNEX XI \n\nA. Faroese legislation on fiscal import duties and \n\ninternal production levies in force on 1 May 1991: \n\n1. Law No. 53 from 11 February 1950 as later amended: \n\nFiscal import duties and production levies on a \n\nnumber of specific products. 2. Law No. 9 from 27 April 1961 as later amended: \n\nA general fiscal import duty of 27% with certain \nexceptions, mainly for raw materials and for goods \nused by the fishing industry. 3. Law No. 32 from 19 May 1979 as later amended: \n\nA general fiscal import duty of 6% with certain \nexceptions, although with fewer exceptions than \nunder No. 2. The European Commission will, at the date of signature \nof the Agreement, at the latest, receive a complete \ncollection of the abovementioned legislation in force \non 1 May 1991. B. The Faroe Islands commit themselves to make the \n\nfollowing changes in their customs and duties \nlegislation: \n\n1. On 1 January 1992: \n\na) A new customs legislation will be enacted, \n\nintroducing a customs tariff based upon the \nHarmonized System, and respecting the GATT-\nobligations of Denmark. b) Goods of EEC origin will be granted duty-free \n\ntreatment with the exceptions mentioned in \nProtocols 2 and 4. 18 \n\n\fC. On 1 January 1993: \n\nThe existing system of fiscal import duties and \nproduction levies is abolished and replaced by a new \nsystem of indirect taxation based upon the following \nelements: \n\na) A value-added tax (VAT), based upon the same \n\nprinciples as those recommended by the Community \nto its member states, including non-discrimination \nof imported goods, and \n\nb) A system of excise duties, levied equally upon \n\ndomestic production and imported goods. 19 \n\n\fPROTOCOL NO 1 \n\nconcerning the special provisions applicable to imports of \ncertain fish and fishery products \n\nArticle 1 \n\nAs regards the products listed in the Annex to this protocol \nand originating in the Faroe Islands: \n\n1. no new customs duty shall be introduced in trade \nbetween the Community and the Faroe Islands; \n\n2. the customs duties and other conditions to be applied \non import into the Community as constituted on the 31 \nDecember 1985 of products originating in and coming \nfrom the Faroe Islands shall be as indicated in the \nannex to this Protocol; \n\n3. the Kingdom of Spain shall reduce its customs duties \n\napplicable to the Faroe Islands in accordance with \nArticle 173 (1) and (2) of the Act of Accession; \n\n4. the Portuguese Republic shall. reduce its customs duties \napplicable to the Faroe Islands in accordance with \nArticle 360 (1) (b) and (2) of the Act of Accession. Article 2 \n\nThe preferential duty rates indicated in the Annex only \napply if the free-at-frontier price, which is determined by \nthe Member States in accordance with Article 21 of \nRegulation (EEC) No 3796/81 (O. J. N* L 379, 31. 12. 1981) as \nlast amended by Regulation (EEC) N* 3468/88 (OJ N\" L 305, \n10. 11. 1988) is at least equal to the reference price fixed, \nor to be fixed, by the Community for the products under \nconsideration or the categories of the products concerned. Article 3 \n\nFor the purpose of eliminating customs duties, reference \nceilings are established in the Annex for certain products \noriginating in the Faroe Islands. Should imports of these products exceed the reference \nceiling, the Community may introduce the full customs duty. Article 4 \n\nThe Faroe Islands shall abolish tariffs and duties on \nimports of fish and fishery products originating in the \nCommunity on the date specified in Article 5 and Annex II to \nthis Agreement. 20 \n\n\fANNEX \n\nThe customs duties and other conditions to be applied on \nimport into the Community of products originating in and \ncoming from the Faroe Islands shall be as indicated below \n\n21 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0301 \n\nLive fish: \n\n\u2014 Other live fish: \n\nex0301 91 OOi \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \n\nSalmo aguabonita, Salmo gilae) \n\n- Trout (Salmo gairdneri) \n\nTQ N 1 \n\n0301 92 00 \n\n\u2014 Eels (Anguilla spp. ) \n\n0301 99 \n\n\u2014 Other \n\nFreshwater fish \n\nex0301 99 llj \n\nPacific salmon (Oncorhynchus spp. ), Atlantic salmon \n(Salmo salar) and Danube salmon (Hucho hucho): \n- Atlantic salmon (salmo salar) \n\n0302 \n\nFish, fresh or chilled, excluding fish filets and other \nfish meat of heading No 0304: \n\n\u2014 Salmonidae, excluding livers and roes: \n\nex0302 11 0d \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \n\nSalmo aguabonita, Salmo gilae): \n\n- Trout (Salmo gairdneri) \n\nex0302 12 0d \n\n\u2014 Pacific salmon (Oncorhynchus spp. ), Atlantic salmon \n\n(Salmo salar) and Danube salmon (Hucho hucho): \n\n- Atlantic salmon (salmo salar) \n\n*0 \n\nTQ N 2 \n\nTQ N\u00b0 1 \n\nTQ N\u00b0 2 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0302 19 00 \n\n\u2014 Other \n\n\u2014 Flat fish (Pleuronectidae, Bothidae, Cynoglossidae, \nSoleidae, Scophthalmidae and Citharidae), excluding \nlivers and roes: \n\n0302 21 \n\n\u2014 Halibut (Reinhardtius hippoglossoides, Hippoglossus \n\nhippoglossus, Hippoglossus stenolepis): \n\n0302 21 10 \n\nLesser or Greenland halibut (Reinhardtius \n\n0302 21 30 \n\n0302 22 00 \n\n0302 23 00 \n\n0302 29 90 \n\n0302 40 \n\nhippoglossoides) \n\nAtlantic halibut (Hippoglossus hippoglossus) \n\n\u2014 Plaice (Pleuronectes platessa) \n\n\u2014 Sole (Solea spp. ) \n\n\u2014 Other \n\u2014 Herrings (Clupea harengus, Clupea pallasii), excluding \n\nlivers and roes: \n\n0302 40 10 \n\n\u2014 From 15 February to 15 June \n\n0302 40 90 \n\n\u2014 From 16 June to 14 February \n\n0302 50 \n\n\u2014 Cod (Gadus morhua, Gadus ogac, Gadus macrocephalus), \n\nexcluding livers and roes: \n\nCO \n\nStatistical Surv \n\nRC N \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0302 50 10 \n\n-- Of the species Gadus morhua \n\n0302 62 00 \n\n0302 63 00 \n\n0302 64 \n\n\u2014 Other fish, excluding livers and roes: \n\n-- Haddock (Melanogrammus aeglefinus) \n\n\u2014 Coalfish (Pollachius virens) \n\u2014 Mackerel (Scomber scombrus, Scomber australasicus, \n\nScomber japonicus): \n\nex0302 64 10 \n\n\u2014 From 15 February to 15 June \n\n- Mackerel (Scomber scombrus) \n\nex0302 64 90 \n\n\u2014 From 16 June to 14 February \n\n0302 65 \n\n0302 65 20 \n\n0302 65 50 \n\n0302 65 90 \n\n0302 66 00 \n\n0302 69 \n\n- Mackerel (Scomber scombrus) \n\n\u2022- Dogfish and other sharks: \n\n\u2014 Dogfish of the species Squalus acanthias \n\n\u2014 Dogfish of the species Scyliorhinus spp. \u2014 Other \n\n\u2022- Eels (Anguilla spp. ) \n\n- Other: \n\n\u2014 Saltwater fish: \n\nto \n\nRedfish (Sebastes spp. ): \n\nRC N 2 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0302 69 31 \n\nOf the species Sebastes marinus \n\nex0302 69 33 \n\nOther : \n\n- Of the species Sebastes mentella \n\n0302 69 41 \n\nWhiting (Merlangus merlangus) \n\n0302 69 45 \n\nLing (Molva spp. ) \n\nex0302 69 65| \n\nHake (Merluccius spp. , Urophycis spp. ) \n\n0302 69 81 \n\n0302 69 85 \n\n- Hake (Merluccius merluccius) \n\nMonkfish (Lophius spp. ) \n\nBlue whiting (Micromesistius poutassou or Gadus \n\n0302 69 98 \n\npoutassou) \n\n0302 70 00 \n\nOther \n\n0303 \n\n- Livers and roes \nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304: \n\n- Other salmonidae, excluding livers and roes: \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\nRC N 6 \n\nRC N 6 \n\nStatistical surv \n\nex0303 21 0d \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \n\nSalmo aguabonita, Salmo gilae): \n\n- Trout (Salmo gairdneri) \n\nTQ N 1 \n\nOf \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. ex0303 22 Od \n\n\u2014 Atlantic salmon (Salmo salar) and Danube salmon \n\n(Hucho hucho): \n\n- Atlantic salmon (salmo salar) \n\nTQ N 2 \n\n0303 29 00 \n\n\u2014 Other \n\n\u2014 Flat fish (Pleuronectidae, Bothidae, Cynoglossidae, \nSoleidae, Scophthalmidae and Citharidae), excluding \nlivers and roes: \n\n0303 31 \n\n\u2014 Halibut (Reinhardtius hippoglossoides, Hippoglossus \n\nhippoglossus, Hippoglossus stenolepis): \n\n0303 31 10 \n\nLessor or Greenland halibut (Reinhardtius \n\nhippoglossoides) \n\nAtlantic halibut (Hippoglossus hippoglossus) \n\n\u2014 Plaice (Pleuronectes platessa) \n\n\u2014 Sole (Solea spp. ) \n\n\u2014 Other: \n\nFlounder (Platichthys flesus) \n\nOther \n\n\u2014 Herrings (Clupea Harengus, Cluper Pallasii) excluding \n\nlivers and roes \n\n0303 31 30 \n\n0303 32 00 \n\n0303 33 00 \n\n0303 39 \n\n0303 39 10 \n\n0303 39 90 \n\n0303 50 \n\nIC \nm \n\n\fRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. RC N \n\nCN Code \n\nDescription \n\nTABLE I \n\n0303 50 10 \n\n\u2014 From 15 February to 15 June \n\n0303 50 90 \n\n\u2014 From 16 June to 14 February \n\n0303 60 \n\n\u2014 Code (Gadus morhua, Gadus ogac, Gadus macrocephalus), \n\nexcluding livers and roes: \n\nex0303 60 10 \n\n\u2014 Of the species Gadus morhua and Gadus ogac \n\n- Of the species Gadus morhua \n\n\u2014 Other fish, excluding livers and roes: \n\n0303 74 \n\n\u2014 Mackerel (Scomber scombrus, Scomber australasicus, \n\nScomber japonicus): \n\nOf the species Scomber scombrus and Scomber jpaonicus: \n\nex0303 74 11 \n\nFrom 15 February to 15 June \n\n- Scomber scombrus \n\nex0303 74 19 \n\nFrom 16 June to 14 February \n\n- Scomber scombrus \n\n\u2014 Dogfish and other sharks: \n\nDogfish of the species Squalus acanthias \n\nDogfish of the species Scyliorhinus spp. 0303 75 \n\n0303 75 20 \n\n0303 75 50 \n\nto \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0303 75 90 \n\n\u2014 Other \n\n0303 79 \n\n\u2022- Other: \n\n\u2014 Saltwater fish: \n\nRedfish (Sebastes spp. ): \n\n0303 79 35 \n\nOf the species Sebastes marinus \n\nex0303 79 37 \n\nOther: \n\n- Of the species Sebastes mentella \n\n0303 79 45 \n\nWhiting (Merlangus merlangus) \n\n0303 79 51 \n\nLing (Molva spp. ) \n\n0303 79 81 \n\nMonkfish (Lophius spp. ) \n\n0303 79 83 \n\nBlue whiting (Micromesistius poutassou or Gadus \n\n0303 79 98 \n\n0303 80 00 \n\npoutassou) \n\nOther \n\nLivers and roes \n\n0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen: \n\nto \n00 \n\nRC N 6 \n\nRC N 6 \n\nStatistical surv, \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 10 \n\n- Fresh or chilled: \n\n\u2014 Fillets: \n\nOf freshwater fish: \n\nex0304 10 11 \n\nex0304 10 13 \n\nOf trout (Salmo trutta, Salmo gairdneri, Salmo \nclarki, Salmo aguabonita, Salmo gilae): \n\n- Of trout (Salmo Gairdneri) \n\nOf Pacific salmon (Oncorhynchus spp. ) Atlantic \nsalmon (Salmo salar) and Danube salmon (Hucho hucho) \n\n- Of Atlantic salmon (salmo salar) \n\nOther: \n\nex0304 10 33J \n\nOf cod (Gadus morhua, Gadus ogac, Gadus \nmacrocephalus) and of fish of the species Boreogadus \nsaida \n\n- Of cod (Gadus morhua) \n\n0304 10 39 \n\nOther \n\n- Of redfish (Sebastes spp. ) \n- Other \n\n\u2014 Other fish meat (whether or not minced): \n\n0304 10 91 \n\n\u2014 Of freshwater fish \n\n0304 10 99 \n\n\u2014 Other \n\nCO \n\nTQ N\u00b0 1 \n\nTQ N\u00b0 2 \n\nRC N 6 \nRC N\u00b0 7 \n\n\fCN Code \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 20 \n\n\u2014 Frozen fillets: \n-- Of freshwater fish: \n\nex0304 20 1 li \n\nOf trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \nSalmo aguabonita, Salmo gilae): \n\n- Of trout (Salmo gairdneri) \n\nex0304 20 13 \n\nOf Pacific salmon (Oncorhynchus spp. ), Atlantic \nsalmon (Salmo salar) and Danube salmon (Hucho hucho): \n- Of Atlantic salmon (salmo salar) \n\n\u2014 Of cod (Gadus morhua, Gadus macrocephalus, Gadus ogac) \n\nand of fish of the species Boreogadus saida: \n\nex0304 20 29 \n\nOther \n\n- Of code of the species Gadus morhua \n\n0304 20 31 \n\n0304 20 33 \n\n-- Of coalfish (Pollachius virens) \n\n-- Of haddock (Melanogrammus aeglefinus) \n\n\u2014 Of redfish (Sebastes spp. ): \n\n0304 20 35 \n\nex0304 20 371 \n\nOf the species Sebastes marinus \n\nOther \n\n0304 20 41 \n\n\u2014 Of whiting (Merlangus merlangus) \n\n- Of the species Sebastes mentella \n\nCO \n\nTQ N\u00b0 1 \n\nTQ N\u00b0 2 \n\nRC N 3 \n\nRC N 6 \n\nRC N 6 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 20 43 \n\n\u2014 Of ling (Molva spp. ) \n\nRC N 8 \n\n\u2014 Of mackerel (Scomber scombrus, Scomber australasicus, \n\nScomber japonicus) and of fish of the species \nOrcynopsis unicolor: \n\nex0304 20 53 \n\nOther \n\n- Of mackerel of the species Scomber scombrus \n\n0304 20 71 \n\n0304 20 75 \n\n0304 20 97 \n\n\u2014 Of plaice (Pleuronectes platessa) \n\n\u2014 Of herring (Clupea harengus, Clupea pallasii) \n\n\u2014 Other \n\n- Of blue whiting \n\n0304 90 \n\n- Other \n\nex0304 90 101 \n\n\u2014 Other: \n\n\u2014 Of freshwater fish \n\n\u2022- Of trout (Salmo gairdneri) \n\n- Of salmon (Salmo salar) \n\n0304 90 21 \n\nCO \n\n\u2014 Other: \n\nOf herring (Clupea harengus, Clupea pallasii): \n\nFrom 15 February to 15 June \n\nRC N 1 \n\nRC N 9 \nStatistical surv \n\nTQ N\u00b0 1 \nTQ N\u00b0 2 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 90 25 \n\nFrom 16 June to 14 February \n\nRC N \n\nOf cod (Gadus morhua, Gadus ogac, Gadus \nmacrocephalus) and of fish of the species Boreogadus \nsaida: \n\nex0304 90 38] \n\nOf cod of the species Gadus morhua \n\n0304 90 41 \n\nOf coalfish (Pollachius virens) \n\nRC N \n\n0304 90 45 \n\nOf haddock (Melanogrammus aeglefinus) \n\n0304 90 57 \n\nOf monkfish (Lophius spp. ) \n\nCO \n*o \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 90 59 \n\nOf blue whiting (Micromesistius poutassou or Gadus \npoutassou) \n\n0304 90 97 \n\nOther \n\nRC N 9 \n\nStatistical surv \n\n0305 \n\nFish, dried, salted or in brine; smoked fish, whether or \nnot cooked before or during the smoking process; fish \nmeal fit for human consumption: \n\n0305 10 00 \n\n- Fish meal fit for human consumption \n\n0305 20 00 \n\n- Livers and roes, dried, smoked, salted or in brine \n\n0305 30 \n\n- Fish fillets, dried, salted or in brine, but not \n\nsmoked : \n\n- Of cod (Gadus morhua, Gadus ogac, Gadus macrocephalus) \n\nand of fish of the species Boreogadus saida: \n\nex0305 30 la \n\nOther \n\n- Of cod of the species Gadus morhua \n\nex0305 30 3d \n\n\u2014 Of Pacific salmon (Oncorhynchus spp. ), Atlantic salmon \n\n(Salmo salar) and Danube salmon (Hucho hucho), salted \nor in brine \n\n0305 30 50 \n\n\u2014 Of lesser or Greenland halibut (Reinhardtius \n\nhippoglossoides), salted or in brine \n\nRC N \n\n- Of Atlantic salmon (Salmo salar) \n\nCO \nCO \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0305 30 90 \n\n\u2014 Other \n\n\u2014 Smoked fish, including fillets: \n\nex0305 43 00 \n\n\u2014 Pacific salmon (Oncorhynhcus spp. ), Atlantic salmon \n\n(Salmo salar) and Danube salmon (Hucho hucho) \n\n- Atlantic salmon (Salmo salar) \n\n0305 42 00 \n\n-- Herrings (Clupea harengus, Clupea pallasii \n\n0305 49 \n\n\u2014 Other: \n\n0305 49 10 \n\nLesser or Greenland halibut (Reinhardtius \n\n0305 49 20 \n\nex0305 49 30 \n\nex0305 49 40 \n\nhippoglossoides) \n\nAtlantic halibut (Hippoglossus hippoglossus) \n\nMackerel (Scomber scombrus, Scomber australasicus, \nScomber japonicus): \n\n- Mackerel (Scomber scombrus) \n\nTrout (Salmo trutta, Salmo gairdneri, Salmo clarki, \nSalmo aguabonita, Salmo gilae): \n\n- Trout (Salmo gairdneri) \n\n0305 49 50 \n\n0305 49 90 \n\nEels (Anguilla spp. ) \n\nOther \n\n\u2014 Dried fish, whether or not salted but not smoked: \n\nCO \n\nRC N 4 \n\nRC N 5 \n\nRC N 5 \n\nRC N\u00b0 5 \n\nRC N\u00b0 5 \n\nRC N\u00b0 5 \n\nRC N\u00b0 5 \n\nRC N\u00b0 5 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0305 51 \n\n\u2014 Cod (Gadus morhua, Gaduc ogac, Gadus macrocephalus): \n\nex0305 51 10 \n\nDried, unsalted \n\n- Of cod of the species Gadus morhua \n\nex0305 51 90 \n\nDried, salted \n\n- Of cod of the species Gadus morhua \n\n- Fish, salted but not dried or smoked and fish in brine \n\nCO \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. ex0305 61 00 \n\n\u2014 Herrings (Clupea harengus, Clupea pallasii) \n\nsalted herrings (Clupea harengus, clupea \npallasii) \n\nex0305 62 00J \n\nCod (Gadus morhua, Gadus ogac, Gaduc macrocephalus) \n\n- Of cod of the species Gadus morhua \n\n0305 69 \n\nOther : \n\n0305 69 90 \n\n\u2022 Other \n\n0306 \n\nCrustaceans, whether in shell or not, live, fresh, chilled \nfrozen, dried, salted or in brine; crustaceans, in shell \ncooked by steaming or by boiling in water, whether or not \nchilled, frozen, dried, salted or in brine: \n\n- Frozen: \n\n0306 13 \n\n\u2014 Shrimps and prawns: \n\n0306 13 10 \n\nOf the family pandalidae \n\n0306 13 90 \n\nOther \n\n0306 19 \n\n0306 19 30 \n\n\u2014 Other: \n\nNorway lobsters (Nephrops norvegicus) \n\n\u00ab \n\nCO \n\n- Not frozen: \n\nTQ N 4 or \nRC N\u00b0 12 \n\nRC N 10 \n\nRC N 11 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0306 29 \n\n\u2014 Other: \n\n0306 29 30 \n\nNorway lobsters (Nephrops norvegicus) \n\n0307 \n\nMolluscs, whether in shell or not, live, fresh, chilled \nfrozen, dried, salted or in brine; aquatic invertebrates \nother than crustaceans and molluscs, live, fresh, chilled, \nfrozen, dried, salted or in brine: \n\n\u2014 Scallops, including queen scallops, of the genera Pecten \n\nChlamys or Placopecten: \n\n0307 21 00 \n\n\u2014 Live, fresh or chilled \n\n0307 29 \n\n\u2014 Other: \n\n0307 29 10 \n\nCoquilles St. Jacques (Pecten maximus), frozen \n\n0307 29 90 \n\nOther \n\n0511 \n\nAnimal products not elsewhere specified or included; \ndead animals of Chapter 1 or 3, unfit for human \nconsumption: \n\n- Other: \n\n0511 91 \n\n\u2014 Products of fish or crustaceans, molluscs or other \n\naquatic invertebrates; dead animals of Chapter 3: \n\nCO \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0511 91 90 : \n\nOther \n\n1604 \n\ni Prepared or preserved fish; caviar and caviar substitutes \nI prepared from fish eggs: \n\n; - Fish, whole or in pieces, but not minced: \n\nexl604 11 ooi - - Salmon: \n\n1604 12 \n\n\u2014 Herrings: \n\n- Atlantic salmon (salmo salar) \n\nTQ N 3 \n\n1604 12 10 \n\nFillets, raw, merely coated with batter or bread \ncrumbs, whether or not prefried in oil, deep frozen \n\nexl604 12 90 \n\nOther: \n\n- Spiced and/or in acid \n\n1604 15 \n\n\u2014 Mackerel: \n\nexl604 15 101 \n\nOf the species Scomber scombrus and Scomber japonicus \n- Of the species Scomber scombrus \n\nTQ N 4 \n\nTQ N 4 or \nRC N\u00b0 12 \n\nTQ N 4 \n\n1604 19 \n\n- - Other: \n\nCO \n00 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. exl604 19 10 \n\n- - - Salmonidae, other than salmon: \n\n- Trout (salmo gairdneri) \n\nOther: \n\n1604 19 91 \n\nFillets, raw, merely coated with batter or bread \ncrumbs, whether or not prefried in oil, deep frozen \n\n1604 19 99 \n\nOther \n\n1604 20 \n\n- Other prepared or preserved fish: \n\nexl604 20 10 \n\n- - Of salmon: \n\nexl604 20 30 \n\n- - Of salmonidae, other than salmon \n\n- Of trout (salmo gairdneri) \n\n- Of Atlantic salmon (salmo salar) \n\nexl604 20 50 \n\n- - Of sardines, bonito, mackerel of the species Scomber \n\nscombrus and Scomber japonicus, fish of the species \nOrcynopxis umicolor: \n\n- Of mackerel of the species scomber \n\nscombrus \n\n1604 20 90 \n\n- - Of other fish \n\n1605 \n\nCrustaceans, molluscs and other aquatic invertebrates, \nprepared or preserved: \n\n1605 20 00 \n\n- Shrimps and prawns \n\nCO \n\nTQ N\u00b0 3 \n\nTQ N\u00b0 4 \n\nTQ N\u00b0 4 \n\nTQ N 3 \n\nTQ N\u00b0 3 \n\nTQ N 4 \n\nTQ N\u00b0 4 \n\nTQ N\u00b0 5 \n\n\fCN Code \n\nDescription \n\nTABLE I \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. exl605 40 0d - Other crustaceans: \n\n- Nephrops norvegicus \n\nTQ N8 5 \n\n2301 \n\nFlours, meals and pellets, of meat or meat offal, of \nfish or of crustaceans, molluscs or other aquatic \ninvertebrates, unfit for human consumption; greaves: \n\n2301 20 00 \n\n- Flours, meals and pellets, of fish or of crustaceans \n\nO \n\n\fCN Code \n\nDescription \n\nTABLE II \n\n0301 \n\nLive fish: \n\n- Other live fish: \n\nex0301 91 0d \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \n\nSalmo aguabonita, Salmo gilae) \n\n- Trout (Salmo gairdneri) \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. TQ n8 1(1) \n700 T \n\n0302 \n\nFish, fresh or chilled, excluding fish filets and other \nfish meat of heading No 0304: \n\n- Salmonidae, excluding livers and roes: \n\nex0302 11 0d \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarke, \n\nSalmo aguabonita, Salmo gilae): \n\n- Trout (Salmo gairdneri) \n\n0303 \n\nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304: \n\n- Other salmonidae, excluding livers and roes: \n\nex0303 21 0d \n\n\u2014 Trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \n\nSalmo aguabonita, Salmo gilae): \n\n- Trout (Salmo gairdneri) \n\n(1) Figures refer to the commercial presentation whole and gutted. For imports falling under HS code \n0304 a coefficient of 2 shall be applied for quantities drawn from the respective tariff quota of \nreference ceiling. \u00a3\u00bb \n\n\fCN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 \n\n0304 10 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen: \n\n- Fresh or chilled: \n\u2014 Fillets: \n\nOf freshwater fish: \n\nex0304 10 11 \n\nOf trout (Salmo trutta, Salmo gairdneri, Salmo \nclarki, Salmo aguabonita, Salmo gilae): \n\n- Of trout (Salmo Gairdneri) \n\n0304 20 \n\n- Frozen fillets: \n\u2014 Of freshwater fish: \n\nex0304 20 llj \n\nOf trout (Salmo trutta, Salmo gairdneri, Salmo clarki, \nSalmo aguabonita, Salmo gilae): \n\n- Of trout (Salmo gairdneri) \n\n0304 90 \n\n- Other: \n\nex0304 90 ld \n\n\u2014 Of freshwater fish: \n\n- Of trout (Salmo gairdneri) \n\n\fCN Code \n\nDescription \n\nTABLE II \n\n0301 \n\nLive fish: \n\n- Other live fish: \n\n0301 99 \n\n- - Other: \n- - - Freshwater fish: \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. TQ N 2(1) \n\n4900 T \n\nex0301 99 13j \n\n- - - - Pacific salmon (Oncorhynchus spp. ), Atlantic \n\nsalmon (Salmo salar) and Danube salmon (Hucho \nhucho): \n\n- Atlantic salmon (salmo salar) \n\nex0302 12 0d \n\n0302 \n\n0303 \n\nFish, fresh or chilled, excluding fish fillets and other \nfish meat of heading No 0304: \n- Salmonidae, excluding livers and roes: \n- - Pacific salmon (Oncorhynchus spp. ), Atlantic salmon \n(Salmo salar) and Danube salmon (Hucho hucho): \n\n- Atlantic salmon (salmo salar) \n\nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304: \n- Other salmonidae, excluding livers and roes: \n\nex0303 22 0d \n\n- - Atlantic salmon (Salmo salar) and Danube salmon \n\n(Hucho hucho): \n\n- Atlantic salmon (salmo salar) \n\n(1) Figures refer to the commercial presentation whole and gutted. For imports falling under HScode \n\nj. 0304 a coefficient of 2 shall be applied for quantities drawn from the respective tariff quota of \n\u00a3. reference ceiling. CN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 \n\n0304 10 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen: \n\n- Fresh or chilled: \n- - Fillets: \n- - - Of freshwater fish: \n\nex0304 10 13 \n\n- - - - Of Pacific salmon (Oncorhynchus spp. ), Atlantic \n\nsalmon (Salmo salar) and Danube salmon (Hucho \nhucho): \n\n- Of Atlantic salmon (salmo salar) \n\n0304 20 \n\n- Frozen fillets: \n- - Of freshwater fish: \n\nex0304 20 13 \n\n- - - Of Pacific salmon (Oncorhynchus spp. ), Atlantic \n\nsalmon (Salmo salar) and Danube salmon (Hucho \nhucho): \n\n- Of Atlantic salmon (salmo salar) \n\n0304 90 \n\n- Other: \n\nex0304 90 ld \n\n- - Of freshwater fish: \n\n- Of Atlantic salmon (salmo salar) \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE II \n\n1604 \n\nPrepared or preserved fish; caviar and caviar substitutes \nprepared from fish eggs: \n\n- Fish, whole or in pieces, but not minced: \n\nexl604 11 00 \n\n- - Salmon: \n\n1604 19 \n\n- - Other: \n\n- Atlantic salmon (salmo salar) \n\nexl604 19 10 \n\n- - - Salmonidae, other than salmon: \n\n1604 20 \n\n- Trout (salmo gairdneri) \n\nexl604 20 10 \n\n- Other prepared or preserved fish: \n\n- - Of salmon: \n\nexl604 20 30 \n\n- Of Atlantic salmon (salmo salar) \n\n- - Of salmonidae, other than salmon \n\n- Of trout (salmo gairdneri) \n\n0 \n\n0 \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. TQ N\u00b0 3 \n400 T \n\nCrt \n\n\fCN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 1604 \n\nPrepared or preserved fish; caviar and caviar substitutes \nprepared from fish eggs: \n- Fish, whole or in pieces, but not minced: \n\nTQ N 4 \n2000 T \n\n1604 12 \n\n- - Herrings: \n\n1604 12 10 \n\n- - - Fillets, raw, merely coated with batter or bread \n\ncrumbs, whether or not prefried in oil, deep \nfrozen \n\n1604 15 \n\n- - Mackerel: \n\nexl604 15 ld \n\n- - - Of the species Scomber scombrus and Scomber \n\njaponicus: \n\n- Of scomber scombrus \n\n1604 19 \n\n- - Other: \n- - - Other: \n\n1604 19 91 \n\n- - - - Fillets, raw, merely coated with batter or \n\nbreadcrumbs, whether or not prefried in oil, \ndeep frozen \n\n1604 19 99 \n\n- - - - Other \n\nOT \n\n\fCN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 1604 20 \n\n- Other prepared or preserved fish: \n\nexl604 20 5d \n\n- - Of sardines, bonito, mackerel of the species Scomber \n\nscombrus and Scomber japonicus, fish of the species \nOrcynopxis umicolor: \n\n- Of mackerel of the species scomber \n\nscombrus \n\n1604 20 90 \n\n- - Of other fish \n\n1605 \n\nCrustaceans, molluscs and other aquatic invertebrates, \nprepared or preserved: \n\n1605 20 00 \n\n- Shrimps and prawns \n\nexl605 40 0d \n\n- Other crustaceans: \n\n- Nephrops norvegicus \n\nTQ N 5 \n\n2000 T \n\nHE* \n\n\fCN Code \n\n0302 \n\n0302 40 \n\nTABLE II \n\nDescription \n\nRate of duty \n\nFish, fresh or chilled, excluding fish fillets and other \nfish meat of heading No 0304 : \n\n- Herrings (Clupea harengus, Clupea pallasii), excluding \n\nlivers and roes : \n\nTariff quota \nTQ in tons \nreference \nceiLling__R;C. RC n\u00b0 1 (1) \n2000 T \n\n0302 40 90 \n\n\u2014 From 16 June to 14 February \n\n0 (2) \n\n0303 \n\n0303 50 \n\nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304 : \n\n- Herrings (Clupea harengus, Clupea pallasii), excluding \n\nlivers and roes : \n\n0303 50 90 \n\n\u2014 From 16 June to 14 February \n\n0 (2) \n\n(1) Duty exemption for herring falling within subheadings 0302 40 90, 0303 50 90, 0304 10 93, \n0304 10 98 and 0304 90 25 within the limits of a global annual tariff quota of 34 000 tonnes \nto be granted by the competent Community authorities and subject to compliance with the reference \nprice. (2) Figures refer to the commercial presentation whole and gutted. For imports falling under \nHS code 0304 a coefficient of 2 shall be applied for quantities drawn from the respective tariff \n\n^ quota of reference ceiling. 00 \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE \n\nII \n\n0302 \n\nFish, fresh or chilled, excluding fish fillets and other \nfish meat of heading No 0304 : \n\n0302 64 \n\n\u2014 Mackerel (Scomber scombrus, Scomber australasicus, \n\nScomber japonicus) : \n\nex0302 64 90 \n\nFrom 16 June to 14 February : \n\n- Mackerel (Scomber scombrus) \n\n0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled of frozen : \n\n0304 20 \n\n- Frozen fillets : \n\n0304 20 31 \n\n- Of coalfish (Pollaechius virens) \n\n0304 90 \n\n- Other : \n\n0304 90 41 \n\nOf coalfish (Pollachius virens) \n\n0 \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC n\u00b0 2 \n3000 T \n\nRC n\u00b0 3 \n25000 T \n\n\u00a3* \nCO \n\n\fCN Code \n\n0305 \n\n0305 30 \n\nTABLE \n\nII \n\nDescription \n\nRate of duty \n\nFish, dried, salted or in brine; smoked fish, whether or \nnot cooked before or during the smoking process; fish \nmeal fit for human consumption : \n\n\u2014 Fish fillets, dried, salted or in brine, but not \n\nsmoked : \n\n0305 30 50 \n\n\u2014 Of lesser of Greenland halibut (Reinhardtius \n\nhippoglossoides), salted or in brine \n\n0305 30 90 \n\n\u2014 Other \n\n0305 \n\nFish, dried, salted or in brine; smoked fish, whether or \nnot cooked before or during the smoking process; fish \nmeal fit for human consumption : \n\n\u2014 Smoked fish, including fillets : \n\nex0305 41 00 \n\n\u2014 Pacific salmon (Oncorhynchus spp. ), Atlantic salmon \n(Salmo salar) and Danube salmon (Hucho hucho) : \n\n- Atlantic salmon (Salmo salar) \n\n0305 49 \n\n\u2014 Other : \n\n0305 49 10 \n\nLesser or Greenland halibut (Reinhardtius \nhippoglosoides) \n\n0305 49 20 \n\nAtlantic halibut (Hippoglossus hippoglossus) \n\no \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC n\u00b0 4 \n5000 T \n\nRC n\u00b0 5 \n1000 T \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE II \n\nex0305 49 30 \n\nMackerel (Scomber scombrus, Scomber australasicus, \nScomber japonicus) : \n\n- Mackerel (Scomber scombrus) \n\nex0305 49 40 \n\nTrout (Salmo trutta, Salmo gairdneri, Salmo clarki, \nSalmo aguabonita, Salmo gilae) : \n- Trout (Salmo gairdneri) \n\n0305 49 50 \n\nEels (Anguilla spp. ) \n\n0305 49 90 \n\nOther \n\n0302 \n\nFish, fresh or chilled, excluding fish fillets and other \nfish meat of heading No 0304 : \n\nOther fish, excluding livers and roes : \n\n0302 69 \n\n\u2014 Other : \n\nRedfish (Sebastes spp. ) : \n\n0302 69 31 \n\nOf the species Sebastes marinus \n\nex0302 69 33 \n\nOther : \n\n- Of the species Sebastes mentella \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC n\u00b0 6 (1) \n12600 T \n\n(1) Figures refer to the commercial presentation whole and gutted. For imports falling under \n\u00e7jl HS code 0304 a coefficient of 3 shall be applied for quantities drawn from this reference ceiling \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE II \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. 0303 \n\nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304 : \n\n- Other fish, excluding livers and roes : \n\n0303 79 \n\n\u2014 Other : \n\nSaltwater fish : \n\nRedfish (Sebastes spp. ) : \n\n0303 79 35 \n\nOf the species Sebastes marinus \n\nex0303 79 37 \n\nOther : \n\n- Of the species Sebastes mentella \n\n0304 \n\n0304 10 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen : \n- Fresh or chilled \n\nRC N \n\n- Fillets \n\nOther: \n\nex0304 10 39 \n\nOther: \n\n- Of red fish: \n\n\fCN Code \n\nDescription \n\nTABLE II \n\n0304 20 \n\n- Frozen fillets : \n\n\u2014 Of redfish (Sebastes spp. ) : \n\n0304 20 35 \n\nOf the species Sebastes marinus \n\nex0304 20 37 \n\nOther : \n\n- Of the species Sebastes mentella \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. RC N\u00b0 6 \n\n0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen : \n\n0304 10 \n\n- Fresh or chilled : \n\n\u2014 Fillets : \n\nOther : \n\nex0304 10 39 \n\nOther \n\n- Other, excluding red fish \n\nRC n 7 \n3000 T \n\nCR \nCO \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE \n\nII \n\n0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen : \n\n0304 20 \n\n- Frozen fillets : \n\n0304 20 43 \n\n\u2014 Of ling (Molva spp. ) \n\n0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen : \n\n0304 20 \n\n- Frozen fillets : \n\nex0304 20 97 \n\n- Other : \n\n0304 90 \n\n0304 90 59 \n\n- Of blue whiting \n\n- Other : \n\nOf blue whiting (Micromesistius poutassou or Gadus \npoutassou) \n\n0 \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC n\u00b0 8 \n550 T \n\nRC n\u00b0 9 \n1800 T \n\n\fCN Code \n\nDescription \n\nTABLE II \n\n0305 \n\nFish, dried, salted or in brine; smoked fish, whether or \nnot cooked before or during the smoking process; fish \nmeal fit for human consumption : \n\n- Fish, salted but not dried or smoked and fish in \n\nbrine : \n\n0305 69 \n\n\u2014 Other : \n\n0305 69 90 \n\nOther \n\n0306 \n\nCrustaceans, whether in shell or not, live, fresh, \nchilled, frozen, dried, salted or in brine; crustaceans, \nin shell, cooked by steaming or by boiling in water, \nwhether or not chilled, frozen, dried, salted or in \nbrine : \n\n- Frozen : \n\n0306 13 \n\n\u2014 Shrimps and prawns : \n\n0306 13 10 \n\nOf the family pandalidae \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC n 10 \n1400 T \n\nRC n 11 \n11000 T \n\nC7! \nor \n\n\fCN Code \n\nDescription \n\nRate of duty \n\nTABLE \n\nII \n\n0305 \n\nFish, dried, salted or in brine; smoked fish whether or \nnot cooked before or during the smoking process; fish meal \nfit for human consumption: \n- fish, salted but not dried or smoked and fish in brine: \n\n0305 61 00 \n\n\u2014 Herrings (clupea harengus, clupea pallasii) \n\n1604 \n\nPrepared or preserved fish, caviar or caviar substitutes \nprepared from fish eggs: \n\n- Fish, whole or in pieces, but not minced \n\n1604 12 \n\n\u2014 Herrings \n\n1604 12 90 \n\nOther \n\n0 \n\n0 \n\nTariff quota \nTQ in tons \nreference \nceiling R. C. RC N\u00b0 12 \n\n500 T \n\nCJt \n\n\fCN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0302 \n\nFish, fresh or chilled, excluding fish fillets and other \nfish meat of heading No 0304 : \n\n\u2014 Flat fish (Pleuronectidae, Bothidae, Cynoglossidae, \nSoleidae, Scophthalmidae and Citharidae), excluding \nlivers and roes : \n\nStatistical \nsurveillance \n\n0302 29 \n\n\u2014 Other : \n\n0302 29 90 \n\nOther \n\n-Other fish, excluding livers and roes : \n\n0302 69 \n\n\u2014 Other : \n\nSaltwater fish : \n\n0302 69 98 \n\nOther \n\n0303 \n\nFish, frozen, excluding fish fillets and other fish meat \nof heading No 0304 : \n\n\u2014 Other fish, excluding livers and roes : \n\n0303 79 \n\n\u2014 Other : \n\nSaltwater fish : \n\n0303 79 98 \n\nOther \n\n\fCN Code \n\nDescription \n\nTABLE II \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0304 \n\nFish fillets and other fish meat (whether or not minced), \nfresh, chilled or frozen : \n\n0304 20 \n\n- Frozen fillets : \n\nex0304 20 97 \n\n\u2014 Other : \n\n- Other excluding blue whiting \n\n0304 90 \n\n0304 90 97 \n\n- Other : \n\n\u2014 Other : \n\nOther \n\n00 \n\n\fPROTOCOL NO 2 \n\nconcerning products subject to special arrangements to take \naccount of differences in the costs of agricultural products \nincorporated therein \n\nArticle 1 \n\nIn order to take account of differences in the cost of the \nagricultural products incorporated in the goods specified in \nthe table annexed to this Protocol, the Agreement does not \npreclude : \n\n(i) the levying, upon import, of a variable component or \n\nfixed amount, or the application of internal price \ncompensation measures ; \n\n(ii) the application of measures adopted upon export. Article 2 \n\n3. The Community as constituted on 31 December 1985 shall \napply the customs duties on imports originating in \nFaroe Islands on 1 January 1992 as indicated in the \ntable annexed to this Protocol. 2. The Kingdom of Spain shall progressively abolish the \ndifference between the basic duties on 1 January 1985 \nto products originating in the Faroe Islands and the \nduties applicable on 1 January 1992 which are shown in \nthe table annexed to this Protocol, in accordance with \nArticle 31 (1) and (3) of the Act of Accession. 3. The Portuguese Republic shall progressively abolish the \n\ndifference between the basic duties on 1 January 1985 \nto products originating in the Faroe Islands and the \nduties applicable on 1 January 1992 which are shown in \nthe table annexed to this Protocol, in accordance with \nArticle 190 (1) and (2) of the Act of Accession. Article 3 \n\nThe Faroe Islands shall abolish tariffs and duties on \nimports of processed agricultural products originating in \nthe Community on the date specified in Article 5 and Annex \nII to this Agreement with the exceptions mentioned in \nProtocol 4, Table II. Should the Faroe Islands introduce such measures for \nprocessed agricultural products as mentioned in Article 1 of \nthis Protocol , the Community shall be duly notified. 59 \n\n\f\u2022TABLE \n\nEUROPEAN ECONOMIC COMMUNtTY \n\nDctcnpuon \n\nHitcW \ndu*> r*\u00ab \n\nButrcrrr. ili. curdled milk and cream, yogurt, kephir and other fermented or acidified mile anc \ncream, whether or not concentrated or containing added sugar or other sweetening rr. j-c: or \nAavocrcc or containing added fruit or cocoa: \n\nCNeadc \n\n0*03 \n\n0403 10 \n\n- Yofurr \n\n0403 10 51 \nto \u00bb9 \n\n- - ria\u00bbocrcc or containing added fruit or cocoa \n\nMOB \n\nn AD F/M \nAD SO. MOB \n\nAridranwil dur\u00bb on flour \nAddaoanal dur* or. sugar \nVariable component \n\n60 \n\n\fCS code \n\nI \n\nDescription \n\n0403 90 \n\n- Other. I \n\n0403 90 71 \n\n- - Flavoured or containing added fruit or cocoa \n\nto 99 \n\n! \n\n0*10 \n\n0?;o 40 \n\n( T it \n\nVegetables uncookec or cooked by stcarr. mg or boiimg in \u00bba:cr. frozen \n\n- Sweet com \n\nVegetables provisionally preserved (for example, by sulphur dioxide gas. m brine, ir sulphur \nwater or m other preservative solutions), but unsuitable \nimmediare \nconsumption \n\nin that state for \n\n( T il 90 \n\n- Other vegetables. rruxrurcs of vegetable! : \n\n- - Vegetables \n\n0\"U 90 30 \n\n151? \n\n1319 13 \n\n1702 \n\n: - - - Sweet corn \ni \n! Industrial mor. ocarbos. vlic farrv acids, acid oil\u00bb frorr. refining, industrial :arr> alcohol* \n! \nJ - Incusmai monocarborylic fatty acta\u00bb \n! - - Tall oil farry acids \n\n! Other sugars, including chemically pure iactosc. maltose. glucose and fructose. <r. solid rorrr. \u2022 sugar svrups not containing added flavocnng or colouring maner. artificial honev. whether or \n: no\u00bb mixed with narural honey. carame! \n\nr o: 50 \n\n1702 90 \n\n1702 90 10 \n\n! - Chemically pvrz fructose \n\n' - Other, including invert sugar \nI \nj - - Chemicali- pure maltose \n\n170* \n\nlr0* 10 \n\n! Sugar confectioncr>. including white chocolate), not containing cocoa \n! \n'\u2022 - Chewing gurr. whether or not sugar-coated \n\nI \n\n\u2022 \n\n\\\"0* 90 \n\nj - Ot. -. sr \n\n; \n\nI \ni \n1 \n\nI \n\nj \n\n1704 90 10 \n\n1~04 \u00ab*C 30 \n\n[ -- Liquorice extract containing more t'ran 10 X b> weight of sucrose bu: no: ro-. tair. :ng arhcr j \n! \n\nadded substances \n\n- M !>>iir. fc- \\ > /. 3 :t \n\n1~0* 90 51 \n\ni - - Other \n\nKate of \ndurv \n\nMOB \n\nMOB \n\nMOB \n\nFree \n\nFree \n\nFree \n\nMOB \nmax 23 X \n\nFree \n\nMOB \nma\u00bb 2\" X \n- AD S/Z \n\nMOB \ntaut 27 X \n- AD S/Z \n\n1106 \n\n| Chocolate and other food preparation\u00bb containing cocoa: \n\n110* 10. ' CIX-OJ po \u2014 Jci. vuninmrij; added s u n: or other tweetenmg mitirr \n\nMOB \n\nISO\u00bb 20 \n\n! - O'hcr preparations in blocks or slabs weighing more than 2 kg or m liquid, pasre. powder, \ngranular or other bulk form in containers or immediate packings, of a content exceeding 2 kg \n\n1*06 20 10 \n\n: - - Containing 31 % or more by weight of cocoa butter or containing a combined wcighr of \n\n31 X or more of cocoa butter and milk fat \n\n1106 20 30 \n\nContaining a combined weight of li X or more, but less than 31 X o:' cocoa butter and \nrr. ilk fat \n\n1 \n\nOther \n\n1S06* 20 50 \n\nCe rua I-: T. g \\\u00ee X o: more by weight of cocoa burtc: \n\n1806 20 \"0 \n\n'\u2022 \n\nChocolate rr. ::k crumb \n\nMOB \nmax 2~ X \n- AD S/Z \n\nMOB \nmax 27 % \n- AD S/Z \n\nMOB \nmax 27 % \n* AD S/Z \n\nMOB \n\n61 \n\n\fo* \n\nDescription \n\n1106 20 90 \n\nOtncr \n\n- Other, m biocks. siabs or bars \n\n1106 31 \n\n- - Fiiied \n\n1106 32 \n\n- - Not filled \n\n1106 90 \n\n- Other: \n\nIBM 90 11 \nCD 39 \n\n- - Chocolate and chocolate products \n\n1106 90 50 \n\n- - Sugar confectionery and substitutes therefor made from sugar substitution products. containing cocoa \n\n1106 90 60 \n\nSpreads containing cocoa : \n\n- Ir. immediate packings of a net capacity of 1 kg or less \n\n- Other \n\n1106 90 \"0 \n\nj - - Preparations containing cocoa for making beverages: \n\n- In immed. atc packing* o: a net capaciry of 1 kg or less \n\n- Other \n\n111* ^J *0 \n\ni - - O'. nc: \nI \nI \n\n- Ir. immediate packings of a net capacity of \\ k. g or less \n\n- OtS( \n\n1901 \n\n1902 \n\n1902 11 \n\n1902 IS \n\n1902 20 \n\nMait extract. food preparations of flour, meal, starch or malt extract, not containing cocos \n| \npowder or containing cocoa powder in a proportion by weight of less than 50 X. nor else-wherr ! \n\u2022pcnScc or included ; food pr\u00e9parations of goods of heading Nos 0401 to 0-*O*. not containing ! \ncocoa powder or containing cocoa powder in a proportion by weight of less than 10 X. no: j \nelsewhere specified or included \n\n! \n\nPasta, whether or not cooked or stuffed (with meat or other substances) or otherwise prepared, \nsuch as spaghetti, macaroni, noodles, lasagne, gnocchi, ravioli, cannelloni. couscous, whether or i \nnot prepared. - Uncooked pasta, not sruffed or otherwise prepared. - - Containing cgjs \n\nOther \n\n- Srurfcc pasta, whether o: not cooked o: otherwise prepared: \n\n! \ni \nI \n\n1902 20 ?:. - - Cthcr \n\nRattof \ndur\u00bb \n\nMOB \nmax 2\" X \n- AD S/Z \n\nMOB \nmax 2~ X \n- AD S. Z \n\nMOB \nmax 2* X \n- AD S/Z \n\nMOB \nmax 27 X \n\u2022 AD S/Z \n\nMOB \nmax 27 X \n\u2022 AD S 'Z \n\nMOB \nmax 2T X \n- AD S Z \n\nMOB \n\nmax 2r X \n- AD S/Z \n\nMOB \nmax 2\" X \n\u2022 A D SZ \n\nMOB \n\nmax 2~ X \n- AD S Z \n\nM OS \nmax 27 X \n- AD S/Z \n\nMOB \n\nma* 2\" X \n- AD S Z \n\nMOB \n\nMOB \n\nMOB \n\nMOS \n\n62 \n\n\fCS coot \n\n1902 30 \n\n1902 40 \n\n1903 \n\n190* \n\n1905 \n\nDescnption \n\n- Other pasta \n\n- Couscous \n\nTapioca and substitutes therefor prepared from starch, in the form of flakes, grams, pcar-. s. siftinp or in similar forms \n\nPrepared foods obtained by the swelling or roasting of c cr\u00e9ais or cereals products. 'for example. corn flakes- ; cereals, other than maire (corn), in grain form, pre-cooked or otherwise ptx?*rsc \n\nBread, pasrry. cakes, biscuits and other bakers* wares, whether or not containing cocoa. communion wafers, em pry cachets of a kind suitable for pharmaceutical use. sealing wafers, nee \npaper and similar products: \n\n1905 10 \n\n- Crispbrcad \n\n1903 20 \n\n1905 30 \n\n- Gingerbread and the like \n\n\u2014 Sweet biscuits, waffles and wafers \n\n1905 *0 \n\nt - Rusks, toasted bread and similar toasted products \n\n1905 90 \n\nj - Other-\n\n1905 90 10 \n\n\u00ce - - V. arros \n\n1905 90 20 \n\nI \n\u2022 - - Cammumcn wafers, empr\u00bb cachers of a kind suitable for pharmaceutical use. sealing \n\nwaters, n :: rape: and similar products \n\n1905 90 3C \n\n: - - - Srrac. not containing added honey, eggs, cheese or fnu:. and containing ?v w-igh: m the \ncr> marrer state not more than 5 X of sugar and not more than 5 X of fst \n\n1905 90 *0 \n\ni - - - waffles anc wafers with a water content exceeding 10 X by weight \ni \ni \n\n1905 90 50 \n\n\u2022 - - - Biscuits, extruded or expanded products, savoury or salted \n\n- Other \n\n1*05 90 60 \n\n- - M'lth added sweetening martrr \n\n1905 90 90 \n\n! \n\nOther \n\nj \n\n2001 \n\n: **\u2022 c\u00e7etahie*. rruit. nuts and other edible parts of plants, prepared or preserved bv virtcgar or acetic \u2022 \nj \n| ace \n\nRare of \ndur\u00bb \n\nMOB \n\nMOB \n\nMOB \n\nMOB \n\nMOB \nmax 2* X \n\u2022 AD F/M \n\nMOB \n\nMOB \nmax 35 X \n- AD S/Z \n\nMOB \n\nMOB \nmax 20 X \n- AD F'M \n\nMOB \n\nMOB \n\nMOB \nmax 30 X \n- AD F/M \n\nMOB \nmax 30 X \n\u2022r AD F/M \n\nMOB \nmax \"\u00bb< X \nT AD S/Z \n\nMOB \nmax 30 X \n- AD F'M \n\n2001 90 \n\ni - Otnet \n\n2001 90 30 \n\n! - - Sweet com ;Zea mays \u00bbir. saccharic\u00bb. 200* \n\n! Other vegetables prepared or preserved otherwise than by vinegar or acetic acid, frozen \n\n200* 10 \n\nj - Potatoes. Other \n\ni \nI \n! \nI - Other vegetables and mixtures of vejetibics : \nl \n\nIn the rorrr. of flour, meal or flake-; \n\n20O4 10 91 \n200* 9G \n\n200* 90 1C \n\n- - S wee: com Zca mays var. saccharara \n\n2005 \n\n2005 20 \n\nOther ve\u00e7rtacics prepared or preserved \u00bb\u2022:. -%nse than by vinegar or acetic acid, not frctcr \n- Potatoes \n\nI \nI \n\n| \n\n, \n\nj \n\n: \n\n; \n\nMOB \n\nMOB \n\nM 05 \n\n63 \n\n\fCNcode \n\nDcacripooa \n\n2005 20 10 \n\n- - In rise form of flour, meal or flaxes \n\n2005 BO \n\n- Sweet corn (Zea mays var. sacrharata) \n\nRase of \n\nMOB \n\nMOB \n\n2008 \n\nFruit, nuo and ocher edible parts of plants, otherwise prepared or preserved, whether or not \ncontaining added sugar or ocher sweetening matter or spirit, DOC elsewhere specified or inducted : \n\n\u2014 Other, including mixtures ocher than chose of subheasding 200S 19: \n\n200199 \n\n-- Other: \n\n\u2014 \u2014 \u2014 Not containing added spirit: \n\n200199 15 \n\n2101 \n\n\u2014 \n\n\u2014 \n\nNot containing added sogax: \n\nMaize (corn), ocher than sweet corn (Zea mays rax. saccharara) \n\nMOB \n\nExtracts, essences and conccncraces, of coffee, tea or mate and preparations with a basis of these \nproducts or with a basis of rpffrr. tea or mace; roasted ^ \" \" \"t and orhrr roasted \"^ft*^ \nsobsxitnses, and extracts, essences and concentr\u00e2tes thereof: \n\n2101 10 \n\n\u2014 Extracts, essences and concentrates, of coffee, and preparations with a basis of these extracts, \n\nessences or concentrates or with a basis of coffee : \n\n\u2014 \u2014 Prcparaoons : \n\n2101 10 99 \n\n2101 20 \n\n- Extracts, essences and corse entr\u00e2tes, of tea or marc, and prcparaoons wich a basts of these \n\ncam acta, essences or concentrates or with a basis of tea or mate : \n\n2101 20 90 \n\n- - Other \n\n2101 30 \n\n- Roasted chiccry and other roasted coffee substitutes, snd extracts, essences and concentrates \n\nthereof: \n\nRoasted chicory and ocher roasted coffee substitutes: \n\n2101 30 19 \n\nOther \n\nExtracts, rtsrnrrs and concentrates of roasted chicory and other roasted coffee suosxxruxes : \n\n2101 30 99 \n\n2102 \n\nOther \n\n\u2022 \nYeasts (active or inactive) ; other single-cell micro-organisms, dead (but not including vacones of \nbeading No 3002} ; prepared baking powders : \n\n2102 10 \n\n- Active yeasts : \n\n2102 10 31 \nm 39 \n\nBakers* yeast \n\n2102 20 \n\n- \n\ninactive yeasts : ocher single-cell micro-organisms, dead : \n\n2102 20 11 \neo 19 \n\n2103 \n\n- - Inactive yeasts \n\nSauces and preparations therefor; mixed condiments and m' v -* seasonings. mustard flour and \nmead and prepared mustard: \n\n2103 10 \n\n- Soya sauce \n\n2103 20 \n\n- Tomato ketchup and ocher tomato sauces \n\n2103 90 \n\n- Other \n\n2104 \n\nSoups and broths and preparations therefor; homogenized composite food prcparaoons: \n\n2104 10 \n\n- Soups and broths znd preparations therefor \n\nMOB \n\nMOB \n\nMOB \n\nMOB \n\nMOB \n\nFree \n\nFree \n\nFree \n\nFree \n\nFree \n\n64 \n\n\fCN \n\nDescription \n\n2105 \n\nIce cream and ocher edible ice, whether or not containing cocoa \n\n2106 \n\n2106 10 \n\nFood preparations not elsewhere specified or included:-\n\n- Protein concentrates and textured protein substances: \n\n2 1 0 ( 10 90 \n\n-- Other \n\n21Q4 90 \n\n- Other: \n\n2106 90 10 \n\n- - Cheese fondues \n\nOther: \n\nex 2106 90 91 \n\n- - - Containing no m ilk fart, milk proteins, sucrose, isoglucote. glucose or starch or \ncontaining less than IJ % milkfat, US X milk proteins, 5 X sucrose ur isocjucoac, 5 X \nglucose or starch : \n\n- Hydrolysates of proteins ; autolysates of yeast \n\n2106 90 99 \n\nOther \n\n- Containing 26 X or more by weight of roilkfats: \n\n- In immediate parkings of a net capacity of 1 kg or less \n\n- Other \n\n- Other \n\n2202 \n\nWaters, including mineral waters and aerated waters, containing added sugar or ocher \nrwcetentng matter or flavoured, and ocher non-alcoholic beverages, not including fruit or \nvegetable juices of heading No 2009 : \n\n2202 10 \n\n- Waters, including mineral waters and aerated waters, containing added sugar or ocher \n\nsweetening matter or flavoured \n\n2202 90 \n\n- Other: \n\n; 2202 90 10 \n\n- - Not containing products of heading Nos 0401 to 0404 or fat obtained from products of \n\nheading Nos 0*01 to 0404: \n\n- Containing sugar (sucrose or invert sugar) \n\n2202 90 91 \nto 99 \n\nOther \n\n2203 \n\n2205 \n\n220S \n\nBeer made from malt \n\nVermouth and ocher wine of fresh grapes flavoured with plants or a romane substances \n\nUndcnarured ethyl alcohol of an alcoholic srrcngrh by volume of less than 10 X vol; spirits, \nliqueurs and other spirituous beverages ; compound alcoholic preparations of a kind used for the \nmanufacture of beverages : -\n\n2 2 0 1 90 \n\n- Other: \n\n- - Other spirituous beverages in containers holding: \n\n2 I or less : \n\n2 2 0 1 90 55 \n\n- \n\nLiqueurs: \n\n- Containing eggs or egg yolks and/or sugar (sucrose or invert sugar) \n\n6 x 2 2 0 1 90 59 \n\n- Other spirituous beverages : \n\n- Containing eggs or egg yolks and/or sugar (sucrose or invert sugar) \n\nex 220190 79 \n\n- Liqueurs and other spirituous beverages: \n\nMort than 2 1 : \n\n- Containing eggs or egg yolks and/or sugar (sucrose or invert sugar) \n\nl a of \nd-ry \n\nMOB \nmax 27 % \n+ AD S/Z \n\nMOB \n\nMOB \n25 ECU/ \n100 k g/ n et \n\nFree \n\nMOB \n\nMOB \n\nFree \n\nFree \nMOB \n\nFree \nFree \n\nECU l /% \nv o l /y \n\n\u2022 ECU \u00abVU. ECU 1 /% \nvol/ y \n+ ECU 6 /U \n\nECU \n\n\\/% \n\nvol/hi \n\n65 \n\n\fCN \n\nDescription \n\n2905 \n\nAcyclic alcohols ind their halogenated, sulphonaced, nitrated or nitrouted derivatives : \n\n- Other polyhydric alcohols : \n\n2905 43 \n\n- - Mannitol \n\n2905 44 \n\n- - D-glucatol (sorbitol) \n\n2915 \n\nSaturated acyclic monocarboxylic acids and their anhydrides, halides. peroxides and \nperoxyacsds^heir halogenated, sulphonated. nitrated or ruerosared derivanves: \n\n- Fox mac acid, its sala and esters: \n\nex 2515 13 \n\n- - Eaters of formic acid : \n\n\u2014 Eaters of mannitol and esters of sorbitol \n\n- Eaters of acetic acid : \n\n2915 39 \n\n- - Other: \n\nex 2913 39 90 \n\nOther: \n\n- Esters of mannitol and esters of sorbitol \n\nex 2915 90 \n\n- Other: \n\n- Eaters of mannitol and esters of sorbitol \n\nMOB \n\nMOB \n\nFree \n\nFree \n\nfrte \n\n2916 \n\nUnsarurated acyclic monocarboxylic acids, cyclic monocarboxylic acids, rhcir anhydrides, \nhilsHn. peroxides and pcroxyacids; thar halogenated. sulphonated. mtrared or mrroaared \nderivanves : \n\n- Unsarurated acyclic monocarboxylic acids, their anhydrides, halides. peroxides, pcroxyacids \n\nand their derivanves \n\n2916 19 \n\nOther \n\n2916 19 90 \n\nOther. - Esters of mannitol and esters of sorbitol \n\nFree \n\n2917 \n\nPolvcarboxylic acids, their anhydrides, halides, peroxides and pcroxyacids. their halogenated. sulphonated. nitrated or nitrosated derivanves: \n\n- Acyclic polycarborylic acids, their anhydrides, halides, peroxides, perorvacids and chesr \n\nderivanves: \n\n2917 19 \n\n- - Other \n\n2917 19 90 \n\nOther: \n\n- \n\nltacomc acid, its sala and esters \n\n2911 \n\nCarboxyUc acids with additional oxygen function and their anhydrides, halides, peroxides and \nperoxyaods; their halogenated, sulphonated. nitrated or nitrosated derivanves : \n\n- Carborvuc s o ds with alcohol function but without ocher oxygen function, their anhydrides, \n\nhalides, peroxides, pcroxyacids and their derivatives : \n\n2911 11 \n\n- - Lactic acid, its salts and esters \n\n2911 14 \n\n- - O mc acid \n\n2911 15 \n\n2911 19 \n\n- - Salts and esters of citric acid \n\nOther: \n\nt 2911 19 90 \n\nOther: \n\n- Glyceric acid, glycolic acid, saccharic acid, isosaccharic acid, hcpcasacchanc acid, their \n\nsala and esters \n\n2532 \n\nHeterocyclic compounds with oxygen hctcro-stom(i) only: \n\n- Compounds containing an unfuscd furan ring (whether or not hydrogenated) in the strucrure: \n\ni 2932 19 \n\nOther: \n- Anhydrous mannitol and sorbitol compounds, excluding malrol and isomaltpl \n\nFree \n\nfret \n\nFree \n\nfrtt \n\nFree \n\nFree \n\n66 \n\n\fCNeoot \n\nDescription \n\nLa* of \n\n2932 90 \n\n- Other: \n\n2932 90 70 \n\n- - Cyclic acetals and internal hemiacetals. whether or not with other oxygen functions, and \n\ntheir halogenated. sulphonated. nitrated or nitrosated derivanves : \n\n: 2932 90 90 \n\nOther: \n\n- a - Mcthylglucotedc \n\n2940 \n\n- Anhydrous mannitol and sorbitol compounds, excluding maltol and isomaltol \n\nSugars, chemically pure, other than sucrose, lactose, maltose, glucose and fructovc : sugar cchcaa \nand sugar esters, and their salts, ocher than produce of heading Nos 2537. 2931 or 2939 : \n\n2940 00 90 \n\n- Other \n\n2941 \n\n2941 10 \n\n3001 \n\nAxiabtoocj \n\n- Penicillins and their derivanves with a pcnicillanic acid structure; sain thereof \n\nGlands and other organs for organo-chcrapcutic uses, dried, whether or not powdered ; caxtacts \nof glands or ocher organs or of their secretions for organo-therapeutic uses ; heparin and io sala ; \nother human or animal substances prepared for therapeutic or prophybcnc uscv not elsewhere \nspecified or included: \n\n3001 90 \n\n- Other: \n\nOther. 3001 90 91 \n\n- - - Heparin and its salrs \n\n3501 \n\nCasein, casemates and ocher casein derivanves: casein glues: \n\n3501 10 \n\n- Casein : \n\n3501 10 10 \n\n- - For the manufacture of regenerated textile fibres ('] \n\n3501 10 50 \n\n3501 10 90 \n\n- - For indusmal uses other than the manufacture of foodstuffs or fodder (') \n\nOther \n\n3501 90 \n\n- Other \n\n3505 \n\nDextrms and other modified starches (for examplcpregeiahnized or esrenficd starches) : glues \nbased on searches, or on dextrins or other modified starches : \n\n3505 10 \n\n- Dcxtnns and other modified \u00abarches : \n\n3505 10 10 \n\n- - Dextrins \n\n3505 10 50 \n\n3505 10 90 \n\n- - Other modified starches: \n\nSearches, estenfied or etherified \n\nOther \n\n3505 20 \n\n- Clues \n\nFree \n\nF r ee \n\nFree \n\nFree \n\nFree \n\nFree \n\nF r ee \n\nFree \n\nFree \n\nMOB \n\nFree \nMOB \nMOB \n\nIt X \n\n3506 \n\nPrepared glues and ocher prepared adhesivcs,noc elsewhere specified or included: produces \nsuitable for use as glues or adhesives^put up for retail sale as glues or adbcuves, not exceeding a \nnet weight of 1 kg: \n\n3506 10 \n\n- Products suitable for use as glues or adhesive\u00bb, put up for retail sale as glues or adhesives, not \n\nexceeding a net weight of 1 kg: \n\nex 3506 10 90 \n\n- - Other: \n\n- With a basis of sodium silicate emulsion or of resin emulsions \n\nFree \n\n- Other: \n\n3506 99 \n\nOther: \n\n3506 99 90 \n\nOther: \n\n- Wrrh a basis of sodium silicate emulsion or of resin emulsions \n\nfrte \n\n(\u2022) Entry under dm subheading, u subfect to conditions laid down in the relevant Community provtsjocu. 67 \n\n\fCN \n\nW09 \n\nDcacnpTioB \n\nftnishrng agents, dye carriers to accelerate the dyeing or fixing of dyesruffj and ocher produco \nand pr\u00e9para b om (for crrampir. dressings and mordants), of a kind used in the ternie, paper, \n\nor like industries, not elsewhere speaficd or included : \n\n10 \n\n- With a basis of amylaceous substances \n\n- Other: \n\n91 \n\n- \u2014 Of a kind used in the textile industry : \n\n\u2014 Osnrammg search or products derived from starch \n\n92 \n\n- - Of a kind used in che paper industry : \n\n\u2014 Containing starch or products derived from search \n\nm 3109 99 \n\n-- Other: \n\n\u2014 Containing starch or products derived from starch \n\nPrepared binders for foundry moulds or cores; chemical produces and preparations of the \nchemical or allied industries (including those consisting of mixtures of natural products), not \ncbewhere spcrafv-d or included; residual products of the chemical or allied industries, not i \nelsewhere sprnfird or included : \n\nex 3X23 10 \n\n- Prepared binders for foundry moulds or cores : \n\n\u2014 Based on rrntbcoc resins \n\n3123 60 \n\n- Sorbitol ocher than that of subheading 2905 *4 \n\n3*23 90 \n\n- Other: \n\n\u00abs 3123 90 40 \n\n- \u2014 Pyroligrures (for example, of calcium); crude calcium tartrate; crude calaum citrate. - Crude calcium citrate \n\nOther: \n\nex 3*23 90 99 \n\nOther: \n\n- Produco of sorbitol cracking \n\n3911 \n\nPetroleum rcsms. couraarone-indene resins, polytcrpcnes, polysulphides, poiysulphones and \nocher products specified in noce 3 to this chapter, not elsewhere specified or included, in primary \nforrfts : \n\nox 3911 10 \n\n- Petroleum resins, coumaronc. indenc or coumarone-indenc resins and polyterpenes : \n\n- Adhesives with a basis of resin emulsions \n\n3 9 1 1 90 \n\n- Ocher: \n\nex 3911 90 10 \n\n- \u2014 Coodemabon or rearrangement porrrrserixarion products whether or not chemicaliy \n\nmortified : \n\n\u2014 Adhesives with a basis of resin emulsions \n\nex 3911 90 90 \n\n- - Other: \n\n\u2014 Adhesives with a basis of resin emulsions \n\n3913 \n\nNatural polymers (for example, alginic acid) and modified natural polymers (for example, \nhardened proteins, chemical derivatives of natural rubber), not cbewhere specified or included, \nm primary forms : \n\n3913 90 \n\n- Other: \n\net 3913 90 90 \n\n-- Other: \n\n\u2014 Dextrin \n\n\u2014 Other, exduding hardened proteins \n\nMOB \nmax 20 X \n\nFree \n\nFree \n\nFree \n\nFree \n\nMOB \n\nFree \n\nFree \n\nFree \n\nFree \n\nFree \n\nfrte \n\nFree \n\n68 \n\n\fPROTOCOL No 3 \n\nconcerning the d\u00e9finition of doe concept of 'orig\u00eenacing products' and methods of \nadministrative cooperation \n\n69 \n\n\fPROTOCOL \nconcerning the definition of the concept of \"originating products' \nand methods of administrative cooperation \n\nTITLE I \n\nDEFINITION OF THE CONCEPT OF \"ORIGINATING PRODUCTS' \n\nArticle 1 \n\nOrIgIn crIter la \n\n1. For the purpose of Implementing the Agreement the following products \nshall be considered as: \n\n1) \n\nProducts originating In the Faroe Islands: \n\n(a) products wholly obtained In the Faroe Islands; \n\n(b) products obtained in the Faroe Islands In the manufacture of \nwhich products other than those referred to In (a) are used, \nprovided that: \nI) the said products have undergone sufficient working or \nprocessing within the meaning of Article 3 of this Protocol, \nor that \n\nII) those products are originating In the Community within the \n\nmeaning of this Protocol; \n\n2) \n\nProducts originating in the Community; \n\n(a) products wholly obtained In the Community; \n\n(b) products obtained In the Community In the manufacture of which \nproducts other than those referred to In (a) are used, provided \nthat: \ni) the said products have undergone sufficient working or \nprocessing within the meaning of Article 3 of this Protocol, \nor that \n\nII) those products are originating In the Faroe Islands within \n\nthe meaning of this Protocol. 2. Notwithstanding paragraph 1(1)(b)(ll), products originating In the \nCommunity, within the meaning of this Protocol, and exported from the \nFaroe Islands Into the Community In the same state or having \nundergone In the Faroe Islands no working or processing going beyond \nthat referred to In Article 3, third paragraph, retain their origin. Notwithstanding paragraph K 2 ) ( b ) ( l l ), products originating in the \nFaroe Islands, within the meaning of this Protocol, and exported from \nthe Community Into to the Faroe Islands or having undergone In the \nCommunity no working or processing going beyond that referred to in \nArticle 3, third paragraph, retain their origin. 70 \n\n\f- 2 -\n\nArticle 2 \n\nWholly obtained products \n\n1. Within the meaning of Article 1, paragraph 1(1)(a) and (2)(a), the \nfollowing shall be considered as wholly obtained either In the \nCommunity or In the Faroe Islands: \n\n(a) mineral products extracted from their soil or from their \n\nseabed; \n\n(b) vegetable products harvested therein; \n\n(c) live animals born and raised therein; \n\n(d) products from live animals raised therein; \n\n(e) products obtained by hunting or fishing conducted therein-, \n\n(f) products of sea fishing and other products taken from the sea \n\nby their vessels; \n\n(g) products made aboard their factory ships exclusively from \n\nproducts referred to In subparagraph (f); \n\n(h) used articles collected there fit only for the recovery of raw \n\nmater I a I s ; \n\n(I) waste and scrap resulting from manufacturing operations \n\nconducted therein; \n\n(j) goods produced there exclusively from the products specified In \n\nsubparagraphs (a) to (I). 2. The term \"their vessels\" In paragraph 1(f) shall apply only to \n\nvessels: \n\nwhich are registered or recorded in the Faroe Islands or in a \nMember States of the Community; \n\nwhich sail under the flag of the Faroe Islands or of a Member \nState of the Community; \n\nwhich are owned to an extent of at least 50% by nationals of \nMember States of ! thje Community, residents or non-residents of \nthe Faroe islands, or by a company with Its head office In one \nof these States or the Faroe Islands, of which the manager or \nmanagers, chairman of the board of directors or the supervisory \nboard, and the majority of the members of such boards are \nnationals of Member States of the Community, residents or non \nresidents of the Faroe Islands and of which. In addition, in \nthe case of partnerships or limited companies, at least half \nthe capital belongs to these States, to the Faroe Islands, to \ntheir public bodies or their nationals; \n\n71 \n\n\f- 3 -\n\nof which the master and officers are nationals of Member States \nof the Community, residents or non-residents of the Faroe \n1 s Iands; \n\nof which at least 75X of the crew are nationals of Member \nStates of the Community, residents or non-residents of the \nFaroe Islands. 3. The terms \"Faroe islands\" and \"the Community\" shall also cover the \nterritorial waters which surround the Faroe Islands and the Member \nStates of the Community. Sea-going vessels. Including factory ships, on which the fish \ncaught Is worked or processed shall be considered as part of the \nterritory of the Community or of the Faroe Islands provided that \nthey satisfy the conditions set out In paragraph 2. Article 3 \n\nSufficiently processed products \n\n1. For the purposes of Article 1, non-orIginatIng materials are \nconsidered to be sufficiently worked or processed when the product \nobtained Is classified In a heading which is different from that In \nwhich all the non-originating materials used in its manufacture are \nclassified, subject to paragraphs 2 and 3. The expressions \"chapters\" and \"headings\" used In this Protocol \nshall mean the chapters and the headings (four-digit codes) used in \nthe nomenclature \nCommodity \nDescription and Coding System (hereinafter referred to as \"the \nHarmonized System\" or H S ). which makes up the Harmonized \n\nThe expression \"classified\" shall refer to the classification of a \nproduct or material under a particular heading. 2. For a product mentioned in columns 1 and 2 of the list in Annex II, \nthe conditions set out in column 3 for the product concerned must \nbe fulfilled Instead of the rule In paragraph 1. For the products of Chapters 84 to 91 Inclusive, as an alternative \nto satisfying the conditions set out In column 3, the exporter may \nopt to apply the conditions set out In column 4 Instead. (a) Where In the list In Annex II a percentage rule is applied In \ndetermining the originating status of a product obtained in the \nCommunity or In the Faroe Islands, the value added by the \nworking or processing shall correspond to the ex-works price of \nthe product obtained, less the value of third-country materials \nImported Into the Community, or the Faroe Islands. (b) The term \"value\" In the list In Annex II shall mean the customs \nvalue at the time of the Import of the non-originating \nmaterials used or, If this Is not known and cannot be \nascertained, the first ascertainable price paid for these \nmaterials in the territory concerned. ^2 \n\n\f- 4 -\n\nWhere the value of the originating materials used needs to be \nestablished, the provisions of the above subparagraph shall be \napplled mutatis mutandis. (c) The term \"ex-works price\" In the list In Annex II shall mean \nthe price paid for the product obtained to the manufacturer in \nwhose undertaking the last working or processing Is carried \nout, provided the price Includes the value of all the materials \nused In manufacture, minus any internal taxes which are, or may \nbe repaid when the product obtained is exported. (d) \"Customs value\" shall be understood as the value determined In \naccordance with the Agreement on Implementation of Article VII \nof the General Agreement on Tariffs and Trade, established in \nGeneva on 12 April 1979. 3. For the purpose of implementing paragraphs 1 and 2 the following \nshall be considered as Insufficient working or processing to confer \nthe status of originating products, whether or not there is a \nchange of heading: \n\n(a) operations to ensure the preservation of products In good \ncondition during transport and storage (ventilation, spreading \nout, drying, chilling, placing In salt, sulphur dioxide or \nother aqueous solutions, removal of damaged parts, and like \noperat ions); \n\n(b) simple operations consisting of removal of dust, sifting or \nthe \n\nscreening, sorting, classifying, matching \nmaking-up of sets of articles, washing, painting, cutting u p ); \n\n(Including \n\n(c) I) changes of packaging and breaking up and assembly of \n\nconsignments; \n\nIi) simple placing In bottles, flasks, bags, cases, boxes, \nfixing on cards or boards etc. , and all other simple \npackaging operations; \n\n(d) affixing marks, labels and other like distinguishing signs on \n\nproducts or their packaging; \n\n(e) simple mixing of products, whether or not of different kinds, \nwhere one or more components of the mixtures do not meet the \nconditions laid down in this Protocol to enable them to be \nconsidered as originating either In the community or In the \nFaroe Islands; \n\n(f) simple assembly of parts of articles to constitute a complete \n\nart icle; \n\n(g) a combination of two or more operations specified \n\nIn \n\nsubparagraph (a) to (f); \n\n(h) slaughter of animals. 73 \n\n\f- 5 -\n\nArticle 4 \n\nNeutral elements \n\nIn order to determine whether a product originates In the Community or \nthe Faroe Islands, It shall not be necessary to establish whether the \nelectrical power, fuel, plant and equipment and machines and tools used \nto obtain such product or whether any materials or products used in the \ncourse of production which do not enter and which were not Intended to \nenter Into the final composition of the product originate in third \ncountrles or not. Article 5 \n\nAccessories, spare parts and tools \n\nAccessories, spare parts and tools dispatched with a piece of \nequipment, machine, apparatus or vehicle which are part of the normal \nequipment and Included In the price thereof or are not separately \ninvoiced are regarded as one with the piece of equipment, machine, \napparatus or vehicle in question. Art I d\u00a9 6 \n\nSets \n\nSets, as defined in General Rule 3 of the Harmonized System, shall be \nregarded as originating when all component articles are originating \nproducts. Nevertheless, when a set Is composed of originating and non-\noriginating articles, the set as a whole shall be regarded as \noriginating provided that the value of the non-orIglnatIng articles \ndoes not exceed 15% of ex-works price of the set. Article 7 \n\nDirect transport \n\nThe preferential treatment provided for under the Agreement applies \nonly to products or materials which are transported between the \nterritory of the Community or of the Faroe Islands without entering \nany other territory. However, goods constituting one single \nconsignment may be transported through territory other than that of \nthe Community or the Faroe Islands, with, should the occasion \narise, transhipment or temporary warehousing In such territory, \nprovided that the goods have remained under the surveillance of the \ncustoms authorities In the country of transit or of warehousing and \nthat they have not undergone operations other than unloading, \nreloading or any operation designed to preserve them In good \ncondition. *f ^ \n\n\f_ 6 -\n\n2. Evidence that the conditions referred to In paragraph 1 have been \nfulfilled shall be supplied to the responsible customs authorities \nby the production of: \n\n(a) a through bill of lading issued In the exporting country or \n\nterritory covering the passage through the country of transit; \n\n(b) or a certificate Issued by the customs authorities of the \n\ncountry of transit: \n\ngiving an exact description of the goods, \nstating the' dates of unloading and reloading of the goods \nor of the embarkation or disembarkation, identifying the \nships used, \ncertifying the conditions under which the goods remained in \nthe transit country; \n\n(c) or falling these, any substantiating documents. Article 8 \n\nTerritorial requirement \n\nThe conditions set out In this Title relative to the acquisition of \noriginating status must be fulfilled without Interruption In the \nCommunity or the Faroe Islands. If originating goods exported from the Community or the Faroe Islands \nto another country are returned, they must be considered as non-\noriglnatlng unless It can be demonstrated to the satisfaction of the \ncustoms authorities that: \n\nthe goods returned are the same goods as those exported, and \n\nthey have not undergone any operation beyond that necessary to \npreserve them In good condition while In that country. TITLE II \n\nPROOF OF ORIGIN \n\nArticle 9 \n\nMovement certificate EUR. 1 \n\nEvidence of originating status of products, within the meaning of this \nProtocol, shall be given by a movement certificate EUR. 1, a specimen of \nwhich appears In Annex I I I to this Protocol. 75 \n\n\f- 7 -\n\nArticle 10 \n\nNormal procedure for the Issue of certificates \n\n1. A movement certificate EUR. 1 shall be Issued on application having \nbeen made In writing by the exporter or, under the exporter's \nresponsibility, by his authorized representative. Such application \nshall be made on a form, a specimen of which appears in Annex III \nto this Protocol, which shall be completed In accordance with this \nProtocol. Applications for movement certificates EUR. 1 must be preserved for \nat least two years by the customs authorities of the exporting \ncountry or territory. 2. The exporter or his representative shall submit with his request \nany appropriate supporting document proving that the products to be \nexported are such as to qualify for the Issue of a movement \ncertificate EUR. 1. He shall undertake to submit at the request of the appropriate \nauthorities, any supplementary evidence they may require for the \npurpose of establishing the correctness of the originating status \nof the products eligible for preferential treatment and shall \nundertake to agree to any Inspection of his accounts and to any \ncheck on the processes of the obtaining of the above products \ncarried out by the said authorities. Exporters must keep for at least two years the supporting documents \nreferred to in this paragraph. 3. A movement certificate EUR. 1 may be Issued only where it can serve \nfor the purpose of \n\nevidence required \n\nas the documentary \nimplementing the agreement. 4. The movement certificate EUR. 1 shall be Issued by the customs \nauthorities of the Faroe Islands If the goods to be exported can be \nconsidered as products originating in the Faroe Islands within the \nmeaning of Article 1 paragraph 1 (1) of this Protocol. The \nmovement certificate EUR. 1 shall be Issued by the customs \nauthorities of a Member State of the European Economic Community If \nthe goods to be exported can be considered as products originating \nin the Community within the meaning of Article 1 paragraph 1 (2) of \nthis Protocol. 5. The customs authorities of the Member States of the Community or \nthe Faroe Islands may Issue movement certificates EUR. 1 under the \nconditions laid down In this Protocol If the goods to be exported \ncan be considered as products originating In the Faroe Islands or \nthe Community within the meaning of Article 1, paragraph 2 of this \nProtocol and provided that the goods covered by the movement \ncertificates EUR. 1 are in the Community or In the Faroe Islands. In these cases, the movement certificates EUR. 1 shall be issued \nsubject to the presentation of the proof of origin previously \nissued or made out. This proof of origin must be kept for at least \ntwo years by the customs authorities of the exporting state or \nterritory. HQ \n\n\f- 8 -\n\n6. Since the movement certificate EUR. 1 constitutes the documentary \nevidence for the application of the preferential tariff and quota \narrangements \nIt shall be the \nresponsibility of the customs authorities of the exporting country \nto take any steps necessary to verify the origin of the goods and \nto check the other statements on the certificate. In the Agreement, \n\nlaid down \n\n7. For the purpose of verifying whether the conditions stated In \nparagraphs 4 and 5 have been met, the customs authorities shall \nhave the right to call for any documentary evidence or to carry out \nany check which they consider appropriate. 8. It shall be the responsibility of the customs authorities of the \nexporting State or territory to ensure that the forms referred to \nin paragraph 1 are duly completed. In particular, they shall check \nwhether the space reserved for the description of the products has \nbeen completed In such a manner as to exclude all possibility of \nfraudulent additions. To this end, the description of the products \nmust be Indicated without leaving any blank lines. Where the space \nIs not completely filled a horizontal line must be drawn below the \nlast line of the description, the empty space being crossed \nthrough. 9. The date of Issue of the movement certificate must be Indicated In \n\nthe part of the certificate reserved for the customs authorities. 10. A movement certificate EUR. 1 shall be Issued by the customs \nauthorities of the exporting State or territory when the products \nto which it relates are exported. It shall be made available to \nthe exporter as soon as actual export has been effected or ensured. Article 11 \n\nssue of EUR. 1 retrospectively \n\n1. In exceptional circumstances a movement certificate EUR. 1 may also \nbe Issued after export of the products to which It relates if It \nwas not Issued at the time of export because of errors or \nInvoluntary omissions or special circumstances. 2. For the Implementation of paragraph 1, the exporter must In the \n\nappiI cat Ion: \n\nIndicate the place and date of export of the products to which \nthe certificate relates, \n\ncertify that no movement certificate EUR. 1 was issued at the \ntime of export of the products In question, and state the \nreasons. 11 \n\n\f- 9 -\n\n3. The customs authorities may issue a movement certificate EUR. 1 \nretrospectively only after verifying that the Information supplied \nIn the exporter's application agrees with that in the corresponding \nfile. Certificates Issued retrospectively must be endorsed with one of \nthe following phrases: \n\n'NACHTRXGLICH AUSGESTELLT'. 'DELIVRE A POSTERIORI', RILASCIATO A \nPOSTERIORI*, 'AFGEGEVEN A POSTERIORI', 'ISSUED RETROSPECTIVELY*. 'UDSTEDT EFTERFOLGENDE', [GREEK VERSION], 'EXPEDIDO A POSTERIORI', \n'EMITADO A POSTERIORI', [FAROESE VERSION]. 4. The endorsement referred to In paragraph 3 shall be inserted In the \n\n\"Remarks\" box on the movement certificate EUR. 1. Article 12 \n\nIssue of a duplicate EUR. 1 \n\n1. in the event of the theft, loss or destruction of a movement \ncertificate EUR. 1, the exporter may apply to the customs \nauthorities which Issued It for a duplicate made out on the basis \nof the export documents In their possession. 2. The duplicate Issued in this way must be endorsed with one of the \n\nfoi lowing words: \n\n'DUPLIKAT', 'DUPLICATA', 'DUPLICATO*. 'DUPLICAAT', 'DUPLICATE', \n[GREEK VERSION], 'DUPLICADO*. 'SEGUNDA VIA*, [FAROESE VERSION]. 3. The endorsement referred to In paragraph 2 shall be Inserted in the \n\n\"Remarks\" box on the movement certificate EUR. 1. 4. The duplicate, which must bear the date of Issue of the original \nmovement certificate EUR. 1, shall take effect as from this date. Article 13 \n\nSimplified procedure for the issue of certificates \n\n1. By way of derogation from Articles 10, 11 and 12 of this Protocol, \na simplified procedure for the Issue of EUR. 1 movement certificates \ncan be used in accordance with the following provisions. 78 \n\n\f- 10 -\n\n2. The customs authorities In the exporting State or territory may \nauthorize any exporter, hereinafter referred to as 'approved \nexporter', making frequent shipments for which EUR. 1 movement \ncertificates may be Issued and who offer, to the satisfaction of \nthe competent authorities, all guarantees necessary to verify the \noriginating status of the products, not to submit to the customs \noffice of the exporting State or territory at the time of export \neither the goods or the application for an EUR. 1 certificate \nrelating to those goods, for the purpose of obtaining an EUR. 1 \ncertificate under the conditions laid down In Article 10 of this \nProtocol. 3. The authorization referred to in paragraph 2 shall stipulate, at \nthe choice of the competent authorities, that box No. 11 \"Customs \nendorsement\" of the EUR. 1 movement certificate must : \n\n(a) either be endorsed beforehand with the stamp of the competent \ncustoms office of the exporting State or territory and the \nsignature, which may be a facsimile, of an off leal of that \noffice, or \n\n(b) be endorsed by the approved exporter with a special stamp which \nhas been approved by the customs authorities of the exporting \nState or territory and corresponds to the specimen given In \nAnnex V of this Protocol. Such stamp may be pre-prlnted on the \nforms. 4. In the cases referred to in paragraph 3 (a), one of the following \nphrases shall be entered in box No 7 'Remarks' of the EUR. 1 \nmovement certificate \n'Procedlmlento simplifIcado', 'Forenklet \nprocedure', 'Verelnfachtes Verfahren', (greek version), 'Simplified \nprocedure', \nsemplIfIcata', \n'Vereenvoudlgde procedure', 'Procedlmento SimplifIcado', (Faroese \nversion). 'Proc\u00e9dure simplifi\u00e9e', \n\n'Procedure \n\n5. Box No 11 'Customs endorsement' of the EUR. 1 certificate shall be \n\ncompleted If necessary by the approved exporter. 6. The approved exporter shall, If necessary, Indicate in box No 13 \n'Request for verification' of the EUR. 1 certificate the name and \naddress of the authority competent to verify such certificate. 7. Where the simplified procedure Is applied, the customs authorities \nof the exporting State or territory may prescribe the use of EUR. 1 \ncertificates bearing a distinctive sign by which they may be \nIdentified. 79 \n\n\f- 11 -\n\n8. In the authorization referred to in paragraph 2 the competent \n\nauthorities shall specify In particular : \n\n(a) the conditions under which the applications for EUR. 1 \n\ncertificates are to be made, \n\n(b) the conditions under which these applications are to be kept \n\nfor at least two years, \n\n(c) in the cases referred to In paragraph 3 (b) the authority \ncompetent to carry out the subsequent verification referred to \nIn Article 25 of this Protocol. 9. The Customs authorities of the exporting State or territory may \ndeclare certain categories of goods Ineligible for the special \ntreatment provided for in paragraphe 2. 10. The customs authorities shall refuse the authorization referred to \nIn paragraph 2 to exporters who do not offer all the guarantees \nwhich they consider necessary. The competent authorities may \nwithdraw the authorization at any time. They must do so where the \napproved exporter no longer satisfies the conditions or no longer \noffers these guarantees. 11. The approved exporter may be required to inform the competent \nauthorities, in accordance with the rule which they lay down, of \nthe goods to be dispatched by him, so that such authorities may \nmake any verification they think necessary before the departure of \nthe goods. 12. The customs authorities of the exporting State or territory may \ncarry out any check on approved exporters which they consider \nnecessary. Such exporters must allow this to be done. 13. The provisions of this Article shall be without prejudice to the \napplication of the rules of the Community and of the Member States \nconcerning customs formalities and the use of customs documents. Article 14 \n\nReplacement of certificates \n\nIt shall at any time be possible to replace one or more movement \ncertificates EUR. 1 by one or more other certificates provided that this \nis done at the customs office where the goods are located. (6) \n\n80 \n\n\f- 12 -\n\nArticle 15 \n\nValidlty of cert IfIcates \n\n1. A movement certificate EUR. 1 must be submitted, within 4 months of \nthe date of Issue by the customs authorities of the exporting State \nor territory, to the customs office of the Importing State or \nterritory where the products are entered. 2. Movement certificates EUR. 1 which are submitted to the customs \nauthorities of the Importing State or territory after the final \ndate of presentation specified in paragraph 1 may be accepted for \nthe purpose of applying preferential treatment, where the failure \nto submit the certificates by the final date set Is due to reasons \nof force majeure or exceptional circumstances. 3. In other cases of belated presentation, the customs authorities of \nthe importing State or territory may accept the certificates where \nthe products have been submitted to them before the said final \ndate. Article 16 \n\nExhibitions \n\nProducts sent from the Community or the Faroe Islands for \nexhibition in a country other than a Member State of the Community \nor the Faroe islands and sold after the exhibition for Importation \nInto the Faroe Islands or the Community shall benefit on \nImportation from the provisions of the Agreement on condition that \nthe products meet the requirements of this Protocol entitling them \nto be recognized as originating In the Community or the Faroe \nIslands and provided that It Is shown to the satisfaction of the \ncustoms authorities that : \n\n(a) an exporter has consigned these products from the Community or \nthe Faroe Islands to the country in which the exhibition Is \nheld and has exhibited them there; \n\n(b) the products have been sold or otherwise disposed of by that \nexporter to someone In the Community or the Faroe Islands; \n\n(c) the products have been consigned during the exhibition or \nImmediately thereafter to the Community or the Faroe Islands In \nthe state in which they were sent for exhibition; \n\n(d) the products have not, since they were consigned for \nexhibition, been used for any purpose other than demonstration \nat the exhibit ion. 81 \n\n\f- 13 -\n\n2. A movement certificate EUR. 1 must be produced to the customs \nauthorities In the normal manner. The name and address of the \nexhibition must be Indicated thereon. Where necessary, additional \ndocumentary evidence of the nature of the products and the \nconditions under which they have been exhibited may be required. 3. Paragraph 1 shall apply to any trade, Industrial, agricultural or \ncrafts exhibition, fair or similar public show or display which is \nnot organized for private purposes In shops or business premises \nwith a view to the sale of foreign products, and during which the \nproducts remain under customs control. Article 17 \n\nSubmission of certificates \n\ncertificates EUR. 1 shall be submitted \n\nMovement \ncustoms \nauthorities In the Importing State or territory In accordance with the \nprocedures laid down by that State or territory. The said authorities \nmay require a translation of a certificate. They may also require the \nImport declaration to be accompanied by a statement from the Importer \nto the effect that the products meet the conditions required for the \nImplementation of the Convention. to the \n\nArt Icle 18 \n\nImportation by instalments \n\nWithout prejudice to Article 3, paragraph 3 of this Protocol, where, at \nthe request of the person declaring the goods at the customs, a \ndismantled or non-assembled article falling within Chapter 84 or 85 of \nthe harmonized system Is Imported by instalments on the conditions laid \ndown by the competent authorities, it shall be considered to be a \nsingle article and a movement certificate may be submitted for the \nwhole article upon Import of the first Instalment. Article 19 \n\nPreservation of certificates \n\ncertificates \n\ncustoms \nMovement \nauthorities of the Importing State or territory In accordance with the \nrules in force In that State or territory. EUR. 1 shall be preserved \n\nby the \n\n82 \n\n\f- 14 -\n\nArticle 20 \n\nForm EUR. 2 \n\n1. Notwithstanding Article 9, the evidence of originating status, \nwithin the meaning of this Protocol, for consignments containing \nonly originating products and whose value does not exceed ECU 4,800 \nper consignment, shall be given by a form EUR. 2, a specimen of \nwhich appears In Annex IV to this Protocol. 2. The form EUR. 2 shall be completed and signed by the exporter or, \nauthorized \n\nunder \nrepresentative In accordance with this Protocol. responsibility, \n\nexporters \n\nhis \n\nthe \n\nby \n\n3. A form EUR. 2 shall be completed for each consignment. 4. The exporter who applied for the form EUR. 2 shall submit at the \nrequest of the customs authorities of the exporting country or \nterritory all supporting documents concerning the use of this form. Article 21 \n\nDiscrepancies \n\nThe discovery of slight discrepancies between the statements made In \nthe movement certificate EUR. 1, In the form EUR. 2 and those made In the \ndocuments submitted to the customs office for the purpose of carrying \nout the formalities for Importing the products shall not \nf&cto \nrender the document null and void If it Is duly established that it \ncorresponds to the products submitted. Ipso \n\nArticle 22 \n\nExemptions from proof of origin \n\nwithout \n\nProducts sent as small packages to private persons or forming part \nof travellers' personal luggage shall be admitted as originating \nproducts \na movement \nrequiring the production \ncertificate EUR. 1 or the completion of form EUR. 2, provided that \nsuch products are not Imported by way of trade and have been \ndeclared as meeting the conditions required for the application of \nthe agreement, and where there is no doubt as to the veracity of \nsuch d\u00e9clar\u00e2t Ion. of \n\n83 \n\n\f- 15 -\n\n2. Imports which are occasional and consist solely of products for the \npersonal use of the recipients or travellers or their families \nshall not be considered as Imports by way of trade if it Is evident \nfrom the nature and quantity of the products that no commercial \npurpose is in view. Furthermore, the total value of these products must not exceed \nECU 340 in the case of small packages or ECU 960 in the case of the \ncontents of travellers' personal luggage. Article 23 \n\nAmounts expressed In ECU \n\n1. Amounts in the national currency of the exporting State or \nterritory equivalent to the amounts expressed in ECU shall be fixed \nby the exporting State or territory and communicated to the other \nparties to the Agreement. When the amounts are more than the \ncorresponding amounts fixed by the importing State or territory, \nthe latter shall accept them if the goods are invoiced in the \ncurrency of the exporting State. If the goods are Invoiced In the currency of another Member State \nof the Community the importing State or territory shall recognize \nthe amount notified by the country concerned. 2. Up to and including 30 April 1993, the ECU, to be used in any given \nnational currency shall be the equivalent In that national currency \nof the ECU as at 3 October 1990. For each successive period of two \nyears, It shall be the equivalent In that national currency of the \nECU as at the first working day In October in the year Immediately \npreceding that two-year period. TITLE III \n\nARRANGEMENTS FOR ADMINISTRATIVE COOPERATION \n\nArticle 24 \n\nCommunication of Impressions of stamps \n\nThe customs authorities of the Member States and the Faroe islands \nshall provide each other, through the Commission of the European \nCommunities, with specimen impressions of stamps used in their customs \noffices for the Issue of EUR. 1 certificates. 84 \n\n\f- 16 -\n\nArticle 25 \n\nVerification of movement certificates EUR. 1 and of forms EUR. 2 \n\n1. Subsequent verification of movement certificates EUR. 1 and of forms \nEUR. 2 shall be carried out at random or whenever the customs \nauthorities of the Importing State or territory have reasonable \ndoubts as to the authenticity of the document or the accuracy of \nthe information regarding the true origin of the products In \nquest ion. 2. In order to ensure the proper application of this Protocol, the \nMember States of the Community and the Faroe Islands shall assist \neach other, through their respective customs administrations, in \nchecking the authenticity of movement certificates EUR. 1 and the \nforms EUR. 2 and the accuracy of the Information concerning the \nactual origin of the products concerned. 3. For \n\nImplementing \n\nthe purpose of \n\ncustoms \nauthorities of the importing State or territory shall return the \nmovement certificate EUR. 1 or form EUR. 2, or a photocopy thereof, \nto the customs authorities of the exporting State or territory, \ngiving, where appropriate, the reasons of form or substance for an \nenquiry. paragraph \n\n1, the \n\nThe relevant commercial documents or a copy thereof, shall be \nattached to the certificate EUR. 1 or form EUR. 2 and the customs \nauthorities shall forward any Information that has been obtained \nsuggesting that the particulars given on the said certificate or \nthe said form are Inaccurate. If the customs authorities of the Importing State or territory \ndecide to suspend execution of the provisions of the agreement \nwhile awaiting the results of the verification, they shall offer to \nrelease the products to the importer subject to any precautionary \nmeasures judged necessary. 4. The customs authorities of the Importing State or territory shall \nbe Informed of the results of the verification as soon as possible. These results must be such as to make It possible to determine \nwhether the disputed movement certificate EUR. 1 or form EUR. 2 apply \nto the products can, In fact, qualify for the application of the \npreferential arrangements. 85 \n\n\f- 17 -\n\n5. Disputes which cannot be settled between the customs authorities \nof the Importing State or territory and those of the exporting \nState or territory, or those which raise a question as to the \ninterpretation of this Protocol, shall be submitted to the [Customs \nCommittee]. 6. For the purpose of the subsequent verification of movement \ncertificates EUR. 1, the customs authorities of the exporting \ncountry must keep the export documents, or copies of certificates \nused in place thereof, for at least two years. Article 26 \n\nSanct ions \n\nPenalties shall be imposed on any person who draws up, or causes to be \ndrawn up, a document which contains Incorrect particulars for the \npurpose of obtaining a preferential treatment for products. Article 27 \n\nFree zones \n\nThe Member States and the Faroe Islands shall take all necessary steps \nto ensure that products traded under cover of a movement certificate \nEUR. 1, which in the course of transport use a free zone situated in \ntheir territory, are not substituted by other goods and that they do \nnot undergo handling other than normal operations designed to prevent \ntheir deterioration. TITLE IV \n\nTHE CANARY ISLANDS, CEUTA AND MELILLA \n\nArticle 28 \n\nApplication of the Protocol \n\n1. The term 'Community' used In this Protocol does not cover the \nCanary Islands, Ceuta or Mel il la. The term 'products originating \nIn the Community' does not cover products originating In these \nzones. 2. This protocol shall apply mutatis mutandis to products originating \nin the Canary Islands, Ceuta and Mel 11 la, subject to particular \nconditions set out in Article 29. 86 \n\n\f- 18 -\n\nArticle 29 \n\nSpecial conditions \n\n1. The following provisions shall apply instead of Article 1 and \nreferences to that Article shall apply mutatis mutandis to this \nArticle. 2. Providing they have been transported directly In accordance with \n\nthe provisions of Article 7, the following shall be considered as: \n\n(1) Products originating In the Canary Islands, Ceuta and Mel il la: \n\n(a) products wholly obtained In the Canary Islands, Ceuta and \n\nMel111 a ; \n\n(b) products obtained In the Canary Islands, Ceuta and Mel I I la \n\nIn the manufacture of which products other than those \nreferred to in (a) are used, provided that: \n\n(I) \n\n(II) \n\nthe said products have undergone \nsufficient \nworking or processing within the meaning of Article \n3 of this Protocol, or that \n\nthose products are originating in the Faroe Islands \nor the Community within the meaning of this \nProtocol provided that they have been submitted to \nworking or processing which goes beyond the \nInsufficient working or processing referred to In \nArticle 3, paragraph 3. (2) Products originating In the Faroe Islands: \n\n(a) products wholly obtained In the Faroe Islands \n\n(b) products obtained In the Faroe Islands In the manufacture \nof which products other than those referred to In (a) are \nused, provided that: \n\n(I) \n\n(II) \n\nthe said products have undergone sufficient working \nor processing within the meaning of Article 3 of \nthis Protocol, or that \n\nthose products are originating In the Canary \nIslands, Ceuta and Mel 11 la or the Community within \nthe meaning of this Protocol provided that they \nhave been submitted to working or processing which \ngoes beyond the Insufficient working or processing \nreferred to In Article 3, paragraph 3. 87 \n\n\f- 19 -\n\n3. The Canary Islands, Ceuta and Mel il la shall be considered as a \n\nsingle territory. 4. The exporter or his authorized representative shall enter \"Faroe \nIslands\" and \"Canary Islands, Ceuta and Mel il la\" In box 2 of \nmovement certificates EUR. 1. In addition, In the case of products \noriginating In the Canary Islands, Ceuta and Mel il la, this shall be \nindicated In box 4 of movement certificates EUR. 1. 5. The Spanish customs authorities shall be responsible for the \napplication of this Protocol In the Canary Islands, and in Ceuta \nand Me 1111 a. 6. Article 30 shall not apply to trade between the Canary Islands, \n\nCeuta and Mel I I la, on the one hand, and the Faroe Islands on the \nother. TITLE V \n\nFINAL PROVISIONS \n\nArticle 30 \n\nDrawback and exemptions from customs duties \n\n1. Without prejudice to the provisions of Article 1 of Protocol 2 and \nArticle 1 of Protocol 4, products which are of the kind to which \nthe Agreement applies, and which are used in the manufacture of \nproducts for which a movement certificate EUR. 1 or a form EUR. 2 are \nissued or completed, can only be the subject of drawback of customs \nduty or benefit from an exemption from customs duty of whatever \nkind when products originating In the Community or the Faroe \nIslands are concerned. 2. In this Article, the term 'customs duty' also means charges having \n\nan effect equivalent to customs duty. 88 \n\n\f- 20 \n\nArticle 31 \n\nPetroleum products \n\nThe products set out In Annex VI shall be temporarily excluded from the \nscope of this Protocol. Nevertheless, the arrangements regarding \nadministrative cooperation and Article 30 shall apply mutat is \nmutandis, to these products. Article 32 \n\nAmendments to the Protocol \n\nThe Joint Committee may decide to amend provisions of this Protocol. Article 33 \n\nAnnexes \n\nThe Annexes to this Protocol shall form an Integral part thereof \n\nArticle 34 \n\nImplementation of the Protocol \n\nThe Community and the Faroe Islands shall each take the steps necessary \nto implement this Protocol. 89 \n\n\fLIST OF ANNEXES \n\nAnnex I : \n\nNotes \n\nAnnex II: \n\nList of working and processing within the meaning of Article \n3, paragraph 2 \n\nAnnex III: \n\nSpecimen of movement certificate EUR. 1 \n\nAnnex IV: \n\nSpecimen of Form EUR. 2 \n\nAnnex V: \n\nSpecimen Impression of the stamp referred to In Article 13, \nparagraph 3 (b) \n\nANNEX VI: \n\nList of products referred to In Article 31 which are \ntemporarily excluded from the scope of this Protocol. 80 \n\n\fANNEX I \n\nHQIE2 \n\nForeword \n\nThese notes shall apply, where appropriate, to all manufactured products \nusing non-originating materials, even If they are not subject to specific \nconditions contained in the list In Annex II but are subject Instead to the \nchange of heading rule set out In Article 3. paragraph 1. Note 1 : \n\n1. 1 \n\nThe first two columns In the list describe the product obtained. The \nfirst column gives the heading number or chapter number used In the \nHarmonized System and the second column gives the description of \ngoods used in that system for that heading or chapter. For each \nentry in the first two columns a rule Is specified in columns 3 or 4. Where, In some cases, the entry In the first column Is preceded by an \n'ex', this signifies that the rule In columns 3 or 4 applies only to \nthe part of that heading or chapter as described in column 2. 1. 2 \n\nWhere several heading numbers are grouped together In column 1 or a \nchapter number Is given and the description of products in column 2 \nIs therefore given In general terms, the adjacent rule in columns 3 \nor 4 applies to all products which, under the Harmonized System, are \nclassified In headings of the chapter or In any of the headings \ngrouped together In column 1. 1. 3 \n\nWhere there are different rules In the list applying to different \nproducts within a heading, each Indent contains the description of \nthat part of the heading covered by the adjacent rule in columns 3 or \n4. 1. 4 \n\nFor the products of Chapters 84 to 91 Inclusive, If no origin rule is \ngiven in column 4, the rule set out In column 3 has to be applied. 91 \n\n\f- 2 -\n\nNote 2: \n\n2. 1 \n\nThe term \"manufacture\" covers any kind of working or processing \nIncluding \"assembly\" or specific operations. However, see Note 3. 5 \nbe Iow. 2. 2 \n\nThe term \"material\" covers any Ingredient, raw material, component \nor part, etc. , used In the manufacture of the product. 2. 3 \n\nThe term \"product\" refers to the product being manufactured, even If \nit is intended for later use in another manufacturing operation. 2. 4 \n\nThe term \"goods\" covers both materials and products. Note 3: \n\n3. 1 \n\n3. 2 \n\n3. 3 \n\nIn the case of any heading not In the list or any part of a heading \nthat is not in the list, the \"change of heading\" rule set out in \nArticle 3, paragraph 1 applies. If a \"change of heading\" condition \napplies to any entry In the list, then it Is contained In the rule In \ncolumn 3. The working or processing required by a rule In columns 3 or 4 has to \nbe carried out only In relation to the non-originating materials \nused. The restrictions contained In a rule In columns 3 or 4 \nlikewise apply only to the non-orIglnatIng materials used. Where a rule states that \"materials of any heading\" may be used, \nmaterials of the same heading as the product may also be used, \nsubject, however, to any specific limitations which may also be \ncontained In the rule. However, the expression \"manufacture from \nmaterials of any heading, Including other materials of heading No. \" \nmeans that only materials classified In the same heading as the \nproduct of a different description than that of the product as given \nIn column 2 of the list may be used. 92 \n\n\f-3 -\n\n3. 4 \n\nIf a product made from non-originating materials which has acquired \noriginating status during manufacture by vlrture of the change of \nheading rule or Its own list rule is used as a material In the \nprocess of manufacture of another product, then the rule applicable \nto the product In which it is Incorporated does not apply to It. For example: \n\nAn engine of heading No. 8407, for which the rule states that the \nvalue of the non-originating materials which may be Incorporated may \nnot exceed 40% of the ex-works price, Is made from \"other alloy steel \nroughly shaped by forging\" of heading heading No. 7224. If this forging has been forged in the country concerned from a non-\noriginating ingot then the forging has already acquired origin by \nvirtue of the rule for heading No. ex 7224 In the list. It can then \ncount as originating in the value calculation for the engine \nregardless of whether it was produced in the same factory or another. The value of the non-origlnatIng Ingot is thus not taken Into account \nwhen adding up the value of the non-originating materials used. Even if the change of heading rule or the other rules contained In \nthe list are satisfied, a product shall not acquire originating \nstatus if the processing carried out, taken as a whole, is \nInsufficient within the meaning of Article 3, paragraph 3. The unit of qualification for the application of the origin rules \nshall be the particular product which is considered as the basic unit \nwhen determining classification using the nomenclature of the \nHarmonized System. In the case of sets of products which are \nclassified by virtue of General Rule 3 for the Interpretation of the \nHarmonized System, the unit of qualification shall be determined in \nrespect of each Item In the set: this provision is equally \napplicable to sets of headings Nos. 6308, 8206 and 9605. Accordingly, it follows that: \n\nwhen a product composed of a group or assembly of articles Is \nclassified under the terms of the Harmonized System In a single \nheading, the whole constitutes the unit of qualification. 3. 5 \n\n3. 6 \n\n93 \n\n\f- 4 -\n\nwhen a consignment consists of a number of identical products \nclassified under the same heading of the Harmonized System, each \nproduct must be taken Individually when applying the origin \nrules. Where, under General Rule 5 of the Harmonized System, packing is \nincluded with the pi oduct for classification purposes, It shall be \nincluded for the purposes of determining origin. Note 4 \n\n4. 1 \n\nThe rule In the list represents the minimum amount of working or \nprocessing required and the carrying out of more working or \nprocessing also confers originating status; conversely, the carrying \nout of less working or processing cannot confer origin. Thus If a \nrule says that non-or Iglnat Ing material at a certain level of \nmanufacture may be used, the use of such material at an earlier stage \nof manufacture is allowed and the use of such material at a later \nstage Is not. 4. 2 \n\nWhen a rule In the list specifies that a product may be manufactured \nfrom more than one material, this means that any one or more \nmaterials may be used. It does not require that all be used. For example: \n\nThe rule for fabrics says that natural fibres may be used and that \nchemical materials, among other materials, may also be used. This \ndoes not mean that both have to be used; one can use one or the other \nor both. If, however, a restriction applies to one material and other \nrestrictions apply to other materials in the same rule, then the \nrestrictions only apply to the materials actually used. For example: \n\nThe rule for sewing machines specifies that both the thread tension \nmechanism used and the zigzag mechanism used must originate; these \ntwo restrictions only apply If the mechanisms concerned are actually \nincorporated Into the sewing machine. 94 \n\n\f- 5 -\n\n4. 3 When a rule In the list specifies that a product must be manufactured \nfrom a particular material, the condition obviously does not prevent \nthe use of other materials which, because of their inherent nature, \ncannot satisfy the rule. For example: \n\nThe rule for heading No. 1904 which specifically excludes the use of \ncereals or their derivatives does not prevent the use of mineral \nsalts, chemicals and other additives which are not produced from \ncereals. For example: \n\nIn the case of an article made from non-woven materials. If the use \nof only non-orIglnatIng yarn Is allowed for this class of article, it \nIs not possible to start from non-woven cloth - even If non-woven \ncloths cannot normally be made from yarn. In such cases, the \nstarting material would normally be at the stage before yarn - that \nis the f ibre stage. See also Note 7. 3 in relation to textiles. 4. 4 \n\nIf In a rule In the list two or more percentages are given for the \nmaximum value of non-originating materials that can be used, then \nthese percentages may not be added together. The maximum value of \nall the non-origlnatIng materials used may never exceed the highest \nof the percentages given. Furthermore, the individual percentages \nmust not be exceeded in relation to the particular materials they \napply to. Note 5 \n\n5. 1 \n\n5. 2 \n\nThe term \"natural fibres\" is used In the list to refer to fibres \nother than artificial or synthetic fibres and Is restricted to the \nstages before spinning takes place, Including waste, and, unless \notherwise specified, the term \"natural fibres\" Includes fibres that \nhave been carded, combed or otherwise processed but not spun. The term \"natural fibres\" Includes horsehair of heading No. 0503, \nsilk of heading Nos. 5002 and 5003 as well as the wool fibres, fine \nor coarse animal hair of heading Nos. 5101 to 5105, the cotton fibres \nof heading Nos. 5201 to 5203 and the other vegetable fibres of \nheading Nos. 5301 to 5305. 95 \n\n\f- 6 -\n\n5. 3 \n\nThe terms \"textile pulp\", \"chemical materials\" and \"paper-making \nmaterials\" are used In the list to describe the materials not \nclassified in chapters 50 to 63, which can be used to manufacture \nartificial, synthetic or paper fibres or yarns. 5. 4 \n\nThe term \"man-made staple fibres\" is used in the list to refer to \nsynthetic or artificial filament tow, staple fibres or waste, of \nheadings Nos. 5501 to 5507. Note 6 \n\n6. 1 \n\nIn the case of the products classified within those headings in the \nlist to which a reference It made to this Note, the conditions set \nout in column 3 of the list shall not be applied to any basic textile \nmaterials used In their manufacture which, taken together, represents \n10% or less of the total weight of all the basic textile materials \nused (but see also Notes 6. 3 and 6. 4 below). 6. 2 \n\nHowever, this tolerance may only be applied to mixed products which \nhave been made from two or more basic textile materials. The following are the basic textile materials: \n\ns i l k, \nwool , \ncoarse animals hair, \nfIne animal hair , \nhorsehair, \ncotton, \npaper-making materials and paper, \nflax, \ntrue hemp, \njute and other textile bast fibres, \nsisal and other textile fibres of the genus Agave, \ncoconut, abaca, ramie and other vegetable textile fibres, \nsynthetic man-made filaments, \nartificial man-made staple filaments, \nsynthetic man-made staple fibres, \nartificial man-made staple fibres. For example: \n\nA yarn of heading No. 5205 made from cotton fibres of heading No. 5203 and synthetic staple fibres of heading No. 5506 Is a mixed yarn. Therefore, non-orIglnatIng synthetic staple fibres that do not \nsatisfy the origin rules (which require manufacture from chemical \nmaterials or textile pulp) may be used up to a weight of 10% of the \nyarn. 7) \n\n96 \n\n\f_ 7 -\n\nFor example: \n\nA woollen fabric of heading No. 5112 made from woollen yarn of \nheading No. 5107 and synthetic yarn of staple fibres of heading No. 5509 Is a mixed fabric. Therefore synthetic yarn which does not \nsatisfy the origin rules (which require manufacture from chemical \nmaterials or textile pulp) or woollen yarn that does not satisfy the \norigin rules (which require manufacture from natural fibres, not \ncarded or combed or otherwise prepared for spinning) or a combination \nof the two may be used up to a weight of 10% of the fabric. For example: \n\nTufted textile fabric of heading No. 5802 made from cotton yarn of \nheading No. 5205 and cotton fabric of heading No. 5210 Is only a \nmixed product If the cotton fabric is itself a mixed fabric being \nmade from yarns classified in two separate headings or if the cotton \nyarns used are themselves mixtures. For example: \n\nIf the tufted textile fabric concerned had been made from cotton yarn \nof heading No. 5205 and synthetic fabric of heading No. 5407, then, \nobviously, the yarns used are two separate basic textile materials \nand the tufted textile fabric Is accordingly a mixed product. For example: \n\nA carpet with tufts made from both artificial yarns and cotton yarns \nand with a Jute backing Is a mixed product because three basic \ntextile materials are used. Thus, any non-originating materials that \nare at a later stage of manufacture than the rule allows may be used, \nprovided their total weight taken together does not exceed 10% of the \nweight of the textiles materials of the carpet. Thus, both the jute \nbacking and/or the artificial yarns could be imported at that stage \nof manufacture, provided the weight conditions are met. 6. 3 \n\n6. 4 \n\nIn the case of fabrics Incorporating 'yarn made of polyurethane \nsegmented with flexible segments of polyether whether or not g Imped' \nthis tolerance Is 20% in respect of this yarn. In the case of fabrics incorporating strip consisting of a core of \naluminium foil or of a core of plastic film whether or not coated \nwith aluminium powder, of a width not exceeding 5 mm, sandwiched by \nmeans of an adhesive between two films of plastic film, this \ntolerance Is 30% In respect of this strip. 97 \n\n\f- 8 -\n\nNote 7 \n\n7. 1 \n\n7. 2 \n\n7. 3 \n\nIn the case of those textile products which are marked in the list by \na footnote referring to this note, textile materials, with the \nexception of linings and inter Iinings, which do not satisfy the rule \nset out in the list In column 3 for the made up product concerned may \nbe used provided that they are classified In a heading other than \nthat of the product and that their value does not exceed 8 % of the \nex works price of the product. Any non-textile trimmings and accesorles or other materials used \nwhich contain textiles do not have to satisfy the conditions set out \nin column 3 even though they fall outside the scope of Note 4. 3. In accordance with Note 4. 3, any non-orIglnatIng \nnon-textile \ntrimmings and accessories or other product, which do not contain any \ntextiles, may, anyway, be used freely where they cannot be made from \nthe materials listed In column 3. For example: \n\nIf a rule in the list says that for a particular textile Item, such \nas a blouse, yarn must be used, this does not prevent the use of \nmetal Items, such as buttons, because they cannot be made from \ntext ile mater la Is. 7. 4 \n\nWhere a percentage rule applies, the value of trimmings and \naccessories must be taken Into account when calculating the value of \nthe non-orIglnatIng materials Incorporated. 98 \n\n\fANNEX M \n\nLIST OF WORKING OR PROCESSING REQUIRED TO BE CARRIED OUT ON \nNON-ORIGINATING MATERIALS IN ORDER THAT THE PRODUCT \nilANUFACTURED CAN OBTAIN ORIGINATING STATUS \n\n99 \n\n\f- 2-\n\nH. 5. Haading \nNb. (1) \n\nDescription of product \n\nWorking or processing \ncarried cut en rxjvoriginating materials \nthat confers originating status \n\n(2) \n\n(3) \n\n2. 01 \n\nMast of bovire sfiirrais, fresh or chilled \n\n2. 02 \n\nMast of bovins animals, frozen \n\nMarufacture from rraterials of any heading ocept meet of \nbovine animals, frozen of heading Nb. 02. 02 \n\nrferrjfacture from materials of any heading except meat of \nbovine animals, fresh or chilled of heading ISb. 02. 01 \n\n2. QS \n\n2. 09 \n\nx Q2. 10 \n\n\u20223. 02 to \n3. 05 \n\nsUttto \n*X06 \n\n\u00a3. 08 \n\nEdible offal of bovine animals, swine, sheep, cpats, \nhorses, asses, nules or ninnies, fresh, chilled or frozen \n\nf**erufacture fran materials of any heeding \u00a9cept carcasses \nof headings Nbs. 02-01 to 02. 03 \n\nfree of \n\nPig fat \n(not \nrendered), fresh, chilled, frozen, salted in orine, cried \nor stroked \n\nleen meat and p a l t ry \n\nfat \n\nMBnfadUdce f ran materials of any heading except carcasses \nof heading 02. 03 and poultry meet of hurting 02. 07 \n\nMaet and edible meet offal, salted, in brine, dried or \narrcked; edible flours and meals of meet or meat offal, \nexcept for ediole flours and meals of meet or meet offal \nof sheep and cpats \n\nNferufacture from materials of any heading except meat and \noffal of heading Nbs. 02. 01 to Q2. Q6 and 02. 06 or poultry \nliver of heading Nb. 02. 07 \n\nfiah, other then live fish \n\nDairy products \n\nrterufacture in which a ll the materials of Dhepter 3 used \nmjst already be origirrating \n\nten/acture \ncreem of heading Nb. 0A. Q1 or 04. 02 \n\nf ran materials of any heading except milk or \n\nBiros' eggs, not in shell and egg yolks, fresh, dried, \ncocked, by steaming or by m il ing in water, moulded, \nfrozen or otherwise preserved, whether or rot containing \nacted sugar or other sweetening matter \n\nrteT/acture from materials of any heading except birds' \ne g^ of reading Nb. 04. 07 \n\n1G0 \n\n\f- 3-\n\nH. S. Heading \nNb. (1) \n\nDescription of procuct \n\nWorking or processing \ncarried out en narKrigineting mBterials \nthat confers originating status \n\n(2) \n\n(3) \n\nex 03. 02 \n\nPrepared pigs', hoes' or boars' bristles and hair \n\nex 03. 05 \n\nBones and horn-cores uncorked \n\nQeening, disinfecting, sorting and stiaid^tening of \nbristles and hair \n\nrferuf acture in wiich a ll the materials of Chapter 2 used \nrrust already be orig^rtating \n\n07. 10 to \n07. 13 \n\nex 07. 10 \n\nEdiole vegetables, \nfrozen or dried, provisionally \npreserved except for readings Nbs. ex 07. 10 and ex 07. 11 \n\nrtenuf acture in which a ll the vegetable rreterials used must \nalready be crig^reting \n\nSweet com (uncocked or cocked by steaming or boiling in \nwattr,, frozen \n\nf^Bnufacture fran fresh or chilled sweet com \n\nex 07. 11 \n\nSweet com, provisionally preserved \n\nt-fen/acture f rem fresh or chilled sweet com \n\n08. 11 \n\nFruit and nuts, uncocked or cocked by steaming or boiling \nin veter, frozen, whether or not containing added soar \nor other swaetening matter: \n\n- containing added sugar \n\n- other \n\n08. 12 \n\nFruit and ruts provisionally preserved (for example, by \n\u00abqiiphr dioxide gas, in brine, in sulphur water or in \nother preservative solutions), tut unsuitable in that \nstale for innediate oonauTption \n\nhferufacture in which the value of any materials of \nChapter 17 used does not exceed 30 % of the value of the \nex-wDiks price of the procuct \n\nf^njfacture in which a ll \nalready be originating \n\nf^rufacture in which a ll \nalready be originating \n\nthe fruit or nuts used must \n\nthe fruit or nuts used must \n\n08. 13 \n\nFruit, dried, other than that of headings Nbs. 0B. Q1 to \n08-36; mixtures of nuts or dried fruits of this Chapter \n\nhferufacture in which a ll \nalready be crigineting \n\nthe f r u it or nuts used rrust \n\n101 \n\n\f- 4-\n\nH. S. readinq \nNO. \" \n\n(1) \n\n06. 14 \n\nDescription of procuct \n\nWorking or prucessirg \ncarried out an rtn-origiretinq materials \nthat confers originating status \n\n(2) \n\n(3) \n\nPeel of citrus fruit or melons (including watermelons), \nfresh, frozen, driea or provisionally preserved in brine, \nin Siiphur water or in other preservative solutions \n\nl^rtufacture in which a ll \nalready be cjriginatinq \n\nthe f r u it or nuts usee mjst \n\nex 09. 01 \n\nCoffee, roasted \n\nhfen/acture f rem nxwroested coffee \n\nex Chap 11 \n\nPrccjcts of the -ni 1 ling \u00eercustry; malt, starches; i r u l i n; \nwheat gluten, except for heading No. ex II. 06 \n\nNterufacture in whidn all the cereals, errihle vegetables, \nroots and titers of heading No. 07. 14 or fruit used rrust \nalready be originating \n\nex 11. 06 \n\nFlour arc \nv^getaoies or\" nmoin\u00e7 \\c. 07. 13 \n\n\"e=_ of\" \n\nthe dried, sneliec \n\nlegjrujncus \n\nDrying arc milling of leguminous vegetarjles of heading \nNo. 07. 06 \n\nD. Q1 \n\nLac; nature. OJ\"E. resins, \u2022curt-reLins arc baisers \n\nNfenjfacture in which the value of any materials of headinc \nNo. 13-01 used may not exceed 50 \u00ab of the ex-works price \nof the product \n\nex 13. 02 \n\nLc-idLKL- arij t ' i i ^ w e if \u2022oerived fro:; vHjrtanle procLcts, \nlaz. f i ej \n\nMarufa'ture fron non-rmifieo mjcxiaaes ard thickeners \n\n113. 01 \n\nLa. \":: otner _ic '\"at anc poultry fat. re-dered, wnethsr or \nncr. Dress\u00e9e :\u2022- so: veit-extracted: \n\n=ts \n\nocres o; wast \n\n- ctner \n\nManufacture from materials of any readme except those of \nheading No. 02-03. 02-06 or 02-27 or cones of tneec\u00e0n\u00e7 \nNo. 03-35 \n\nf-terufacture frem meat or edible offal of swine of reading \nNo. '02-03 or \u00db2. QS or of meet arc ediole offal of poultry \nof headirQ No. 02. 07 \n\n15. 02 \n\nFats of oovine animais, sheep or cpats, raw or rendered, \nwhetrer or not pressea or solvent-odracted: \n\nh-tenufacture from materials of any heading except those of \nreading No. Q2. Q1, 02-02, 02. 04 or 02. 06 or cones of \nreading Nb. 05. 06 \n\n- fats fror Danes or waste \n\nQnt'o \n\nCbnt'G \n\n102 \n\n\fH. S. heading \nNb. (1) \n\n13. 02 \n(Ctrt'd) \n\n13. 04 \n\n- 5-\n\nDescription of product \n\nVbrking or processing \ncarried cut on rron^rigineting materials \nthat confers originating status \n\n(2) \n\n(3) \n\n- other \n\nrferuf acture in vhich a ll the animal materials of Chapter 2 \nused must already be origpjoting \n\nFats and oils and their fractions, of fish or marine \nmarmals, whether or not \ntut not chenicelly \nrTodified: \n\nrefined, \n\n- solid fractions of fish n i ls and fats and o i ls of \n\nmarine IIUIIIHIS \n\n- other \n\nrfenufacture from materials of any heading incluling other \nrraterials of reeding Nb. 15. 04 \n\nr^rufacture \nChapters 2 and 3 used must already' be cricketing \n\nin vhich a ll \n\nthe animal materials of \n\nex 13. 03 \n\nRefined lanolin \n\nI'Brufacture from exude wool grease of heading Nb. 15. 05 \n\n13. 06 \n\nOther animal fats and oils and their fractions, whether \nor 'XJt refined, but not crenically modified: \n\n- solid fracticns \n\n- other \n\nf*bnufacture from materials of any reading including other \nmaterials of hearting No. 15. 06-\n\nhterufacture in vhich a ll the animal materials of Ohapter 2 \nused must already be crioplneting \n\nex 13. 07 to \n15. 15 \n\nFixed vegetable oils and their fractions, whetrer or not \nrefined, tut not crenically modified: \n\n- solid fractions, except for that of jojoba o il \n\nt-fenufacture fran other materials of readings Nbs. 15. 07 to \n15. 15 \n\n- other, except for: \n\n- Tung o i l; myrtle wax and japan wax \n- those for technical or industrial uses other than the \n\nmanufacture of feedstuff s for huren ooneuiptien \n\nrfenuf acture in vhich a ll the vegetable oeterials used oust \nalready te eri\u00e7pnBting \n\n103 \n\n\f- 6 -\n\nrwrrift-im of p r a i ct \n\n*br>o. Ty cr praoeesing \n^rripri nir rr. nrn-nr-iginaming tmtiorijVIc \nthat confers originating status \n\n(2) \n\n(3) \n\n*r. *,*. \u2022; nr \n\\*\u00bbJ*T\u00bbKU f**-Q rmn n i ls \u00ab ri f-npir f r s r t i r r Kr \nr ^ y p p H w j, v**3ther or not refined t ut not further \npr<4-arfcd \n\ni<ft-i. ifccrure \naanarials used itust alm^ry be originating \n\nin ^ ua \n\nall \n\nthp animal and vwgBtahltf \n\nrLS. riaaduxj \ntto. (1) \n\nax 15. 16 \n\nex 15. 17 \n\ntaiuLe lirjrid mixtures of vegetable o i ls of headings. >rj*. 15. 07 to 15. 15 \n\nl^njfacture in v^urn a ll the vegetable insfcprial. s used nust \nalready oe originating \n\nex 15. 19 \n\ni \n\nt \n\n\"16. 01 \n\n! 16. 02 \n\n16. 03 \n\n16. 04 \n\n16. 05 \n\nIndustrial \nratty \nar~:nrifll vexes \n\nalcohols naving \n\nthe dm act FT of \n\nftenracrure frcm uatenals of any heading including fatty \nacids of hearting. c. 15. 19 \n\njj siiiti. arri similar pradLict-. s, of m\\&. went- offal cr \n:JUU pr^ararjcns raeeJ cr> u t it ^-coajcts \nj \n\ni^i \n\nMin if. irfi m \u2022 f m n. i i i i n j !. if ChajTrnr 1 \n\nJt. *r p ^ a r ed or preserved IVBZL, neat offal or blood \nl \n|\u00a3>:tr=cts and. :u\u2014iscs or jLifcg. arjwtic invertiixaras \n\njuices of m=\u00abr. , \n\nfisn or crustaceans, \n\n!\u00abhri TTH. -n ITP f mn aniirelq of Chapter 1 \n\ni-feriifacture frcm arurrals of Chapter 1. H\u00bbever, a ll fish, \ni-r,-F~=r\u00bb=r\u00ab, mnn !**-\u00ab=; err cjtnpr ac^Btic ira^rtihrates used \nnust already be originating. -re-ared or preserved f i av caviar and caviar substitutes \npr=~ared fran f i ^i eggs \n\n>brufacture in tfiioh a ll tne fish or fish eggs used nust \naLraay be arogirafcirig \n\nJrod^acesns, mnilliscs and OG-HT aj. Hri,r \njf-^xireG or pceserved \n\ninvertebrates, \n\nin \u00abr,im all \n\ncKjwi-i- orvertixxares used nust \n\nthe crustaceans, nolluscs cr \nalready be \n\npfr-iif-^-nw-p \nXK \noriginating \n\nex 17. U1 \n\nJ=Li= or ceet sugar and chari rally pure sucrose, in solid \nfzc:^ flavoured or coloured \n\nin unicr. the value of any materials of \n\niv^nnf^-nTinp \nChapter 17 used does not e&csed 30 % of the ex-vorks price \nof the prodjet \n\n17. 02 \n\ninclirlirrj rhffT><~*lly p rv 1-arirse, imltraR. jtii_r sujars \nrjhrr-*** and fructose, \ncencaining added \nor mlouring natter; \na r t i f i c i al honey\u00bb vtether or not mi Mai witii natural \nncney; caramel: \n\nin solid foea; sugar syrups net \n\nflavouring \n\n- -TATii ml \"ly prr> maltrw* ard frurtnse \n\ni\u00abfarij\u00a3acnre fron mFrt-prials of any heading in-flirting other \n\u2022nHtarials cf heading t o. T7. Q2 \n\nOant'd \n\nCtnt'd \n\n104 \n\n\fH. S. deeding \nNo. (1) \n\n17. 02 \n(Cont'd) \n\n- 7-\n\nDaacripticn cf product \n\n\u00abxbDung cr processing \nciuxiBri out an ncn-^idginating '\"***** i\u00bbie \nthat confers originating sfTtfiis \n\n(2) \n\n(3) \n\n- other caipifv in lyJSf\u00ee fi jm, flavcured or coloured \n\n- odier \n\n3X 17. 03. tuasses resulting fran the extraction or refining of \ns-gar, flavored or coloured \n\n17. 04 \n\nccnfecticnery \n\n-. iyr \ncontaining oocoa \n\n( including write cnccolate), not \n\n18. 06 \n\nJ xxx. ucG\u00e8 arc otner feed preparations containing caeca \n\nin which the value cf any nwh\u00b0rifl1<> cf \n\nManufacture \nChapter 17 used does not exceed 30 % cf tire ex-works price \nof the product \n\ntenufacture \nbe originating \n\nin which a ll the rmrhprials used nust already \n\nin whim the value cf any BBtgrials of \n\ni-bnufacture \nChapter 17 i**^ \u00e2ne-* not exceed 30 % cf the ex-warks price \nof tne product. toufacture in which a ll the m t e r i a ls used are clpissifieri \nin a heading other than that of the prorrlrrt, provided the \nvalue of any otner materials cf Chapter 17 used does not \nexceed 3D i cf tne ex-works price cf the predxet \n\n{\"fenufacture in wnieri a ll the. TBterials used are classified \nin a heading other than tnat cf the predict, provided the \nvaL*s of any nHterials of Chapter 17 used doss not exceed \n30 't cf the ex-works price of the predict \n\n19. 01 \n\n19. 02 \n\nt, not elsewhere spart fiad cr \n\n\u2022hj: extract; food preparations of fleur, ireal, starch cr \n;a;xt extract, not containing cocoa p x ir or containing \nfy weight of less than \ncccoi pewier in a p r o r a t i on \n5>t \nfood \npreparations of goods of headings rtos. 04. 01 to 04. 04, \n: \u00abj. ccntaining cr-mB powder or containing cocoa powder in \na urqjcrtLcn by weight cf less than 10 \u00bb, not elsewhere \n^>^-ir-iPri cr included; \n\nincluded; \n\n-. nit extract \n\n- other \n\nt\u00abfanufdctxre from cereals of Chapter 10 \n\n>anufactiire in which a ll the nanadals used are cQassififld \nin a heading other than that cf t h e p r o i r t, provided the \nvalue cf any rm**T-'*ig of Chapter 17 used doss not exceed \n30 % cf the ex^orks price of t t e p r c d j et \n\nsubstances) or otherwise prepared, \n\nr&sta, whether cr net cooked cr stuffed (with meat cr \nas \nocner \nspagnefcti, naoarcni, nccdlfis, lasagne, gnoochi, ravioli, already be originating. cannelloni; acusccus, whsbher or not prepared \n\nsuch \n\n>anjfacture in which a ll the OETRTVIS (except darun wheat), \ntreat, ngy r ^ ^ l, fish, crustaceans or nril'afrs used nust \n\n105 \n\n\fU. S. iteding \nNo. (D \n\na. 03 \n\n3. 04 \n\n*. 05 \n\nJ. 01 \n\n3. 02 \n\nJ. 03 \n\n- 8-\n\nDescription of product \n\n*brxiny or processing \ncarried out on rcn-criginadting materials \nthat confers originating status \n\n(2) \n\n(3) \n\nia1n. xs and substitutes therefor prepared fran \nstarch. in une fozzn cf fi\u00e2tes, grains, pearls, siftings cr in \nsiaJLar fcms \n\nl-tervfacture fran ittaterials of any heading \nstaron of needing i o. 11. 06 \n\nexcept potato \n\nireparad foods attained by the swelling or roasting of \ncereals or cereal predicts (for exanple, com flakes); \nfran. oertu-s, otner \nf \npre^ceoxedar otherwise prepared: \n\nthan nata? \n\nin grain \n\n(com), \n\n- not ccntaining cocoa \n\n- cereals, other than jraia* (cam), in grain form, \n\nijr^-cao<ed or otherwise prepared \n\n- Jtner \n\n- caitixining cocoa \n\nrreau, pastry, cakes, h - i\u00ab \" \"^ and otner bakers' wares, \nwr*-ci=-r or not containing occoa; caurunien wafers, enpty \n<~A-np^ cf a kind suitable far pharrrpimirical use, \nsealing wafers, r i ce paper and sinilar products \n\n\u2022\u2022fen if am ire fran lreterials of any heading. HDwever, grains \nand cats of sveet cacn, prqnred ar preserved, cf heading \nNos 2001, 2004 and 2005 and uncocked, boiled cr steamed \nsweet com, frozen, of neading No 0710 nay not be used \n\n-fenufdcture in whion: \n- a ll the rPT-Fwls and t n s ir derivatives (ejcapt maiae cf. ^TPHPR \"2ea Indirata' and curun wheat and their \n\nthe \nderivatives) used nust be wnaDy cfctained, and \n\n- tne value of any oHtenals of Chapter 17 used dees not \n\nexceed 30 \\ cf fe ex-worxs price cf the product \n\nidu\u00f4, prcvided \n\ni^tenufccture fran nHterials not classified within heading \ntne value cf any rmrherials of \nNo. Chapter 17 n<yri does not exceed 30 % cf the ex-works price \nof t ie p r o i rx \n\nffenufacture fran \u00eeieterials of any heading, except those of \nChapter 11 \n\nVfegetaoles, fruit, nuts and other edible parts cf plants, \nprepared cr preserved ty vinegar cr acetic a dd \n\ni-anufacture in which a ll the fruit, nuts cr vegetables \nused nust already be originating \n\nituBtces prepared cr preserved otherwise than Dy vinegar \nor argrir a dd \n\nttuxfacture \ng r in rating \n\nin which a ll the tanstaes used most already be \n\ni-usTrjoiB and truffles, prepared or preserved otherwise \nu an cy vinegar or acetic a dd \n\n>arufacture in which a ll the nushrcars or truffles used \nnust already be originating \n\n1C6 \n\n\f- 9-\n\nIjescripticn ox product \n\n\u00abarxing or processing \nr^rripn o-it an ncn-cciginating n*t-*mr\\x\\* \nthat confers originating status \n\n(2) \n\n(3) \n\nJC iir vegetables prepared or preserved otherwise than by \nvireg\u00e2r or acetic acid, frcaen or not frozen \n\ni<Bnufacture in wru-^i a ll the vegetables used oust already \nce originating \n\nrr\u2014t-, TJXS, \njtuerved oy sugar (drained, glac\u00e9 or crystallised) \n\nfruit-peel and otner parts of plants, \n\nin which the value cf any nwtTar-i*tg cf \n\nrtenufacture \nChapter 17 used dees not exceed 30 % of the ex-works price \nof tne product \n\nJ U ^, fruit j e l l i e s, narnBlades, fruit or nut pur\u00e9e and \n\u00c9\\-it or nut pastes, being cocwed pr\u00e9parations, wnether \nor net containing added sugar or other sweetening >iatler \n\n_-: _JI, nuts and a\u00fbner ediDle parts of plants cxherwise \n- r e a r ee or preserved, whether cr not containing added \nsu^ur jr otner sweetening nHtter or spirit, not elsewhere \n-^ -if-. nr: or included: \n\nin wtiicn \n\ni-an. if. i-. ture \nChapter 17 used most not exceed 30 % of the ex-warks price \nof the procuct \n\ntne value cf any rraterials of \n\nkLS, \ndeading \nNo. (1) \n\n2a 04 and \n20. 05 \n\n20. 06 \n\n20. 07 \n\n20. Ob \n\n- f_-uit and nuts cooked otherwise tnan cy steaning or \niijL-ing xn water, not containing added sugar, frozen \n\nparufacture in whicn a il the fruit and nuts uaad mist \nalready te originating \n\n- nuts, net ocntaining added sugar or s p i r i ts \n\n- jejer \n\nrtenufacture in whim the value of the originating nuts and \no il seeds of headings I t s. 06. 01, 08. 02 and 12. 02 to 12. 07 \nused exceeds 60 % cf the ex^orks price of the prccuct \n\ni\u00bban. ifacture in whim a ll the naterials used are classifiprl \nin a needing other than tnat of the p t n i r t, rrovidad the \nvalue of any riaterials of Chapter 17 used abas not exceed \n30 % cf the ex-sorks price of the proir-r \n\n\u00ab 2 0. 09 \n\nfruit Tuioes (including gr^p0 nust), unferanented and not \ncontaining er^e=r\\ s p i r i t, whether or not containing added \nsujar or other sweetening natter \n\ni-fenufacture in which a ll the naterials used are classified \nin a heading other than that of tdTeprodxrt, provided the \nvalue cf any naterials of Chapter 17 used doss not exceed \n30 fc cf the ex-works price of the predict \n\n107 \n\n\f- 1 0-\n\nH. 5. reeding \nND. (1) \n\nCeseription of product \n\nWorking or processing \ncarried out en non^xiejinating materials \nthat confers \u0153igireting status \n\n(2) \n\n(3) \n\nex 21. 01 \n\nRoasted chioory and extracts, twmoes and oercentrates \nthereof \n\nterufacture in which a ll the ohicory uaed must already be \ncrirginating \n\nex 21. 03 \n\n- Sauces and preparations thereof; mixed cendinrants and \n\nmixed seasonings \n\nr-tertufacture in which a ll the materials used are classified \nin a heading other than that of the p r r r i r t. however, \nrnjstard flour or meal or prepared mustard may be used \n\n- Prepared mustard \n\nrterjfacture from rnustard flour or meal \n\n21. \u00bb \n\nSoups and broths and preparations therefcr; haitrjenized \ncoTposite food preparations: \n\n- soups and broths and procurations therefor \n\n- roroganijzed conposite food preparations \n\nex 21. 05 \n\nSugar syrups, flavoured or coloured \n\nf-fenufacture from materials of any reading, exoept prepared \nor preserved vegetables of headings Nos. 2D. Q2 to 2D. Q3 \n\nThe rule for the heading in which the product wxild be \nclassified in bulk shall apply \n\nf**erufacture in which the value of any naterials of \nOhepter 17 used must not exceed 30 \u00ab of the ex-warks price \nof the product \n\n22. 01 \n\n22. 02 \n\nWBters, including natural or a r t i f i c i al mineral waters \nanc aerated waters, not containing added sugar or other \nsweetening matter nor flavoured; ice and snow \n\nNferufacture in which a ll the water used must already be \noriginating \n\nWaters, ireli. riing mineral veters and aerated waters, \ncontaining added sugar or other sweetening natter or \nflavoured, and other \nrren-sJrxhlic beverages, not \nircduding fruit or vegetaole juices of reading to. 2D. 09 \n\nNfenufacture in which a ll the materials used are classified \nin a heeding other than that of the pnxuet, provided the \nvelue of any materials of Ohepter 17 used dbes not exceed \n30 % of the ex-works price of the product and any f r u it \njuice used (except for pineapple, lime and grapefruit \njuices) must already be cri\u00fb^reting \n\nex 22. 04 \n\nWine of \norape must with the addition of alcohol \n\nfresh grapes, innli rting fortified wires, and \n\nr-terufacture from other orape must \n\n22. 05, \nex 22. 07, \nex 22. 06 and \nex 22. 09 \n\nThe fnllrwing, ccntaining grape rraterials: vernrjuth end \nother wine of fresh grapes flavoured with plants or \nararetic suhetances; ethyl adcorol and other spirits, \ndenatured or not; spirits, licueurs and other spirituous \nbeverages; crjTpcund alrrfnlin pr\u00e9parations of a kind uaed \nfor the manufacture of beverages; vinegar \n\nf*Bnufacture from materials of any heeding, exoept grapes \nor any material derived fran \u00abgrapes \n\nex 22. 06 \n\nWhidd. es of an alccrolic stiength by VOIUTE of less than \n\n50 % vol. f-fenufacture in which the value of any cereal based spirits \nused does not exceed 15 % cf the ex-works price of the \nproduct \n\n108 \n\n\f- u-\n\nDescription of prcduct \n\nWorking or proosssing \ncarried cut en non^xigineting rraterials \nthat confers cri\u00e7^nating status \n\n(2) \n\n(3) \n\nFlours, rreels and pellets, of meat or meat offal, of fiah \nor \naqntin \nirr^rtetrates, unfit for furran ccrejTption ; greaves \n\nrrolluscs or \n\ncrustaceans, \n\nother \n\nof \n\nResidues from the rrartufacture of starch fran maize \n(excluding corrjentrated stepping liquors), of a protein \ncoTtent, calculated on the dry prccixt, exceeding 40K by \nweight \n\nrvanufacture in which a ll the materials of Ohepters 2 and 3 \nuaed must already be erig\u00e0nating \n\nr^anufacture in which a ll the maize used must already be \norioplnatirg \n\nH. S. hfrrring \nNb. (1) \n\n2301 \n\nex 23. 03 \n\nex 23. 06 \n\nOil cake and other solid residues resulting from the \nextraction of olive oil, containing more then 3 % of \nolive oil \n\nr^Brufacture in which a ll the olives used must already be \noricpnating \n\n23. CF \n\n24. 02 \n\nPreparations of a kind uaed in animal feeding \n\ntei/acture \nmaat, fiah or milk used must alieady be orig\u00e0nating \n\nin which a ll the cereals, sugar or molasses, \n\nCigars, cheroots, cigarillos and cigarettes, of tchanm \nor of tfTHTn substitutes \n\nr-tenuf acture in which at \nunrrBnufactured h t H ru or \nto. 24. Q1 used must already be cric^reting \n\nleast 70 % by wei\u00e7ht of the \nrefuse of heeding \n\nt d H in \n\nex 24. 03 \n\nSTCking tujbacco \n\nleast 70 % by weight of the \nr-fen/acture in which at \nunrrao/actured trharm or tobacco refuse of heading to. 24. 01 used must alieady be originsting \n\n109 \n\n\fHS \nHeading \nNo. O) \n\nex 2504 \n\nex 2515 \n\nex 2516 \n\nDescription of product \n\nworking or processing \n\ncarried out on non-originating cater i a I s \nthat confers originating status \n\n(2) \n\n(3) \n\nNatural crystalline graphite, with \nenriched carbon content, purified \nand ground \n\nMarble, ierely cut by sawing or \notherwise Into blocks or slabs of a \nrectangular (Including square) shape, \nof a thickness not exceeding 25 ci \n\nGranite porphyry, basalt, sandstone \nand other \u2022onuiental and building \nstones, ierely cut by sawing or \notherwise, into blocks or slabs of a \nrectangular (including square) shape, \nof a thickness not exceeding 25 CR \n\nEnriching of the carbon content, purifying and \ngrinding of crude crystalline graphite \n\nCutting, by sawing or otherwise, of marble (even \nIf already sawn) of a thickness exceeding 25 cm \n\nCutting, by sawing or otherwise, of stones (even \nif already sawn) of a thickness exceeding 25 cm \n\nex 2518 \n\nCalcined dolomite \n\nCalcination of dolomite not calcined \n\n110 \n\n\f(2) \n\n(3) \n\nex 2519 \n\nCrushed natural magnesium carbonate (magnesite). m hermetically sealed containers, and magnesium \noxide, whether or not pure, other than \nfused \nmagnesia or dead-burned (sintered) magnesia \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a heading other than that of the \nproduct. However, natural magnesium \ncarbonate \n(magnesite) may be used \n\nex 252C \n\nPlasters specially prepared for dentistry-\n\nManufacture in which the value of ail the materials \nused does not exceed 50 \u00b0/o of the ex-works price of \nthe product \n\nex 2524 \n\nNatural asbestos fibres \n\nManufacture from asbestos concentrate \n\nex 2525 \n\nMica powder \n\nGrinding of mica or mica waste \n\nex 2530 \n\nEarth colours, calcined or powdered \n\nCalcination or grinding of earth colours \n\nOils in which the weight of the aromatic consti \ntuents exceeds that of the non-aromatic consti \ntuents, being oils similar to mineral oils obtained bv \ndistillation of high temperature coal ur, of which \nmore than 65 \u00b0/e by volume distils at a temperature \nof up ic 25C rC (including mixtures of petroleum \nspin: and benzole), for use as power or heating \nfuel* \n\nThese are Annex II products \n\nMineral oiU nnd products ol thrir distillation, bitu \nminous substances, mineral waxes \n\nI hrsr are Annex 11 product^ \n\nex 2707 \n\n2 7> \nto \n2~)5 \n\nex Ch. ir'cr \n\norganic \n\nchemicals. Inor^snic \ninorganic \ncompounds of precous metaK of rare earth meta!'. o* radioactive elements or o* isotope1. except for \nheading Nos ex 2-11 and t- 2S33 for which the \n\"j!rr are set out beic*\u00bb \n\nor \n\nex 2811 \n\n>u!n-. ur tncxiae \n\nex 2k-3 \n\nAiunvmum sulphate \n\nex Char* \n\nOrca-iic chemicals, excep'. for head-ng Nos ex \n: \u00ab : !. ex 29:2, ex 29:5, 2915. ex 2932. 2933. nnd \n2\u00b03J. for which the position is set out below \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a heading o t hc than tha: of the \nprocuct However, materials classified within the same \nheading mav be used provided their value does no: \nexceed 2: V: of the ex-works price of the product \n\nManufacture from suiphur dioxide \n\nManufacture \nused does not exceed ?Z \"\u2022': \nthr product \n\nin which the vaiue of all the materials \n\u2022. he ex-work 1 price or \n\nManufacture \nthe materials used are \nclassified within a heading other than that of the \n\nin which all \n\nEroduci However, materials classified within the same \neading may be used provided their value does not \nexece\u00e0 2C 3/c of the ex-works price of the product \n\nex 29C1 \n\nex 29C2 \n\nex 29:5 \n\nex 295; \n\nArvclic hvdrocarbons for use as power or heating \nfuels \n\nThese are. Annex II products \n\nCvclanes and cyclenes \nthan azulenes), \nbenzene, toluene, xylenes, for use as power or \nheating fuels \n\n(other \n\nThese arc Annex II products \n\nMeta! alcoholates of alcohols of this heading and \nof ethanol or glycerol \n\nbatv-rated acyclic monocarncx-. lic acids and their \nanhsdndes. halides. peroxices and peroxvacid'. their \nor \nhalogenated. nurosated derivatives \n\nsulphonated. nitrated \n\n\u2014 Interna! \n\nand \nsulphonated. nitrated or mtrosated d\u00e9riv\u00e2tes \n\nethers \n\ntheir \n\nhalogenated. Manufacture from materials of any heading, including \nother materials of heading Ne 29C5. However, metai \nalcoholates of this heading may be used, provided the:: \nvalue does not exceed 21 3/: of the ex-works price of \nthe product \n\nManufacture from materials of an;, heading Howe, e:. the value of all the materials of heading Nos 2915 and \n2\u00b0 16 used mav not exceed 2Z '\u2022': of the ex-works price \no? the product \n\nManufacture from materials of am heading However. tne value of all the materials of heading No 29C9 used \nmav not e. xcecc 2: '-/: of the ex-works price of the \nproduct \n\n111 \n\n\f0) \n\nex 2932 \n\n(cont'd) \n\n2933 \n\n2934 \n\n(2) \n\n(3) \n\n\u2014 Cyclic acetals and internal hemiaceuls and their \nhalogenated, sulphonated, nitrated or nitrosated \nd\u00e9riv\u00e2tes \n\nHeterocyclic compounds with nitrogen hetero-\natom(s) only; nucleic acids and their salts: \n\nManufacture from materials of any heading \n\n\u2014 Lactams, other than 6-hexanelactam (epsilon-\ndiazepines; \n\ncaprolactam); \nazocines (whether or not hydrogenated) \n\nmonoazepines; \n\n\u2014 Other \n\nand \n\nacid \n\nOther heterocyclic compounds \n\u2014 6-Aminopenicillanic acid, 7-aminocephalospo-\nranic \n7-aminodesacetoxycephal \nosporanic acid; compounds containing a pheno-\nthiazine \nnot \nhydrogenated), not further \nfused; monothia-\nmonoazipines; monothiins; monooxamono-\nazines; monooxamonoazoles (whether or not \nhydrogenated) \n\nring-system. (whether \n\nor \n\nManufacture from materials of any heading. However, \nthe value of all the materials of heading Nos 2932 and \n2933 used may not exceed 30 \u00b0/o of the ex-works price \nof the product (') \n\nManufacture from matenals of any heading. However, \nthe value of all the matenals of heading Nos 2932 and \n2933 used may not exceed 20 \u00b0/o of the ex-works price \nof the product \n\nManufacture from materials of any heading. However, \nthe value of all the materials of heading Nos 2932. 2933 and 2934 used may not exceed 3C % of the ex-\nworks price of the product (') \n\n\u2014 Other \n\nManufacture from materials of an\\ heading However, \nthe value of all the matenals of heading Nos 2932, \n2933 and 2934 used may not exceed 20 c/e of the ex-\nworks price of the product \n\nex Chapter 3C \n\nPharmaceutical products, except for heading Nos \n3002, 30C3 and 3004, for which the rules are set \nout below \n\n3002 \n\n(excluding yeasts) and \n\nHuman blood; animal blood prepared for thera \npeutic, prophylactic or diagnostic uses; anusera and \nother blood tractions; vaccines, toxins, cultures of \nmicro-organisms \nsimilar \nproducts: \n\u2014 Products consisting of two or more constituents \nwhich have been mixed together for therapeutic \nor prophylactic uses or unmixed products for \nthese uses, put up in measured doses or in forms \nor packings for retail sale \n\n\u2014 Other: \n\n\u2014 Human blood \n\nAnimal blood prepared for therapeutic or \nprophylactic uses \n\nBlood fractions other than antisera, haemo \nglobin and serum globulin \n\nHaemoglobin, blood globulin and serum \nglobulin \n\nOthe \n\nManufacture \nclassified within a heading other \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\nEroduci However, materials classified within the same \n\neading may be used provided \n\ntheir value does not \n\nexceed 20 \u00b0/o of the ex-works pnee of the product \n\nManufacture from materials of any heading, including \nother materials of heading No 30C2. The materials of \nthis description may also be used, provided their value \ndoes not exceed 2C \u00b0/c of the ex-works pnee of the \nproduct \n\nManufacture from materials of any heading, includin_ \nS \nother materials of heading No 30C2 The materials o \nthis desenption may also be used, provided their value \ndoes not exceed 2C \u00b0/e of the ex-works price of the \nproduct \nManufacture from materials of any heading, including \nother materials of heading No 30\u00d42. The materials of \nthis description may also be used, provided their value \ndoes not exceed 20 % of the ex-works price of the \nproduct \n\nManufacture from materials of any heading, including \nother materials of heading No 3002. The materials of \nthis description may also Be used, provided their value \ndoes not exceed 20 % of the ex-works price of the \nproduct \nManufacture from materials of any heading, including \nother materials of heading No 30C2 The materials o? \nthis description may also be used, provided their value \ndoes not exceed 20 \u00b0/o of the ex-works price of the \nproduct \nManufacture from materials of any heading, including \nother matenals of heading No 30C2 The materials of \nthis description may also be used, provided their value \ndoes not exceed 2C \u00b0/c of the ex-works price of the \nproduct \n\n(') This rule shal; onlv jpph until 31 March 1991 \n\n(8) \n\n112 \n\n\f(2) \n\n(3) \n\n3003 \nand \n30:4 \n\nMedicaments \n30C2. 3005 or 3006) \n\n(excluding goods of heading No \n\nManufacture in which: \n\n\u2014 all the materials used are classified within a heading \nother than that of the product. However, matenals \nof heading No 3003 or 3004 may be used provided \ntheir value, taken together, docs not exceed 20 \u00b0/e \nof the ex-works price of the product, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 % of the ex-works price of the product \n\nex Chapter 31 \n\nFertilizers except for heading No ex 3105 for which \nthe rule is set out below \n\nManufacture \nin which all the materials used are \nclassified within a heading other than that of the \n\nEroduct However, materials classified within the same \n\neading may be used provided their value does not \n\nexceed 20 \u00b0/o of the ex-works pnee of the product \n\nex 31C5 \n\nMineral or chemical fertilizers containing two or \nthree of the fertilizing elements nitrogen, phos \nphorus and potassium; other fertilizers; goods of \nthis chapter, \nin \npackages of a gross weight not exceeding 1C kg, \nexcept for: \n\nin tablets or similar forms or \n\n\u2014 Sodium nitrate \n\u2014 Calcium cyanamide \n\u2014 Potassium sulphate \n\u2014 Magnesium potassium sulphate \n\nManufacture in which: \n\n\u2014 all the materials used are classified within a heading \nother than that of the product. However, materials \nclassified within the same heading may be used \nprovided their value does not exceed 2C \u00b0/c of the \nex-works price of the product, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 \u00b0/c of the ex-works price of the product \n\nex Chapt' \n\nTanning or dyeing extracts, tannins and their deri \nvatives, dyes, pigments and other colouring matter, \npaints and varnishes; putts and other mastics, inks, \nexcept for heading Nos ex 32C1 and 32C5. for \nwhich the rules are set out below \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a heading other than that of the \nproduct However, materials classified within the same \nheading may be used provided their value does not \nexceed 2C \u00b0/c of the ex-works price of the product \n\nTannins and their salts, ethers, ester* and other \nOrrivatives \n\nManufacture from tanning extracts of vegetable ongin \n\nColour lakes, preparations as specified in note 3 to \nthi< chapter based on colour lakes Cl \n\nex Chapter 33 \n\ntoilet preparations, except for heading No 3301, \nfor which the rule is set out beiow \n\n33:i \n\noils \n\n(terpeneless or not), \n\nEssential \nincluding \nconcretes and absolutes; resinoids; concentrates of \nessential oils in fats, in fixed oils, in waxes or the \nlike, obtained by enfleurage or maceration; terpenic \nby-products of the detcrpenation of essential oils; \naqueous distillates and aqueous \nsolutions of \nessential oils \n\nManufacture from materials of any heading, except \nheading Nos 32C3. 3204 and 3215. However, materials \nfrom heading No 3205 mav be used provided their \ns. ilue does not exceed 2: c/: of the ex-works price of \nthe product \n\nManufacture \nthe materials used are \nclassified within a heading other than that of the \n\nin which all \n\nEroduct. However, materials classified within the same \n\neading may be used provided their value does no*, \n\nexceed 2C \u00b0/e of the ex-works price of the product \n\nManufacture from materials of any heading, including \nmaterials of a different 'group' (:) within this heading. However, materials of the same group may be used, \nprovided their value does not exceed 2C \u00b0/o of the ex-\nworks pnee of the product \n\n(') Note. ; io Charti-- \"O sa\\< iha: these preparations arr those of a kind used for colouring anv material or used a* ingredient\u00bb m the manufacturing of \n\ncolour np preparations, provided thev are not classified within another heading in Chapter >Z \n\n(r) A 'jroun is reci*'i'\"H \u00bbi \u00bb\"v pan; of the heading separated from the reit b\\ a semicolon \n\n113 \n\n\f(J) \n\n(2) \n\nex Chapter 34 \n\nSoap, organic surface-active agents, washing prepa \nrations, \nlubricating preparations, artificial waxes, \nprepared waxes, polishing or scouring preparations, \ncandles and \nsimilar articles, modelling pastes, \n'dental waxes' and dental preparations with a basis \nof plaster; except for heading Nos ex 3403 and \n3404, for which the position is set out below \n\nex 3403 \n\nLubricating preparations containing petroleum oils \nor \nbituminous minerals, \nprovided they represent less than 70 % by weight \n\nobtained \n\nfrom \n\noils \n\nManufacture \nclassified within a heading other \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\nEroduct. However, materials classified within the same \n\neading may be used provided their value does not \n\nexceed 20 \u00b0/o of the ex-works pnee of the product \n\nThese are Annex II products \n\nex 3404 \n\nArtificial waxes and prepared waxes: \n\n\u2014 *w\"ith a basis of paraffin, petroleum waxes, \nwaxes obtained from bituminous minerals, slack \nwax or scale wax \n\nThese are Ajinex II products \n\n\u2014 Other \n\nManufacture from materials of any heading, except: \n\n\u2014 hydrogenated oils having the character of waxes of \n\nheading No 1516 \n\n\u2014 fatty acids not chemically defined or industrial fatty \nalcohols having the character of waxes of heading \nNo 1519 \n\n\u2014 matenals of heading No 3404 \n\nHowever, these materials may be used provided their \nvalue does not exceed 20 \u00b0/c of the ex-works pnee of \nthe product \n\nex Chapter 35 \n\nAlbuminoidal substances; modified starches; glues; \nenzymes; except for heading Nos 3505 and ex 3507 \nfor which the rules are set out below \n\n3505 \n\nDextrins and other modified starches (for example, \npregelatinized or esterified starches), glues based \non starches, or on dextrins or other modified \nstarches: \n\nin which all \n\nthe matenals used are \nManufacture \nclassified within a heading other \nthe \nproduct \"However, matenals classified within the same \nheading may be used provided \ntheir value does not \nexceed 2C \u00b0/c of the ex-works price of the product \n\nthat of \n\nthan \n\nStarch ethers and esters \n\n\u2014 Oih< \n\nManufacture from materials of any heading, including \nother matenals of heading No 3505 \n\nManufacture from materials of any heading, except \nthose of heading No 1108 \n\nex 3507 \n\nPrepared \nincluded \n\nenzymes not elsewhere \n\nspecified \n\nor \n\nManufacture \nin which the value of all the materials \nused does not exceed 50 \u00b0/o of the ex-works price of \nthe product \n\nChapter 36 \n\nExplosives; pyrotechnic products; matches; pyro-\nphonc alloys, certain combustible preparations \n\nex Chapter 37 \n\nPhotographic or cinematographic goods; except for \nheading Nos 3701, 3702 and 3704 for which the \nrules are set out below \n\nManufacture \nclassified within a heading other \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\nEroduct. However, materials classified within the same \n\neading may be used provided their value does not \n\nexceed 20 % of the ex-works pnee of the product \n\nManufacture \nclassified within a heading other \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\nEroduct. However, matenals classified within the same \n\neading may be used provided their value does not \n\nexceed 20 \u00b0/o of the ex-works price of the product \n\n114 \n\n\f(I) \n\n3701 \n\n(2) \n\nO) \n\nPhotographic plates and film in the flat, sensitized, \nunexposed, of any material other \nthan paper, \npaperboard or textiles; instant pnnt film in the flat, \nsensitized, unexposed, whether or not in packs: \n\n\u2014 Instant print film for colour photography, in \n\npacks \n\n\u2014 Other \n\n37c: \n\n3704 \n\nPhotographic film in rolls, sensitized, unexposed, of \nany material other than paper, paperboard or \ntextiles, \nin rolls, sensitized, \nfilm \nunexposed \n\ninstant print \n\nPhotographic plates, film, paper, paperboard and \ntextiles, exposed but not developed \n\nex Chapter 36 \n\nchemical \n\nMiscellaneous \nfor \nheading Nos ex 3801, ex 3803, ex 3805, ex 3806, \nex 3807, 3808 to 3814, 3818 to 3820, 3822 and \n3823 for which the rules are set out below \n\nproducts; \n\nexcept \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a headine other than that of the \nproduct However, materials from heading No 3702 \nmay be used provided their value does not exceed \n30 \u00b0/o of the ex-works price of the product \n\nManufacture \nthe materials used are \nclassified within a heading other than heading No 3701 \nor 3702 \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a heading other than heading No 37C1 \nor 3702 \n\nin which all \n\nthe materials used are \nManufacture \nclassified within a heading other than heading Nos \n3701 to 3704 \n\nin which all \n\nin which all \n\nManufacture \nthe matenals used are \nclassified within a heading other than that of the \nproduct. However, materials classified within the same \nheading may be used provided their value does not \nexceed 20 \u00b0/c of the ex-works price of the product \n\nex 3801 \n\nColloidal graphite in suspension in oil and semi-\ncolloidal graphite, carbonaceous pastes for elec \ntrodes \n\nManufacture in which the value of all the materials \nused does not exceed 5C \u00b0/c of the ex-works price of \nthe product \n\nGraphite in paste form, being a mixture of more \nthan 3C Vc by weight of graphite with mineral \noils \n\nManufacture from materials of any heading However, \nthe value of the materials of heading No 3*'3 usee \nmust not exceed 2: \u00b0/: of the ex-works price of the \nproduct \n\nex 38C? \n\nex 38:5 \n\nRefined tall oil \n\nRefining of crude tall oil \n\nSpirits of sulphate turpentine, purified \n\nPurification by distillation or refining of raw spirits of \nsulphate turpentine \n\nex 38D6 \n\nEster gums \n\nManufacture from resin acids \n\nex 383-7 \n\ni \n\n1\"ood pitch (wood tar pitch) \n\nDistillation of wood tar \n\n380K \nto \n3814 \n3818 \nto \n382C \n3822 \nand \n3823 \n\n| Miscellaneous chemical products \n\nadditives \n\nPrepared \noil. containing petroleum oils or oils obtained from \nbituminous minerals, of heading No 3811 \n\nlubricating \n\nfor \n\nThe following of heading No 3823: \n\n\u2014 Prepared binders for foundry moulds or \ncores based on natural resinous products \n\n\u2014 Naphthenic acids, their water insoluble salts \n\nana their esters \n\n\u2014 Sorbitol other than that of heading No 2905 \n\n\u2014 Petroleum sulphonates. excluding petroleum \nsulphonates of alkali metals, of ammonium \nor of ethanolamines; thiophenated sulphonic \nacids of oils obtained \nfrom bituminous \nminerals, and their salts \n\n\u2014 Ion exchangers \n\n\u2014 Getters for vacuum tubes \n\n\u2014 Alkaline iron oxide for the purification of \n\ngas \n\nThese arc Annex 11 products \n\nin which all \n\nManufacture \nthe materials used are \nclassified within a heading other than that of the \nproduct. However, matenals classified within the same \nheading may be used provided their value does not \nexceed 2C % of the ex-works price of the product \n\n115 \n\n\f0) \n\n3108 \nto \n3814 \n3818 \nto \n3820 \n3822 \nand \n3823 \n(cont'd) \n\n(2) \n\n(3) \n\n\u2014 Ammoniacal gas \n\nliquors and spent oxide \n\nproduced in coal gas purification \n\n\u2014 SuJphonaphtbenic \n\nacids, \n\ntheir \n\nwater \n\ninsoluble salts and their esters \n\n\u2014 Fusel oil and Dippei's oil \n\n\u2014 Mixtures of salts having different anions \n\n\u2014 Copying pastes with a basis of gelatin, \nwhether or not on a paper or textile backing \n\nOther \n\nManufacture in which the value of all the materials \nused does not exceed 50 % of the ex-works price of \nthe produa \n\nex 3901 to 3915 \n\nPlastics in primary forms, waste, parings and scrap, of \nplastic; except for beading No ex 3907 for which the \nrule is set out below \n\n\u2014 Addition bomopolymerizarion products \n\nManufacture is which: \n\nOther \n\n\u2014 the value of all the materials used does not exceed 50 % \n\nof the ex-works price of the product, and \n\n\u2014 the value of any materials of Chapter 39 used does not \nexceed 20% of the ex-works price of the produa (') \n\nManufacture \nin which the value of the materials of \nChapter 39 used does not exceed 20 % of the ex-works \nprice of the produa (') \n\nex 3907 \n\nCopolymer, made from polycarbonate and acrylo-\nnitrile-butadicne-styrene copolymer (ABS) \n\nManufacrure in which all the materials used are classified \nwithin a heading other than that of the produa. However, \nmaterials classified within the same heading may be used \nprovided their value does not exceed 50 % of the ex-works \nprice of the produa \n\nex 3916 to 3921 \n\nSemi-manufactures and articles of plastics, except \nfor headings Irfos ex 3916, ex 3917 and ex 3920, for \nwhich the rules are set our below \n\n\u2014 Flat products, \n\nfurther worked \n\nonly \nsurface-worked or cut \ninto forms other than \nrectangular (including square); other products, \nfurther worked than only surface-worked \n\nthan \n\nManufacture in which the value of any materials of \nChapter 39 used does not exceed 50% of the ex-works \nprice of the produa \n\n\u2014 Other \n\n\u2014 Addition homopolymerization products \n\nManufacture in which: \n\n\u2014 Other \n\n\u2014 the value of all the materials used does not exceed 50 % \n\nof the ex-works price of the produa, and \n\n\u2014 the value of any materials of Chapter 39 used does \nnot exceed 20% of the ex-works price of \nthe \nprodua (') \n\nManufacrure in which the value of any matenals of \nChapter 39 used does not exceed 20% of the ex-works \nprice of the produa ( ' ) \n\n(') In the ca*e of product! composed of rruncnaJi classified within both heading Not 3901 to 3906 , on the one hand, and within heading Not 3907 to 3911, on the \n\nother hand, chu restriction only applies to that group of matenali which predominates by weight in the produa. 116 \n\n\f(1) \n\ntt) \n\n(3) \n\nex 3916 and ex 3917 \n\nProfile shapes and tubes \n\nManufacture in which: \n\n! \n\nex 3920 \n\nlonomer sheet or film \n\n\u2014 the value of all the materials used doe\u00bb not exceed 50 % \n\nof the ex-works price of the p r o d u a, and \n\n\u2014 the value of any materials classified in the same beading \nas the produa does not exceed 20 % of the ex-works \nprice of the p r o d ua \n\nManufacture from a thermoplastic partial salt which \nis a copolymer of ethylene and metacryuc acid partly \nneutralized with metal ions, mainly zinc and sodium \n\n3922 \nto \n3926 \n\nArticles of plastic \n\nManufacture in which the value of all the materials \nused does not exceed 50 Vo of the ex-works price of \nthe produa \n\nex 4001 \n\nLaminated slabs of crepe rubber for shoes \n\nLamination of sheets of natural rubber \n\n4005 \n\n4012 \n\nCompounded rubber, unvulcanized, \nforms or in plates, sheets or strip \n\nin primary \n\nManufacture in which the value of all the materials \nused, except natural rubber, does not exceed 50 \u00b0/b of \nthe ex-works price of the produa \n\nRetreaded or used pneumatic tyres of rubber; solid \nor cushion tyres, interchangeable tyre treads and \ntyre flaps of rubber: \n\n\u2014 Retreaded pneumatic, solid or cushion, tyres of \n\nRetreading of used tyres \n\nrubber \n\n\u2014 Other \n\nManufacture from materials of any heading, except \nthose of heading No 4011 or 4012 \n\nex 4 0 37 \n\nArticles of hard rubber \n\nManufaaure from hard rubber \n\n117 \n\n\f(>\u2022 \n\n(2) \n\n(3) \n\nex 4102 \n\nRaw skins of sheep or lambs, without wool on \n\nRemoval of wool from sheep or lamb skins, with wool \non \n\n4104 \nto \n4107 \n\n4109 \n\nLeather, without hair or wool other than leather of \nheading No 4108 or 4109 \n\nRetanning of pre-tanned leather \nor \nManufacture \nin which all the materials used are \nclassified within a heading other than that of the \nprodua \n\nPatent \nmetallized leather \n\nleather and patent \n\nlaminated \n\nleather; \n\nManufaaure from leather of heading Nos 4104 to \n4107 provided its value does not exceed 50 \u00b0/o of the \nex-works price of the produa \n\nex 4302 \n\nTanned or dressed furskins, assembled: \n\n\u2014 Plates, crosses and similar forms \n\n\u2014 Other \n\nBleaching or dyeing, \nto cutting and \nassembly of non-assembled unned or dressed furskins \n\nin addition \n\nManufacture from non-assembled, unned or dressed \nfurskins \n\n4303 \n\nArticles of apparel, clothing accessories and other \narticles of furskin \n\nManufaaure from non-assembled, unned or dressed \nfurskins, of heading No 43C2 \n\nex 4403 \n\nV o od roughly squared \n\nManufaaure from wood in the rough, whether or not \nstripped of its bark or merely roughed down \n\nex 4407 \n\nex 440R \n\nex 4409 \n\nex 4410 \nto \nex 4413 \n\nex 4415 \n\nex 4416 \n\n^ o od sawn or chipped lengthwise, sliced or peeled, \nof a thickness exceeding 6 mm. planed, sanded or \nfinger-jointed \n\nPlaning, sanding or finger-jointing \n\nsheets and sheets \n\nVeneer \nfor plywood, of a \nthickness not exceeding 6 mm. spliced, and other \nwood \nlengthwise, sliced or peeled, of a \nthickness not exceeding 6 mm, planed, sanded or \nfinger-jointed \n\nsawn \n\n\u2014 V o od (including stnps and friezes for parquet \nflooring, not assembled') continuously shaped \nchamfered. (tongued, \nV-tomted. beaded, moulded, rounded or the \nlike i along any of its edges or faces, sanded or \nfinger-jointed \n\ngrooved, \n\nrebated, \n\nSplicing, planing, sanding or f'in\u00e7er-iointing \n\nSanding or finger-jointing \n\n\u2014 Bcadings and mouldings \n\nBeading or moulding \n\nBeadings \nskirting and other moulded boards \n\nand mouldings, \n\nincluding moulded \n\nBeading or moulding \n\nPacking cases, boxes, crates, drums and similar \npackings, of wood \n\nManufaaure from boards not cut to size \n\nCasks, barrels, vats, \nproducts and parts thereof, of wood \n\ntubs and other coopers' \n\nManufacture from riven sxaves. not further worked \nthan sawn on the two principal surfaces \n\nex 4418 \n\n\u2014 Builders' joinery and carpentrv of wood \n\nin which all \n\nManufaaure \nthe materials used are \nclassified within a heading other than that of the \nproduct. However, cellular wood panels, shingles and \nshales may be used \n\n\u2014 Beadings and mouldings \n\nBeading or moulding \n\nex 4421 \n\nMatch splints; wooden pegs or pins for footwear \n\nManufacture from w-ood of any heading except drawn \nwood of heading No 44C9 \n\n118 \n\n\f(1] \n\n(2) \n\n(3) \n\n4503 \n\nArticles of natural cork \n\nManufacture from cork of heading No 4501 \n\nex 4811 \n\nPaper and paperboard, ruled, lined or squared only \n\nManufaaure from paper-making materials of Chapter \n47 \n\n4816 \n\n4817 \n\nCarbon paper, self-copy paper and other copying \nor transfer papers (other than those of heading No \n4809), duplicator stencils and offset plates, of \npaper, whether or not put up in boxes \n\nManufaaure from paper-making materials of Chapter \n47 \n\nEnvelopes, letter cards, plain postcards and corre \nspondence cards, of paper or paperboard; boxes, \npouches, wallets ana writing compendiums, of \npaper or paperboard, conuining an assortment of \npaper suuonery \n\nManufacture in which: \n\u2014 all the materials used are classified within a heading \n\nother than that of the product, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 % of the ex-works price of the produa \n\nex 4818 \n\nToilet paper \n\nex 4819 \n\nCanons, boxes, cases, bags and other packing \ncontainers, of paper, paperboard, cellulose wadding \n\nntainers, of paper, paperi \nwebs of cellulose fibres \n\" \n\nfit \n\n' \n\nex 482: \n\nLetter pads \n\nManufaaure from paper-making materials of Chapter \n47 \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the produa, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 % of the ex-works pnee of the produa \n\nManufaaure in which the value of all the materials \nused does not exceed 50 % of the ex-works price of \nthe produa \n\nex 4823 \n\nOther paper, paperboard, cellulose wadding and \nwebs oi cellulose fibres, cut to size or shape \n\nManufaaure from paper-making materials of Chapter \n47 \n\n49C9 \n\n49i: \n\nex 50C3 \n\n5501 \nto \n5507 \n\nillusrrated postcards; printed cards \nPnnted or \nbeanng \nor \nannouncements, whether or not illustrated, with or \nwithout envelopes or trimmings \n\ngreetings, messages \n\npersonal \n\nCalendars of any kind, printed, including calendar \nblocks : \n\n\u2014 Calenders of \n\ntype or with \nreplaceable blocks mounted on bases other than \npaper or paperboard \n\n'perp\u00e9tuai' \n\nthe \n\n\u2014 Other \n\nSilk waste \nfor \nreeling, yarn waste and garnetted stock), carded or \ncombed \n\ncocoons unsuiuble \n\n(including \n\nManufaaure \nheading No 4909 or 4911 \n\nfrom materials not classified within \n\nManufaaure in which: \n\u2014 ail the materials used are classified within a heading \n\nother than that of the produa, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 \u00b0/o of the ex-works pnee of the produa \n\nManufacture \nheading No 4909 or 4911 \n\nfrom materials not classified within \n\nCarding or combing of silk waste \n\nMan-made suple fibres \n\nManufacture from chemical materials or textile pulp \n\nex Chapters 50 to 55 \n\n: Yarn, monofilament and thread \n\nManufacture from ('): \n\n(') For special condtiunt reining to producu rosde of * mixture of textile materials, KC muoductory nou 6 \n\n\u2014 raw silk, sQk waste, carded or combed or otherwise \n\nprocessed for spinning, \n\n\u2014 other natural fibres, not carded, combed or otherwise \n\nprocessed for spinning, \n\n\u2014 chemical materials or textile pulp, or \n\n\u2014 paper-making marenals \n\n119 \n\n\f8. 8. 88 \n\nOfficial Journal of the European Communities \n\nNo L 216/33 \n\n(l) \n\n(2) \n\n(3) \n\nex Chapter 50 \n\nto \nChapter 55 \n\nVoven fabrics: \n\u2014 Incorporating rubber thread \n\n\u2014 Other \n\nManufaaure from single yam (') \n\nManufaaure from (') : \n\u2014 coir yam, \n\u2014 natural fibres, \n\u2014- man-made staple fibres not carded or combed or \n\notherwise processed for spinning, \n\u2014 chemical materials or textile pulp, or \n\u2014 paper \nor \nPrinting accompanied by at least two preparatory or \nfinishing operations (such as scouring, bleaching, \nmercerizing, beat setting, raising, calendering, shrink \nresistance processing, permanent finishing, decaoxing, \nimpregnating, mending and burling) where the value of \nthe unprinted fabric used does not exceed 47,5 \u00b0/o of \nthe ex-works price of the produa \n\nex Chapter 56 \n\nPadding, fell and non-wovens; special yarns, twine \ncordage, ropes and cables and articles thereof \nexcept for heading Nos 5602, 5604, 5605 and 5606, \nfor which the rules are set out below \n\nManufaaure from (l): \n\u2014 coir yam, \n\u2014 natural fibres, \n\u2014 chemical materials or textile pulp, or \n\u2014 paper-making materials \n\n5602 \n\nFelt, whether or not impregnated, coated, covered \nor laminated: \n\n\u2014 Needleloom felt \n\nManufaaure from (') : \n\u2014 natural fibres, \n\u2014 chemical materials or textile pulp \nHowever: \n\u2014 polypropylene filament of heading No 5402, \n\u2014 polypropylene fibres of heading No 5503 or 5506, \n\nor \n\n\u2014 polypropylene filament tow of heading No 5501, \nof which the d\u00e9nomination in all cases of a single \nfilament or fibre is less than 9 decitex may be used \nprovided that their value does not exceed 40 Wo of the \nex-works price of the produa \n\n\u2014 Other \n\nManufaaure from (*): \n\u2014 natural fibres, \n\u2014 man-made staple fibres made from casein, or \n\u2014 chemical materials or textile pulp \n\n5604 \n\nRubber thread and cord, textile covered; textile \nyam, and strip and the like of beading No 5404 or \n5405, impregnated, coated, covered or sheathed \nwith rubber or plastics: \n\n\u2014 Rubber thread and cord, textile covered \n\nManufaaure from rubber thread or cord, not textile \ncovered \n\nC) For special conditions relating to producu made of a mixture of textile materials, sec introductory note 6. 11^ \n\nJL r\u00ab \u2022. / \n\n\f(1) \n\n5604 \n(cont'd) \n\n\u2014 Other \n\n(2) \n\n(3) \n\n5605 \n\n5606 \n\nMetallized yam, whether or not gimped, being \ntextile yam, or strip or the like of heading No 5404 \nor 5405, combined with metal in the form of \nthread, strip or powder or covered with metal \n\nGimped yam, and strip and the like of heading No \n5404 or 5405, gimped (other then those of heading \nNo 5605 and gimped horsehair yam); chenille yam \n(including flock chenille yam); loop wale-yam \n\nChapter 57 \n\nCarpets and other textile floor coverings: \n\n\u2014 Of needleloom felt \n\nManufacture from ('): \n\u2014 natural fibres not carded or combed or otherwise \n\nprocessed for spinning, \n\n\u2014 chemical materials or textile pulp, or \n\u2014 paper-making materials \n\nManufacture from('): \n\u2014 natural fibres, \n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, \n\u2014 chemical materials or textile pulp, or \n\u2014 paper-making matenals \n\nManufaaure from (') : \n\u2014 natural fibres, \n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, \n\u2014 chemical materials or textile pulp, or \n\u2014 paper-making materials \n\nManufaaure from ('): \n\u2014 natural fibres, or \n\u2014 chemical materials or textile pulp \nHowever: \n\u2014 polypropylene filament of heading No 5402, \n\u2014 polypropylene fibres of heading No 5503 or 5506, \n\nor \n\n\u2014 polypropylene filament tow of heading No 5501, \nof which the denomination in all cases of a single \nfilament or fibre is less than 9 decitex may be used \nprovided that their value does not exceed 40 % of the \nex-works pnee of the produa \n\n\u2014 Of other felt \n\nOther \n\nManufaaure from (') : \n\u2014 natural fibres not carded or combed or otherwise \n\nprocessed for spinning, or \n\n\u2014 chemical materials or textile pulp \n\nManufacture from ('): \n\u2014 coir yarn, \n\u2014 synthetic or artificial filament yarn, \n\u2014 natural fibres, or \n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning \n\n) For special condiuons rdaung to producu made of a mixture of textile materials, see introductory note 6 \n\nm \n\n\f(1) \n\n(2) \n\n(3) \n\nex Chapter 58 \n\nSpecial woven fabrics; tufted textile fabrics; lace; \ntapestries; \nfor \nheading Nos 5805 and 5810; the rule for heading \nNo 5810 is set out below: \n\nembroidery, \n\ntrimmings, \n\nexcept \n\n\u2014 Combined with rubber thread \n\nManufaaure from single yarn (') \n\n\u2014 Other \n\nManufaaure from ('); \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u00ab\u2014 chemical materials or textile pulp \n\nPrinting accompanied by at least two preparatory or \nfinishing operations \n(such as scouring, bleaching, \nmercerizing, heat setting, raising, calendering, shrink \nresistance processing, permanent finishing, decatizing, \nimpregnating, mending and burling) where the value of \nthe unprinted fabric used does not exceed 47,5 \u00b0/o of \nthe ex-works pnee of the produa \n\n5810 \n\nj Embroidery in the piece, in strips or in motifs \n\nManufacrure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the produa, and \n\n\u2014 the value of all the materials used does not exceed 50 % \n\nof the ex-works price of the product \n\n5901 \n\nfabrics coated with gum or amylaceous \nTextile \nsubstances, of a kind used for the outer covers of \nbooks or the like; tracing cloth, prepared painting \ncanvas, buckram and similar stiffened textile fabrics \nof. -> kind u<ed for hat foundations \n\nManufacture from varn \n\n59:2 \n\nTyre cord fabric of high tenacitv yarn of nylon or \nother nolyamides, polyester*, or viscose rayon \n\n\u2014 Conuining not more than ?\u2022: V: by weight of \n\nManufacture from varn \n\ntextile materials \n\nOtr \n\nfabrics \n\nTextile \ncoated, covered or \nis-^inaied with plastics, othr' than those of heading \nNi- 5902 \n\nimpregnated \n\nManufacture from chemical materials or textile pulp \n\nManufacture from varn \n\nLinoleum, whether or not cut \nfloor \ncoverings consisting of a coating or covering \napplied on a textile backing, whether or not cut to \nshape \n\nto shape, \n\nManufaaure from varn C) \n\n59C3 \n\n5904 \n\n5905 \n\nTextile wall coverings: \n\n\u2014 Impregnated, coated, covered or laminated with \n\nManufacture from varn \n\nrubber, plastics or other materials \n\nfi For specii ciimt,\u2022 \u2022\u2022 ->\u2022 rci. -uinc, to products made of. 1 m u t u rr ot :r\u00abulr materials, ice intrr\u00abjuctorv note 6 \n\n122 \n\n\f(1) \n\n5905 \n(cont'd) \n\nOther \n\n(2) \n\n(3) \n\nManufacture from ('): \n\n\u2014 coir yarn, \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or textile pulp \n\nor \nPrinting accompanied by at least two preparatory or \nfinishing operations \n(such as scouring, bleaching, \nmercerizing, heat setting, raising, calendering, shrink \nresisunce processing, permanent finishing, decatizing, \nimpregnating, mending and burling) where the value of \nthe unprinted fabric used does not exceed 47,5 Vo of \nthe ex-works price of the produa \n\nManufaaure from (') : \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or texule pulp \n\nManufaaure from chemical materials \n\nManufaaure from yarn \n\nManufaaure from yarn \n\n5906 \n\nRubberized \nheading No 5902: \n\ntextile fabrics, other than those of \n\n\u2014 Knitted or crocheted fabrics \n\n\u2014 Other fabrics made of synthetic filament yarn, \ncontaining more than 90 % by weight of textile \nmatenals \n\n\u2014 Other \n\n5907 \n\nTextile fabrics otherwise \nimpregnated, coated or \ncovered; painted canvas being theatrical scenery, \nstudio backcloths or the like \n\nex 5908 \n\nIncandescent gas mantles, impregnated \n\nManufaaure from tubular knitted gas mantle fabric \n\n5909 \nto \n5911 \n\nTextile articles of a kind suiuble for industrial use: \n\n\u2014 Polishing discs or rings other than of felt of \n\nheading No 5911 \n\n\u2014 \"Woven fabrics, of a kind commonly used in \npapermaking or other technical uses, felted or \nnot, whether or not \nimpregnated or coated, \ntubular or endless with single or multiple warp \nand/or weft, or flat woven with multiple warp \nand/or weft of heading No 5911 \n\nManufaaure from yarn or waste fabrics or rags of \nheading No 6310 \n\nManufacture from ('): \n\n\u2014 coir yarn, \n\n\u2014 from the following materials: \n\n\u2014 yarn of polytetrafluoroethylene (') ('). \u2014 yarn, multiple, of poh/amide, coated, \n\nim \n\npregnated or covered with a phenolic resin ('), \n\n\u2014 yam of synthetic texule fibres of aromatic poly \nof \n\namides, obuined \nm-phenyienediamine and isophihaiic acid (*), \n\nby polycondensation \n\n\u2014 monofil of polytetrafluoroethylene (*) ('), \n\n\u2014 yarn of synthetic textile fibres of pory-^-phe-\n\nnylene terephthalamide ('), \n\n\u2014 glass fibre yarn, coated with phenol resin and \n\ngimped with acrylic yam (*) ('), \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or textile pulp \n\n(') For special conditions relaunf. to producu made of a mixture of textile materials, see introductory nou 6. (') This provision shall apply until 31 March 1991. (') The use of this material is rcstncted to the manufacture of woven fabrics of a kind used in paper-making machinery. 123 \n\n\f(2) \n\n(3) \n\n<1> \n\n5909 \nto \n5911 \n(cont'd) \n\n\u2014 Otht \n\nChapter 60 \n\nKnitted or crocheted fabrics \n\nChapter 61 \n\nArticles of apparel and clothing accessories, knitted \nor crocheted: \n\n\u2014 Obuined by sewing \n\ntogether or otherwise \nassembling, two or more pieces of knitted or \ncrocheted fabric which have been either cut to \nform or obtained directlv to form \n\n\u2014 Other \n\nManufaaure from('): \n\n\u2014 coir yarn, \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or texule pulp \n\nManufaaure from (*) : \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or textile pulp \n\nManufaaure from yarn (') \n\nManufaaure from ('): \n\n\u2014 natural fibres, \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or textile pulp \n\nex Chapt-. -r 62 \n\nArticles of apparel and clothing accessories, not \nknitted or crocheted, except for heading Nos ex \n62:2. ex 6204, ex 6206. eit 6209, ex 6210. 6213, \n6214. ex 6216 and ex 6217 for which the rules are \nset out below \n\nManufaaure from yarn (') \n\nex 62C2 \nex 6204 \nex 6206 \nex 6209 \nand \nex 6217 \n\nex 62IC \nex 6216 \nand \nex 6217 \n\n6213 \nand \n6214 \n\nSomen's, girls' and babies' clothing and 'other \nmade-up clothing accessories', embroidered \n\nFire-resistant equipment of fabric covered with foil \nof alumimzed polyester \n\nHandkerchiefs, shawls, scarves, mufflers, mantillas, \nveils and the like: \n\nManufaaure from yam (') \n\nor \nManufacture from unembroidered fabnc provided the \nvalue of the unembroidered \nfabnc used does not \nexceed 40 \u00b0/o of the ex-works pnee of the produa (') \n\nManufacture from yarn (') \n\nor \nManufacture from uncoated fabric provided the value \nof the uncoated fabric used does not exceed 40 Vfc of \nthe ex-works pnee of the produa (') \n\nEmbroidered \n\n\u2014 Other \n\nManufacture from unbleached single yarn (') (') \n\nor \nManufaaure from unembroidered fabric provided the \nvalue of the unembroidered \nfabric used does not \nexceed 40 \u00b0/c of the ex-works once of the produa (') \n\nManufacture from unbleached single yarn (') (') \n\n(') For spe:ial conditions relating to products made cf a mixture of textile materials, see introductory note 6 \n(') See introductr-- note 7 \n\n124 \n\n\f(1) \n\n301 to 6304 \n\n(2) \n\n(3i \n\nBlankets, travelling rugs, bed linen CTC; curtains, etc. ; \nother furnishing articles \n\n\u2014 of felt, of non-wovens \n\n\u2014 Otha: \n\n\u2014 Embroidered \n\nManufacture from ('): \n\n\u2014 natural fibres, or \n\n\u2014 chemical materials or textile pulp \n\nManufaaure from unbleached single yam (Ml2) \n\nor \n\nManufacture from unembroidered fabric (other than \nknitted or crocheted) provided \nthe \nunembroidered fabric used does not exceed 40 % of the \nex-works price of the produa \n\nthe value of \n\n\u2014 Other \n\nManufaaure from unbleached single yarn (')(*) \n\n6305 \n\nSacks and bags, of a kind used for the packing of \ngoods \n\nManufaaure from('): \n\n\u2014 natural fibres, \n\n6306 \n\nTarpaulins, sails for boats, sailboards or landcraft, \nawnings, sunblinds, tents and camping goods: \n\n\u2014 Of non-wovens \n\nOtht \n\nex 6307 \n\nOther made-up articles, including dress patterns \n\n\u2014 man-made suple fibres not carded or combed or \n\notherwise processed for spinning, or \n\n\u2014 chemical materials or texule pulp \n\nManufacture from('): \n\n\u2014 natural fibres, or \n\n\u2014 chemical materials or texule pulp \n\nManufacture from unbleached single yarn (') \n\nManufaaure in which the value of all the materials \nused does not exceed 40 \u00b0/o of the ex-works price of \nthe product \n\n6308 \n\n6401 \nto \n64C5 \n\n6503 \n\n6505 \n\n6601 \n\nSet* consisting of woven fabric and yarn, whether \nor not with accessories, for making up into rugs, \nupestries-, embroidered uble cloths or serviettes or \nsim:iar textile articles, put up in packings for reuil \nsair \n\nEach item in the set must satisfy the rule which would \napply to it if it were not included in the sa. However, \nnon-originating articles may be incorporated provided \ntheir toul value does not exceed 15 \u00b0/e of the ex-works \nprice of the set \n\nF o - \" e ar \n\nFelt hats and other felt headgear, made from the \nha: bodies, hoods or plateaux of heading No 6501, \nwhether or not lined or trimmed \n\nHats and other headgear, knitted or crocheted, or \nmade up from lace, telt or other textile fabric, in \nthe piece (but not in strips), whether or not lined or \ntrimmed, hair-nets of any material, whether or not \nlined or trimmed \n\nManufacture from matenals of any heading except for \nassemblies of uppers affixed to inner soles or to other \nsole components of heading No 6406 \n\nManufacture from yarn or textile fibres (') \n\nManufacture from yarn or textile fibres \n\nUmbrellas and sun umbrellas (including walking-\nstick umbrellas, garden umbrellas and \nsimilar \nu m b r e l l a s) \n\nin which the value of all the materials \nManufaaure \nused does not exceed 5C \u00b0/o of the ex-works pnee of \nthe produa \n\n(') For special conditions relanns to products made of a mixture of textile materials, see introduaorv note 6 \n(') For knitted or crocheted articles, not elastic or rubbcnred, obtained by sewing or assembly of pieces of knitted or crocheted fabnc \u00abcut out or knitted directly to \n\nshape) see introouctory note ~ \n\n(') See introduaorv note 7 \n\n125 \n\n\fOJ \n\n(2) \n\n(3) \n\nex 6803 \n\nArticles of slate or of agglomerated slate \n\nManufaaure from worked slate \n\n6812 \n\nex 6814 \n\n7006 \n\n7007 \n\n7008 \n\n7009 \n\n7010 \n\nArrides of asbestos; articles of mixtures with a basis of \nasbestos or of mixtures with a basis of asbestos and \nmagnesium carbonate \n\nManufaaure from materials of any heading \n\nArticles of mica; including agglomerated or recon \nstituted mica on a support of paper, paperboard or \nother materials \n\nManufaaure from worked mica (including agglom \nerated or reconstituted mica) \n\nGlass of heading No 7003, 7004 or 7005, bent, \nedge-worked, \nengraved, drilled, enamelled or \notherwise worked, but not framed or fitted with \nother materials \n\nManufaaure from materials of heading No 7001 \n\nSafety glass, consisting of toughened (tempered) or \nlaminated glass \n\nManufacture from materials of heading No 7001 \n\nMultiple-walled insulating units of glass \n\nManufaaure from matenals of heading No 7001 \n\nGlass mirrors, whether or not framed, including \nrear-view mirrors \n\nManufaaure from materials of heading No 7001 \n\nCarboys, bottles, flasks, jars, pots, phials, ampoules \nand other conuiners, of glass, of a kind used for \nthe conveyance or packing of goods, preserving jars \nof glass, stoppers, lids and other closures, of glass \n\nthe materials used are \nManufaaure \nclassified within a heading other than that of the \nprodua \n\nin which all \n\nor \nCutting of glassware, provided the value of the uncut \nglassware does not exceed 3: :/: of the ex-works price \nof the product \n\n701 : \n\nGlassware of a knd used for table, kitchen, toilet, \noffice, indoor decoration or similar purposes (other \nthan :hai of heading No ~Z)Z or 7018) \n\nManufaaure \nthe matenals used are \nclassified within a heading other than that of the \nprodua \n\nin which all \n\nand \nCutting of glassware, provided the value of the uncut \nglassware does not exceed 5C \u2022!'. of the ex-works price \nof the product \n\nHand-decoration \n(with the exception of silk screen \nprinting) of hand-blown glassware, provided the value \nof the hand-blown glassware doc* not exceed 50 V: of \nthf ex-works price of the product \n\nex 701e \n\nArticles (other than yarn). \"*' glass fibres \n\nManufacture from \n\nex 7102 \nex 7103 \nand \nex 7104 \n\n7106 \n710? \nand \n711C \n\nWorked precious or semi-precious stones (natural \nsynthetic or reconstructed) \n\nManufaaure from unworked precious or semi-precious \nstones \n\nslivers, \n\nrovings. yarn or \n\nchopped \n\n\u2014 uncoloured \nstrands, or \n\n\u2014 glass wool \n\nPrecious metals: \n\n\u2014 I. 'nwrought \n\nManufaaure \nheading No 7106, 7108 or 711: \n\nfrom matenals not classified within \n\nor \nElectrolytic, thermal or chemical separation of precious \nmetals of heading No 7106. 7 i :8 or 7110 \n\nAlinving of preciouv metals ol (u-. iding No 7106. \" i :* \nIT \"MC with each other or \u00bbit!. base metaK \n\nScrrv-mar. ufactured or ;r rewder form (All) \n\nManufacture from unwrought precious metals \n\n126 \n\n\f(1) \n\nex 7107 \nex 7109 \nand \nex 7111 \n\n7116 \n\n(2) \n\n(3; \n\nMetals \nfactured \n\nclad with precious m e u l s, \n\nsemi-manu \n\nM a n u f a a u re \nunwrought \n\nfrom metals clad with precious metals, \n\nArticles of natural or cultured pearls, precious or \nsemi-precious stones (natural, synthetic or recon-\ns t r u a e d) \n\nManufacture \nin which the value of all the matenals \nused does not exceed 50 \u00b0/c of the e x - w o r ks p n ee of \nthe p r o d ua \n\n7117 \n\nImitation jewellery \n\nM a n u f a a u re \ndassified within a heading other \np r o d ua \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\n7207 \n\nSemi-finished products of \n\niron or non-alloy steel \n\nor \nfrom base metal parts, not plated or \nManufacture \ncovered with p r e d o us m e u l s, provided the value of all \nthe materials used d o es not exceed 50 \u00b0/e of the ex-\nworks price of the p r o d ua \n\nManufacture \n7 2 0 2, 7 2 0 3, 7204 or 7205 \n\nfrom materials of heading No \n\n7 2 0 1. 7208 \nto \n7216 \n\n72P \n\nex 72 IS \n7219 \nto \n7222 \n\nex 722* \n7225 \nto \n7227 \n\n7226 \n\nFla:-rolled p r o d u c u, bars and rods, angles, shapes \na rc sections of iron or non-allov steel \n\nManufacture \nheading No 7206 \n\nfrom \n\ningots or other primary \n\nforms of \n\n^T:re r>* :r?r. or n o n - a l l ov steel \n\nS<-:ni !-:i:\u00ab!ini products, \nanc \nster:. - -c \n\nflat-roller, products, bars \nangles, shapes and secuo';s of stainless \n\nstainless steel \n\nSem'-:'i-. :sned products, \nflat-rolled products, bars \nanc r c c. in irregulariy w o u nd coils, of other alloy \nstee! \n\nOihv- nars and rods of other alloy steel; angles. shape: anc sections, of other alio; \nsteel, hollow \ndni: r. irs anc rods, of alloy or non alloy steel \n\nManufacture from semi-finished materials of heading \nNo 7207 \n\nManufai tu re from \nheading No 72 ! S \n\ninp< \n\n->lhr- r'\"\". ar-. fnrrtv. Manufacture \nNo 7216 \n\nfrom semi-finished materials of heading \n\nManufacture \nheading Nc 722* \n\nfrom \n\ningots or other p-rr. ars- forms of \n\n| Manufacture \nj \n\nfrom \nheading No 7206. 72IF or 7 2 2-\n\ningots cr other pr. mary forms of \n\n722\u00b0 \n\nI \n\nI ' Vc \n\n\u2022\u2022' other allov steel \n\nManufaitj-t- \nNo 72Z * \n\nfrom semi-finishec material' of heading \n\nex 7331 \n\n73C2 \n\n73D4 \n7305 \nand \n7306 \n\nex \" 3. 0\" \n\n730F \n\n2 n e r \u2022 -i i : : n g \n\nM a n u f a c t j -e from materials of heading No 7206 \n\nRaiiw. -. y or tramway track construction material of \n,^r steel, the f o l l o w i n g: rails, check-rails and \niron \nrack rasis. switch blades, crossing frogs, point rods \nand otner crossing pieces, sleepers (cross-ties), fish \nplates, \n(base \nplatesi. rail clips, bedplates, ties and other material \nspeciah. -. ed for jointing or fixing rails \n\nchair w e d g e s, \n\nsole plates \n\nchairs, \n\nManufacture from materials of heading No 7206 \n\nT u b e ', nines and hollow- profiles, of \nlhar ras: irr. ni or steel \n\niron \n\n(other \n\nManufacture \n7207, 721* or 7224 \n\nfrom materials of heading No \"206, \n\nTube cr pipe fittings of stainle's stee! 'ISO \nNo X :CrNi. V'n l \"] 2 '. consisting nf several \nparts \n\nreaming, \n\nTurning. ' drilling, \nthreading, \ndcburring and sand-blasting of forged bianks \nthe value of which blanks dr>es not exceed \n3 5% of the ex works price of the product \n\nstructures \n\n'excluding prefabricated. ar. ice masts, roofs, roofing \n\nouildings of \nSt. -w\"_r-- \n(for \nhrac-r-r. No 9406) and parts of \nlock-gates, \ncxarr-. r'-. bridges and bridge-sections, \nt o w ; -, \nframeworks, \ndoo-s and w i - d o ws and their frame? nnd thresholds \nand \nshutters, \nfor \niron or steel; \"plates, rods, angles, \nc o l u m n s. , of \nshapes, sections, tubes and the \nfor \nuse ir structures, of iron or steel \n\nlike, prepared \n\nbalustrades, \n\ndo-vs. pillars \n\nin which all \n\nthe materials used are \nManufacture \nclassified within a heading other \nthe \nproduct Hc^e^er, welded angies. sharts and sections \nof heading No 7301 mav not be usee \n\nthat of \n\nt h a- \n\n127 \n\n\f(!) \n\n(2) \n\n(3) \n\nex 7315 \n\nSkid-chains \n\nManufaaure in which the value of all the materials of \nheading No 7315 used does not exceed 50 \u00b0/o of the \nex-works price of the product \n\nex 7322 \n\nRadiators \nheated \n\nfor central heating, not electrically \n\nManufacture in which the value of all the materials of \nheading No 7322 used does not exceed 5 % of the ex-\nworks price of the product \n\nex Chapter 7* \n\nCopper and articles thereof, except for heading \nNos 74C1 to 7405; the rule for heading No ex 7403 \nis se: out below \n\nManufacture in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the produa. and \n\n\u2014 the value of al! the materials used does not exceed \n\n5: c/o of the ex-works price of the orodua \n\nex 7 4 -: \n\nC\"T>r*r- allovs. unwroug!1 \n\nManufacture \nwaste and scrap \n\nfrorr. -efinec corner, unwrought. o: \n\nex Chapter 7 5 \n\nNickel and articles thereof, except for heading N-J>S \n\u2022 ? :i to \" 5 : 3. Manufacture in which \n\n\u2014 all the materials used arc classified within a heading \n\nother than that of '. he product, and \n\n\u2014 the value of ai! the mate-:. -\u00bb!- -. -s-c coe< not rxcerd \n\n1T \"'- of the (\u2022\u00bb\u2022*. '\u2022\u2022\u2022. :--!'. ?\u2022 ~'. -:v p'. <du;-. ex Chapter \n\nAluminium and articles thereof, except for heading \nN'n' \"rOl, \"602 and c\\ \"616; :he rules for heading \nNos ~n01 and ex 761* are se: o,it below \n\n76<M \n\n\u2022wrought aiurriniu-n \n\nex 7616 \n\ncloth. \u2022Viuminium amcles other thar. tar. gauze, cloth, gnil. netting, \nfencing, reinforcin; \nfabric and similar \nlg \nmaterials (including endless bands) of aluminium \nwire, and expanded metal of aluminium \n\n1 Manufacture in which: \n\n! \u2014 all the materials used are classified wirhin a heading \n; \n\nother thar. rha: of the product, and \n\nl \u2014 the value of all the materials used does not exceed 50 % \nj \n\nof the ex-works price of the produa \n\nj Manufacture by thermal or electrolytic treatment from \nun. illoyed aluminium or waste and scrap of aluminium \n\nManufacture in which \n\n\u2014 ail the matenals used are classified within a heading \nother than that of the product. However, gauze, \ncloth, grill, netting, fencing, reinforcing fabric and \nsimilar materials \nendless bands) of \n(including \naluminium wire. or expanded metal of aluminium \n\u2022\u2022'. a-, be used, ant! \n\n\u2014 the value of all the matenals used does not exceed \n\nf : V: of the ex-works prtce of -. he produa \n\nex Chapter 7\u00a5 \n\nLead and amcles thereof. exrcpi for heading Nos \n' - !! and 7R:2: the rule for h-adtng No T*CI is set. ' Manufacture ir. which \nI \n\u2022 \u2014 a. : the materials usee arc class'* -. -c wnhir. a heading. ,. , \n\n, \n\n, \n\n, \n\n, \n\nother than :na: of the Droauc:. ar. d \n\nj \u2014 the value of all :he materials used does not exceed \n;: '\u2022': of the ex-wnrK. s price '\"\u00bbf *nr product \n\n9) \n\n128 \n\n\f(1) \n\n(2) \n\n(3) \n\n7801 \n\nUnwrought lead: \n\n\u2014 Refined lead \n\n\u2014 Other \n\nex Chapter 79 \n\nZinc and articles thereof, except for heading Nos \n7901 and 7902; the rule for heading No 7901 is set \nout below \n\n7901 \n\nUnwrought zinc \n\nex Chaoter 8: \n\nTin and articles thereof, except for heading Nos \n8001. 8002 and 8007; the rule for heading No 8001 \nis set out below \n\n8001 \n\nUnwrought tin \n\nex Chapter 81 \n\nOther base meuls, wrought; articles thereof \n\n8206 \n\nTools of two or more of the heading Nos 8202 to \n8205, put up in sets for retail sale \n\nManufaaure from 'bullion' or 'work' lead \n\nManufaaure \nin which all the materials used are \nclassified within a heading other than that of the \nproduct. However, waste and scrap of heading No \n7802 may not be used \n\nManufacture in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the product, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 % of the ex-works price of the produa \n\nin which all \n\nManufaaure \nthe materials used are \nclassified within a heading other than that of the \nprodua. However, waste and scrap of heading No \n7902 may not be used \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the produa, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 % of the ex-works pnee of the produa \n\nin which all \n\nManufaaure \nthe matenals used are \nclassified within a heading other than that of the \nproduct. However, waste and scrap of heading No \n8002 may not be used \n\nManufaaure in which the value of all the matenals \nclassified within the same heading as the products used \ndoes not exceed 50 \u00b0/o of the ex-works price of the \nprodua \n\nin which all \n\nManufaaure \nthe materials used are \nclassified within a heading other than heading Nos \n8202 to 8205. However, tools of heading Nos 8202 to \n8205 may be incorporated into the set provided their \nvalue does not exceed 15 % of the ex-works pnee of \nthe s\u00ab \n\n8207 \n\nInterchangeable tools for hand tools, whether or \n(for \nnot power-operated, or for machine-tools \nexample, for pressing, stamping, punching, tapping, \nthreading, drilling, boring, broaching, milling, \nturning or screwdrrving), including dies for drawing \nor extruding metal, and rock-drilling or earth-\nboring tools \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the product, and \n\n\u2014 the value of all the matenals used does not exceed \n\n40 \u00b0/e of the ex-works pnee of the produa \n\n82CP \n\nKnives and cutting blades, for machines or for \nmechanical appliances \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the product, and \n\n\u2014 the value of all the matenals used does not exceed \n\n40 \u00b0/o of the ex-works price of the product \n\n129 \n\n\f(1) \n\nex 8211 \n\n8214 \n\n8215 \n\n(2) \n\n(3) \n\nKnives with cutting blades, serrated or not (includ \ning pruning knives), other than knives of heading \nNo 8208 \n\nManufaaure in which all the materials used are classi \nfied within a heading other than that of the product \nHowever, knife blades and handles of base metal may \nbe used \n\nOther articles of cudery (for example, hair clippers, \nbutcher's or kitchen cleavers, choppers and mincing \nknives, paper knives); manicure or pedicure sets \nand instruments (including nail files) \n\nManufaaure in which all the materials used are classi \nfied within a heading other than that of the produa. However, handles of base metal may be used \n\nSpoons, forks, ladles, skimmers, cake-servers, fish-\nknives, butter-knives, sugar tongs and similar kit \nchen or tableware \n\nManufaaure in which all the materials used are classi \nfied within a heading other than that of the produa \nHowever, handles of base metal may be used \n\nex 8306 \n\nStatuettes and other ornaments, of base metal \n\nManufaaure in which all the materials used are classi \nfied within a heading other than that of the produa. However, the other materials of heading No 8306 may \nbe used provided their value does not exceed 30 \u00b0/o of \nthe ex-works price of the produa \n\nHS heading No j \n\nDescription of product \n\n'Working or processing carried out on non-onginaung materials \nthat confers origmaung status \n\n(11 \n\n(21 \n\n(3) \n\nrx Chaptrr S 4 \n\nNuclru \nreactors ('), boilers, ma \nchiner, and mechanical appliances, \nparts thereof: except for those fall \ning within the following headings \n! or parts of headings for which the \n\nrules are set out below. j 84:;. S4C3. ex 8404, 8406 to 84C9. i 8-\u00bb!l, 6412, ex 8413, ex 8414, \n! 8415. 8418, ex 8419, 8420, 8423. i 8425 to 8430, ex 8431, 8439, 84*1. i M44 to 8447, ex 8448, 8452, 8456 \nj to $*6b. 8469 to 8472, R480. 8<. s2. S4M and 8485 \n\nManufaaure \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n4C 7c of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare onlv used up to a value of \n5 \u00b0/e of the ex-works price of \nthe product \n\nManufacture \nin which the value of \nall the matenals used does not ex \nceed 30 s/e of the ex-works price of \nthe product \n\n8402 \n\nSteam or other vapour generating \nboilers 'other than central heating \nhot water boilers capable also oi \nproducing \nsteam), \nlow preasure \nsuper heated water boilers \n\n8403 \nand \nex 8404 \n\nCentral heating boilers, other than \nthose of heading No 8402, and \nauxiliary plant for central heating \nboilers \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 -/o of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare onlv used up to a value of \n5 \u00b0/o ot the ex-works price of \nthe produa \n\nManufaaure in which all the ma \nterials used are classified within a \nheading other than heading No \n8403 or 8404. However, materials \nwhich are classified within heading \nNo 8403 or 8404 may be used pro \nvided their value, taken together, \ndoes not exceed 5 % of tne ex-\nworks pnee of the product \n\nManufacture \nin which the value of \nall the materials used does not ex \nceed 25 6/e of the ex-works pnee of \nthe produa \n\nManufaaure \nin which the value of \nall the matenals used does not ex \nceed 40 \u00b0/c of the ex-works price of \nthe product \n\nISO \n\n\f(1) \n\n8406 \n\n8407 \n\n8406 \n\n8409 \n\n(2) \n\n(3) \n\n(4) \n\nSteam turbines and other vapour \nturbines \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 -/o of the ex-works price of \nthe produa \n\nSpark-ignition \nrotary \nengines \n\nor \ninternal combustion piston \n\nreciprocating \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe produa \n\nCompression-ignition internal com \nbustion piston engines (diesel or \nsemi-diesel engines) \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe produa \n\nParts suitable for use solely or prin \ncipally with the engines of heading \nNo 8407 or 8408 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 % of the ex-works price of \nthe produa \n\n8411 \n\nTurbo-jets, \nother gas turbines \n\nturbo-propellers \n\n8412 \n\nOther engines and motors \n\nand \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 6/o of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare onlv used up to a value of \n5 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe product \n\nex 8413 \n\nRotary positive, displacement pumps \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/c of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified \nin the \nsame heading as the produa are \nonly used up to a value of 5 \u00b0/e \nof the ex-works price of the \nprodua \n\nex 8414 \n\nIndustrial fans, blowers and the like \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/o of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare onlv used up to a value of \n5 6/c of the ex-works price of \nthe product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 25 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 \u00b0/o of the ex-works price of \nthe produa \n\n131 \n\n\f(2) \n\n(3) \n\n(4) \n\nAir conditioning machines, com \nprising a motor-driven fan and ele \nments for changing the temperature \nand humidity, including those ma \nchines in which the humidity can \nnot be seperatery regulated \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe produa \n\n(U \n\n8415 \n\n8418 \n\nfreezers and other \nRefrigerators, \nrefrigerating or \nequip \nment, electric or other heat pumps \nother than air conditioning ma \nchines of heading No 8415 \n\nfreezing \n\nex 8419 \n\nMachines for the wood, paper pulp \nand paper board industnes \n\n842: \n\nCalendering or other rolling ma \nchines, other than for metals or \nglass, and cylinders therefor \n\n8423 \n\nw'eighing machinery \n(excluding \nbalances of a sensitivity of 5 eg or \nbetter), \nincluding weight-operated \ncounting or checking machines; \nweighing machine weights of all \nkinds \n\nManufaaure \nin which the value of \nall the matenals used does not ex \nceed 25 \u00b0/e of the ex-works price of \nthe produa \n\nManufacture in which the value of \nall the materials used does not ex \nceed 3C -/: of the ex-works price of \nthe product \n\nin which the value of \nManufaaure \nall the matenals used does not ex \nceed 30 \u00b0/c of the ex-works price of \nthe product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 \u00b0/c of the ex-works pnee of \nthe product \n\nManufaaure: \n\n\u2014 in *\u2022\u2022- rh the value of all the \nis used does not exceed \n-f the ex-works price of \nduct, and \n\nm: * \n4C \nthe \n\n\u2014 wh- \n\nwithin the above limit, \nthe materials classified within \nthe same heading as the produa \nare onlv used up to a value of \n5 \u00b0/o of the ex-works price of \nthe product, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nthe value of the \nnot exceed \noriginating materials used \n\nManufacture: \n\n\u2014 in which the value of all the \nmatenals used docs not exceed \n40 -/: of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \narc only used up to a value of \n25 \u00b0/c of the ex-works price of \nthe produa \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/c of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n25 \u00b0/e of the ex-works price of \nthe produa \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 V: of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare onlv used up to a value of \n5 \u00b0/: of the ex-works price of \nthe product \n\n1 ?9 \n\nJ. \u00ab-* rW \n\n\f(0 \n\n8425 \nto \n8428 \n\n8429 \n\n843C \n\n(2) \n\n(\u00bb \n\n(*) \n\nLifting, handling, \nloading machinery \n\nloading or un \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 % of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8431 are only used \nup to a value of 5 Vo of the ex-\nworks price of the produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 \u00b0/b of the ex-works price of \nthe produa \n\nSelf-propelled bulldozers, angle-\ndozers, graders, levellers, scrapers, \nmechanical \nexcavators, \nshovels, \nshoval \nloaders, temping machines \nand road rollers: \n\n\u2014 Road rollers \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works pnee of \nthe produa \n\nOther \n\nManufaaure : \n\nlevelling, \nOther moving, grading, \ntemping, \nexcavating, \nscraping, \ncompacting, extracting or boring \nmachinery, for earth, minerals or \nores, pile-driven and pile-extraa-\nors, \nsnow-\nblowers \n\nsnow-ploughs \n\nand \n\nex 8431 \n\nPans for road rollers \n\n8439 \n\nMachinery \nfor making pulp of \nfibrous cellulosic material or for \nmaking or finishing paper or paper-\nboard \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/o of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe value of the materials classi \nfied within heading No 8431 \nare only used up to a value of \n5 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/c of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe value of the materials classi \nfied within heading No 8431 \nare only used up to value of \n5 % of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 \u00b0/o of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit,' \nthe materials classified within \nthe same heading as the product \nare only used up to a value of \n25 \u00b0/e of the ex-works price of \nthe produa \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 \u00b0/o of the ex-works price of \nthe produa \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 \u00b0/c of the ex-worki price of \nthe product \n\nManufaaure in which the vaJue of \nall the materials used does not ex \nceed 30 \u00b0/o of the ex-works price of \nthe produa \n\n133 \n\n\f(1) \n\n8441 \n\n8444 \nto \n8447 \n\nex 8448 \n\n8452 \n\n8456 \nto \n8466 \n\n8469 \nto \n8472 \n\n(2) \n\n(3; \n\n(4) \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nOther machinery for making up \npaper pulp, paper or paperboard, \nincluding cutting machines of all \nkinds \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 % of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n25 Vo of the ex-works price of \nthe produa \n\nMachines of these headings for use \nin the textile industry \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nAuxiliary machinery for use with \nmachines \nfor heading Nos 8444 \nand 84*5 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works price of \nthe product \n\nSewing machines, other than book \nsewing machines of heading No \n8440; furniture, bases and covers \nspecially desig ;d for sewing ma \nchines; sewing machine needles. Sewing machines \n(lock stitch \nonly\u00bb with heads of a weight \nnot exceeding 16 kg without \nmotor or 17 kg with motor \n\nOther \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 % of the ex-works price of \nthe product. \u2014 w-here the value of all of the \nnon-originating materials used \nin assembling the head (without \nmotor) does not exceed \nthe \nvalue of \nthe originating ma \nterials used, and \n\n\u2014 the thread tension, crochet and \nzigzag mechanisms used are al \nready originating \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 \u00b0/: of the ex-works price of \nthe product \n\nMachine-tools and machines and \ntheir parts and accessories of head \ning Nos 8456 to 8466 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 % of the ex-works price of \nthe product \n\n(for \n\nOffice machines \nexample, \ntypewriters, calculating machines, \ndata-processing ma \nautomatic \nchines, \nmachines, \nstapling machines) \n\nduplicating \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 % of the ex-works price of \nthe product \n\n134 \n\n\f(1) \n\n8480 \n\n(2) \n\n(3) \n\n(\u00ab) \n\nMoulding boxes for metal foundry; \nmould bases; moulding patterns; \nmoulds for metal (other than ingot \nmoulds), metal \ncarbides, glass, \nmineral materials, rubber or plastics \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 50 Vo of the ex-works price of \nthe product \n\nManufacture in which the value of \nall the materials used does not ex \nceed 25 V\u00bb of the ex-works price of \nthe produa \n\n8482 \n\nBall or roller bearings \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe produa \n\n8484 \n\n6485 \n\nGaskets and similar joints of metal \nsheeting combined with other ma \nterial or of two or more layers of \nmetal; sets or assortments of gas \nkets and similar joints, dissimilar in \ncomposition, put up \nin pouches, \nenvelopes or similar packings \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 % of the ex-works pnee of \nthe product \n\nMachinery parts, not containing \nelectrical \ninsulators, \nconneaors, \ncoils, contacts or other electrical \nfeatures, not specified or included \nelsewhere in this chapter \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 \u00b0/o of the ex-works pnee of \nthe produa \n\nex Chapter 85 \n\nElectrical machinery and equipment \nand pans thereof; sound recorders \nand reproducers, television \nimage \nand sound recorders and repro \nducers and parts afid accessories of \nsuch articles; except for those fall \ning within the following headings \nor parts of headings for which the \nrules are set out below: \n\n8501, 8502, ex 8518, 8519 to 8529, \n8535 to 8537, ex 8541, 8542, 8544 \nto 8548 \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works pnee of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe produa \n\nManufacture \nin which the value of \nall the materials used dots not ex \nceed 30 vc of the ex-works pnee of \nthe produa \n\n8501 \n\nI Electric motors and generators (ex-\n! eluding generating sets) \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8503 are only used \nup to a value of 5 Vo of the ex-\nworks price of the product \n\n135 \n\n\f\"> \n\n8502 \n\nElearic generating sets and rotary \nconverters \n\n(2j \n\n(3) \n\n(4) \n\nManufacture in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8501 or 8503, \ntaken together, are only used \nup to a value of 5 Vo of the ex-\nworks price of the produa \n\nManufaaure : \n\nManufaaure in which: \n\n\u2014 the value of all the materials used \ndoes not exceed 25 Vo of the ex-\nworks price of the product, and \n\n\u2014 the value of all the transistors of \nheading No 8541 used does not \nexceed 3 Vo of the ex-works price \nof the product \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed \nthe \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the transistors \nof headine No 8541 used does \nnot exceed 3 Ve of the ex-works \nprice of the product \n\nex 8518 \n\nMicrophones and stands therefor; \nloudspeakers, whether \nnot \nmounted in their enclosures; audio \nfrequency electric amplifiers; elec \ntric sound amplifier sets \n\nor \n\n8519 \n\nTurntables irecord-decks), record-\nplayers. cassette-players and other \nsound reproducing apparatus, not \nincorporating a sound recording \ndevice \n\nElectric gramophones \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 V: of the ex-works price of \nthe product, \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed \nthe \nongtnating materials used, and \n\nthe value of \n\n\u2014 the value of all the transistors \nof heading No 8541 used does \nnot exceed 3 % of the ex-works \nprice of the product \n\n\u2014 Othc \n\nManufaaure : \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vc of the ex-works price of \nthe produa, \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed \nthe \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the transistors \nof headine No 654 i used does \nnot exceed 3 Vc of the ex-works \nprice of the product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 Vc of the ex-works price of \nthe product \n\nManufaaure \nin which the value of \nall the matenals used does not ex \nceed 30 Vc of the ex-works price of \nthe produa \n\n136 \n\n\f(2) \n\n(3) \n\n(4) \n\n(1) \n\n8520 \n\nMagnetic tape recorders and other \napparatus, \nsound \nwhether or not \nincorporating a \nsound reproducing device \n\nrecording \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 % of the ex-works price of \nthe produa \n\nManufaaure: \n\nin which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\nwhere the value of all the non-\noriginating materials used does \nnot exceed the value of the \noriginating materials used, and, \n\nthe value of all the transistors \nof headine No 8541 used does \nnot exceed 3 % of the ex-works \nprice of the produa \n\nManufaaure : \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed \nthe value of the \noriginating materials used, and \n\n\u2014 the value of all the transistors \nof heading No 854 1 used does \nnot exceed 3 Vo of the ex-works \nprice of the produa \n\n8521 \n\nVideo recording or reproducing \napparatus \n\n8521 \n\nPans and accessories of apparatus \nof heading Nos 8519 to 8521 \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works price of \nthe produa \n\n8523 \n\n8524 \n\nPrepared unrecorded media \nfor \nsound recording or similar recor \nding of other phenomena, other \nthan products of Chapter 37 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nRecords, tapes and other recorded \nmedia for sound or other similarly \nincluding \nphenomena, \nrecorded \nmatrices and masters for the pro-\nduaion of records, but excluding \nproducts of Chapter 37: \n\n\u2014 Matrices and masters for the \n\nproduction of records \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\n\u2014 Other \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8523 are only used \nup to a value of 5 Vo of the ex-\nworks price of the. product \n\nin which the value of \nManufaaure \nall the materials used does not ex \nceed 30 Vc of the ex-works price of \nthe produa \n\n137 \n\n\f(I) \n\n8525 \n\n(2) \n\n(3) \n\nTransmission apparatus for radio-\ntelephony, radio-telegraphy, radio \nbroadcasting or television, whether \nreception \nor \nincorporating \nrecording or \napparatus or sound \nreproducing \ntelevision \ncameras \n\napparatus; \n\nnot \n\nManufaaure: \n\nManufaaure in which: \n\n\u2014 the value of all the materials used \ndoes not exceed 25 Vo of the ex-\nworks price of the p r o d u a, and \n\n\u2014 the value of ail the transistors of \nheading No 8541 used does not \nexceed 3 Vo of the ex-works price \nof the p r o d ua \n\nin which- the value of all the \nmatenals used does not exceed \n40 % of the ex-works price of \nthe product, \n\nwhere the value of all the non-\noriginating materials used does \nnot exceed \nthe \noriginating materials used, and \n\nthe value of \n\nthe value of all the transistors \nof headinr No 8541 used does \nnot exceed 3 Vo of the ex-works \nprice of the product \n\nManufaaure: \n\nManufaaure in which: \n\n\u2014 the value of all the materials used \ndoes not exceed 25 Vo of the ex-\nworks price of the p r o d u a, and \n\n\u2014 the value of all the transistors of \nheading No 8541 used does not \nexceed 3 Vc of the ex-works price \nof the product \n\n\u2014 in which the value of all the \nmatenals used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\n\u2014 where the value of all the non-\noriginaung materials used does \nnot exceed \nthe \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the \n\ntransistors \nof heading No 8541 used does \nnot exceed 3 Vo of the ex-works \nprice of the product \n\nManufacture \n\nManufacture in which \n\n\u2014 the value of all the matenals used \ndoes not exceed 25 Vc of the ex-\nworks price of the product, and \n\n\u2014 the value of ali the transistors of \nheading No 8541 used does not \nexceed 3 V: of the ex-works pnee \nof the product \n\n\u2014 in which \n\nthe value of all the \nmaterials used does not exceed \n4: V; of the ex-work? price of \nthe product, \n\n\u2014 where the value of al! the non-\nonginating materials used does \nthe \nnot exceed \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the \n\ntransistors \nof heading No 854 1 used does \nnot exceed 3 Vc of the ex-works \nprice of the product \n\n8526 \n\nRadar apparatus, radio navigational \naid apparatus and \nremote \ncontrol apparatus \n\nradio \n\nfor \n\napparatus \n\nradio-telegraphy \n\nradio \nKr('-p:uin \nu-iephon;. or \nradio-b-rvadcasung. whether or no: \nthe same housing. combined, \nwnh \nrepro-\nrecording or \nducng apparatus or a clock \n\nsound \n\nin \n\n852' \n\n8528 \n\nand \n\nreceivers \n\nmonitors \n\nTelevision \nvideo \nprojeaors), \ncombined, \nwith \nsound or video recording or repro \nducing apparatus: \n\n(including \nvideo \nwhether \nnot \nthe same housing, \nreceivers or \n\nin \nradio-broadcast \n\nor \n\n\u2014 Video recording or reproducing \napparatus incorporating a video \ntuner \n\nManufacture: \n\n\u2014 in which \n\nthe value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, \n\nin which the value of \nManufaaure \nall \nthe matenals used does not \nexceed 30 Vc of the ex-works price \nof the product \n\n138 \n\n\f(1) \n\n8528 \n(cont'd) \n\n(2) \n\n(3) \n\n(\u00ab) \n\nwhere the value of all the non-\noriginating materials used does \nthe \nnot exceed \nonginating materials used, and \n\nthe value of \n\nthe value of all the transistors \nof headint No 8541 used does \nnot exceed 3 Vo of the ex-works \nprice of the p r o d ua \n\n\u2014- Other \n\nManufaaure : \n\nManufaaure in which: \n\n\u2014 the value of all the materials used \ndoes not exceed 25 Vo of the ex-\nworks price of the product, and \n\n\u2014 the value of all the transistors of \nheading No 8541 used does not \nexceed 3 Vo of the ex-works price \nof the p r o d ua \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\n\u2014 where the value of all the non-\noriginating materials used does \nthe \nnot exceed \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the transistors \nof heading No 8541 used does \nnot exceed 3 Vo of the ex-works \nprice of the product \n\n8529 \n\nPans suitable for use solely or prin-\ncipallv with the apparatus of head \ning Nos 8525 to 8528 \n\nSuitable for use solely or princi \npally with video recording or \nreproducing apparatus \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe p r o d ua \n\n\u2014 Other \n\nManufaaure: \n\nManufaaure in which: \n\n8535 \nand \n8536 \n\nElearical apparatus for switching \nor proteaing elearical circuits, or \nin \nfor making connections \neleancal circuits \n\nto or \n\n\u2014 the value of all the materials used \ndoes not exceed 25 Vo of the ex-\nworks price of the p r o d u a, and \n\n\u2014 the value of all the transistors of \nheading No 8541 used does not \nexceed 3 Vo of the ex-works price \nof the p r o d ua \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe p r o d ua \n\n\u2014 in which \n\nthe value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed \nthe \noriginating materials used, and \n\nthe value of \n\n\u2014 the value of all the transistors \nof heading No 8541 used does \nnot exceed 3 Vo of the ex-works \nprice of the p r o d ua \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe matenals classified within \nheading No 8538 are only used \nup to a value of 5 Vo of the ex-\nworks price of the product \n\n139 \n\n\f(1) \n\n8537 \n\nex 8541 \n\n(2) \n\n(3) \n\n(4) \n\nBoards, panels (including numerical \ncontrol panels), consoles, desks, \ncabinets and other bases, equipped \nwith two or more apparatus of \nheading No 8535 or 8536, for elec \ntric control or the distribution of \nelectricity, \nincor \nporating instruments or apparatus \nof Chapter 90, other than switching \napparatus of heading No 8517 \n\nincluding those \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8538 are only used \nup to a value of 5 Vo of the ex-\nworks price of the produa \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 % of the ex-works price of \nthe produa \n\ntransistors \n\nDiodes, \nsemi-conductor \nwafers not ya cut into chips \n\nand \ndevices, \n\nsimilar \nexcept \n\nManufaaure \nin which the value of \nall the matenals used does not ex \nceed 25 Vo of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the pro \nducts are only used up to a \nvalue of 5 Vo of the ex-works \nprice of the product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 Vo of the ex-works pnee of \nthe product \n\n8542 \n\nElectronic \nmicroassemblies \n\nintegrated circuits and \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works pnee of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 8541 or 8542, \ntaken together, are only used \nup to a value of 5 Vc of the ex-\nworks price of the produa \n\nManufacture in which the value of \nall the materials used does not ex \nceed 4C Vc of the ex-works price of \nthe product \n\nj Insulated (iecluding enamelled or \nj anodized) wire, cable \n(including \nI ro-axial cable) and other insulated \nelectric conductors, whether or not \nfitted with conneaors; optical fibre \ncables, made up of \nindividually \nsheathed fibres, whether or not as \nsembled with electric conduaors or \nfitted with connectors \n\nCarbon elearodes, carbon brushes, \nlamp carbons, battery carbons and \nother articles of graphite or other \ncarbon, with or without metal, of a \nkind used for elearical purposes \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\n8544 \n\n8545 \n\n8546 \n\nElectrical insulators of anv material \n\nManufacture in which the value of \na!) the materials used does not ex \nceed 40 Vc of the ex-works price of \nthe produa \n\n140 \n\n\f(1) \n\n8547 \n\n8548 \n\n8601 \nto \n8607 \n\n8608 \n\n(2) \n\n(3) \n\n(4) \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe p r o d ua \n\nfrom \n\nInsulating fittings for electrical ma \nchines, appliances or equipment, \nbeing fittings wholly of insulating \nmaterial apart \nany minor \ncomponents of metal (for example, \nthreaded socket) incorporated dur \ning moulding solely for purposes of \nassembly outer \ninsulators of \nheading No 8546; electrical con \nduit tubing and joints therefor, of \nbase metal \ninsulating \nlined with \nmaterial \n\nthan \n\nElectrical parts of machinery or ap \nparatus, not specified or \nincluded \nelsewhere in this chapter \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nRailway or \nrolling-stock and parts thereof \n\ntramway \n\nlocomotives, \n\nRailway or tramway track fixtures \nand fittings; mechanical (including \nsignalling, \nelectromechanical) \nsafety or traffic control equipment \nfor railways, tramways, roads, in \nland waterways, parking facilities, \npor. installations or airfields; pans \nof the foregoing \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 4 0% of the ex-works price of \nthe p r o d ua \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe p r o d u a, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare onlv used up to a value of \n5 Vo of the ex-works price of \nthe product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 % of the ex-works pnee of \nthe p r o d ua \n\n8609 \n\nContainers \ncontainers \n(including \nfor the transport of fluids) specially \ndesigned and equipped for carnage \nby one or more modes of transpon \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nex Chapter 8' \n\n8709 \n\nthan \n\nrailway or \nVehicles other \nrolling-stock and parts \ntramway \nand accessories thereof; except for \nthose falling within the following \nheadings or parts of headings for \nwhich the rules are set out below: \n8709 to 8711, ex 8712, 8715 and \n8716 \n\nor \n\ntrucks, self-propelled, not \nV o r ks \nhandling \nlifting \nfitted with \nequipment, of the type used in fac \ntories, warehouses, dock areas or \nairports for short distance transpon \nof goods; t r a a o rs of the type used \non railway station platforms, pans \nof the foregoing vehicles \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vb of the ex-works price of \nthe p r o d ua \n\nManufaaure : \n\n\u2014 in which the value of ail the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe p r o d u a, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare only used up to a value of \n5 Vo of the ex-works pnee of \nthe p r o d ua \n\nManufacture \nin which the value of \nall the matenals used does not ex \nceed 30 Vo of the ex-works price of \nthe p r o d ua \n\n141 \n\n\f( Il \n\n8710 \n\n(2) \n\n(3) \n\n(4) \n\nTanks and other armoured fighting \nvehicles, motorized, whether or not \nfitted with weapons, and parts of \nsuch vehicles \n\nManufaaure : \n\nin which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\nwhere, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 % of the ex-works price of \nthe produa \n\nManufacture in which the value of \nall the materials used does not ex \nceed 30 Vc of the ex-works price of \nthe produa \n\n8711 \n\nMotorcycles \n(including mopeds) \nand cycles fitted with an auxiliary \nmotor, with or without side-cars; \nside-cars: \n\n\u2014 With \n\nreciprocating \n\ninternal \ncombustion piston engine of a \ncylinder capacity: \n\n\u2014 Not exceeding 50 cc \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed the value of the ori \nginating materials used \n\nExceeding 50 cc \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vc of the ex-works price of \nthe produa, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed the value of the on-\nginating materials used \n\nOther \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vb of the ex-works price of \nthe product, and \n\n\u2014 where the value of all the non-\nonginatine materials used does \nnot exceed the value of the ori \nginating matenals used \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 20 Vo of the ex-works pnee of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 25 Vc of the ex-works price of \nthe produa \n\nManufacture in which the value of \nall the matenals used does not ex \nceed 30 Vo of the ex-works pnee of \nthe produa \n\nex 8712 \n\nBicycles without ball bearings \n\nManufaaure from materials not \nclassified within heading No 8714 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\n142 \n\n\f(1) \n\n(2) \n\n(3) \n\n(4) \n\n8715 \n\nBaby carriages and paru thereof \n\nManufaaure: \n\n8716 \n\nTrailers and semi-trailers; other ve \nhicles, not mechanically propelled; \npans thereof \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 % of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe product \n\n8801 \nand \n8802 \n\n8803 \n\n8804 \n\nBalloons and dirigibles; aircraft; \nspacecraft and spacecraft \nlaunch \nvehicles \n\nManufaaure in which all the mate \nrials used are classified within a \nheading other than that of the pro \ndua \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works price of \nthe produa \n\nPans of goods of heading No 8801 \nor 88:2 \n\nManufaaure in which the value of \nall the materials of heading No \n8803 used does not exceed 5 Vo of \nthe ex-works price of the produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works pnee of \nthe produa \n\nParachutes \ndirigible \n(including \nparachutes) and rotochutes, parts \nthereof and accessories thereto: \n\n\u2014 Rotochutes \n\n\u2014 Other \n\nManufaaure from materials of any \nheading including other materials \nof heading No 8804 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials of heading No \n8804 used does not exceed 5 Vo of \nthe ex-works price of the produa \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\n8805 \n\nAircraft launching gear; deck-arre-\nstor or similar gear; ground flying \ntrainers; parts of the foregoing arti \ncles \n\nManufaaure in which the value of \nall the materials of heading No \n8805 used does not exceed 5 Vo of \nthe ex-works price of the produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\nChapter 89 \n\nShips, boats and floating struaures \n\nManufaaure in which all the mate \nrials used are classified within a \nheading other than that of the pro \ndua However, hulls of heading \nNo 8906 may not be used \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\n14i3 \n\n\f(1) \n\n(2) \n\n(3) \n\n<*) \n\nex Chapter 90 \n\nOptical, photographie, cinemato \ngraphic, measuring, checking, pre \ncision, medical or surgical instru \nments and apparatus; pans and ac \ncessories thereof; except for those \nfalling within the following hea \ndings or parts of headings \nfor \nwhich the rules are set out below: \n\n9001, 9002, 9004, ex 9005, ex \n9006, 9007, 9011, ex 9014, 9015 to \n9020 and 9024 to 9033 \n\nManufacture : \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 30 % of the ex-works price of \nthe product \n\n9001 \n\n9002 \n\nfibres and optical \n\nOptical \nfibre \nbundles; optical fibre cables other \nthan those of heading No 8544; \nsheets and plates of polarizing ma \nterial; lenses (including contact len \nses), prisms, mirrors and other op \ntica! elements, of any material, un \nmounted, other than such elements \nof glasrs not optically worked \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nLenses, prisms, mirrors and other \noptical elements, of anv material, \nmounted, beir. ,. parts of or fittings \nfor instruments or apparatus, other \nthan such elements of glass not op-\nticallv worked \n\nManufacture in which the value of \nall the materials used does not ex \nceed 4C Vo of the ex-works price of \nthe produa \n\n9o:4 \n\nSpectacles, goggles and the \ncorrective, protective or other \n\nike. Manufacture in which the value of \nall the materials used does not ex \nceed 4C Vc of the ex-works price of \nthe product \n\nex 9005 \n\n! Binoculars, monoculars, other opti-\n, ca! telescopes, and mountings the \nrefor, except for astronomical re \nfracting telescopes and mountings \n\ni therefor \n\nPhotographic (other than cinema \ntographic i cameras, photographic \nflashlight apparatus and flashbulbs \nother \nignited \nflashbulbs \n\nelectricallv \n\nthan \n\nex 9 Xo \n\n(10) \n\nManufaaure \nin which the value of \nall the matenals used does not ex \nceed 30 Vo of the ex-works price of \nthe product \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vc of the ex-works price of \nthe produa, \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare only used up to a value of \n5 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed the value of the ori \nginating materials used \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 V: of the ex-works price of \nthe product. Manufacture \nin which the value of \nall the materials used does no: ex \nceed 3C V: of the ex-works price of \nthe product \n\n144 \n\n\f(1) \n\n(2) \n\n(3) \n\n(<\u00ef \n\nex 9006 \n\n(cont'd) \n\n9007 \n\nCinematographic cameras and pro-\njeaors, whether or not incorpora \nting sound recording or reprodu \ncing apparatus \n\n9011 \n\nCompound optical microscopes, in \ncluding those for photomicrogra \nphy, cinephotomicrography or mi-\ntroprojection \n\nwhere, within the above limit, \nthe materials classified within \nthe same heading as the product \nare only used up to a value of \n5 Vo of the ex-works price of \nthe product, and \n\nwhere the value of all the non-\noriginaung materials used does \nnot exceed the value of the on-\nginaung materials used \n\nManufaaure : \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, \n\n\u2014 where, within\" the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where the value of all the non-\nonginaung materials used does \nnot exceed the value of the ori \nginating materials used \n\nManufacture: \n\n\u2014 in which the value of ail the \nmaterials used does not exceed \n40 Vo of the ex-works pnee of \nthe produa, \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of. 5 Vc of the ex-works price of \nthe produa, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed the value of the ori \nginating materials used \n\nex 9014 \n\nOther navigational instruments and \nappliances \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\n9015 \n\n(including photogram-\nSurveying \nmetncal surveying), hydrographie, \noc\u00e9anographie, hydroiogical, me \nteorological or geophysical instru \nments and appliances, excluding \ncompasses; rangefinders \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe product \n\nin which the value of \nManufaaure \nall the matenals used does not ex \nceed 30 Vo of the ex-works price of \nthe product \n\n145 \n\n\f(1\u00bb \n\n9016 \n\n9017 \n\n(2) \n\n(3) \n\nW \n\nBalances of a sensitivity of 5 eg or \nbetter, with or without weights \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nDrawing, marking-out or mathe \nmatical calculating instruments (for \nexample, drafting machines, panto \ngraphs, protractors, drawing sets, \nslide rules, disc calculators); instru \nments for measuring length, for use \nin the hand (for example, measu \nring rods and tapes, micrometers, \ncallipers, not specified or included \nelsewhere in this chapter \n\n9018 \n\nInstruments and appliances used in \nmedical, surgical, dental or veteri \nnary sciences, including scintigra \nphic apparatus, other electro-medi \ncal apparatus and sight-testing in \nstruments \n\n\u2014 Dentists' chairs \n\nincorporating \ndentai appliances or dentists' \nspittoons \n\nManufaaure from materials of any \nheading, including other materials \nof heading No 901? \n\nOther \n\nManufaaure: \n\n9 : i( \n\n1 Mechano-iherapy appliances: mas-\n! sage apparatus, psychological apti-\nozone \n, lude-tesung, \niherapv. oxygen \ntherapy, aerosol \ntherap;. artificial respiration or ot \nher therapeutic respiration appara-\n\napparatus. i tus \n\n902: \n\nOther breathing appliances and gas \nmasks, excluding proteaive masks \nhaving neither mechanical parts nor \nreplaceable filters \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n4: V: of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limn, \nthe materials classified within \nthe same heading as the product \nare onh used up to a value of \n5 \u2022/; of the ex-works price of \nthe product \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n4C V: of the ex-works price of \nthe produa, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare only used up to a value of \n5 Vc of the ex-works price of \nthe produa \n\nManufaaure: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vc of the cx-*orks price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the product \nare onlv used up to a value of \n5 V: of the ex-works price of \nthe product \n\nManufacture \nin which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works pnee of \nthe product \n\nin which the value of \nI Manufacture \n: al! the materials used does not ex-\n! ceed 25 Vc of the ex-works price of \n; the product \ni \n\nManufacture \nin which the value of \nall the materials used does not ex \nceed 25 Vc of the ex-works price of \nthe produa \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 25 Vc of the ex-works price of \nthe product \n\n146 \n\n\f(1) \n\n9024 \n\n9025 \n\n9026 \n\n9027 \n\n(2) \n\n(3) \n\n(4) \n\nMachines and appliances for testing \nihr hardness, sirrngth, compressibi \nlity, elasticity or other mechanical \nproperties of materials (for exam \npie, metals, wood, textiles, paper, \nplastics) \n\nManufacture in which the value of \nall the materials used doe\u00bb not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nHydrometers and similar floating \ninstruments, \nthermometers, pyro \nmeters, barometers, hygrometers \nand psychrometers, recording or \nnot, and any combination of these \ninstruments \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vs of the ex-works price of \nthe product \n\nInstruments and apparatus for mea \nsuring or checking the flow, level, \npressure or other variables of \nli \nquids or gases (for example, flow \nmeters, level gauges, manometers, \nheat meters), excluding instruments \nand apparatus of heading No 9014. 9015, 9C28 or 9032 \n\napparatus); \n\nInstruments and apparatus for phy \nsical or chemical analysis (for ex \nrefraaome-\nample, polanmeters, \nters, spectrometers, gas or smoke \ninstruments \nanalysis \nand apparatus \nfor measuring or \nchecking viscosity, porosity, expan \nsion, surface tension or the like; in \nstruments and apparatus for measu \nring or checking quantities of heat. sound or light dnclud:ng exposure \nmeters), microtomes \n\n9028 \n\nGas. liquid or electricitv suppK or \nproduction meters, incuding cali \nbrating meters therefor \n\n\u2014 Pans and accessones \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\nOther \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works pnee of \nthe product, and \n\n\u2014 where the value of all the non-\noriginating materials used does \nnot exceed the value of the ori \nginating materials used \n\n9029 \n\nRevolution \ncounters, production \ncounters, taximeters, mileometers, \npedometers and the like; speed in \ndicators and \ntachometers, other \nthan those of heading No 9014 or \nQ015. stroboscopes \n\nManufacture in which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works price of \nthe product \n\nManufacture in which the value of \nall the matenals used does not ex \nceed 30 Vc of the ex-works price of \nthe product \n\n147 \n\n\f(2) \n\n(3J \n\n( 4) \n\nOscilloscopes, spectrum analysers \nand other instruments and appara \ntus for measuring or checking elec \ntrical quantities, excluding meters \nof heading No 9028; instruments \nand apparatus for measuring or de \ntecting alpha, beta, gamma, X-ray, \ncosmic or other ionizing radiations \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\n0\u00bb \n\n9030 \n\n9031 \n\nor \n\nchecking \n\nMeasuring \ninstru \nments, appliances and machines, \nnot specified or included elsewhere \nin this chapter; profile projeaors \n\n9032 \n\nAutomatic regulating or controlling \ninstruments and apparatus \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe product \n\n9033 \n\nPans and accessories (not specified \nor included elsewhere in this chap \nter) for machines, appliances, in \nstruments or apparatus of Chapter \n90 \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works pnee of \nthe product \n\nex Chapter 91 \n\nClocks and watches and pans the \nreof, except for those falling under \nthe following headings for which \nthe rules are set out below: \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vc of the ex-works price of \nthe product \n\n91Z5. 9109 to 9113 \n\n91C5 \n\n] Other clocks \n\nManufaaure. 91 0^ \n\nClock mowments. complet\u00bb- and \nassembled \n\n911! \n\nComplete watch or clock move \nments, unassembled or partly as \nsembled (movement sets); incom \nplete watch or clock movements, \nassembled; rough watch or clock \nmovements \n\n\u2014 in which the value of all the \n\nmaterials used does not exceed j \n40 V; of the ex-works price of l \n| \nthe produa, and \n\n\u2014 where the value of all the non-\noriginating matenals used does \nnot exceed the value of the ori \nginating materials used \n\nManufacture \n\n\u2014 in which the value of ail. the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe produa, and \n\n\u2014 where the value of all the non-\nonginatine materials used does \nnot exceed the value of the ori \nginating materials used \n\nManufacture: \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works pnee of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nheading No 9114 are only used \nup to a value of 5 :/c of the ex-\nworks price of the product \n\nManufaaure \nin which the value of \nall the materials used does not ex \nceed 3C Vc of the ex-works price of \nthe product \n\nManufacture \nin which the value of \nall the materials used docs not ex \nceed 30 Vc of the ex-works price of \nthe product \n\nManufacture \nin which the value of \nall the materials used does not ex \nceed 30 Vc of the ex-works price of \nthe produa \n\n148 \n\n\fManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe product \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 30 Vo of the ex-works price of \nthe produa \n\n(2) \n\n(3) \n\n<*) \n\n(1) \n\n9111 \n\nWatch cases and parts thereof \n\nManufaaure : \n\nin which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\nwhere, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo ot the ex-works price of \nthe produa \n\nManufaaure : \n\n\u2014 in which the value of all the \nmaterials used does not exceed \n40 Vo of the ex-works price of \nthe product, and \n\n\u2014 where, within the above limit, \nthe materials classified within \nthe same heading as the produa \nare only used up to a value of \n5 Vo of the ex-works price of \nthe product \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 Vo of the ex-works price of \nthe produa \n\nManufaaure in which the value of \nall the materials used does hot ex \nceed 50 Vo of the ex-works price of \nthe product \n\nManufaaure in which the value of \nall the materials used does not ex \nceed 40 % of the ex-works price of \nthe produa \n\n9112 \n\nClock cases and cases of a similar \ntype for other goods of this chap \nter, and parts thereof \n\n9113 \n\nWatch straps, watch bands and \nwatch bracelets, and parts thereof: \n\n\u2014 Of base metal, whether or not \nplated, or clad with precious \nmetal \n\n\u2014 Other \n\nChapter 92 \n\nMusical instruments, parts and ac-\ncessones of such articles \n\nHS heading No \n\nb \n\nO \n\nI \n\nDescription of produa \n~ \n\nv *\u00bb \n\nY \n\n(2) \n\nV o r k m6 or P\">\u00ab\u00ab-\u00ab-l \u00ab*\"\u00ab<- o u- on \"on-ong. naung maurnah \nlj) at confen onginaung status \n(3) \n\nChapter 93 \n\nArms and ammunitions; parts and accessories \nthereof \n\nManufaaure in which the value of all the materials \nused does not exceed 50 Vo of the ex-works price of \nthe produa \n\nex 9401 \nand \nex 9403 \n\nBase metal furniture, incorporating unstuffed cot- \nton cloth of a weight of 300 g/m' or less \n\nfied \n\nManufacture in which all the materials used are classi-\nwithin a heading other than that of the produa \n\nor \nManufaaure from cotton cloth already made up in a \nform ready for use of heading No 9401 or 9403, provi \nded: \n\u2014 its value does not exceed 25 Vo of the ex-works \n\npnee of the produa, and \n\n' \n\n\u2014 all the other materials used are already originating \nand are classified within a heading other than \nheading No 9401 or 9403 \n\n149 \n\n\f(I) \n\n9405 \n\n(2) \n\n(3) \n\nLamps and lighting fittings including searchlights \nand spotlights and parts thereof, not elsewhere \nspecified or included; illuminated signs, illuminated \nname-plates and the like, having a permanently \nfixed light source, and parts thereof not elsewhere \nspecified or included \n\nManufaaure in which the value of all the materials \nused does not exceed 50 Vo of the ex-works price of \nthe product \n\n9406 \n\nPrefabricated buildings \n\n9503 \n\ntoys, reduced-size \n\nOther \n('scale') models and \nsimilar recreational models, working or not; \npuzzles of all kinds \n\nManufacture in which the value of all the materials \nused does not exceed 50 Vo of the ex-works pnee of \nthe produa \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the produa, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 Vo of the ex-works price of the product \n\nex 9506 \n\n95Cv \n\nex 9601 \nand \nex 9602 \n\nex 96C3 \n\nArticles and equipment for gymnastics, athletics, \nother sports (excluding \ntennis) or outdoor \ngames not specified or included elsewhere in this \nchapter, swimming pools and paddling pools \n\ntable \n\nthe product However, \n\nManufaaure from materials not classified within the \nsame heading as \nroughly \nshaped blocks for making golf clubs heads may be used \nana \nthe same \nheading may also be used provided their value does not \nexceed 5 Vc of the ex-works price of the product \n\nthe other materials classified within \n\nrods, \n\nFishing \nfishing \nfish-hooks and other \ntackle, fish landing nets, butterfly nets and similar \nnet-s. decoy 'birds' (other than those of heading No \n02 :c or Q~:5) and similar hunting or shooting \nrequisites \n\nline \n\nManufacture \nclassified within a heading other \n\nin which all \n\nthe materials used are \nthe \n\nthat of \n\nthan \n\nCroduct. However, materials classified within the same \n\neading mav be used provided \n\ntheir value does not \n\nexceed 5 Vc of the ex-works price of the product \n\nAnicles of animal, vegetable or mineral carving \nmaterials \n\nManufacture from \nsame heading \n\n'worked' caning materials of the \n\nBrooms and brushes, (except for besoms and the \nlike and brushes made from marten or squirrel \nhair), hand-operated mechanical \nfloor sweepers, \nnot motorized, paint pads and rollers, squeegees \nand mops. Manufaaure \nin which the value of all the materials \nused does not exceed 5: V: of the ex-works price of \nthe produa \n\n9605 \n\nTravel sets for personal toilet, sewing or shoe or \nclothes cleaning \n\n9606 \n\n9608 \n\nButtons, press-fasteners, snap-fasteners and press-\nstuds, button moulds and other parts of \nthese \narticles; button blanks \n\nBall point pens, felt lipped and other porous-tipped \npens and markers, fountair pens, stylograph pens \nand other pens; duplicating stylos, propelling or \nsliding pencils, pen-holders, pencil-holders and \nsimilar holders; pans (including caps and clips) of \nthe foregoing anicles, other than those of heading \nNo 9609 \n\nEach item in the set must satisfy the rule which would \napply to it if it were not included in the set. However, \nnon-originating articles may be incorporated, provided \ntheir toul value does not exceed 15 Vo of the ex-works \nprice of the set \n\nManufaaure in which: \n\n\u2014 all the materials used are classified within a heading \n\nother than that of the product, and \n\n\u2014 the value of all the materials used does not exceed \n\n50 Vc of the ex-works price of the product \n\nin which all \n\nthe materials used are \nManufaaure \nclassified within a heading other \nthe \nproduct However, nibs or nib points may be used and \nthe other materials classified within the same heading \nmav also be used provided their value does not exceed \n5 Vc of the ex-works price of the product \n\nthai of \n\nthan \n\n150 \n\n\f(1) \n\n1 \n\n(2) \n\n1 \n\n(3) \n\n9612 \n\n9613 \n\nTypewriter or similar ribbons, inked or otherwise \nprepared for givmg impressions whether or not on \nspools or \u00abn cartndges; mk-pads, whether or not \ninked, with or without boxes \n\nCigarette lighters and other lighters, whether or not \nmechanical or electrical, and parts thereof other \nthan flints and wicks: \n\u2014 Lighten with piezo igniter \n\n\u2014 Other \n\nManufacture in which \n_ \nd \nf ^ \n\nd| ^ \n^ \n\n^ , \n^ \n\n^ \n\nl a j j i f i cd v i t h in \na nd \n\n^ \nv \n\nh e a di \n\n\u2014 the value of all the materials used does not exceed \n\n50 Vo of the ex-works price of the produa \n\nManufaaure in which the value of all the materials of \nheading No 9613 used does not exceed 30 Vo of the \nex-works price of the product \n\nManufaaure in which the value of all the materials of \nheading No 9613 used does not exceed 5 Vo of the ex-\nworks price of the produa \n\nex 9614 \n\nSmoking pipes or pipe bowls \n\nManufaaure from roughly shaped blocks \n\n151 \n\n\f1. 2. 3. ANNEX III \n\nMOVEMENT CERTIFICATES EUR. 1 \n\nMovement certificates EUR. 1 shall be made out on the form of which a \nspecimen appears In this Annex. This form shall be printed in one \nor more of the languages In which the Agreement Is drawn up. Certificates shall be made out In one of these languages and In \naccordance with the provisions of the domestic law of the exporting \nState or territory. If they are handwritten, they shall be completed \nIn Ink and In capital letters. Each certificate shall measure 210 x 297 mm; a tolerance of up to \nminus 5 mm or plus 8 mm In the length may be allowed. The paper used \nmust be white, sized for writing, not containing mechanical pulp and \nweighing not less than 25 g/ms. It shall have a printed green \ngull loche pattern background making any falsification by mechanical \nor chemical means apparent to the eye. The Member States of the Community and the Faroe Islands may reserve \nthe right to print the certificates themselves or may have them \nprinted by approved printers. In the latter case each certificate \nmust inclue a reference to such approval. Each certificate must \nbear the name and address of the printer or a mark by which the \nprinter can be identified. It shall also bear a serial number, \nIdentified. either \n\nprinted \n\nwhich \n\nnot, \n\ncan \n\nby \n\nbe \n\nIt \n\nor \n\n(ui \n\nJ- U\u00bb Vw \n\n\fF Exporter iummm M \n\nMOVEMENT CERTIFICATE \n\nEUR. 1 \n\nNo A 000. 000 \n\nX Consignee *am\u00ab n* \n\ntOpt\u00abn\u00bbl) \n\n2. Certificat* used In preferential trade bet \n\nand \n\n(hMii woraorwx\u00bb eoitfunu. ef csunviet ot erreont. 4. Country, group of countries \nor territory In which the \nproducts are considered as \noriginating \n\nS. Country, group of countrtea \nor territory of destination \n\nS. Transport d\u00e9tails i \n\n7. Remarks \n\nt. Item number; Marks \n\nNumber and kind of \n\n('); Description of goods \n\n9. 10. m \n\ni \n\nor other mea \nsure (Utrec, \nm\\ etc. ) \n\n, CUSTOMS ENDORSEMENT \n\nDeclaration c-enlfie\u00e2 \n\nExport document (') \n\nForm \n\n_\u2014 No \n\nCustoms ome* \n\nIssuing country or territory \n\nDate \n\n12. DECLARATION BY THE EXPORTER \n\nI. me undersigned, declare that \u2022J-i-, goods \ndescribee above m en tne condnons requirad \nfor tne issu* ot this certificat*. Place anc date \n\n53 \n\n\f13. REQUEST FOR VtMRCATION. to: \n\n14. RESULT OF VERIFICATION. Verification carried out snows trust This ceruicat* (') \n\n\u2022\n\nwas issued by the customs office indicated \ntne information contajnec therein is accurate \n\nD does not meet the requirements as :c \u00abjthenticiry _. -. : \n\naccuracy (see remarKs appended). Verrf. cii. or. of me authenticity and accuracy of tnis certificate \nis requested. (Pan* and oat*; \n\n(Piaca anc sale) \n\nStamp \n\nSump \n\n(Signature) \n\nfStonature) \n\n(') msec x \\r :->\u00ab appropriait sex \n\nNOTES \n\nCermcatss must not contain erasures or words wrttten over one another. Any alt\u00e9rations must be made by deleting the mco-'rct \nparticulars and adding any nacaner/ corrections. Any suet) aftafatoi must be mitafled by me person who completed The certifi \ncate anc endorsed by the customs authorities of The issuing country or terrnory. No spaces musn be left b e o w ri the items entered on the cerBncal* and each Item must be preceded by an item nurrzzr. A hor. zomaJ line must be drawn irnmediatery below the last Kern. Any unused space must be struck through ir. sucn a manne as \nto mave am/ later aocttons impoaalbie. GocCs rr. uST be oescrfped In accordance with commandai practice and with sufficient detail to enaole them tc be. oentifiec \n\n154 \n\n\fAPPLICATION FOR A MOVEMENT CERTIFICATE \n\n1. Experte* * - mt \u2022\u2022> -na-eai. ue-aeji \n\na. Con\u00bbi\u00e7->\u00bb\u00ab I N^ \n\niu- aaaraae, eeaawyi (Oeta-naii \n\nE U R. 1 \n\nN. A ooo ooo \n\nSa* M IH \u2022 \u00ab \u2022 * \u2022\u00ab a ai ara fiw-niii. , uaa \n\n2. Application for a certificate to be used in pr\u00e9f\u00e9rer-::al trade \n\nbetween \n\nand \n\n(inaar- aeerepnat* caurnnti grouea a\u00bb sewmnaa er awmen* \n\n4. Country, group of countries \nor territory In which the \nproducts ana considered as \noriginating \n\nS. Country, group of countries \nor territory of des t. nation \n\nC. Transpon details Ot-a-a-ari \n\n7. Remarks \n\nItem number: Menu and nuRSbers; Number and kind of \n\n('); Description of goods \n\n10. Invoices \n\nl'-ouonal) \n\nor other mea \nsure (litres, \nm\\ etc. ) \n\n155 \n\n\fDECLARATION ft THE EXPORTER \n\nI. tht jndersigned. exporter of the goods described overleaf. DEC-ARE mat the goods meet the conditions required for the iasue of the attached certificate \n\nSPECIFY \n\nas follows the caxumitances which have enabled these goods to meet the above conditions: \n\nSUBM!~ \n\nthe following supporting documents (') \n\nUNDE-'AKE to submit at the request of the appropriai* authorities, any supporting evidence which these authorities may --quire \nfor the purpoaa of cssutng the an ached teititVaia, and undertake. If required to agree to any inspecbon. ;: my \naccounts and to any check on the processes of rrwajfacture of the above goods, earned out by the said authon ies : \n\nREQUEST me issue of the agauhad certificate for these goods. (Place anfl oat a] \n\n(S\u00bbgnatur\u00bb) \n\n(') For example: import Ooajrnenta. movement certificates. Invoices, marwfacturer\u00bb 3acia<-*t. on*. etc. r\u00bbr\u00bbrnnc t= tn\u00ab pnwucis isec in m*nui. ;iura \n\nor to :ne c-ooai re-exported S-i Vw same stale. 156 \n\n\fANNEX IY \n\nFORy EUR. 2 \n\n1. 2. 3. Form EUR. 2 shall be made out on the form of which a specimen appears \nIn this Annex. This form shall be printed In one or more of the \nlanguages in which the Agreement is drawn up. Forms shall be made \nout In one of these languages and In accordance with the provisions \nof the domestic law of the exporting State or territory. If they are \nhandwritten, they shall be completed In Ink and In capital letters. Each Form EUR. 2 shall measure 210 x 297 mm; a maximum tolerance of up \nto minus 5 mm or plus 8 mm In the length may be allowed. The paper \nused must be white, sized for writing, not containing mechanical pulp \nand weighing not less than 64 g/mt. The Member States of the Community and the Faroe Islands may reserve \nthe right to print the forms themselves or may have them printed by \napproved printers. In the latter case each form must Include a \nreference to such approval. Each form must bear the name and address \nof the printer or a mark by which the printer can be Identified. It \nshall also bear a serial number, either printed or not, by which It \ncan be identIfled. FORM E U R. 2 NO \n\n2 I Exporter Name it \n\nd Form used in preferential trade \n\nbatween r) \n\nj 3 | Declaration by exporter \n\n* I Consignee iNene lu* address, country \n\nI. the undersigned, exporter of the gooes described : flow. declare that the goods comply with the -esumtments :. ' the \ncompletion of this form anc mat me goods have obtain-;- the \nstatus of originating products wrthm me provisions governing \npreferential trade show. -, m bcx i. UJ Place and date \n\n| 6 | Signature of exporter \n\nRemark: \n\nj 6 | Country ot origin (') \n\nI S j Country of da\u00bbt\u00bbiuruc:i (') \n\nTO J Gross mesa (kg) \n\nI Manu. Numbers of ci. iiiljiwteait; Description of goods \n\n*2j Authority \n(*) \n\u2014' responsible for verification of the declara \n\nthe exporting courrtn. In \n\ntion by the exporter \n\nmart lha C O J ^ ^S groups ex uajertaa er terreonaa concaned ('I a *v to any nrWuaiajri atreaOy cemeC e i / t rN eppropnan autnorniee p] The ic*m co&rtry et or-jn maana \nary. group ?* countnea or terrearjr aewr* tat eaeai ara coraaoerac io &\u2022 ortgaveng J*| The larm 'country maana country proue o> coumnaa or i\u00abrniory ef oaanr\u00ab. \u00ab&fv \n\n3 f\"58 \n\n\fI 3j Request for nsrtflcatJon \n\nThe ve':t\u2022cation of The declaration by the exporter on the front \nof this -orm is requested (*) \n\n0 Result of venfkaruon \n\nV\u00e9rification carried ou: snows mat (') \ni\u2014t the stat*ments ano particulars giv\u00abn m this i ; -r are \n\naccurst*. \u2022\n\nform does not meet \n\nthis \naccuracy and authenticity (see remarks appended \n\nre j u r e m e n ts ai \n\nthe \n\nto \n\n(Place and Oaae) \n\n19. Sump \n\n(Puce and oaiei \n\nIS. Stamp \n\n(Signature) \n\n(Signature) \n\n) SuDaaouani \u00abanncaOom or torma SU*, t eMat Se i \nMernwuer. \u2022\u2022^\u2022\u2022amg ma auinaneuay \u00abf tie lenna \n\nDamae oui ai random ar * \nend ma true ongr. o* ma good* in i \n\naumonnai or ma hnpomng S UM \n\nOCJOI a n mn \n\n:. r*cy of ma \n\n(') Ineen I n t ra \u00abpprepnau Do* \n\nInstructions for the conajietton of form EUR. 2 \n\nA form EUP. 2 may be made out only for goods which m the exporting country futfii the conditions specified by tr>fc provisions ;=veming \nthe trade -^errec :c in box t. Thaae provisions must be studied earafufy betor* the form is completed. In the case ot a consignment by parce\u00bb post the exporter attaches the form to me dispatch note \nin the case ot \u2022 =ons*gnm*r oy letter \npost he encloses tne form in a r\"\"*'\"fJ\" The reference \"EUR. 2* and the serial numoer of tne form should be staiea on me customs green \nJabeJ declaration Ci or on the customs declaration G2/CP3. as appropriate. These instructions do not exarnpt the exporter from complying with any other formalities required by customs or postal regulations \n\nAn exporter who uses this \u00aborra h abflged to submit to the appropriate authonbes any supporting evidence which they may require and to \nto any inspection by them of res accounts and of the processes of manufacture of the goods described in box * 1 of this fc-'-n \n\n159 \n\n\fAUKLUL__JL \n\nSPECIMEN \n\nIMPRESSION OF THE STAMP MENTIONED \n\nIN \n\nARTICLE 1 3, PARAGRAPH 3f&> \n\n30 mm \n\n(1) \n\nInitials or coat of arms of the exporting State or territory \n\n(2) \n\nSuch Information as Is necessary for the Identification of the \napproved exporter. 1 CO \n\n\fANNEX VI \n\nLIST OF PRODUCTS REFERRED TO \n\nIN ARTICLE 31 WHICH ARE TEMPORARILY \n\nEXCLUDED FROM THE SCOPE OF THIS PROTOCOL \n\nHS heading No \n\nDescription of product \n\nex 2737 \n\nOils \nin which the weight of the aromatic constituents exceeds that of the \nnon-aromatic constituents, being oils similar to mineral oils obtained by distil \nlation of high temperature coal tar, of which more than 65 Vc by volume distilis at \na temperature of up to 250 *C (including mixtures of petroleum spirit and \nbenzole), for use as power of heating fuels \n\n2709 io 2715 \n\nMineral oils and producu of their distillation ; bituminous substances: mineral \nwaxes \n\nex 29:1 \n\nAcylic hydrocarbon for use as power or heating fuels \n\nCvclancs and cyclenes (other than azulenes), benzene, toluene, xylenes, for use as \npower or heating fuels \n\nLubricating preparations containing petroleum oils or oils obtained from bitu \nminous minerals, provided they represent less than 70 % by weight. Artificial waxes and prepared waxes with a basis of paraffin, petroleum waxes, \nwaxes obtained from bituminous minerals, siack wax or scale wax \n\nPrepared additives for lubricating oil. containing petroleum oils or oils obtained \nfrom bituminous minerals \n\nex 3*:\u00ab \n\nex 381! \n\nJ. 61 \n\n\fProtocol No 4 \nconcerning agricultural products subject to special provisions applicable to imports \n\nIn accordance with Article 17 of this Agreement, the European Economic Community grants to products \noriginating in and coming from the Faroe Islands the fol lowing tariff quotas: \n\nArticle 1 \n\nCN Code \n\nDescription \n\nRate of duty Tariff quota \n\nTQ in tons \nreference \nceiling R. C. 0204 \n\nMeat of sheep or goats, fresh, chilled or frozen \n\n0206 80 99 \n\nEdible offal of sheep and goats, fresh or chilled \n\n0206 90 99 \n\nEdible offal of sheep and goats, frozen \n\n0210 90 11 \n\nMeat of sheep or goats, salted, in brine, dried or smoked \nwith bone in \n\n20 T (1) \n\n0210 90 19 \n\nMeat of sheep or goats, salted, in brine, dried or \nsmoked, boneless \n\n0210 90 60 \n\nEdible meat offal of sheep or goats, salted, in brine, \ndried or smoked \n\nex 1601 \n\nSausages and similar products of meat, meat offal or \nblood; food preparations based on these products: \n\n- Of sheep and goats \n\nex 1602 \n\nOther prepared or preserved meat, meat offal or blood: \n\n- Of sheep and goats \n\n2309 10 11 Pet food \n\n2309 90 41 Fish feed \n\n1000 T \n\n5000 T \n\n(1) This quota will be implemented in the framework of the autonomous rjegime established. sQi \n\nby Counojil Regulation (EEC) No 3643/85. to \n\n\fArticle 2 \n\nIn accordance with Article 5 and Annex II of this \nAgreement, the Faroe Islands shall grant freedom of \ntariffs and duties to goods of EEC origin, falling \nwithin the Chapters 1 - 24 in the Harmonized System, \nwith the following exceptions: \n\n0204 \n\nMeat of sheep or goats, fresh, \nchilled or frozen. 0206 80 99 \n\nOther edible offal, fresh and chilled \nof sheep and goats. 0206 90 99 \n\nOther edible offal, frozen, of sheep \nand goats. 0210 90 11 \n\nMeat, salted, in brine, dried and \nsmoked, of sheep and goats, with bone \nin. 0210 90 60 \n\nOffal, of sheep and goats. 0210 90 90 31-40. Edible flours and meals of meat \n\nand meat offal of sheep and goats. 0401 \n\n0402 \n\n0403 \n\nex 1601 \n\nex 1602 \n\nMilk and cream, not concentrated nor \ncontaining added sugar or other \nsweetening matter \n\nMilk and cream, concentrated or \ncontaining added sugar or other \nsweetening matter. Buttermilk, curdled milk and cream, \nyogurt, kephir and other fermented or \nacidified milk and cream, whether or \nnot concentrated or containing added \nsugar or other sweetening matter or \nflavoured or containing added fruit, \nnuts or cocoa. Sausages and similar products of \nmeat, meat offal or blood of sheep \nand goats; food preparations based on \nthese products of sheep and goats. Other prepared or preserved meat, \nmeat offal or blood, of sheep and \ngoats. J \u20ac3 \n\n\fDECLARATIONS \n\nDeclaration by the European Economic Community concerning \nArticle 23 (1) of the Agreement \n\nThe European Economic Community declares that, in the context of \nthe autonomous implementation of Article 23 (1) of the Agreement \nwhich is incumbent on the Contracting Parties, it will assess any \npractices contrary to that Article on the basis of criteria \narising from the application of the rules of Articles 85, 86, 90 \nand 92 of the Treaty establishing the European Economic \nCommunity. Declaration by the European Economic Community concerning the \nregional application of certain provisions of the Agreement \n\nThe European Economic Community declares that the application of \nany measures it may take under Articles 23, 24, 25 or 26 of the \nAgreement, in accordance with the procedure and under the \narrangements set out in Article 27, or under Article 28 may be \nlimited to one of its regions by virtue of Community rules. JOINT DECLARATION CONCERNING THE REVIEW OF THE TRADE AGREEMENT IN \nKEEPING WITH THE DEVELOPMENT OF EEC-EFTA TRADE RELATIONS \n\nIf the Community - upon the conclusion of new agreements or \narrangements between the Community and the Member States of EFTA \nin the context of the establishment of a European Economic Area -\ngrants concessions to the EFTA countries going beyond those \ngranted to the Faroe Islands in areas covered by this Agreement, \nthe Community will, upon request from the Faroe Islands, consider \nin a positive spirit, case-by-case, to what extent and on what \nbasis corresponding concessions could be offered to the Faroe \nIslands. If agreements or arrangements are concluded between the Faroe \nIslands and the Member States of EFTA whereby the Faroe Islands \ngrant concessions to EFTA countries going beyond those granted to \nthe Community in areas covered by this Agreement, the Faroe \nIslands will, upon request from the Community, consider in a \npositive spirit, case-by-case, to what extent and on what basis \ncorresponding concessions could be offered to the Community. Ui \n\n\fExchange of letters on mutual assistance \n\nDraft letter from the Head of the delegation of Denmark and the \nFaroe Islands \n\nSir \n\nI have the honour to confirm that the Government of Denmark and \nthe Home Government of the Faroe Islands are prepared to conclude \nan agreement with the European Economic Community on mutual \nadministrative assistance in customs matters as soon as such an \nagreement has been concluded with one or more of the Member \nStates of the European Free Trade Association. I also confirm \nthat the agreement on mutual administrative assistance in customs \nmatters to be concluded between the European Economic Community \nand the Government of Denmark and the Home Government of the \nFaroe Islands shall be based upon the agreement or agreements \nconcluded between the European Economic Community and one or more \nof the Member States of the European Free Trade Association. Please accept, Sir, the assurance of my highest consideration. (S) \n\nHead of the delegation of Denmark and \n\nthe Faroe Islands \n\nDraft letter from the Head of the delegation of the European \nEconomic Community \n\nSir, \n\nIn your letter of today's date you inform me as follows: \n\n\"I have the honour to confirm that the Government of Denmark and \nthe Home Government of the Faroe Islands are prepared to conclude \nan agreement with the European Economic Community on mutual \nadministrative assistance in customs matters as soon as such an \nagreement has been concluded with one or more of the Member \nStates of the European Free Trade Association. I also confirm \nthat the agreement on mutual administrative assistance in customs \nmatters to be concluded between the European Economic Community \nand the Government of Denmark and the Home Government of the \nFaroe Islands shall be based upon the agreement or agreements \nconcluded between the European Economic Community and one or more \nof the Member States of the European Free Trade Association. Please accept, Sir, the assurance of my highest consideration. I have the honour to acknowledge receipt of your letter. Please accept, Sir, the assurance of my highest consideration. (S) \n\nHead of the delegation of the \nEuropean Economic Community \n\n165 \n\n\f\fISSN 0254-1475 \n\nCOM(91) 323 final \n\nDOCUMENTS \n\nEN \n\n02 \n\nCatalogue number : CB-CO-91-368-EN-C \n\nISBN 92-77-75271-8 \n\nOffice for Official Publications of the European Communities \nL^2985 Luxembourg"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/5638e6b4-856a-4539-85e9-59165888ec05", "title": "WRITTEN QUESTION No. 1729/91 by Sir James SCOTT-HOPKINS to the Commission. Dangerous dogs", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,SCOTT-HOPKINS", "date": "1991-08-07", "subjects": "competence of the Member States,domestic animal,public safety", "workIds": "celex:91991E001729", "eurovoc_concepts": ["competence of the Member States", "domestic animal", "public safety"], "url": "http://publications.europa.eu/resource/cellar/5638e6b4-856a-4539-85e9-59165888ec05", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/9565588d-6b82-497a-ad5a-69e9d5573fac", "title": "WRITTEN QUESTION No. 1735/91 by Mrs Mich\u00e8le ALLIOT-MARIE to the Commission. Origin of industrial products imported into the Community from the countries of Eastern Europe", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "ALLIOT-MARIE,European Parliament", "date": "1991-08-07", "subjects": "Eastern Bloc countries,association agreement (EU),free-trade area,generalised preferences,industrial product,originating product", "workIds": "celex:91991E001735", "eurovoc_concepts": ["Eastern Bloc countries", "association agreement (EU)", "free-trade area", "generalised preferences", "industrial product", "originating product"], "url": "http://publications.europa.eu/resource/cellar/9565588d-6b82-497a-ad5a-69e9d5573fac", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/3d4e203f-c70f-405b-9b92-9ef01e9e12e8", "title": "WRITTEN QUESTION No. 1717/91 by Mrs Christine CRAWLEY to the Commission. Use of ' CE' European Standards Mark", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "CRAWLEY,European Parliament", "date": "1991-08-07", "subjects": "EU trade mark,European standard,approximation of laws,harmonisation of standards,product safety,quality label,safety standard,toy industry", "workIds": "celex:91991E001717", "eurovoc_concepts": ["EU trade mark", "European standard", "approximation of laws", "harmonisation of standards", "product safety", "quality label", "safety standard", "toy industry"], "url": "http://publications.europa.eu/resource/cellar/3d4e203f-c70f-405b-9b92-9ef01e9e12e8", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/30dcee80-9123-4ec7-8eba-6d57ace86aae", "title": "Bev\u00f6lkerungsstatistik 1991.,Demographic statistics 1991.,Statistiques d\u00e9mographiques 1991.", "langIdentifier": "ENG", "mtypes": "pdfa1b,print_sftcv", "workTypes": "http://publications.europa.eu/ontology/cdm#publication_general,http://publications.europa.eu/ontology/cdm#work", "authors": "Eurostat", "date": "1991-08-07", "subjects": "EU Member State,births,composition of the population,foreign national,marriage rate,population statistics", "workIds": "PUB_CA7091726", "eurovoc_concepts": ["EU Member State", "births", "composition of the population", "foreign national", "marriage rate", "population statistics"], "url": "http://publications.europa.eu/resource/cellar/30dcee80-9123-4ec7-8eba-6d57ace86aae", "lang": "eng", "formats": ["pdfa1b", "print_sftcv"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/ae744fbe-fb43-4f14-9703-b4de3c77003a", "title": "WRITTEN QUESTION No. 1719/91 by Mrs Christine CRAWLEY to the Commission. CAP reforms", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "CRAWLEY,European Parliament", "date": "1991-08-07", "subjects": "EU aid,European convention,common agricultural policy,livestock farming,protection of animals,transport of animals", "workIds": "celex:91991E001719", "eurovoc_concepts": ["EU aid", "European convention", "common agricultural policy", "livestock farming", "protection of animals", "transport of animals"], "url": "http://publications.europa.eu/resource/cellar/ae744fbe-fb43-4f14-9703-b4de3c77003a", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/48d9316a-91f0-40a6-be2d-f90555fcfadd", "title": "WRITTEN QUESTION No. 1715/91 by Mr Thomas MEGAHY to the Commission. ' Organic' foodstuffs", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,MEGAHY", "date": "1991-08-07", "subjects": "Council of the European Union,agricultural product,foodstuff,labelling,organic farming,regulation (EU)", "workIds": "celex:91991E001715", "eurovoc_concepts": ["Council of the European Union", "agricultural product", "foodstuff", "labelling", "organic farming", "regulation (EU)"], "url": "http://publications.europa.eu/resource/cellar/48d9316a-91f0-40a6-be2d-f90555fcfadd", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/871eff93-0bc6-4cd2-b60a-056c7d8369cc", "title": "WRITTEN QUESTION No. 1731/91 by Mr Herman VERBEEK to the Commission. Fraud involving EC funds", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,VERBEEK", "date": "1991-08-07", "subjects": "EU aid,Netherlands,competence of the Member States,desiccated product,export refund,fraud,jurisdiction,milk by-product,powdered milk", "workIds": "celex:91991E001731", "eurovoc_concepts": ["EU aid", "Netherlands", "competence of the Member States", "desiccated product", "export refund", "fraud", "jurisdiction", "milk by-product", "powdered milk"], "url": "http://publications.europa.eu/resource/cellar/871eff93-0bc6-4cd2-b60a-056c7d8369cc", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/0b7ad5bf-d3ef-4813-b04b-4998550d1e51", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) AMENDING REGULATION ( EEC ) NO 3976/87 ON THE APPLICATION OF ARTICLE 85 ( 3 ) OF THE TREATY TO CERTAIN CATEGORIES OF AGREEMENTS AND CONCERTED PRACTICES IN THE AIR TRANSPORT SECTOR", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-07", "subjects": "air transport,competition,inter-company agreement,intra-EU transport", "workIds": "celex:51991PC0272(02),comnat:COM_1991_0272(02)_FIN,oj:JOC_1991_225_R_0010_01", "eurovoc_concepts": ["air transport", "competition", "inter-company agreement", "intra-EU transport"], "url": "http://publications.europa.eu/resource/cellar/0b7ad5bf-d3ef-4813-b04b-4998550d1e51", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 272 final \n\nBrussels, 7 August 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\namending Regulation (EEC) No 3975/87 laying down the \n\nHiH* \n\nprocedure for the application of the rules on \n\ncompetition to undertakings in the \n\nair transport sector, \n\nand \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\nSafe' \n\namending Regulation (EEC) No 3976/87 on the application \n\nof Article 85(3) of the Treaty to certain categories of \n\nagreements and concerted practices in the \n\nair transport sector \n\nwm \n\n(presented by the Commission) \n\n\f- 2 -\n\nA. AMENDMENT TO REGULATION (EEC) No 3975/87 ON PROCEDURE FOR THE \n\nAPPLICATION OF COMPETITION RULES \n\n1. The Commission's powers to enforce the competition rules in the air \n\ntransport sector by means of fact-finding, imposing orders and \n\nsanctions and granting individual exemptions is limited, by Council \nRegulation (EEC) No 3975/87<1>, to international transport between \n\nMember States. The Commission's powers do not extend to either \n\ndomestic transport nor to transport between a Member State and a \n\nthird country. 2. In its Judgment of 11 April 1989 in the \"Ahmed Saeed\" case (1) the \n\nCourt of Justice confirmed its Judgment in the \"Nouvelles \nFronti\u00e8res case\"( 2) as regards the application of Article 85 of \n\nthe Treaty and ruled that Article 86 is directly applicable by \n\nnational courts, even in the absence of an implementing regulation \n\nunder Article 87 or of action by a Member State cartel authority or \n\nby the Commission (under Article 88 or Article 89 respectively). The Court's judgment means that where a dominant airline succeeds, \n\nother than by normal competitive means, in eliminating competition, \n\neven on a domestic or on a Community-third country route, this \n\nbehaviour is an abuse contrary to Article 86. Since there is no \n\nblock exemption for airlines to discuss, let alone agree, fares on \n\nCommunity-third \n\ncountry \n\nroutes, \n\nthe elimination \n\nof \n\nprice \n\ncompetition resulting from such discussions or agreements is liable \n\nto be an abuse of the dominant or joint dominant position which in \n\nmany instances exists on such routes. The Court also ruled that a \n\nMember State is in breach of its Treaty obligations if it approves \n\nfares which infringe Article 85 or Article 86. Such would be the \n\ncase for instance where a uniform agreed price structure has \n\nresulted from consultations which have not been exempted pursuant \n\nto Article 85(3). (1) OJ No L 374, 31. 12. 1987. (2) Judgment of 11 April 1989 in Case 66/86, [1989] ECR \n\n\f- 3 -\n\n3. Since, in respect of both domestic and of EC-third country air \n\ntransport, the Commission has no power to grant exemptions under \n\nArticle 85(3) nor to use normal procedures to rule on abuses of \n\ndominant position under Article 86, there is now a serious \n\nuncertainty in which air carriers can not know what practices and \n\narrangements they may legitimately engage in on such routes. If, \n\neven inadvertently, they act unlawfully, they run the risk of \n\nactions in national courts leading to the payment of compensation. Moreover, Member States face comparable uncertainties when \n\napproving the fares filed by carriers on such routes. In order to \n\nestablish a framework of certainty, the Council should now give the \n\nCommission the necessary powers to clarify how Articles 85 and 86 \n\napply to domestic and to extra-Community air transport. 4. The Commission accordingly proposed(3) that the Council adopt \n\nregulations extending the scope of its powers to enforce the \n\ncompetition rules in respect of domestic and third-country air \n\ntransport. The Council has however not yet acted on that proposal. 5. Since the Council has committed itself, in the framework of the \n\nthird package of air transport liberalisation measures, to lay down \n\nrules on cabotage it will be necessary to adopt at the same time \n\nmeasures enabling the Commission to enforce the competition rules \n\nto transport within a Member State. 6. Therefore the Commission now withdraws its earlier proposal insofar \n\nas it applied to domestic transport, and makes a new proposal \n\n(Annex I) consisting in a regulation to delete the limitation to \n\ninternational transport within the Community, so that domestic \n\ntransport entirely within a single Member State is also covered by \n\nRegulation (EEC) No 3975/87. (Annex I). (3) C0M(417) final, 8. 9. 1989. - 4 -\n\nB. AMENDMENT TO REGULATION (EEC) No 3976/87 ON GROUP EXEMPTIONS \n\n7. The Commission's powers to adopt group exemptions is limited, by \n\nCouncil Regulation (EEC) No 3976/87<4>, to International transport \n\nbetween Member States. For similar reasons to those set forth \n\nabove, these powers should now be extended to domestic transport \n\nentirely within a Member State. 8. As part of the second package of liberalisation measures in the air \n\ntransport sector the Council extended the validity of Regulation \n\n(EEC) No 3976/87 empowering the Commission to adopt for a limited \n\nperiod a number of group exemptions to the competition rules so \n\nthat air carriers could adapt progressively to a more competitive \n\nenvIronment. The Commission on that basis adopted three R\u00e9gul\u00e2tions(5): \n\n- Regulation (EEC) No 82/91 of 26 July 1988 concerning ground \n\nhand Iing services; \n\n- Regulation (EEC) No 83/91 relating to computer reservation \n\nsystems for air transport services; and \n\n- Regulation (EEC) No 84/91 concerning Joint planning and \n\ncoordination of capacity, consultations on tariffs on scheduled \n\nair services and slot allocation at airports. 9. The Commission's general experience with these group exemptions is \n\nthat they satisfy a genuine need for legal certainty among air \n\ncarriers and other market operators, while providing an incentive \n\nto abandon previous more restrictive agreements. 10. In view of the further liberalisation now proposed, the Commission \n\nis of the opinion that the same objectives can be pursued after \n\n31 December \n\n1992. This would \n\nimply that, subject \n\nto the \n\ncircumstances as they appear at the time, in particular the terms \n\n(4) OJ No L 374, 31. 12. 1987. (5) OJ No L 10, 15. 1. 1991. - 5 -\n\nof the third package adopted by the Council, the group exemptions \n\nwill be substantially renewed subject to some tightening of \n\nconditions (as set out below) which is made desirable by progress \n\nattained \n\nin creating a more competitive environment. The \n\npossibilities for cooperation to be left to airlines will depend on \n\nthe extent to which the new regulatory framework creates room for \n\nincreased competition. 11. The Commission intends to make the following changes to the \n\nexisting regulations : \n\n- replacement of the exemption for capacity discussions by an \n\nexemption for binding schedule coordination (the exemption for \n\nnon-binding schedule consultations will be maintained); \n\n- (if appropriate) alignment of the exemption for slot allocation \n\ndiscussions on the results of discussions by the Council on \n\ncommon rules for slot allocation (subject to the need to ensure \n\ncompatibility of the outcome of the discussions with Article \n\n85(3) of the EEC Treaty). The exemptions for computer reservation systems- and ground \n\nhandling agreements can be renewed without significant changes, \n\nexcept for changes necessary to take account of alterations in the \n\narrangements of the computer reservation systems. The exemption \n\nfor tariff consultations, including the obligations to interline, \n\nwill be renewed with some minor changes which will not affect the \n\nsubstance of air carriers' obligations but will clarify the \n\nconditions in practice. The Commission considers it useful to have power to adopt a group \n\nexemption in favour of Joint operations on new routes with \n\nrelatively few passengers for limited periods, in line with the \n\npractice which was developed in individual cases during the past \n\nfew years. - 6 -\n\n12. In order to secure adoption of the new group exemptions by the time \nthe present exemptions expire, on 31 December 1992, the extension \nof Regulation (EEC) No 3976/87 in order to enable the Commission to \nadopt these new group exemptions, should be in place by 30 June \n1992. The Commission will then follow the normal procedure provided by \nRegulation (EEC) No 3976/87, i. e. it will invite comments by third \nparties and consult the Advisory Committee on Restrictive Practices \nand Dominant Positions in Air Transport. 13. The Commission accordingly proposes that the Council adopt a \nregulation modifying Regulation (EEC) No 3976/87 in the following \nways (Annex II): \n\n(I) the Regulation would also apply to domestic transport \n\nentirely within a single Member State; \n\n(il) the Regulation is given an indefinite validity; \n\n(ill) the possibility of an exemption for joint operations between \n\nairlines will be provided for; \n\n(iv) the conditions contained in Article 2(2) of the Regulations \nare deleted, as is appropriate in a regulation of indefinite \nduration; and \n\n(v) a standard clause (new Article 3) is included on the duration \nand review of the Commission's implementing regulations. C. CHANGES TO EARLIER PROPOSAL TO ENFORCE THE COMPETITION RULES IN \n\nRESPECT OF DOMESTIC AND THIRD-COUNTRY TRANSPORT \n\n14. In view of the inclusion of domestic air transport in the proposals \nfor a third air transport package, the Commission now limits its \nearlier proposal to enforce the competition rules in respect of \ndomestic and third-country transport, to transport to third \ncountries. As a result, Annex II of the earlier proposal (C0M(89) 417 final, \nOJ No C 248 of 29 September 1989, p. 9) is withdrawn. i\u00a3 \n\u00c8* \n\n|j. , \n\u00a3. %' \nt \n\u00a3-. I\\ \nK \n5* \n\ni. *\u2022' \n\n\f- 7 -\n\nANNEX I \n\nProposal for a \n\nCOUNCIL REGULATION (EEC\u00cf \n\namending Regulation (EEC) No 3975/87 \n\nlaying down the procedure for the application of the rules \n\non competition to undertakings in the air transport sector \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular, Article 87 thereof, \n\nHaving regard to the proposal from the Commission^) \n\nHaving regard to the opinion of the European Pari lament<2>, \n\nHaving regard to the opinion of the Economic and Social Committee*3^ \n\nWhereas Regulation (EEC) No 3975/87<4) formed part of a package of \n\ninterrelated measures adopted by the Council as a first step towards \n\ncompleting the internal market in transport; whereas its scope was \n\naccordingly limited to international air transport between Community \n\nairports; \n\nWhereas, therefore, the Commission has no means at present of \n\ninvestigating directly cases of suspected infringement of Article 85 \n\nand 86 of the Treaty in respect of air transport within a Member State \n\nand lacks such powers to take decisions or impose penalties as are \n\nnecessary for it to authorise agreements under Article 85(3) and to \n\n(1) OJ No C \n\n(2) OJ No C \n\n(3) OJ No C \n\n(4) OJ No L 374, 31. 12. 1987, p. 1. bring to an end infringements established by it in relation to \n\ntransport within a Member State; \n\n- 8 -\n\nWhereas air transport entirely within a Member State now also is \n\nsubject to Community liberalisation measures; whereas it is therefore \n\ndesirable that rules should be laid down under which the Commission, \n\nacting in close and constant liaison with the competent authorities of \n\nthe Member States, may take the requisite measures for the application \n\nof Articles 85 and 86 of the Treaty to this area of air transport, in \n\nsituations where trade between Member States may be affected; \n\nWhereas there is a need to produce a secure and clear legal framework \n\nfor domestic air transport within a Member State, while ensuring a \n\ncoherent application of the competition rules; whereas therefore the \n\nscope of Regulation (EEC) No 3975/87 should be extended to this area of \n\nair transport, \n\nHAS ADOPTED THIS REGULATION : \n\nArticle 1 \n\nThe word \"international\" is hereby deleted in Article 1(2) of \n\nRegulation (EEC) No 3975/87. Article 2 \n\nThis Regulation shall enter into force on the day following that of its \n\npublication in the Official Journal of the European Commun!tes. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Council \nThe President \n\nr \n\nL-, \nI \nr _ \nf-. *-\n\n\fANNEX II \n\nProposal for a \nCWNCIU RE6UIATIQN (EEC) \n\namending Regulation (EEC) No 3976/87 \n\non the application of Article 85(3) of the Treaty to certain \n\ncategories of agreements and concerted practices \n\nin the air transport sector \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular Article 87 thereof, \n\nHaving regard to the proposal from the Commission*1), \n\nHaving regard to the opinion of the European P aN lament*2), \n\n, \n\nHav ing regard to the opinion of the Economic and Socla I ComrnltteeC3^, \n\nWhereas in accordance with Council Regulation (EEC) No 3975/87*4), as \namended by Regulation (EEC) No \nto implement the competition rules in respect of air transport within a \n\nthe Commission has power \n\n(5), \n\nMember State; whereas it is therefore desirable to provide for the \n\npossibility of adopting block exemptions applicable to that area of \n\ntransport; \n\n(1) OJ No C \n\n(2) OJ No C \n\n(3) OJ No C \n\n(4) OJ No L 374, \n(5) OJ No \n\n31. 12. 1987, p. 1 \n\n\f- 10 -\n\nWhereas Council Regulation (EEC) No 3976/87(6), as amended by \nRegulation (EEC) No 2344/90( 7 ), empowers the Commission to declare by \n\nway of Regulation that the provisions of Article 85(1) do not apply to \n\ncertain categories of agreements between undertakings, decisions by \n\nassociations of undertakings and concerted practices; \n\nWhereas the power to adopt these block exemptions has been granted for \n\na limited period, expiring on 31 December 1992, during which air \n\ncarriers can adapt to the more competitive environment introduced by \n\nchanges in the regulatory systems applicable to intra-Community \n\ninternational air transport; \n\nWhereas a continuation of block exemptions after that date is justified \n\nby the further measures to liberalize the air transport sector adopted \n\nby the Community; whereas the scope of these block exemptions and the \n\nconditions attached to them should be defined by the Commission, in \n\nclose liaison with the Member States, taking into account changes to \n\nthe competitive environment achieved since the entry into force of \n\nRegulation (EEC) No 3976/87, \n\nHAS ADOPTED THIS REGULATION : \n\nArticle 1 \n\nRegulation (EEC) No 3976/87 is hereby amended as follows: \n\n1. The word \"international\" is deleted in Article 1. 2. Article 2(2) is replaced by the following: \n\n\"2. The Commission may, in particular, adopt such regulations in \n\nrespect of agreements, decisions or concerted practices which \n\nhave as their object any of the following: \n\n(6) OJ No L 374, 31. 12. 1987, p. 9. (7) OJ No L 217, 11. 8. 1990, p. 15. - 11 -\n\n- joint planning and coordination of airline schedules; \n\n- consultations on tariffs for the carriage of passengers \n\nand baggage and of freight on scheduled air services; \n\n- Joint operations on new scheduled air services; \n\n- slot allocation at airports and airport scheduling; \n\n- common purchase, development and operation of computer \n\nreservation systems relating to timetabling, reservations \n\nand ticketing by air transport undertakings; \n\n- technical and operational ground handling at airports, \n\nsuch as aircraft push back, refuelling, cleaning and \n\nsecurity; \n\n- handling of passengers, mail, freight and baggage at \n\nairports; \n\n^, services for the provision of In-flight caterIngv\" \u2022*\u2022\u2022\u2022'-\u2022\u2022 \n\n3. Article 3 is replaced by the following: \n\n\"Article 3 \n\nA regulation pursuant to Article 2 shall be made for a specified \n\nperiod. It may be repealed or amended where circumstance have changed with \n\nrespect to any factor which was basic to its being made; in such \n\ncase, a period shall be fixed for modification of the agreements \n\nand concerted practices to which the earlier Regulation applies. \" \n\n4. Article 8 Is deleted. - 12 -\n\nArticle 2 \n\nThis Regulation shall enter into force on 1 July 1992. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Counci \nThe President \n\n\f- 13 -\n\nFiche d'impact sur les PME et l'emploi \n\n1. OBLIGATIONS ADMINISTRATIVES DECOULANT DE L'APPLICATION DE LA \n\nLEGISLATION POUR LES ENTREPRISES \n\nLes compagnies a\u00e9riennes devront suivre certaines proc\u00e9dures en vue de \nrespecter les r\u00e9gies de concurrence. 2. AVANTAGES POUR L'ENTREPRISE \n\nL'environnement plus concurrentiel devrait b\u00e9n\u00e9ficier tous les \nop\u00e9rateurs \u00e9conomiques, y compris les PME. En outre les r\u00e9gies de \nconcurrence prot\u00e8gent des petites compagnies a\u00e9riennes contre des \npratiques abusives \u00e9ventuelles de la part de concurrents en position \ndominante. Les exemptions par cat\u00e9gorie envisag\u00e9es par la proposition augmenteront \nla s\u00e9curit\u00e9 juridique des compagnies qui participent \u00e0 des accords \ncompatibles avec l'article 85 $ 3 du Trait\u00e9 CEE. 3. INCONVENIENTS POUR L'ENTREPRISE (Co\u00fbt suppl\u00e9mentaire) \n\nNon \n\n4. EFFETS SUR L'EMPLOI \n\nNon \n\n5. r *-T~lL EU CONCERTATION PREALABLE AVEC LES PARTENAIRES SOCIAUX ? \n\nNon \n\n\u2022m Y A-T-IL UNE ALTERNATIVE *Wim XmfHMGHMm \n\n\u00ef^ ^^^^^^^^^^^^^^^^^^ \n\nr \n\n* \n\n^ \n\nNon \n\n\f\fISSN 0254-1475 \n\nCOM(91) 272 final \n\nDOCUMENTS \n\nEN \n\n08 07 \n\nCatalogue number : CB-CO-91-369-EN-C \n\nISBN 92-77-75280-7 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/aaeaa590-73b9-475c-9da4-87018c6bf88c", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) AMENDING A DEFINITIVE ANTI-DUMPING DUTY FOLLOWING A PARTIAL REVIEW OF ANTI-DUMPING MEASURES CONCERNING IMPORTS OF UREA ORIGINATING IN VENEZUELA AND TERMINATING THE REVIEW OF ANTI-DUMPING MEASURES CONCERNING IMPORTS OF UREA ORIGINATING IN TRINIDAD AND TOBAGO", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-07", "subjects": "dumping,fertiliser,third country", "workIds": "celex:51991PC0312,comnat:COM_1991_0312_FIN", "eurovoc_concepts": ["dumping", "fertiliser", "third country"], "url": "http://publications.europa.eu/resource/cellar/aaeaa590-73b9-475c-9da4-87018c6bf88c", "lang": "eng", "formats": ["pdf"], "text": "COMVIISSION OF THE EUROPEAN COMVIUNITIES \n\nC0MC91) 312 final \n\nBrussels, 7 August 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\nameMing a definitive anti-dumping duty following a partial review \n\nof anti-dumpiig measures oorrerning inports of urea originating \n\nin Venezuela and terminatir^ the review of anti-dumping measures \n\nooirerniig imports of urea originating in Trinidad and Tobago \n\n(presented by the Commission) \n\nl- SjtjMig & '\u2022'-i-L. '-^. l. ^. xi2i \n\nm3&\u00a3. f|\" \n\n\u2022*&::, \n\n\fEXPLANATORY MEMORANDUM \n\nconcerning the Council Regulation amending a definitive anti-dumping duty \n\nfollowing a partial review of anti-dumping measures concerning imports of \n\nurea originating in Venezuela and terminating the review of anti-dumping \n\nmeasures concerning imports of urea originating in Trinidad and Tobago. I. PROCEEDING \n\nIn a notice published in the Official Journal of the European \nCommunities,1 the Commission announced the opening of an \n\ninvestigation to review anti-dumping measures imposed on imports of \n\nurea originating in Trinidad and Tobago and Venezuela by Council \nRegulation (EEC) No 450/892 and Commission Decision \nNO 89/143/EEC. 3 \n\nThe requests for a review were based on Article 14 of Regulation \n\n(EEC) No 2423/88 concerning changes of circumstances. As regards \n\nTrinidad and Tobago, the alleged change of circumstances concerned \n\na fall in production costs and a substantial increase in the price \n\nof exports to the Community, which, it was claimed, had put an end \n\nto dumping. The change of circumstances alleged by Venezuela \n\nconcerned a change in the official exchange rate used by the \n\nCommission in the previous proceeding to establish the dumping \n\nmargin. 1 OJ No C 55, 2. 3. 1991, p. 4. 2 OJ No L 52, 24. 2. 1989, p. 1. 3 OJ No L 52, 24. 2. 1989, p. 37 \n\n\f- 2 -\n\n11 \u2022 \n\nTRINIDAD AND TOBAGO \n\na) \n\nDumping \n\nA transaction-by-transaction comparison of the constructed normal \n\nvalue and export prices to the Community led to the conclusion that \n\ndumping had ceased. b) \n\nInjury \n\nIn the absence of dumping, the Commission did not consider it \n\nworthwhile to review the question of injury. c) \n\nConclusion \n\nGiven the absence of a duming margin and the honesty of the \n\nexporter involved, the Trinidad and Tobago Urea Company Ltd (TTUC), \n\nthe Commission is of the opinion that the anti-dumping measures \n\ncurrently imposed on this country should be abolished. III. VENEZUELA \n\na) \n\nDumping \n\nAs there had been no exports to the Community, the new exchange \n\nrate cited as a change of circmustances had not been applied, and \n\nit was therefore not possible to make a comparison with the new \n\nnormal value established in the course of the investigation. b) \n\nInjury \n\nAs regains the injury, the Venezuelan exporters' arguments that \n\nsince there had been no exports to the Community, the injury to \n\nCommunity producers had been eliminated and that Community \n\nproducers had substantially increased their prices were not \n\nconsidered sufficiently relevant by the Commission. - 3 -\n\nThe Commission considers that the suspension of exports can be \n\ninterpreted neither as an indication of the elimination of the \n\ninjury nor as a change of circumstances justifying a review of the \n\ninjury. The alleged increase in Community producers' prices is held \n\nto be a normal consequence of the imposition of anti-dumping \n\nmeasures. o) \n\nConclusion \n\nGiven the above, the Commission considered that in the absence of \n\nexports to the Community, it was unable to gauge the accuracy of \n\nthe argument put forward by the Venezuelan exporters concerning the \n\nelimination of dumping as a result of the application of the new \n\nexchange rate. Consequently, the Commission felt that the fairest \n\nsolution for the exporters involved, Nitroven and Pequiven, would \n\nbe to abolish the current ad valorem anti-dumping duty of 21. 5%, \n\nreplacing it with a variable duty based on the exporters' new \n\nnormal value, as established during the course of this proceeding. Consequently, the Commission submits a proposal for a Council \n\nRegulation: \n\n- terminating the review of the anti-dumping measures imposed on \n\nimports of urea originating in Trinidad and Tobago and cancelling \n\nthe undertaking imposed by Council Regulation (EEC) No 3339/87 and \n\nconfirmed by Commission Decision No 89/143/EEC of 21 February 1989; \n\n- Imposing a variable definitive anti-dumping duty on imports of \n\nurea originating in Venezuela exported by Nitroven and Pequiven, \n\nand retaining the ad valorem anti-dumping duty on other imports of \n\nurea originating in Venezuela. COUNCIL KBGOLATTCN (EEC) No \n\nOf \n\namending a definitive anti-dumping duty following a partial review \n\nof anti-dumping measures concerning imports of urea originating \n\nin Venezuela and terminating the review of anti-dumping measures \n\nconcerning Imports of urea originating in Trinidad and Tobago \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES \n\nHaving regard to the Treaty establishing the European Economic Community, \n\nHaving regard to Council Regulation (EEC) No 2423/88 of 11 July 1988 on \n\nprotection against dumped or subsidized imports from countries not members \nof the European Economic Ccaranunity,1 and in particular Articles 9, 12 and \n\n14 thereof, \n\nHaving regard to the proposal from the Commission, submitted after \n\nconsultations within the Advisory Committee as provided for by the above \n\nRegulation, \n\nWhereas: \n\nA. PROCEDURE \n\n(1) \n\nIn November 1990, pursuant to Article 14 of Council Regulation \n\n(EEC) No 2423/88, the Commission received a request for a review of \n\nthe anti-dumping measures imposed on imports of urea originating in \n\nTrinidad and Tobago and Venezuela by Council Regulation (EEC) \nNo 450/892 and Commission Decision No 89/143/EEC. 3 \n\n1 OJ No L 209, 2. 8. 1988, p. 1. 2 OJ No L 52, 24. 2. 1989, p. 1. 3 OJ No L 52, 24. 2. 1989, p. 37. (2) \n\nWith regard to Trinidad and Tobago, this request was made by the \n\nTrinidad and Tobago Urea Company Ltd, the successor to the National \n\nEnergy Corporation of Trinidad and Tobago Ltd, which had offered an \n\nundertaking in connection with the abovementionned Decision which \n\nhad been accepted. The review was requested on the ground of a \n\nchange in circumstances, resulting from the fact that a fall in \n\nproduction costs and a substantial increase in the prices of \n\nexports to the Community had put an end to any dumping. (3) \n\nWith regard to Venezuela, the request made by Venezolana del \n\nNitrogeno CA (Nitroven) and Petroquimica de Venezuela SA (Pequiven) \n\nfor a review of the definitive anti-dumping duty of 21. 5% Imposed \n\nby Council Regulation (EEC) No 450/89 was based on the change in \n\ncircumstances brought about by an adjustment on 14 March 1989 of \n\nthe official rate of exchange which had been used by the Commission \n\nto compare the normal value and the export price in order to \n\ncalculate the dumping margin. According to these companies, the \n\napplication of the new exchange rate would show that there was no \n\ndumping. SUBSEQUENT PROCESSING \n\n(4) \n\nHaving concluded that the requests contained sufficient evidence of \n\na change in circumstances, the Commission announced its decision to \n\nopen an investigation in a Notice of review of anti-dumping \n\nmeasures concerning Imports of urea originating in Trinidad and \n\nTobago or in Venezuela published in the Official Journal of the \nEuropean Communities. 4 \n\n(5) \n\nThe Commission officially notified the producers/exporters directly \n\ninvolved and the representatives of the exporting countries. 4 OJ No C 55, 2. 3. 1991, p. 4. - 3 -\n\n(6) \n\nThe Commission collected and verified all information it deemed \n\nnecessary to enable it to establish the facts and carried out \n\nchecks at the premises of the exporting companies involved, namely: \n\n- Trinidad & Tobago Urea Co Ltd (TTUC), Port of Spain, Trinidad \n\n- Petroqubnica de Venezuela SA (Pequiven), Caracas, Venezuela \n\n- Venezolana del Nitrogeno CA (Nitroven), Caracas, Venezuela \n\n- Palmaven SA, Caracas, Venezuela \n\n(7) \n\nThe investigation of dumping as provided for in Article 7 paragraph \n\n1 point c) of Council Regulation (EEC) No 2423/88 covered the \n\nperiod from 1 January 1990 to 31 December 1990. C. PRODUCT \n\n(8) \n\nThe product in question is a nitrogen compound whose chemical \n\nformula is 00 (NH2)2. It is produced synthetically from a \nreaction between ammonia and carbonic acid and comprises \n\napproxijnately 45% nitrogen. Urea is sold in prilled form (Trinidad \n\nand Tobago), granular form (Venezuela) or liquid form. It is mainly \n\nused as fertilizer. Urea falls within CN codes 3102 10 10 and 3102 10 99. - 4 -\n\nD. DUMPING REVIEW \n\nI. TRINIDAD AND TOBAGO \n\na) Normal value \n\n(9) \n\nAs TTUC's average urea sales price on its domestic market was lower \n\nthan the production cost during the period of the investigation, \n\nthe constructed normal value was used, in accordance with \n\nArticle 2(3)(b)(ii) of Council Regulation (EEC) No 2423/88. (10) \n\nThe constructed normal value was calculated by adding a profit \n\nmargin of 7% to the cost of production. This margin was held to be \n\nreasonable, given that in the current economic climate, it \n\nrepresents the minimum necessary to allow urea producers to run \n\ntheir plants under normal operating conditions while producing an \n\nacceptable return on capital employed and securing the investment \n\nfinancing required to continue operating at a profit. b) Export prices \n\n(11) \n\nExport prices were established on the basis of the prices actually \n\npaid or payable for the product sold for export to the Community, \n\nin accordance with Article 2(8) (a) of Regulation (EBC) No 2423/88. c) Comparison \n\n(12) \n\nThe constructed normal value was compared, transaction by \n\ntransaction, with export prices at the ex-factory stage. In accordance with Article 2(10) of Regulation (EEC) No 2423/88, \n\nthe Commission made due allowance in the form of adjustments for \n\ndifferences affecting price comparability, such as transport, \n\ninsurance and handling charges, credit terms, commissions and \n\nancillary costs. 5 -\n\nd) Anti-dumping margin \n\n(13) \n\nAn examination of the above facts showed that no dumping was taking \n\nplace. II- VENEZUELA \n\na) Normal value \n\n(14) \n\nAs urea is sold on the domestic Venezuelan market at prices fixed \n\nby government decree that are lower than the cost of production, \n\nthe constructed normal value was used, in accordance with \n\nArticle 2(3)(b)(ii) of Regulation (EEC) No 2423/88. (15) \n\nThe constructed normal value was calculated by adding a profit \n\nmargin of 7% to the cost of production. This margin was held to be \n\nreasonable, given that in the current economic climate, it \n\nrepresents the minimum necessary to allow urea producers to run \n\ntheir plants under normal operating conditions while producing an \n\nacceptable return on capital employed and securing the investment \n\nfinancing required to continue operating at a profit. k) Export prices \n\n(16) \n\nNo urea originating in Venezuela was exported to the Community \n\nduring the investigation period. c) Comparison \n\n(17) \n\nUnder these circumstances, it was not possible to compare the \n\nnormal value and the export price. - 6 -\n\nE. CONCLUSION \n\nI. TERMINATION OF THE REVIEW AS REGARDS TRINIDAD AND T0BM3O \n\n(18) \n\nGiven that there is no evidence of dumping and in view of the \n\nbehaviour of the exporter involved, which has generally respected \n\nits undertaking and has also substantially increased the prices of \n\nits exports to the Community, the Council is of the opinion that \n\nthe anti-dumping measures currently Ijonposed on this country should \n\nbe lifted. (19) \n\nUnder these circumstances, the Council considers that the review of \n\nthe anti-dumping measures concerning iirports of urea originating in \n\nTrinidad and Tobago should be terminated. (20) \n\nThis conclusion has not met with any objections from the anti \n\ndumping committee. H. AMENDMENT OF THE DEFINITIVE DUTIES AS REGARDS VBJKZUKLA \n\n(21) \n\nAs regards Venezuela, in the absence of any exports to the \n\nCcramunity it is not possible to verify the accuracy of the argument \n\nput forward by the exporters claiming that the application of the \n\nnew official exchange rate has put an end to dumping. Consequently, \n\nthe fairest solution would appear to be to abolish the ad valorem \n\nduty of 21. 5% currently in force, replacing it with a variable duty \n\nbased on the new normal value for the exporters, as established in \n\nthe course of the present procceeding. (22) \n\nAs regards the injury, in their request the exporters argued that \n\nthe injury had been eliminated as a result of the fact that there \n\nhad been no exports to the Community, and that the prices of \n\nOammunity producers had risen steadily since the imposition of the \n\nanti-dumping duty. - 7-\n\nThe Council observes that as a result of the previous anti-dumping \n\nproceeding, the exporters decided to suspend all exports to the \n\nCommunity. The Council is of the opinion that this suspension can \n\nbe interpreted neither as an indication that the injury has been \n\neliminated, nor as a change of circumstances justifying a review of \n\nthe injury. Furthermore, as regards the claim that Community producers have \n\nraised their prices, even should this claim be substantiated, these \n\nprice increases would be a normal consequence of the existence of \n\nanti-dumping measures. Consequently, the Council does not consider the arguments advanced \n\nconcerning injury to be relevant. (23) \n\nHowever, as noted above, the Council considers that a fair response \n\nto the exporters' request would be to take account of the results \n\nof this proceeding and to base the variable anti-dumping duty on \n\nthe exporters' new normal value. This variable anti-dumping duty is established in the form of a \n\nminimum price, free at Community frontier, calculated on the basis \n\nof the cost of producing the urea as established in the course of \n\nthe investigation period, plus a reasonable profit margin plus the \n\nancillary costs incurred up to the Community frontier. On this \n\nbasis, the minimum price free at Community frontier is ECU. per \ntonne. 5 It should be noted that this minimum price is lower than \n\nthe price used as a basis for calculating the ad valorem duty \n\nestablished in the previous proceeding. (24) \n\nThe ad valorem duty of 21. 5% is retained for imports of urea \n\noriginating in Venezuela, with the exception of urea exported by \n\nPequiven and Nitroven. (25) \n\nThese conclusions have not met with any objections from the anti \n\ndumping committee. 5 In accordance with the provisions of Article 5 of Regulation (EEC) \nNo 2423/88 concerning the non-disclosure of business secrets, this \nfigure has been deliberately omitted from the published version of this \nregulation. 8 -\n\n(26) \n\nAll the producers/exporters involved in this proceeding and the \n\nrepresentatives of the Community producers were informed of the \n\nmain facts and considerations on the basis of which it was proposed \n\nto recommend the termination of the review as regards Trinidad and \n\nTobago and the amendment of the definitive measures as regards \n\nVenezuela. They were also granted a period of time in which to make \n\ntheir comments known following notification. The Commission noted \n\ntheir remarks and took due account of them. HAS ADOPTED TEES REGULATION: \n\nArticle 1 \n\n1. The review of anti-dumping measures concerning iinports of urea \n\noriginating in Trinidad and Tobago is hereby terminated. 2. The undertaking made by the National Energy Corporation of Trinidad \n\nand Tobago Ltd, and taken up by the Trinidad and Tobago Urea \n\nCompany Ltd, which had been accepted by Council Regulation (EEC) No \n\n3339/87 and confirmed by Commission Decision No 89/143/EEC, is \n\nhereby cancelled. Article 2 \n\nThe anti-dumping duty of 21. 5% (additional code 8550) imposed by \n\nRegulation (EEC) No 450/89 on imports of urea originating in \n\nVenezuela and falling within CN codes 3102 10 10 and 3102 10 99 \n\nshall be retained for iinports of urea originating in Venezuela, \n\nwith the exception of urea produced and exported to the Community \n\nby Venezolana del Nitrogeno CA (Nitroven) and Petroquimioa de \n\nVenezuela SA (Pequiven) (additional code 8549), for which the \n\nanti-dumping duty shall be the difference between the net price per \n\ntonne free at Community frontier, not cleared through customs, and \n\nthe sum of ECU 110. 5 per tonne. - 9 -\n\nArticle 3 \n\nThe provisions in force concerning customs duties shall apply. Article 4 \n\nThis Regulation shall enter into force on the day following that of \nits publication in the Official Journal of the European \nCommunities. This Regultion shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Council, \n\n\f\fISSN 0254-1475 \n\nCOM(91)312final \n\nDOCUMENTS \n\nEN \n\n11 02 \n\nCatalogue number : CB-CO-91-367-EN-C \n\nISBN 92-77-75262-9 \n\nOffice for Official Publications of the European Communities \n1^2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/5fbc9efb-1199-4815-a828-341d2bca481b", "title": "WRITTEN QUESTION No. 1732/91 by Mr Herman VERBEEK to the Commission. Trade in protected species of plants and animals", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,VERBEEK", "date": "1991-08-07", "subjects": "fraud,international trade,protected species,protection of animal life,protection of plant life,simplification of formalities,wildlife", "workIds": "celex:91991E001732", "eurovoc_concepts": ["fraud", "international trade", "protected species", "protection of animal life", "protection of plant life", "simplification of formalities", "wildlife"], "url": "http://publications.europa.eu/resource/cellar/5fbc9efb-1199-4815-a828-341d2bca481b", "lang": "eng", "formats": ["print"]}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/bcac85b8-2d06-42c8-821b-d6ed17d70346", "title": "WRITTEN QUESTION No. 1720/91 by Mr Alexandros ALAVANOS to the Commission. River Acheloos diversion", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "ALAVANOS,European Parliament", "date": "1991-08-07", "subjects": "Central Greece,environmental impact,environmental protection,protection of animal life,public works,watercourse", "workIds": "celex:91991E001720", "eurovoc_concepts": ["Central Greece", "environmental impact", "environmental protection", "protection of animal life", "public works", "watercourse"], "url": "http://publications.europa.eu/resource/cellar/bcac85b8-2d06-42c8-821b-d6ed17d70346", "lang": "eng", "formats": ["print"]}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/e5323ffe-698f-4763-b58d-ea6aa52353aa", "title": "WRITTEN QUESTION No. 1721/91 by Mr Michael WELSH to the Commission. Motor-cycle safety", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,WELSH", "date": "1991-08-07", "subjects": "European standard,road safety,safety device,safety standard,two-wheeled vehicle,vehicle parts", "workIds": "celex:91991E001721", "eurovoc_concepts": ["European standard", "road safety", "safety device", "safety standard", "two-wheeled vehicle", "vehicle parts"], "url": "http://publications.europa.eu/resource/cellar/e5323ffe-698f-4763-b58d-ea6aa52353aa", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/10baf663-f3a7-474f-af2e-8a616ec2c13e", "title": "WRITTEN QUESTION No. 1706/91 by Mrs Marie JEPSEN to the Commission. Repayment of customs duty overpaid to the Community (Court of Justice ruling in case 148/87)", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,JEPSEN", "date": "1991-08-07", "subjects": "Denmark,common customs tariff,fishing net,fishing vessel,import tax,judicial proceedings,redemption", "workIds": "celex:91991E001706", "eurovoc_concepts": ["Denmark", "common customs tariff", "fishing net", "fishing vessel", "import tax", "judicial proceedings", "redemption"], "url": "http://publications.europa.eu/resource/cellar/10baf663-f3a7-474f-af2e-8a616ec2c13e", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/c23d94e5-a679-4fd8-a3f5-7fb86907baae", "title": "WRITTEN QUESTION No. 1744/91 by Mr Elio DI RUPO to the Council. Cooperation as regards the right of custody for visiting rights in respect of children", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "DI RUPO,European Parliament", "date": "1991-08-07", "subjects": "common position,competence of the Member States,family law,illegal restraint,judicial cooperation", "workIds": "celex:91991E001744", "eurovoc_concepts": ["common position", "competence of the Member States", "family law", "illegal restraint", "judicial cooperation"], "url": "http://publications.europa.eu/resource/cellar/c23d94e5-a679-4fd8-a3f5-7fb86907baae", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/2c6927fc-39a9-4ad0-833d-35a95eda5fd5", "title": "WRITTEN QUESTION No. 1709/91 by Mrs Astrid LULLING to the Commission. Prohibitive delays in the approval of electronic products in Europe", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,LULLING", "date": "1991-08-07", "subjects": "Luxembourg,Spain,approval,import licence,market protection,quality label,telecommunications equipment", "workIds": "celex:91991E001709", "eurovoc_concepts": ["Luxembourg", "Spain", "approval", "import licence", "market protection", "quality label", "telecommunications equipment"], "url": "http://publications.europa.eu/resource/cellar/2c6927fc-39a9-4ad0-833d-35a95eda5fd5", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/eda1fd1e-94b0-457e-9091-fd684cb56d31", "title": "WRITTEN QUESTION No. 1716/91 by Mr Thomas MEGAHY to the Commission. Emergency food aid for famine relief", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,MEGAHY", "date": "1991-08-07", "subjects": "Africa,agricultural market,cereals,developing countries,emergency aid,food aid,leguminous vegetable,source of aid,vegetable oil", "workIds": "celex:91991E001716", "eurovoc_concepts": ["Africa", "agricultural market", "cereals", "developing countries", "emergency aid", "food aid", "leguminous vegetable", "source of aid", "vegetable oil"], "url": "http://publications.europa.eu/resource/cellar/eda1fd1e-94b0-457e-9091-fd684cb56d31", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/f5eb5c16-a610-49d0-9648-a76ee980ebc8", "title": "WRITTEN QUESTION No. 1736/91 by Mr Jacques VERNIER to the Commission. Tax-free sales of tobacco and alcohol and public health", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,VERNIER", "date": "1991-08-07", "subjects": "alcohol,alcoholic beverage,alcoholism,duty-free sale,excise duty,intra-EU transport,public health,smoking,tobacco", "workIds": "celex:91991E001736", "eurovoc_concepts": ["alcohol", "alcoholic beverage", "alcoholism", "duty-free sale", "excise duty", "intra-EU transport", "public health", "smoking", "tobacco"], "url": "http://publications.europa.eu/resource/cellar/f5eb5c16-a610-49d0-9648-a76ee980ebc8", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/e4d37f63-e83d-41e8-b8a9-e99a54380060", "title": "WRITTEN QUESTION No. 1728/91 by Sir James SCOTT-HOPKINS to the Commission. Reports of milk superlevy", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,SCOTT-HOPKINS", "date": "1991-08-07", "subjects": "agricultural quota,common agricultural policy,countervailing charge,data collection,free service,marketing year,milk", "workIds": "celex:91991E001728", "eurovoc_concepts": ["agricultural quota", "common agricultural policy", "countervailing charge", "data collection", "free service", "marketing year", "milk"], "url": "http://publications.europa.eu/resource/cellar/e4d37f63-e83d-41e8-b8a9-e99a54380060", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/4e0ab0bf-93e6-44c1-b85f-d691b871839b", "title": "WRITTEN QUESTION No. 1746/91 by Mr Derek PRAG to the Commission. Grants to trade union organizations", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,PRAG", "date": "1991-08-07", "subjects": "Community budget,EU aid,European Trade Union Institute,economic support,occupational health,occupational safety,social partners,trade union", "workIds": "celex:91991E001746", "eurovoc_concepts": ["Community budget", "EU aid", "European Trade Union Institute", "economic support", "occupational health", "occupational safety", "social partners", "trade union"], "url": "http://publications.europa.eu/resource/cellar/4e0ab0bf-93e6-44c1-b85f-d691b871839b", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/ebcdb53e-cc90-49fa-b5bf-b1d9fe13155f", "title": "WRITTEN QUESTION No. 1727/91 by Mr Kenneth COLLINS to the Commission. Hallmarking of silverware and jewellery", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "COLLINS,European Parliament", "date": "1991-08-07", "subjects": "EU law,approximation of laws,consumer information,consumer protection,jewellery and goldsmith's articles,labelling,precious metal,producer's liability,trade restriction,trademark", "workIds": "celex:91991E001727", "eurovoc_concepts": ["EU law", "approximation of laws", "consumer information", "consumer protection", "jewellery and goldsmith's articles", "labelling", "precious metal", "producer's liability", "trade restriction", "trademark"], "url": "http://publications.europa.eu/resource/cellar/ebcdb53e-cc90-49fa-b5bf-b1d9fe13155f", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/caf0d780-649e-4555-9073-4c4e80ab2b18", "title": "WRITTEN QUESTION No. 1734/91 by Mr Giuseppe MOTTOLA to the Commission. Request for the repeal of Regulation (EEC) No. 1413/91 -incalculable harm to the tobacco-growing sector.", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,MOTTOLA", "date": "1991-08-07", "subjects": "agricultural guidance,contract,crop yield,plant breeding,product quality,tobacco", "workIds": "celex:91991E001734", "eurovoc_concepts": ["agricultural guidance", "contract", "crop yield", "plant breeding", "product quality", "tobacco"], "url": "http://publications.europa.eu/resource/cellar/caf0d780-649e-4555-9073-4c4e80ab2b18", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/4b1159a7-7f29-49fb-88ed-f81f2b0db3da", "title": "WRITTEN QUESTION No. 1751/91 by Mrs Ursula BRAUN-MOSER to the Council. Vocational training in alternative medicine/ homeopathy", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "BRAUN-MOSER,European Parliament", "date": "1991-08-07", "subjects": "Germany,alternative medicine,equivalence of diplomas,freedom to provide services,health care profession,higher education,recognition of diplomas,right of establishment,vocational training", "workIds": "celex:91991E001751", "eurovoc_concepts": ["Germany", "alternative medicine", "equivalence of diplomas", "freedom to provide services", "health care profession", "higher education", "recognition of diplomas", "right of establishment", "vocational training"], "url": "http://publications.europa.eu/resource/cellar/4b1159a7-7f29-49fb-88ed-f81f2b0db3da", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/284098b6-6d93-4587-9ea6-8b39828eb887", "title": "WRITTEN QUESTION No. 1724/91 by Mr Alex SMITH to European Political Cooperation. Contracts of employment for EC nationals outside the Community", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,SMITH ALEX", "date": "1991-08-07", "subjects": "EU national,competence of the Member States,third country,work contract", "workIds": "celex:91991E001724", "eurovoc_concepts": ["EU national", "competence of the Member States", "third country", "work contract"], "url": "http://publications.europa.eu/resource/cellar/284098b6-6d93-4587-9ea6-8b39828eb887", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/e086b1a8-3248-4725-9938-628b206e8a12", "title": "WRITTEN QUESTION No. 1708/91 by Mr Jean-Claude PASTY to the Commission. Situation of honey producers in the Community", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,PASTY", "date": "1991-08-07", "subjects": "EU aid,apiculture,competition,customs duties,honey,import,third country", "workIds": "celex:91991E001708", "eurovoc_concepts": ["EU aid", "apiculture", "competition", "customs duties", "honey", "import", "third country"], "url": "http://publications.europa.eu/resource/cellar/e086b1a8-3248-4725-9938-628b206e8a12", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/2bd214b4-bd3d-4e3d-abde-52fce1f5ec3e", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) AMENDING REGULATION ( EEC ) NO 3975/87 LAYING DOWN THE PROCEDURE FOR THE APPLICATION OF THE RULES ON COMPETITION TO UNDERTAKINGS IN THE AIR TRANSPORT SECTOR", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-07", "subjects": "air transport,competition,intra-EU transport", "workIds": "celex:51991PC0272(01),comnat:COM_1991_0272(01)_FIN,oj:JOC_1991_225_R_0009_01", "eurovoc_concepts": ["air transport", "competition", "intra-EU transport"], "url": "http://publications.europa.eu/resource/cellar/2bd214b4-bd3d-4e3d-abde-52fce1f5ec3e", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 272 final \n\nBrussels, 7 August 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\namending Regulation (EEC) No 3975/87 laying down the \n\nHiH* \n\nprocedure for the application of the rules on \n\ncompetition to undertakings in the \n\nair transport sector, \n\nand \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\nSafe' \n\namending Regulation (EEC) No 3976/87 on the application \n\nof Article 85(3) of the Treaty to certain categories of \n\nagreements and concerted practices in the \n\nair transport sector \n\nwm \n\n(presented by the Commission) \n\n\f- 2 -\n\nA. AMENDMENT TO REGULATION (EEC) No 3975/87 ON PROCEDURE FOR THE \n\nAPPLICATION OF COMPETITION RULES \n\n1. The Commission's powers to enforce the competition rules in the air \n\ntransport sector by means of fact-finding, imposing orders and \n\nsanctions and granting individual exemptions is limited, by Council \nRegulation (EEC) No 3975/87<1>, to international transport between \n\nMember States. The Commission's powers do not extend to either \n\ndomestic transport nor to transport between a Member State and a \n\nthird country. 2. In its Judgment of 11 April 1989 in the \"Ahmed Saeed\" case (1) the \n\nCourt of Justice confirmed its Judgment in the \"Nouvelles \nFronti\u00e8res case\"( 2) as regards the application of Article 85 of \n\nthe Treaty and ruled that Article 86 is directly applicable by \n\nnational courts, even in the absence of an implementing regulation \n\nunder Article 87 or of action by a Member State cartel authority or \n\nby the Commission (under Article 88 or Article 89 respectively). The Court's judgment means that where a dominant airline succeeds, \n\nother than by normal competitive means, in eliminating competition, \n\neven on a domestic or on a Community-third country route, this \n\nbehaviour is an abuse contrary to Article 86. Since there is no \n\nblock exemption for airlines to discuss, let alone agree, fares on \n\nCommunity-third \n\ncountry \n\nroutes, \n\nthe elimination \n\nof \n\nprice \n\ncompetition resulting from such discussions or agreements is liable \n\nto be an abuse of the dominant or joint dominant position which in \n\nmany instances exists on such routes. The Court also ruled that a \n\nMember State is in breach of its Treaty obligations if it approves \n\nfares which infringe Article 85 or Article 86. Such would be the \n\ncase for instance where a uniform agreed price structure has \n\nresulted from consultations which have not been exempted pursuant \n\nto Article 85(3). (1) OJ No L 374, 31. 12. 1987. (2) Judgment of 11 April 1989 in Case 66/86, [1989] ECR \n\n\f- 3 -\n\n3. Since, in respect of both domestic and of EC-third country air \n\ntransport, the Commission has no power to grant exemptions under \n\nArticle 85(3) nor to use normal procedures to rule on abuses of \n\ndominant position under Article 86, there is now a serious \n\nuncertainty in which air carriers can not know what practices and \n\narrangements they may legitimately engage in on such routes. If, \n\neven inadvertently, they act unlawfully, they run the risk of \n\nactions in national courts leading to the payment of compensation. Moreover, Member States face comparable uncertainties when \n\napproving the fares filed by carriers on such routes. In order to \n\nestablish a framework of certainty, the Council should now give the \n\nCommission the necessary powers to clarify how Articles 85 and 86 \n\napply to domestic and to extra-Community air transport. 4. The Commission accordingly proposed(3) that the Council adopt \n\nregulations extending the scope of its powers to enforce the \n\ncompetition rules in respect of domestic and third-country air \n\ntransport. The Council has however not yet acted on that proposal. 5. Since the Council has committed itself, in the framework of the \n\nthird package of air transport liberalisation measures, to lay down \n\nrules on cabotage it will be necessary to adopt at the same time \n\nmeasures enabling the Commission to enforce the competition rules \n\nto transport within a Member State. 6. Therefore the Commission now withdraws its earlier proposal insofar \n\nas it applied to domestic transport, and makes a new proposal \n\n(Annex I) consisting in a regulation to delete the limitation to \n\ninternational transport within the Community, so that domestic \n\ntransport entirely within a single Member State is also covered by \n\nRegulation (EEC) No 3975/87. (Annex I). (3) C0M(417) final, 8. 9. 1989. - 4 -\n\nB. AMENDMENT TO REGULATION (EEC) No 3976/87 ON GROUP EXEMPTIONS \n\n7. The Commission's powers to adopt group exemptions is limited, by \n\nCouncil Regulation (EEC) No 3976/87<4>, to International transport \n\nbetween Member States. For similar reasons to those set forth \n\nabove, these powers should now be extended to domestic transport \n\nentirely within a Member State. 8. As part of the second package of liberalisation measures in the air \n\ntransport sector the Council extended the validity of Regulation \n\n(EEC) No 3976/87 empowering the Commission to adopt for a limited \n\nperiod a number of group exemptions to the competition rules so \n\nthat air carriers could adapt progressively to a more competitive \n\nenvIronment. The Commission on that basis adopted three R\u00e9gul\u00e2tions(5): \n\n- Regulation (EEC) No 82/91 of 26 July 1988 concerning ground \n\nhand Iing services; \n\n- Regulation (EEC) No 83/91 relating to computer reservation \n\nsystems for air transport services; and \n\n- Regulation (EEC) No 84/91 concerning Joint planning and \n\ncoordination of capacity, consultations on tariffs on scheduled \n\nair services and slot allocation at airports. 9. The Commission's general experience with these group exemptions is \n\nthat they satisfy a genuine need for legal certainty among air \n\ncarriers and other market operators, while providing an incentive \n\nto abandon previous more restrictive agreements. 10. In view of the further liberalisation now proposed, the Commission \n\nis of the opinion that the same objectives can be pursued after \n\n31 December \n\n1992. This would \n\nimply that, subject \n\nto the \n\ncircumstances as they appear at the time, in particular the terms \n\n(4) OJ No L 374, 31. 12. 1987. (5) OJ No L 10, 15. 1. 1991. - 5 -\n\nof the third package adopted by the Council, the group exemptions \n\nwill be substantially renewed subject to some tightening of \n\nconditions (as set out below) which is made desirable by progress \n\nattained \n\nin creating a more competitive environment. The \n\npossibilities for cooperation to be left to airlines will depend on \n\nthe extent to which the new regulatory framework creates room for \n\nincreased competition. 11. The Commission intends to make the following changes to the \n\nexisting regulations : \n\n- replacement of the exemption for capacity discussions by an \n\nexemption for binding schedule coordination (the exemption for \n\nnon-binding schedule consultations will be maintained); \n\n- (if appropriate) alignment of the exemption for slot allocation \n\ndiscussions on the results of discussions by the Council on \n\ncommon rules for slot allocation (subject to the need to ensure \n\ncompatibility of the outcome of the discussions with Article \n\n85(3) of the EEC Treaty). The exemptions for computer reservation systems- and ground \n\nhandling agreements can be renewed without significant changes, \n\nexcept for changes necessary to take account of alterations in the \n\narrangements of the computer reservation systems. The exemption \n\nfor tariff consultations, including the obligations to interline, \n\nwill be renewed with some minor changes which will not affect the \n\nsubstance of air carriers' obligations but will clarify the \n\nconditions in practice. The Commission considers it useful to have power to adopt a group \n\nexemption in favour of Joint operations on new routes with \n\nrelatively few passengers for limited periods, in line with the \n\npractice which was developed in individual cases during the past \n\nfew years. - 6 -\n\n12. In order to secure adoption of the new group exemptions by the time \nthe present exemptions expire, on 31 December 1992, the extension \nof Regulation (EEC) No 3976/87 in order to enable the Commission to \nadopt these new group exemptions, should be in place by 30 June \n1992. The Commission will then follow the normal procedure provided by \nRegulation (EEC) No 3976/87, i. e. it will invite comments by third \nparties and consult the Advisory Committee on Restrictive Practices \nand Dominant Positions in Air Transport. 13. The Commission accordingly proposes that the Council adopt a \nregulation modifying Regulation (EEC) No 3976/87 in the following \nways (Annex II): \n\n(I) the Regulation would also apply to domestic transport \n\nentirely within a single Member State; \n\n(il) the Regulation is given an indefinite validity; \n\n(ill) the possibility of an exemption for joint operations between \n\nairlines will be provided for; \n\n(iv) the conditions contained in Article 2(2) of the Regulations \nare deleted, as is appropriate in a regulation of indefinite \nduration; and \n\n(v) a standard clause (new Article 3) is included on the duration \nand review of the Commission's implementing regulations. C. CHANGES TO EARLIER PROPOSAL TO ENFORCE THE COMPETITION RULES IN \n\nRESPECT OF DOMESTIC AND THIRD-COUNTRY TRANSPORT \n\n14. In view of the inclusion of domestic air transport in the proposals \nfor a third air transport package, the Commission now limits its \nearlier proposal to enforce the competition rules in respect of \ndomestic and third-country transport, to transport to third \ncountries. As a result, Annex II of the earlier proposal (C0M(89) 417 final, \nOJ No C 248 of 29 September 1989, p. 9) is withdrawn. i\u00a3 \n\u00c8* \n\n|j. , \n\u00a3. %' \nt \n\u00a3-. I\\ \nK \n5* \n\ni. *\u2022' \n\n\f- 7 -\n\nANNEX I \n\nProposal for a \n\nCOUNCIL REGULATION (EEC\u00cf \n\namending Regulation (EEC) No 3975/87 \n\nlaying down the procedure for the application of the rules \n\non competition to undertakings in the air transport sector \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular, Article 87 thereof, \n\nHaving regard to the proposal from the Commission^) \n\nHaving regard to the opinion of the European Pari lament<2>, \n\nHaving regard to the opinion of the Economic and Social Committee*3^ \n\nWhereas Regulation (EEC) No 3975/87<4) formed part of a package of \n\ninterrelated measures adopted by the Council as a first step towards \n\ncompleting the internal market in transport; whereas its scope was \n\naccordingly limited to international air transport between Community \n\nairports; \n\nWhereas, therefore, the Commission has no means at present of \n\ninvestigating directly cases of suspected infringement of Article 85 \n\nand 86 of the Treaty in respect of air transport within a Member State \n\nand lacks such powers to take decisions or impose penalties as are \n\nnecessary for it to authorise agreements under Article 85(3) and to \n\n(1) OJ No C \n\n(2) OJ No C \n\n(3) OJ No C \n\n(4) OJ No L 374, 31. 12. 1987, p. 1. bring to an end infringements established by it in relation to \n\ntransport within a Member State; \n\n- 8 -\n\nWhereas air transport entirely within a Member State now also is \n\nsubject to Community liberalisation measures; whereas it is therefore \n\ndesirable that rules should be laid down under which the Commission, \n\nacting in close and constant liaison with the competent authorities of \n\nthe Member States, may take the requisite measures for the application \n\nof Articles 85 and 86 of the Treaty to this area of air transport, in \n\nsituations where trade between Member States may be affected; \n\nWhereas there is a need to produce a secure and clear legal framework \n\nfor domestic air transport within a Member State, while ensuring a \n\ncoherent application of the competition rules; whereas therefore the \n\nscope of Regulation (EEC) No 3975/87 should be extended to this area of \n\nair transport, \n\nHAS ADOPTED THIS REGULATION : \n\nArticle 1 \n\nThe word \"international\" is hereby deleted in Article 1(2) of \n\nRegulation (EEC) No 3975/87. Article 2 \n\nThis Regulation shall enter into force on the day following that of its \n\npublication in the Official Journal of the European Commun!tes. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Council \nThe President \n\nr \n\nL-, \nI \nr _ \nf-. *-\n\n\fANNEX II \n\nProposal for a \nCWNCIU RE6UIATIQN (EEC) \n\namending Regulation (EEC) No 3976/87 \n\non the application of Article 85(3) of the Treaty to certain \n\ncategories of agreements and concerted practices \n\nin the air transport sector \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular Article 87 thereof, \n\nHaving regard to the proposal from the Commission*1), \n\nHaving regard to the opinion of the European P aN lament*2), \n\n, \n\nHav ing regard to the opinion of the Economic and Socla I ComrnltteeC3^, \n\nWhereas in accordance with Council Regulation (EEC) No 3975/87*4), as \namended by Regulation (EEC) No \nto implement the competition rules in respect of air transport within a \n\nthe Commission has power \n\n(5), \n\nMember State; whereas it is therefore desirable to provide for the \n\npossibility of adopting block exemptions applicable to that area of \n\ntransport; \n\n(1) OJ No C \n\n(2) OJ No C \n\n(3) OJ No C \n\n(4) OJ No L 374, \n(5) OJ No \n\n31. 12. 1987, p. 1 \n\n\f- 10 -\n\nWhereas Council Regulation (EEC) No 3976/87(6), as amended by \nRegulation (EEC) No 2344/90( 7 ), empowers the Commission to declare by \n\nway of Regulation that the provisions of Article 85(1) do not apply to \n\ncertain categories of agreements between undertakings, decisions by \n\nassociations of undertakings and concerted practices; \n\nWhereas the power to adopt these block exemptions has been granted for \n\na limited period, expiring on 31 December 1992, during which air \n\ncarriers can adapt to the more competitive environment introduced by \n\nchanges in the regulatory systems applicable to intra-Community \n\ninternational air transport; \n\nWhereas a continuation of block exemptions after that date is justified \n\nby the further measures to liberalize the air transport sector adopted \n\nby the Community; whereas the scope of these block exemptions and the \n\nconditions attached to them should be defined by the Commission, in \n\nclose liaison with the Member States, taking into account changes to \n\nthe competitive environment achieved since the entry into force of \n\nRegulation (EEC) No 3976/87, \n\nHAS ADOPTED THIS REGULATION : \n\nArticle 1 \n\nRegulation (EEC) No 3976/87 is hereby amended as follows: \n\n1. The word \"international\" is deleted in Article 1. 2. Article 2(2) is replaced by the following: \n\n\"2. The Commission may, in particular, adopt such regulations in \n\nrespect of agreements, decisions or concerted practices which \n\nhave as their object any of the following: \n\n(6) OJ No L 374, 31. 12. 1987, p. 9. (7) OJ No L 217, 11. 8. 1990, p. 15. - 11 -\n\n- joint planning and coordination of airline schedules; \n\n- consultations on tariffs for the carriage of passengers \n\nand baggage and of freight on scheduled air services; \n\n- Joint operations on new scheduled air services; \n\n- slot allocation at airports and airport scheduling; \n\n- common purchase, development and operation of computer \n\nreservation systems relating to timetabling, reservations \n\nand ticketing by air transport undertakings; \n\n- technical and operational ground handling at airports, \n\nsuch as aircraft push back, refuelling, cleaning and \n\nsecurity; \n\n- handling of passengers, mail, freight and baggage at \n\nairports; \n\n^, services for the provision of In-flight caterIngv\" \u2022*\u2022\u2022\u2022'-\u2022\u2022 \n\n3. Article 3 is replaced by the following: \n\n\"Article 3 \n\nA regulation pursuant to Article 2 shall be made for a specified \n\nperiod. It may be repealed or amended where circumstance have changed with \n\nrespect to any factor which was basic to its being made; in such \n\ncase, a period shall be fixed for modification of the agreements \n\nand concerted practices to which the earlier Regulation applies. \" \n\n4. Article 8 Is deleted. - 12 -\n\nArticle 2 \n\nThis Regulation shall enter into force on 1 July 1992. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Counci \nThe President \n\n\f- 13 -\n\nFiche d'impact sur les PME et l'emploi \n\n1. OBLIGATIONS ADMINISTRATIVES DECOULANT DE L'APPLICATION DE LA \n\nLEGISLATION POUR LES ENTREPRISES \n\nLes compagnies a\u00e9riennes devront suivre certaines proc\u00e9dures en vue de \nrespecter les r\u00e9gies de concurrence. 2. AVANTAGES POUR L'ENTREPRISE \n\nL'environnement plus concurrentiel devrait b\u00e9n\u00e9ficier tous les \nop\u00e9rateurs \u00e9conomiques, y compris les PME. En outre les r\u00e9gies de \nconcurrence prot\u00e8gent des petites compagnies a\u00e9riennes contre des \npratiques abusives \u00e9ventuelles de la part de concurrents en position \ndominante. Les exemptions par cat\u00e9gorie envisag\u00e9es par la proposition augmenteront \nla s\u00e9curit\u00e9 juridique des compagnies qui participent \u00e0 des accords \ncompatibles avec l'article 85 $ 3 du Trait\u00e9 CEE. 3. INCONVENIENTS POUR L'ENTREPRISE (Co\u00fbt suppl\u00e9mentaire) \n\nNon \n\n4. EFFETS SUR L'EMPLOI \n\nNon \n\n5. r *-T~lL EU CONCERTATION PREALABLE AVEC LES PARTENAIRES SOCIAUX ? \n\nNon \n\n\u2022m Y A-T-IL UNE ALTERNATIVE *Wim XmfHMGHMm \n\n\u00ef^ ^^^^^^^^^^^^^^^^^^ \n\nr \n\n* \n\n^ \n\nNon \n\n\f\fISSN 0254-1475 \n\nCOM(91) 272 final \n\nDOCUMENTS \n\nEN \n\n08 07 \n\nCatalogue number : CB-CO-91-369-EN-C \n\nISBN 92-77-75280-7 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/54ef116a-7221-43e9-85b5-264cf80070ab", "title": "Commission Regulation (EEC) No 2399/91 of 6 August 1991 concerning the classification of certain goods in the combined nomenclature", "langIdentifier": "ENG", "mtypes": "fmx4,html,pdfa1b,print,xhtml", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-06", "subjects": "Combined Nomenclature,common customs tariff,iron,oxide,sugar product", "workIds": "celex:31991R2399,oj:JOL_1991_220_R_0005_020", "eurovoc_concepts": ["Combined Nomenclature", "common customs tariff", "iron", "oxide", "sugar product"], "url": "http://publications.europa.eu/resource/cellar/54ef116a-7221-43e9-85b5-264cf80070ab", "lang": "eng", "formats": ["fmx4", "html", "pdfa1b", "print", "xhtml"], "text": "L_1991220EN. 01000501. xml\n\n\n\n\n\n\n\n\n\n\n8. 8. 1991\u00a0\u00a0\u00a0\n\n\nEN\n\n\nOfficial Journal of the European Communities\n\n\nL 220/5\n\n\n\n\n\nCOMMISSION REGULATION (EEC) No 2399/91\nof 6 August 1991\nconcerning the classification of certain goods in the combined nomenclature\nTHE COMMISSION OF THE EUROPEAN COMMUNITIES,\nHaving regard to the Treaty establishing the European Economic Community,\nHaving regard to Council Regulation (EEC) No 2658/87 of 23 July 1987\u00a0(1) on the tariff and statistical nomenclature and on the Common Customs Tariff, as last amended by Commission Regulation (EEC) No 2242/91\u00a0(2), and in particular Article 9,\nWhereas in order to ensure uniform application of the combined nomenclature annexed to the said Regulation, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation;\nWhereas Regulation (EEC) No 2658/87 has set down the general rules for the interpretation of the combined nomenclature and these rules also apply to any other nomenclature which is wholly or partly based on it or which adds any additional subdivisions to it and which is established by specific Community provisions, with a view to the application of tariff or other measures relating to trade in goods;\nWhereas, pursuant to the said general rules, the goods described in column 1 of the table annexed to the present Regulation must be classified under the appropriate CN codes indicated in column 2, by virtue of the reasons set out in column 3;\nWhereas the measures provided for in this Regulation are in accordance with the opinion of the nomenclature Committee,\nHAS ADOPTED THIS REGULATION:\nArticle 1\nThe goods described in column 1 of the annexed table are now classified within the combined nomenclature under the appropriate CN codes indicated in column 2 of the said table. Article 2\nThis Regulation shall enter into force on the 21st day after its publication in the Official Journal of the European Communities. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 August 1991. For the Commission\n\nJean DONDELINGER\n\nMember of the Commission\n\n\n\n\n\n(1)\u00a0\u00a0OJ No L 256, 7. 9. 1987, p. 1. (2)\u00a0\u00a0OJ No L 204, 27. 7. 1991, p. 21. ANNEX\n\n\n\n\n\n\n\nDescription of goods\n\n\nClassification CN Code\n\n\nReasons\n\n\n\n\n(1)\n\n\n(2)\n\n\n(3)\n\n\n\n\n\n\n\n\n\n\n1. Preparation in powder form for the manufacture of confectionery. Composition:\n84,4 % by weight dehydrated egg white (total protein content: 69,1 % by weight),\n14,6 % by weight maltodextrin (expressed in starch: 9,3 % by weight),\n1 % by weight gelatine. 2106\u00a090\u00a099\n\n\nClassification is determined by the provisions of General Rules 1 and 6 for the interpretation of the Combined Nomenclature, by additional note 1 to chapter 21 and by the texts of CN codes 2106, 2106\u00a090 and 2106\u00a090\u00a099. The product is not a protein concentrate of code 2106\u00a010\u00a090. 2. Artificial iron oxide containing approximately 95 % Fe2O3 and approximately 4 % alumina and silica, resulting from the manufacturing process. 2821\u00a010\u00a000\n\n\nClassification is determined by the provisions of General Rules 1 and 6 for the interpretation of the Combined Nomenclature, note 1 a) to Chapter 28 and by the texts of CN codes 2821 and 2821\u00a010\u00a000 (see also the Explanatory Notes to the HS, heading 28. 21, part A)"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/65505086-f04f-4c52-a79d-8299b5718af5", "title": "WRITTEN QUESTION No. 1699/91 by Mr Carlos ROBLES PIQUER to the Commission. Community directive to protect independent television productions in Europe", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,ROBLES PIQUER", "date": "1991-08-06", "subjects": "European audiovisual area,approximation of laws,audiovisual communications policy,audiovisual production,television", "workIds": "celex:91991E001699", "eurovoc_concepts": ["European audiovisual area", "approximation of laws", "audiovisual communications policy", "audiovisual production", "television"], "url": "http://publications.europa.eu/resource/cellar/65505086-f04f-4c52-a79d-8299b5718af5", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/f0660e5a-9147-4302-acd7-0c13a8d17f0f", "title": "WRITTEN QUESTION No. 1692/91 by Mr George STEVENSON to the Council. Celebrations in Tibet -formal anniversary of the annexation of Tibet by China -23 May 1991", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,STEVENSON", "date": "1991-08-06", "subjects": "China,human rights,military occupation,protection of freedoms,repression", "workIds": "celex:91991E001692", "eurovoc_concepts": ["China", "human rights", "military occupation", "protection of freedoms", "repression"], "url": "http://publications.europa.eu/resource/cellar/f0660e5a-9147-4302-acd7-0c13a8d17f0f", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/67c4d897-4267-4802-9d22-3795c4052b22", "title": "WRITTEN QUESTION No. 1670/91 by Mr Carles-Alfred GAS\u00d3LIBA I B\u00d6HM to the Commission. Promoting the teaching of Japanese in the Community", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,GASOLIBA I BOEHM", "date": "1991-08-06", "subjects": "Japan,executive,foreign language,language teaching,student", "workIds": "celex:91991E001670", "eurovoc_concepts": ["Japan", "executive", "foreign language", "language teaching", "student"], "url": "http://publications.europa.eu/resource/cellar/67c4d897-4267-4802-9d22-3795c4052b22", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/b49a775e-4d0d-4513-b194-3e0aec998a4a", "title": "WRITTEN QUESTION No. 1665/91 by Mr Jos\u00e9 VALVERDE L\u00d3PEZ to the Commission. The development of paper manufacturing by ' neutral process' in the EC", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,VALVERDE LOPEZ", "date": "1991-08-06", "subjects": "EU production,book trade,paper,research and development,technological change,technological process", "workIds": "celex:91991E001665", "eurovoc_concepts": ["EU production", "book trade", "paper", "research and development", "technological change", "technological process"], "url": "http://publications.europa.eu/resource/cellar/b49a775e-4d0d-4513-b194-3e0aec998a4a", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/7aab5c17-d7da-4eca-954b-b297eb79eca4", "title": "WRITTEN QUESTION No. 1689/91 by Mr Francesco SPERONI to the Commission. Geographically-based discrimination against Community citizens", "langIdentifier": "ENG", "mtypes": "print", "workTypes": "http://publications.europa.eu/ontology/cdm#question_parliamentary,http://publications.europa.eu/ontology/cdm#question_written,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Parliament,SPERONI Francesco Enrico", "date": "1991-08-06", "subjects": "EU national,Mezzogiorno,anti-discriminatory measure,free movement of workers,residence", "workIds": "celex:91991E001689", "eurovoc_concepts": ["EU national", "Mezzogiorno", "anti-discriminatory measure", "free movement of workers", "residence"], "url": "http://publications.europa.eu/resource/cellar/7aab5c17-d7da-4eca-954b-b297eb79eca4", "lang": "eng", "formats": ["print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/af4640da-0841-4eeb-8f76-64ed342b09f8", "title": "PROPOSAL FOR A COUNCIL DIRECTIVE ON THE INDICATION BY LABELLING AND STANDARD PRODUCT INFORMATION OF THE CONSUMPTION OF ENERGY AND OTHER RESOURCES OF HOUSEHOLD APPLIANCES", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_directive_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-06", "subjects": "consumer information,energy consumption,household electrical appliance,labelling,noise level", "workIds": "celex:51991PC0285,comnat:COM_1991_0285_FIN,oj:JOC_1991_235_R_0005_01", "eurovoc_concepts": ["consumer information", "energy consumption", "household electrical appliance", "labelling", "noise level"], "url": "http://publications.europa.eu/resource/cellar/af4640da-0841-4eeb-8f76-64ed342b09f8", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OP THE EUROPEAN COMMUNITIES \n\nC0M(91) 285 final - SYN 356 \n\nBrussels, 6 August 1991 \n\nProposal for a \n\nCOUNCIL DIRECTIVE \n\non the indication by labelling and standard product information \n\nof the consumption of energy and other resources \n\nof househoId appIi ances \n\n(presented by the Commission) \n\nT@Zf|y*s \n\naHE \n\nHi \n\nt?P \npa\u00bb \nm. m*> \n\n\u00abs \n\n\f>---2\u20142 -\n\nC O N T E N T? \n\nEXPLANATORY MEMORANDUM \n\nI. Introduction \n\nII. History of energy labelling in the Community \n\nIII. Need for energy labelling and product information \n\nIV. Costs and benefits of an energy labelling scheme \n\nV. Criteria for the proposed Directive \n\nVI. Comments on Articles of the proposed Directive \n\nPROPOSAL FOR A COUNCIL DIRECTIVE \n\nPage \n\n3 \n\n3 \n\n5 \n\n6 \n\n7 \n\n8 \n\n9 \n\n14 \n\n\f- 3 -\n\nEXPLANATORY MEMORANDUM \n\nI. INTRODUCTION \n\n1. This Directive, and the Community labelling scheme for domestic \n\nappliances that will flow from it, have a dual purpose: \n\nto encourage energy conservation through a better consumer \n\nunderstanding and \n\nto ensure that measures taken by Member States in this area do \n\nnot hinder trade. 2. The Council of Ministers, at their meeting on 16 September 1986, set \n\nnew energy objectives for the Community in 1995, which included a \n\nfurther improvement in energy efficiency of at least 20%. An evaluation \n\nof the energy policies of the Member States carried out in 1988 \n\nindicated that the Council's 1995 energy efficiency objective was \n\nunlikely to be attained unless stronger policy measures were taken. Energy efficiency efforts, and in particular investment in discrete \n\nenergy efficiency projects, seemed to be decreasing. A recent \n\nevaluation of the Member State's energy policies confirmed the trend \n\nobserved in 1988. If the rate of efficiency improvements remains at its \n\npresent average level then the Community can only expect to improve \n\nenergy efficiency by another 10% over 1988/95. This would be equivalent \n\nto an energy efficiency improvement of under 14% for the period \n\n1985/95, significantly less than the objective established in 1986. While the rate of improvement prior to the 1986 oil price collapse was \n\nclearly better than that thereafter, the fact that at no point in time \n\nin the past have efficiency improvements reached the rate needed to \n\nsatisfy Community energy policy objectives indicates that more \n\nstringent measures must be undertaken. 3. Recent changes in the perception of the security of future oil supplies \n\ngenerated by the Gulf Conflict and the concern for the environment have \n\nplaced energy efficiency high on the political agenda. 4. The complacency exhibited in the area of energy efficiency has meant \n\n- A \n\n-\n\nthat the effect of economic growth on energy consumption has not been \n\nnullified by increasing efficiency, so that energy consumption has \n\nincreased from 645 Mtoe in 1982 to 711 Mtoe in 1989. Energy consumption \n\nin industry has been almost static over the period (mainly due to \n\nindustrial restructuring) while substantial \n\nincreases in energy \n\nconsumption have been recorded in the transport and building sectors. More specifically in the principal area covered by this Directive, \n\ndomestic electrical demand rose from 581 Twh in 1982 to 789 Twh in \n\n1989, an increase of 35%. Thus domestic electricity consumption has \n\nrisen from 8. 1% of total energy consumption in 1982 to 9. 5% in 1989. 5. The combined Energy/Environment Council meeting in Luxembourg on \n\nNovember 1990 set a new target to stabilise Community C 02 emissions \n\nby the year 2000 at 1990 levels. Since energy efficiency represents the \n\nsingle most effective means of reducing C02 emission, the achievement \n\nof the Council's stated objective will require the application of \n\nrobust energy efficiency policies within the Community. 6. In order to assist Member States to pursue an energy efficiency policy \n\nthe Council on 5 June 1989 approved a Community action programme for \n\nimproving the efficiency of electricity use (PACE)*1). Moreover the \n\nCommission on 3 October 1990 proposed a Community energy efficiency \n\nprogramme (SAVE)*2) beginning in 1991 and having a duration of five \n\nyears. The main thrust of this programme is a comprehensive series of \n\nlegislative actions supported by targetted pilot actions as well as a \n\nsignificant effort to improve information flows between Member States \n\nand between the Community and other interested parties. This proposal \n\nforms part of the SAVE programme. 7. The current Directive addresses the problem of how specific energy \n\nefficiency of household appliances may be improved, through better \n\nconsumer \n\ninformation, and hence \n\nincreased competition between \n\nmanufacturers. The principal effect will be on electricity consumption, \n\nbut appliances using other forms of energy, such as gas, will also be \n\nincluded. In view of this, the Commission considers the introduction of \n\nimplementing directives for the appliances listed in the Directive as a \n\nmatter of urgency. (1) \n(2) \n\n0J No L 157, 9. 6. 1989, p. 32. C0M(90) 365 final. - 5 -\n\nII. HISTORY OF ENERGY LABELLING IN THE COMMUNITY \n\n8. In 1979 the Council passed Directive 79/530/EEC*3> intended to \n\nintroduce a Community wide scheme for energy labelling of household \n\nappliances. This allowed, but did not oblige, Member States to \n\nintroduce obligatory energy labels. At the same time the Council passed \n\nan implementing directive concerning ovens (Directive 79/531/EEC( 4 )). The Commission brought forward proposals for a number of other \n\nappliances. However, mainly as a result of disagreement over technical \n\nmeasurement standards, and margins of error, none of these proposals \n\nwas accepted by the Council. This meant that interest in the scheme, \n\nand so its impact, was low. However, following this, a number of Member \n\nStates took their own initiative. Germany, in particular, introduced a \n\nvoluntary scheme concerning the main domestic appliances. This \n\nintroduced labels, initially based on those in the Commission \n\nproposals, and product information. More recently, interest has \n\nrevived, and several Member States including the Netherlands, Denmark \n\nand the UK have been working on their own schemes. In the case of \n\nDenmark this led to a formal proposal for an obligatory scheme. This \n\nwas notified to the Commission on 22 April 1990 under Directive \n\n83/189/EE*5), which provides for \n\nMember States to inform the \n\nCommission of new technical standards and regulations and allows for \n\ntheir deferral, where their introduction would create barriers to the \n\nfree movement of goods. The Commission then decided that such a scheme \n\nwas likely to hinder trade between Member States. Accordingly, under \n\nArticle 9(2) of that Directive, it asked Denmark to defer its proposal \n\nfor a year and announced its intention to propose a harmonized scheme \n\nwithin that time limit. Since the failure to agree on further \n\nimplementing directives, further work has been done on measurement \n\nstandards and methods, and there is general acceptance of a method of \n\ndealing with margins of error. Moreover, Member States experience with \n\ntheir own schemes has led to the resolution of many of these technical \n\nproblems. This should allow previous technical problems to be overcome. (3) \n(4) \n(5) \n\n0J No L 145, 13. 6. 1979, p. 1. 0J No L 145, 13. 6. 1979, p. 7. 0J No L 109, 26. 4. 1983, p. 8. III. NEED FOR ENERGY LABELLING AND PRODUCT INFORMATION \n\n- 6 -\n\n9. The purpose of this scheme is to inform potential purchasers of the \n\nenergy consumption of the various appliances on offer, so they can take \n\naccount of this, and of the resultant running costs, in making their \n\npurchase decisions. Various surveys have shown that the energy \n\nconsumption of domestic appliances varies widely, and that, at current \n\nlevels of efficiency, there is no particular relationship between \n\nenergy efficiency and price or performance. Thus, if potential \n\npurchasers were aware of and understood their differences, they would \n\ntend to buy appliances which were more energy efficient, cost less to \n\nrun, and caused less environmental concern. This would, through the \n\nnormal competitive process, put considerable pressure on manufacturers \n\nto increase their efforts to produce more efficient appliances. However, at present, while some customers do receive this information, \n\nmost do not. As a result most purchasers show no preference for energy \n\nefficient appliances, and in most Member States the market fails to \n\nencourage the manufacture of such appliances. 10. The scheme may also make users of these appliances more aware of how \n\nenergy consumption depends on the way they use the appliance. This may, \n\nindirectly encourage them to use these appliances more efficiently. 11. It is difficult to assess the likely impact of a labelling and \n\ninformation scheme on the energy efficiency of appliances. However, \n\ntechnical estimates indicate that, even though the average energy \n\nconsumption of appliances has fallen substantially over the last \n\ndecade, there are still very large potential savings of perhaps a \n\nquarter of 208 Twh(6X7) 0f electricity consumed by appliances listed \nin this directive. Clearly this potential saving will not be achieved \n\nby labelling and information alone. Experience in for example the U. S. would indicate that labelling and information schemes work best to \n\nachieve these savings when combined with other measures, such as \n\nminimum efficiency standards (either voluntary or compulsory) or fiscal \n\nmeasures. (6) \n\n(7) \n\nEstimate desired from Fitchner 'The potential for energy saving in the \napplication of electrical energy'. Some of the appliances may also use other forms of energy such as \ngas or hot water, but the majority of energy use is electric. IV. COSTS AND BENEFITS OF AN ENERGY LABELLING SCHEME \n\n- 7 -\n\n12. As stated above it is difficult to give estimates of the benefit of the \n\nintroduction of a universal energy labelling scheme, or indeed given \n\nthe flexibility of this scheme, to estimate its costs. However it is \n\nvery clear that the benefits far outweigh the costs. For example for a \n\nrefrigerator, the average energy saving to the consumer over an \n\nappliance lifetime, resulting from the introduction of labelling may be \n\nof the order of ECU 25-50, while the cost of the labelling scheme, per \n\nappliance will be less than ECU 1. While the figure for other \n\nappliances may of course vary considerably, it is still clear that the \n\nbenefits will be one or two orders of magnitude greater than the costs. 8 -\n\nV. CRITERIA FOR THE PROPOSED DIRECTIVE \n\n13. The object of this scheme is to persuade consumers to buy and \n\nmanufacturers to produce more energy efficient appliances. It may also, \n\nindirectly encourage their more efficient use. In order to maximize its \n\nimpact there are a number of basic criteria it should fulfil: \n\n(i) The scheme must be uniform. If there are a variety of differing \n\ndesigns of labels, or of product information fiches, for the same \n\ntype of appliance, consumers may be confused when comparing rival \n\nappliances, and so may ignore the energy consumption information \n\naltogether. (ii) The scheme must be universal, all appliances of a given type must \n\nbe labelled. Otherwise there is a danger that consumers may \n\nprefer not to be reminded of the cost of running an appliance, \n\nand so may prefer a less efficient, but unlabel led, appliance to \n\na more efficient one, displayed with a label. (iii) The label and the fiche must be as clear as possible, while \n\nconveying as much relevant information as possible. (iv) The scheme should include both a label, for those who buy 'on \n\nimpulse' and a product fiche for those who are willing to devote \n\nmore time to studying the relative merits of various possible \n\nappliances. (v) The scheme should be flexible. In particular it should allow for \n\nupdating in the tight of improved efficiency of appliances, for \n\nthe introduction of minimum efficiency standards (either \n\nvoluntary or mandatory) and for the introduction of further \n\nappliances. (vi) The scheme should be as simple to run as possible, and lead to \n\nthe minimum possible costs. (vii) Finally the scheme should eliminate any barriers to trade between \n\nMember States in respect of energy labelling and product \n\ninformation and should seek to foster the single market. - 9 -\n\nVI. COMMENTS ON ARTICLES OF THE PROPOSED DIRECTIVE \n\nComments on Article 1 \n\nThis describes the objectives of the directive. As stated above these are to \n\navoid the obstacles to the single market that would result from the imposition \n\nof labelling schemes by individual Member States. It seeks to do this by the \n\nintroduction of a uniform Community scheme that achieves the benefits sought \n\nfrom the national schemes, and, as far as possible, meets the above criteria. The Article also lists those appliances whose Community wide use consumes the \n\nmost energy, and makes provision for addition to this list. This may prove \n\nnecessary either as the result of the introduction of new appliances, or \n\nbecause the global energy use of an existing appliance increases, e. g. as a \n\nresult of increasing ownership. Comments on Article 2 \n\nThis provides for harmonized measurement standards and methods, so that each \n\nmodel needs only follow one test procedure. It puts responsibility for this \n\ntesting and its accuracy on the manufacturer, or its representative, who will \n\nbe best placed to carry it out. It also provides for the keeping of technical documentation, within the \n\nCommunity, so that should there be a dispute as to the accuracy of a label or a \n\nfiche, then the basis on which the manufacturer made its claims can be more \n\neasiI y assessed. Comments on Article 3 \n\nThis requires the manufacturer to provide both a label and a fiche of product \n\ninformation. The label is intended for those who wish to buy the appliance \n\nimmediately. The fiche provides rather more complete information on the main \n\ncharacteristics including the energy efficiency of appliances (e. g. the energy \n\nconsumption of the various cycles). This information is provided in a standard \n\n\f- 10 -\n\nform that allows those potential purchasers, who wish to study the comparative \n\nmerits of various competing models to have more complete information available \n\nin a standard form to take away and compare at leisure. It also provides a \n\nsource of this information for others (Member States, consumer organizations, \n\ndealers etc. ) who want to provide comparative tables. It may also be used to \n\ninclude information as to the environmental consequences of using the \n\nappliance, and on how to use the appliance appropriately. Comments on Article 4 \n\nThis deals with the respective responsibilities of dealers (mainly retailers) \n\nand manufacturers. It should be noted that only a very small proportion of \n\nappliances are displayed in shops or elsewhere, the vast majority being \n\nsupplied direct to customers, probably still in their protective packing. Under \n\nthe existing Directive (79/530/EEC) manufacturers are obliged to supply a \n\ncomplete set of labels with each appliance. This leads to a large waste of \n\nlabels as only a small proportion are used. Moreover in the single market \n\nmanufacturers do not know where an appliance will finally be sold, and so which \n\nlanguage label to supply. In view of this the present Directive provides for dealers to attach the label, \n\nensuring it is in the correct language, and implying that it needs only be \n\nsupplied in numbers sufficient for those appliances that are actually \n\ndisplayed. Manufacturers are allowed to work out their own system for the \n\nsupply of labels in the most cost effective way possible. However, as dealers \n\nwill not be able to display, and so effectively to sell, appliances if they do \n\nnot have labels the Article provides for a rapid back up system in case the \n\nmanufacturers' system fails, for example in the case of parallel trade, to \n\nsupply the relevant label. The Article also deals with the legal responsabiIity for incorrect labels or \n\ninformation fiches. It provides that were a manufacturer provided incorrect \n\ninformation, or otherwise failed to fulfil its obligations then the ultimate \n\nresponsibility lies with it. However, as it will be difficult to directly \n\npursue manufacturers, the Directive provides for retailers to have Joint legal \n\nresponsibility, but provides for them to be indemnified by manufacturers. - 11 -\n\nComments on Article S \n\nThis allows for the implementing directives to make provision for the supply of \n\nenergy consumption information in those cases where potential purchasers will \n\nnot see an item displayed, so helping them to make a rational choice of \n\nappliance. At present this would mainly apply to mail order, and 'catalogue \n\nshops'. The Article is only permissive, as it would not, given present \n\nexperience, be possible to make provision for all such selling techniques, \n\nincluding any yet to be developed, nor would it make administrative sense to \n\nprovide for techniques that only account for a low level of sales. Comments on Article 6 \n\nThis applies where other Community legislation provides for other information \n\nabout the same appliances, in particular for information on airborne noise, \n\nwhich was to be included on the label provided for under the previous energy \n\nlabelling Directive (79/530). This will allow for the amalgamation of labels or \n\ninformation fiches where this seems appropriate. Comments on Article 7 \n\nThis specifies the role to be played by Member States in the implementation of \n\nthis scheme. Apart from ensuring the proper running of the scheme in indent (a) \n\nand (b), it obliges them (indent c) to prohibit rival labelling schemes if \n\nthese could lead to confusion. Indent (d) provides that dealers must be able to \n\ntake direct legal action to force manufacturers to fulfil their duties. This \n\nallows for a large degree of self policing. Similarly, indent (e) provides that \n\nconsumers can take action against retailers, who will normally be much closer, \n\nand so easier to deal with. It should be noted that the measures specified in \n\nthis Article need not be statutory. Thus those Member States with working \n\nvoluntary \n\nenergy \n\nlabelling \n\nand \n\ninformation \n\nschemes, \n\ncould \n\nenforce \n\nmanufacturers' obligations by contract. - 12 -\n\nComments on Article 8 \n\nThis provides Member States to monitor compliance with this Directive and the \n\nimplementing directives. They may subcontract their duties under this Directive \n\nto delegated bodies. Comments on Article 9 \n\nThis is a single market provision, which prohibits Member States from banning \n\nthe marketing of appliances on grounds relating to energy consumption \n\ninformation, where they comply with the Directive, and with the relevant \n\nimplementing directive. It does not effect any rights in relation to appliances \n\nnot covered by an implementing directive, nor does it affect any rights \n\nrelating to other grounds, in particular in relation to minimum efficiency \n\nstandards. Comments on Article 10 \n\nThis provides for the Commission, assisted by a committee, to take the \n\nimplementing directives and to add further appliances to the list in Article 1. Comments on Article 11 \n\nIn accordance with the Commissions's declaration annexed to the Single European \n\nAct, this provides for a consultative committee, which allows for the rapid and \n\nefficient decision making required for harmonization measures taken under \n\nArticle 100a. The consultative committee is set up in accordance with \n\nArticle 2, procedure 1 of Council Decision 87/373/EEC^8^, which deals with the \n\nform and procedure of such committees. This Article also provides for the \n\nconsultative committee to receive information and analysis on the operation of \n\nthe scheme. Comments on Article 12 \n\nThis Article lists the elements to be specified in the implementing directives. (8) \n\n0J No L 197, 18. 7. 1987, p. 33. - 13 -\n\nComments on Article 13 \n\nThis provides for the existing framework Directive (79/530) to be repealed. This is delayed until after Member States have implemented the present \n\nDirective, as otherwise there is a danger that measures that had been taken to \n\nimplement it could loose their legal force before they had been replaced. Comments pp Article 14 \n\nThis deals with the timetable for the introduction of this Directive. - 14 -\n\nProposal for a \n\nCOUNCIL DIRECTIVE \n\non the indication by labelling and standard product information \n\nof the consumption of energy and other resources \n\nof househoId app11ances \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Community, and in \n\nparticular Article 100a thereof, \n\nHaving regard to the proposal from the Commission^1), \n\nIn cooperation with the European Parliaments2^, \n\nHaving regard to the opinion of the Economic and Social Committee^3), \n\nWhereas it is important to take measures to progressively achieve the internal \n\nmarket by 31 December 1992; \n\nWhereas certain Member States already have their own voluntary schemes for \n\nenergy labelling and the provision of other energy consumption information for \n\ndomestic appliances; whereas one Member State has formally proposed to \n\nintroduce its own compulsory labelling scheme, and other Member States are \n\nconsidering its introduction; whereas the existence of a number of compulsory \n\nnational schemes would create barriers to intra-Community trade; \n\n(1) \n(2) \n(3) \n\nOJ No \nOJ No \nOJ No \n\n\f- 15 -\n\nWhereas Article 130r of the Treaty requires a prudent and rational utilization \n\nof natural resources, whereas the rational use of energy is one of the \n\nprincipal means by which this objective can be respected and environmental \n\npoI lut ion reduced; \n\nWhereas the provision of accurate, relevant and comparable information on the \n\nspecific energy consumption of household appliances may influence the public's \n\nchoice in favour of those appliances which consume less energy, thus prompting \n\nmanufacturers to take steps to reduce the consumption of the appliances which \n\nthey manufacture; whereas it will also, indirectly, encourage the efficient use \n\nof these appliances; whereas in the absence of this information, the operation \n\nof the market for these appliances will fail to promote adequately the rational \n\nuse of energy; \n\nWhereas this improvement in the operation of the market for these appliances \n\nwill be best achieved if there is a uniform label for all appliances of each \n\ntype, if potential customers receive supplementary standardized information \n\nrelating to these appliances, and if those who do not see the appliance \n\ndisplayed, and so have no opportunity to see the label, are also supplied with \n\nthis information; \n\nWhereas to this end the energy consumption of and other information concerning \n\neach type of appliance concerned must be measured in accordance with harmonized \n\nstandards and methods and it must be possible to check the application of these \n\nstandards at the marketing stage; \n\nWhereas Council Directive 79/530/EEC<4> ought to promote these aims for \n\nhousehold appliances; whereas however, as only one implementing Directive for \n\nelectric ovens has been passed, and as few Member States have introduced this \n\nlabel, it is now necessary to learn from the experience gained and strengthen \n\nthe provision of that Directive; whereas Directive 79/530/EEC must therefore be \n\nreplaced; whereas Council Directive 79/531/EEC(5) regarding energy labelling \n\nfor ovens, will need to be revised and subsequently integrated into the present \n\nscheme; \n\n(4) \n(5) \n\nOJ No L 145, 13. 6. 1979, p. 1. OJ No L 145, 13. 6. 1979, p. 7. - 16 -\n\nWhereas completely voluntary schemes would lead to only some apr' cnces being \n\nlabelled, or supplied with standard product information; wh. re:s there is a \n\ndanger that this would induce confusion for some consumers; whereas the present \n\nscheme must therefore ensure universal energy labelling and universal provision \n\nof the standard product information fiches of the relevant appliances; \n\nWhereas household appliances use a wide variety of forms of energy, with \n\nelectricity and gas being the most important; whereas the Directive must \n\ntherefore in principle cover appliances using any form of energy; \n\nWhereas Council Directive 86/594/EEC of 1 December 1986<6) on airborne noise \n\nemitted by household appliances, provides for an indication of noise emission \n\nto be included in energy labels, where these exist; whereas provision must \n\ntherefore be made for the incorporation, where appropriate, of other \n\ninformation and labelling covered by Community schemes-, \n\nWhereas only those types of appliances whose aggregate energy use is \n\nsignificant and where there is significant scope for increased efficiency need \n\nbe included, \n\nHAS ADOPTED THIS DIRECTIVE: \n\nArticle 1 \n\n1. The purpose of this Directive is the harmonization of national \n\nregulations on the publication, particularly by means of labelling and \n\nof product information, of information on energy consumption and \n\ninformation supplementary \n\nthereto for the following household \n\nappliances, even when these are sold for non-household uses: \n\n- refrigerators, freezers and their combinations \n\n- washing machines, driers and their combinations \n\n- dishwashers \n\n- ovens \n\n- water heaters \n\n- lighting appliances \n\n(6) \n\nOJ No L 344, 6. 12. 1986, p. 24. - 17 -\n\nFurther household appliances may be added to the list in accordance \n\nwith Article 10(b). 2. This Directive shall not apply to the rating plate or its equivalent \n\naffixed for safety purposes to such appliances. 3. For the purpose of this Directive \"dealer\" shall mean a retailer or \n\nother person who sells or displays household appliances to end users. Article 2 \n\n1. The information relating to the consumption of energy, other essential \n\nresources and supplementary information of household appliances shall \n\nbe drawn up on a comparative basis for the consumer's benefit in \n\naccordance with standards and methods laid down by Directives relating \n\nto each type of appliance adopted in implementation of this Directive. 2. This information and the details of the attachment of the label shall \n\nbe defined by directives relating to each type of appliance adopted in \n\nimplementation of this Directive. 3. The manufacturer shall establish the technical documentation described \n\nin paragraph (4) and it, or its authorized representative established \n\nin the Community, shall keep this documentation at the disposal of the \n\nnational authorities for inspection purposes for a period of not less \n\nthan 10 years after the last product has been manufactured. Where neither the manufacturer nor its authorized representative is \n\nestablished in the Community, the obligation to keep the technical \n\ndocumentation available shall be the responsibility of the person who \n\nplaces the product on the Community market. 4. Technical documentation shall enable the accuracy of the label and the \n\nproduct information fiche to be assessed. It shall include: \n\n\f- 18 -\n\na general description of the product, \n\nthe results of design calculations carried out, where these are \n\nrelevant, \n\ntest reports, \n\nwhere values are derived from those obtained for similar models, \n\nthe same information for these models. Artlcio 3 \n\n1. All manufacturers or their representatives established within the \n\nCommunity \n\nplacing \n\nthe household \n\nappliances \n\nspecified \n\nin the \n\nimplementing directives on the market shall supply a label in \n\naccordance with this Directive. 2. In addition to the labels, manufacturers or their authorized \n\nrepresentatives established in the Community shall provide a fiche of \n\nproduct \n\ninformation. This fiche shall be contained \n\nin product \n\nbrochures, or other literature where these are provided by the \n\nmanufacturer, or its representative established in the Community, with \n\nthe appllance. 3. Retailers, or other interested parties, may use the information \n\ncontained in labels and in the product information fiche to provide \n\ncomparative tables giving the relative performance of various models. Article. 4 \n\nIn respect of labelling and product information the following provisions shall \n\napply: \n\n(a) \n\nWhenever an appliance specified in an implementing directive is \n\ndisplayed, dealers shall attach an appropriate label, in the position \n\nspecified in the relevant implementing directive, and in the relevant \n\n\f- 19 -\n\nlanguage version. They shall be responsible to their customers and to \n\nthe public authorities for the accuracy of the label and the product \n\ninformation fiche. However, the relevant manufacturer, and where \n\napplicable its authorized representative, shall indemnify dealers if \n\nthe former supply incorrect labels or product information fiches, or \n\notherwise fail to fulfil the requirements of this Directive, or of an \n\nimplementing directive. (b) \n\nThe manufacturer or its authorized representative shall supply free of \n\ncharge to dealers specified in (a), the necessary labels. They shall \n\nalso provide information as to where the label is to be attached, in \n\naccordance with this Directive and the relevant implementing directive. Manufacturers or their representatives established in the Community are \n\nfree to choose their own system for delivery of labels. However, they \n\nmust also provide, with each appliance, an address and telex or fax \n\nnumber to which a dealer can send a request for labels. They must then \n\ntake all necessary steps to ensure that the necessary labels are \n\ndelivered within 5 working days of their receipt of the request. They \n\nshall be primarily responsable for ensuring that the labels and product \n\ninformation they supply complies in all respects with the requirements \n\nof this Directive, and of the relevant implementing directive. A r t K le 5 \n\nWhere the relevant appliances are offered for sale by mail order, by catalogue, \n\nor by other means which imply that the potential customer cannot be expected to \n\nsee the appliance displayed, the implementing directives may make provision to \n\ninsure that the potential customer is provided with the information specified \n\nin the label, or the product information fiche. Article 6 \n\nThe implementing directives shall require that the label and the fiche contain \n\ninformation on airborne noise, where such information is produced pursuant to \n\nDirective 86/594. It may also require that other public information relating to \n\nthe relevant appliance, which is produced pursuant to other Community \n\nlegislation, shall be incorporated on the label, or in the fiche. - 20 -\n\nArticle 7 \n\nEvery Member State shall take all necessary measures to ensure: \n\na) \n\nthat all manufacturers, their representatives and dealers \n\nestablished in their territory fulfil their obligations under \n\nthis Direct ive; \n\nb) \n\nthat any label relating to energy consumption which is displayed \n\nwithin its territory to potential purchasers and which is \n\nattached to an appliance, in relation to which an implementing \n\ndirective is in force, complies in all respects with the \n\nrequirements of this Directive and of the relevant implementing \n\ndirect ives-, \n\nc) \n\nthat the display in a similar manner of labels, marks, symbols or \n\ninscriptions relating to energy consumption which do not comply \n\nwith the requirements of this Directive and of the relevant \n\nimplementing directives is prohibited, if this is likely to \n\nmislead or confuse; \n\nd) that, where manufacturers or their representatives fail to fulfil \n\ntheir obligation under this Directive, or an implementing \n\ndirective, that dealers are able to take appropriate legal action \n\nto enforce compliance, and to recover damages; \n\ne) \n\nthat, where dealers fail to fulfil their obligations under this \n\nDirective, that actual or potential customers, or other \n\ninterested parties, are able to take appropriate legal action to \n\nenforce compliance and to recover damages. Article 8 \n\nCompliance with the national provisions bringing into force this \n\nDirective, and the implementing directives, shall be verified, by \n\nMember States, after the appliance has been placed on the market. Member States shall supply the Commission with any appropriate \n\ninformation and statistics on the operation of the system. - 21 -\n\nArticle 9 \n\n1. No Member State may either prohibit or restrict the placing on the \n\nmarket of the household appliances covered by an implementing directive \n\non grounds relating to the indication by labelling of their energy \n\nconsumption or other information compulsorily included on the label, \n\nwhere the provisions of this Directive and of the implementing \n\ndirectives are satisfied. 2. Without prejudice to the outcome of any checks carried out by Member \n\nStates once such appliances are displayed to potential purchasers, \n\nMember States shall deem the attaching of the relevant label to and the \n\nprovision of the relevant fiche for the household appliances covered by \n\nan implementing directive and which have been placed on the market, or \n\ndisplayed, to comply with the provisions of this Directive and the \n\nimplementing directives in respect of labelling, and of the product \n\ninformation fiche. Article 10 \n\nThe main measures relating to the establishment and operation of the scheme \n\nshall be adopted and adapted to technical progress in accordance with the \n\nprocedure laid down in Article 11. These measures include: \n\na) \n\nthe implementing directives; \n\nb) \n\nthe addition of further household appliances to the list in \n\nArticle 1(1) where significant energy savings are likely to be \n\nachieved. - 22 -\n\nArticle 11 \n\nA consultative committee composed of the representatives of the Member States \n\nand chaired by the representative of the Commission is hereby set up to assist \n\nthe Commission in taking the measures referred to in this Directive and, in \n\nparticular, in Article 10. The representative of the Commission shall submit to the committee a draft of \n\nthe measures to be taken. The committee shall deliver its opinion on the draft \n\nwithin a time limit which the chairman may lay down according to the urgency of \n\nthe matter, if necessary by taking a vote. The opinion shall be recorded in the minutes; in addition, each Member State \n\nshall have the right to ask to have its position recorded in the minutes. The Commission shall take the utmost account of the opinion delivered by the \n\ncommittee. It shall inform the committee of the manner in which its opinion has \n\nbeen taken into account. Article 12 \n\nThe implementing directives shall specify: \n\na) \n\nthe exact definition of the type of appliances to be included; \n\nb) \n\nthe measurement standards and methods to be used in obtaining the \n\ninformation referred to in Article 2(2); \n\nc) \n\nthe design and content of the label specified in Article 3(1); \n\nd) \n\nthe location in which the label shall be fixed to the appliance. Where appropriate it may also make provisions for a label to be \n\nattached to or printed on the packaging; \n\ne) \n\nthe content of the fiche of further information specified in \n\nArticle 3(2). They may also specify its format, and other details \n\nas to how it shall be provided; \n\n\f- 23 -\n\nf) \n\nthey may specify the information to be provided in the case of \n\noffers for sale covered by Article 5, and the manner in which it \n\nis to be provided. Article 13 \n\nDirective 79/530/EEC is hereby repealed, with effect from the moment when all \n\nMember States bring into force the provisions necessary to comply with this \n\nDirect ive. Directive 79/531/EEC shall be considered as implementing this Directive for \n\nelectric ovens; however, Member States may refrain from its compulsory \n\nimplementation, until a date set in a revised implementing directive adopted \n\npursuant to Article 10. Article 14 \n\n1. Member States shall adopt the provisions necessary to comply with this \n\nDirective by 1 July 1992 and shall bring them into force by 1 January \n\n1993. They shall immediately notify the Commission of their adoption. When Member States adopt these provisions, these shall contain a \n\nreference to this Directive or shall be accompanied by such reference \n\nat the time of their official publication. The procedure for such \n\nreference shall be adopted by Member States. 2. Member States shall communicate to the Commission any measures which \n\nthey take in the field covered by this Directive. Article 1S \n\nThis Directive is addressed to the Member States. Done at Brussels, \n\nFor the Council \n\nThe President \n\n\f\fISSN 0254-1475 \n\nCOM(91) 285 final \n\nDOCUMENTS \n\nEN \n\n10 \n\nCatalogue number : CB-CO-91-321-EN-C \n\nISBN 9?-77-74J95-9 \n\nOffice ft- \n1^2985 Luxembourg. icialluv. ions Ox uxc European Comnr \n\n'ies"}
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+{"cellarURIs": "http://publications.europa.eu/resource/cellar/16404696-09c1-471c-8210-439de7e560de", "title": "Commission Regulation (EEC) No 2363/91 of 2 August 1991 on the sale by the procedure laid down in Regulation (EEC) No 2539/84 of beef held by certain intervention agencies and intended for export to the Soviet Union and amending Regulation (EEC) No 569/88", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "France,USSR,frozen product,intervention stock", "workIds": "celex:31991R2363,oj:JOL_1991_216_R_0017_028", "eurovoc_concepts": ["France", "USSR", "frozen product", "intervention stock"], "url": "http://publications.europa.eu/resource/cellar/16404696-09c1-471c-8210-439de7e560de", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/da021b84-d73a-4972-a548-ba98576ced49", "title": "Commission Regulation (EEC) No 2368/91 of 2 August 1991 amending Regulation (EEC) No 3310/86 on the Community recording of market prices on the basis of the scale for the classification of carcasses of adult bovine animals", "langIdentifier": "ENG", "mtypes": "html,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#legislation_secondary,http://publications.europa.eu/ontology/cdm#regulation,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "EU market,beef,carcase,cattle,market prices", "workIds": "celex:31991R2368,oj:JOL_1991_216_R_0035_033", "eurovoc_concepts": ["EU market", "beef", "carcase", "cattle", "market prices"], "url": "http://publications.europa.eu/resource/cellar/da021b84-d73a-4972-a548-ba98576ced49", "lang": "eng", "formats": ["html", "pdfa1b", "print"]}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/8f3fe24b-1e1a-437f-9d91-ff9b5e9066b3", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) EXTENDING THE PROVISIONAL ANTI-DUMPING DUTY ON IMPORTS OF OXALIC ACID ORIGINATING IN INDIA AND CHINA", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "China,India,organic acid", "workIds": "celex:51991PC0320,comnat:COM_1991_0320_FIN", "eurovoc_concepts": ["China", "India", "organic acid"], "url": "http://publications.europa.eu/resource/cellar/8f3fe24b-1e1a-437f-9d91-ff9b5e9066b3", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 320 final \n\nBrussels, 2 August 1991 \n\n;'\u2022\u00a3\u00a3. Proposal for a \n\nCOUNCIL REGULATION (EEC) \n\nextending the provisional anti-dumping duty on Imports of oxalic acid \n\noriginating in India and China \n\n(presented by the Commission) \n\n\fEXPLANATORY MEMORANDUM \n\n1. Commission Regulation (EEC) No 1472/91 of 29 May 1991 imposed a \n\nprovisional anti-dumping duty on imports of oxalic acid originating in \n\nIndia and China. 2. Examination of the facts has not yet been completed. 3. The Commission has informed the exporters known to be concerned of Its \n\nintention to extend the validity of the provisional duty for an \n\nadditional period of two months. The exporters have raised no \n\nobjection. 4. Accordingly, pursuant to Article 11 (5) of Council Regulation (EEC) \n\ntslo. 2423/88, the Commission is putting before the Council a draft \n\nRegulation extending the validity of the provisional ant I-clumping duty \n\non Imports of oxalic acid originating In India and China for an \n\nadditional period of two months. A \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) No \n\n/91 \n\nOf \n\n1991 \n\nextending the provisional anti-dumping duty on imports of oxalic acid \n\noriginating in India and China \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES \n\nHaving regard to the Treaty establishing the European Economic Community, \n\nHaving regard to Council Regulation (EEC) No 2423/88 of 11 July 1988 on \n\nprotection against dumped or subsidized Imports from countries not \nmembers of the European Community^1), and In particular Article 11 \n\nthereof, \n\nHaving regard to the the Commission proposal, \n\nWhereas, Commission Regulation (EEC) No 1472/91<2) Imposed a \n\nprovisional anti-dumping duty on Imports of oxalic acid originating in \n\nIndia and China, \n\nWhereas examination of the facts has not yet been completed and the \n\nCommission has informed the exporters known to be concerned of Its \n\nintention to propose an extension of the validity of the provisional duty \n\nfor an additional period of two months, \n\nWhereas the exporters have raised no objections, \n\n(1) \n\n(2) \n\nOJ N* L 209, 02. 08. 1988, p. 1 \n\nOJ N* L 138, 01. 06. 1991, p. 62 \n\n\fHAS ADOPTED THIS REGULATION: \n\nArticle 1 \n\nThe validity of the provisional ant I-dumping duty on Imports of oxalic \n\nacid originating in India and China imposed by Regulation (EEC) \n\nn' 1472/91 is hereby extended for a period of two months. It shall cease \n\nto apply if, before the expiry of that period, the Council adopts \n\ndefinitive measures or the proceeding is terminated under Article 9 of \n\nRegulation (EEC) n' 2423/88. Article 2 \n\nThis Regulation shall enter into force on the day following its \n\npublication In the Official Journal of the European Communities. This Regulation shall be binding In Its entirety and directly applicable \n\nin all Member States. Done at Brussels, \n\nFor the Council \n\n\fISSN 0254-1475 \n\nCOM (91) 320 final \n\nDOCUMENTS \n\nEN \n\nil 02 \n\nCatalogue number : CB-CO-91-358-EN-C \n\nISBN 92-77-74981-4 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/d2ef3ef9-9c4b-4a27-b72b-d1325d9bf1b2", "title": "AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE WIDENING THE SCOPE OF DIRECTIVES 65/65/EEC AND 75/319/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES ON MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS ON HOMEOPATHIC MEDICINAL PRODUCTS", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_directive_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "alternative medicine,approximation of laws,homeopathic product,labelling,marketing standard,medicinal product", "workIds": "celex:51991PC0313(01),comnat:COM_1991_0313(01)_FIN,oj:JOC_1991_244_R_0008_01", "eurovoc_concepts": ["alternative medicine", "approximation of laws", "homeopathic product", "labelling", "marketing standard", "medicinal product"], "url": "http://publications.europa.eu/resource/cellar/d2ef3ef9-9c4b-4a27-b72b-d1325d9bf1b2", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMVTUNITIES \n\nC0M(91) 313 final - SYN 251 and 252 \n\nBrussels, 2 August 1991 \n\nsilt \n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directives 65/65/EEC and 75/319/EEC on the \n\napproximation of the laws of the Member States on medicinal \n\nproducts and laying down additional provisions on \n\nhomeopathic medicinal products \n\nSYK 251 \n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directive 81/851/EEC on the approximation of \n\nthe laws of the Member States on veterinary medicinal products \n\nand laying down additional provisions on homeopathic \n\nSYN 252 \n\nveterinary medicinal products \n\n(presented by the Commission pursuant to Article 149(3) \nof the EEC-Treaty) \n\n\f- 2 -\n\nEXPLANATORY MEMORANDUM \n\nAt its plenary session on 13 June 1991, the European Parliament, on first reading \n\nof the co-operation procedure, gave its opinion upon two proposals for Directives \n\nrelating to homeopathic medicines for human and veterinary use - COM(90)72 of \n\n22. 03. 90, SYN 251-252. The Commission has decided, in accordance with Article 149, paragraph 3 of the EEC \n\nTreaty, to amend its proposals in order to incorporate into the text 17 out of the \n\n28 amendements adopted by the Parliament. The primary aims of the amendments accepted by the Commission are : \n\n- to avoid the distortion of competition between manufacturers \n\n- to maintain the principle of a free choice of therapies \n\n- to assimilate anthroposophic medicines as homeopathic medicines when described \n\nin an off I cal pharmacopoeia \n\n- to introduce appropriate references to homeopathic and anthroposophic \n\nprinciples. - 3 -\n\nBy contrast, the Commission rejected other amendments for three principal reasons. Certain of the amendments go far beyond the limits of those proposals which deal \n\nwith the free movement of medicines, for example; training for and engaging in \n\nprofessional practice, and the way in which the cost of medicines to the patient \n\nis met by public funding. Some amendments show excessive partiality towards particular medical traditions, \n\nbearing in mind that the Commission must remain neutral in the debate between \n\n\"conventional\" and \"alternative\" medicine. Other amendments would widen excessively the scope of the simplified registration \n\nprocedure (Article 7 ), to the extent that a full marketing authorization \n\n(Article 9) would become an exception to the normal rule. It is worth recalling that since 1965 throughout the Community the normal basis \n\nfor a marketing authorization has been three standard criteria (quality, safety \n\nand efficacy) leading the competent authorities to undertake an evaluation of the \n\nrisks and benefits expected of the medicament in question. 4 -\n\nHowever, the simplified registration procedure, in the form proposed by the \n\nCommission, constitutes rather an administr\u00e2tive notification, adequate for \n\nhomeopathic medicines which do not present any known risk by virtue of their \n\nmethod of administration (oral) and the low concentration of their active \n\nconstituents, which is fixed at less than one part per million. Manufacturing \n\nquality can be verified from the dossier supplied. The other routes of administration described by the pharmacopoeias, especially \n\ninjectibles, or stronger concentrations of active constituents, can, in certain \n\ncases, expose patients to potential risks and necessitate because of this a more \n\ncomprehensive authorization procedure based upon an evaluation of the risks and \n\nbenefits by the competent authorities in accordance with the provisions of \n\nArticle 9. - 5 -\n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directives 65/65/EEC and 75/319/EEC on the \n\napproximation of the laws of the Member States on medicinal \n\nproducts and laying down additional provisions on \n\nSYN 251 \n\nhomeopathic medicinal products \n\n(Presented by the Commission in accordance with article 149, \n\nparagraph 3 of EEC Treaty) \n\nOriginal proposal \n\nAmended proposal \n\nTitles and visas unchanged \n\nFirst recital \n\nWhereas differences currently existing \n\nWhereas differences currently existing \n\nbetween the provisions laid down by \n\nbetween the provisions laid down by \n\nlaw, regulation or administrative \n\nlaw, regulation or administrative \n\naction in the Member States may hinder \n\naction in the Member States may hinder \n\ntrade in homeopathic medicinal \n\ntrade in homeopathic medicinal \n\nproducts within the Community; \n\nproducts within the Community and thus \n\nlead to discrimination and distorsion \n\nof competition between manufacturers of \n\nthese products; \n\n2nd recital unchanged \n\nRecital 2a (new) \n\nWhereas freedom of choice with regard \n\nto therapy needs to be safeguarded; \n\nwhereas, despite considerable dif \n\nferences in the status of alternative \n\nmedicines in the various Member States, \n\npatients should be guaranteed free \n\naccess to the therapy of their choice, \n\nprovided all precautions are taken to \n\nensure the quality and safety of \n\nproducts; \n\n3rd recital unchanged \n\n\fOriginal proposal \n\nAmended proposa \n\n- 6 -\n\nFourth recital \n\nWhereas homeopathic medicine is \n\nWhereas homeopathic medicine is \n\nofficially recognized in certain \n\nofficially recognized in certain \n\nMember States but is only tolerated \n\nMember States but is only tolerated \n\nin other Member States; whereas, \n\nin other Member States; \n\ntherefore, it is appropriate to \n\nrecognize certain national homeopathic \n\ntraditions without imposing them \n\nthroughout the Community; \n\n5th, 6th and 7th recitals unchanged \n\nEighth recital \n\nWhereas, having regard to the \n\nWhereas, having regard to the \n\nparticular characteristics of these \n\nparticular characteristics of these \n\nmedicinal products, such as their \n\nmedicinal products, such as their ' \n\nvery low content of active principles \n\nvery low content of active principles \n\nand the difficulty of applying to them \n\nand the difficulty of applying to them \n\nthe conventional statistical methods \n\nthe conventional statistical methods \n\nrelating to clinical trials, it is \n\nrelating to clinical trials, it is \n\nappropriate to provide a simplified \n\nappropriate to provide a simplified \n\nregistration system for those \n\nregistration system for those \n\ntraditional homeopathic medicinal \n\ntraditional homeopathic medicinal \n\nproducts which are placed on the market \n\nproducts which are placed on the market \n\nwithout specific therapeutic \n\nwithout specific therapeutic \n\nindications in a preparation which \n\nindications in a preparation and dosage \n\ndoes not present a risk for the patient; \n\nwhich does not present a risk for the \n\npatient; \n\n9th recital unchanged \n\n\f- 7 -\n\nOriginal proposal \n\nAmended proposal \n\nArt \n\nicle 1 \n\nFor the purposes of this Directive \n\nFor the purposes of this Directive \n\n\"homeopathic medicinal product\" shall \n\n\"homeopathic medicinal product\" shall \n\nmean any medicinal product prepared in \n\nmean any pharmaceutical preparation \n\naccordance with a homeopathic manufac \n\nprepared in accordance with a \n\nturing procedure described by the \n\nhomeopathic manufacturing procedure \n\nEuropean Pharmacopoeia, or in the \n\ndescribed by the European \n\nabsence thereof, by the official \n\nPharmacopoeia, or in the absence \n\npharmacopoeia of a Member State. thereof, by the official pharmacopoeia \n\nof a Member State. For the purposes of this Directive \n\nanthroposophical medicinal products \n\ndescribed by an official pharmacopoeia \n\nshall be treated as equivalent to \n\nhomeopathic medicinal products. Homeopathic preparations are \n\nHomeopathic preparations are produced \n\nproduced from products, substances \n\nfrom products, substances or composi \n\nor compositions called homeopathic \n\ntions called homeopathic stocks by \n\nstocks by successive dilutions. successive dilutions and potentiation. A homeopathic medicinal product may \n\nalso contain a member of different \n\ncomponents. A homeopathic preparation may contain, \n\nwith the exception of catalysts, only \n\nhomeopathic stocks in a minimum \n\ndilut ion of 1:10. Articles 2, 3, 4, 5 and 6 unchanged \n\nArticle 7, paragraph 1 unchanged \n\nArticle 7 (2) \n\nSeventh indent a (new) \n\n- a sentence advising the user to \n\nconsult a competent therapist whilst \n\nusing the medicinal product if the \n\nif the symptoms persist. Rest of the article unchanged \n\n\fOriginal proposal \n\nAmended proposa \n\n- 8 -\n\nArticle 8, introductory phrase and first three indents \n\nAn application for a simplified \n\nAn application for a simplified \n\nregistration submitted by the person \n\nregistration submitted by the person \n\nresponsible for marketing may cover \n\nresponsible for marketing may cover \n\na series of preparations derived from \n\na series of preparations derived from \n\nthe same homeopathic stock. The \n\nthe same homeopathic stock or stocks. following documents shall be included \n\nThe following documents shall be \n\nwith the application in order to \n\nincluded with the application in order \n\ndemonstrate, in particular, the \n\nto demonstrate, in particular, the \n\npharmaceutical quality and the batch \n\npharmaceutical quality and the batch \n\nconsistency of the products concerned : \n\nconsistency of the products concerned \n\nscientific name of the homeopathic \n\n- scientific name of the homeopathic \n\nstock, together with a mention of \n\nstock or stocks, together with a \n\nthe various routes of administra \n\nmention of the various routes of \n\ntion, pharmaceutical forms and \n\nadministration, pharmaceutical forms \n\ndilut ions to be registered; \n\nand strengths to be registered; \n\ndossier describing how the \n\n- dossier describing how the \n\nhomeopathic stock is obtained and \n\nhomeopathic stock or stocks is/are \n\ncontrolled, and Justifying its \n\nobtained and controlled, and \n\nhomeopathic nature, on the basis \n\nJustifying its homeopathic nature, \n\nof an adequate homeopathic biblio \n\non the basis of an adequate homeopa \n\ngraphy; \n\nthic or anthroposophical bib Iio-\n\ngraphy; \n\nmanufacturing and control file \n\n- manufacturing and control file \n\nfor each pharmaceutical form and \n\nfor each pharmaceutical form and \n\na description of the method of \n\na description of the method of \n\ndilut ion; \n\ndilution and potent iat ion; \n\nRest of the article unchanged \n\n\fOriginal proposal \n\nAmended proposal \n\n- 9 -\n\nArticle 9 (1) \n\n1. Homeopathic medicinal products \n\n1. Homeopathic and antroposophical \n\nother than those referred to in \n\nmedicinal products other than those \n\nArticle 7 shall be authorized and \n\nreferred to in Article 7 shall be \n\nlabel led in accordance with the \n\nauthorized and labelled pursuant to \n\nprovisions of Articles 5 to 21 of \n\nthe provisions of Articles 5 to 21 of \n\nDirective 65/65/EEC and Articles 1 \n\nDirective 65/65/EEC and Articles 1 \n\nto 7 of Directive 75/319/EEC, \n\nto 7 of Directive 75/319/EEC, \n\nincluding the provisions concerning \n\nincluding the provisions concerning \n\nproof of therapeutic effect. proof of therapeutic effect, in \n\naccordance with the basic principles \n\nand special nature of homeopathic or \n\nanthroposophlcal medicine. Article 9(2) unchanged \n\nArticle 10 (1) and (2) unchanged \n\nArticle 10 (3) (new) \n\n3. Not later than 31 December 1995 the \n\nCommission shall present a report to \n\nthe Council and to the European \n\nParliament concerning the operation of \n\nthis Directive. Article 11 unchanged \n\n\f- 10 -\n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directive 81/851/EEC on the approximation of \n\nthe laws of the Member States on veterinary medicinal products \n\nand laying down additional provisions on homeopathic \n\nSYN 252 \n\nveterinary medicinal products \n\n(presented by the Commission in accordance with Article 149, \n\nparagraph 3 of the EEC Treaty) \n\nOriginal proposal \n\nAmended proposal \n\nFirst recital \n\nWhereas differences currently \n\nWhereas differences currenlty \n\nexisting between the provisions laid \n\nexisting between the provisions laid \n\ndown by law, regulation or administra \n\ndown by law, regulation or administra \n\ntive action by the Member States may \n\ntive action in the Member States may \n\nhinder trade in homeopathic medicinal \n\nhinder trade in homeopathic medicinal \n\nproducts within the Community; \n\nproducts within the Community and thus \n\nlead to discrimination and distorsion \n\nof competition between manufacturers of \n\nthese products; \n\n2nd recital unchanged \n\nRecital 2a (new) \n\nWhereas freedom of choice with \n\nregard to therapy needs to be \n\nsafeguarded; \n\n3rd recital unchanged \n\nFourth recital \n\nWhereas homeopathic medicine is \n\nWhereas homeopathic medicine is \n\nofficially recognized in certain \n\nofficially recognized in certain \n\nMember States but is only tolerated \n\nMember States but is only tolerated \n\nin other Member States; whereas, \n\nin other Member States; \n\ntherefore, it is appropriate to \n\nrecognize certain national homeopathic \n\ntraditions without imposing them \n\nthroughout the Community; \n\n5th, 6th and 7th recitals unchanged \n\n\fOriginal proposal \n\nAmended proposal \n\n- 11 -\n\nEighth \n\nrecital \n\nWhereas, having regard to the \n\nWhereas, having regard to the \n\nparticular characteristics of these \n\nparticular characteristics of these \n\nmedicinal products, such as their \n\nmedicinal products, such as their \n\nvery low content of active principles \n\nvery low content of active principles \n\nand the difficulty of applying to them \n\nand the difficulty of applying to them \n\nthe conventional statistical methods \n\nthe conventional statistical methods \n\nrelating to clinical trials, it is \n\nrelating to clinical trials, it is \n\nappropriate to provide a simplified \n\nappropriate to provide a simplified \n\nregistration system for those \n\nregistration system for those \n\ntraditional homeopathic veterinary \n\ntraditional homeopathic veterinary \n\nmedicinal products which are placed \n\nmedicinal products which are placed \n\non the market without specific \n\ntherapeutic indications in a \n\npreparation which does not present \n\na risk for the animal or the consumer \n\nof animal products; \n\non the market without specific \n\ntherapeutic indications in a \n\npreparation and dosage which does not \n\npresent a risk for the animal or the \n\nconsumer of animal products; \n\n9th recital unchanged \n\nArt icle 1 \n\nFor the purposes of this Directive \n\nFor the purposes of this Directive \n\n\"homeopathic veterinary medicinal \n\n\"homeopathic veterinary medicinal \n\nproduct\" shall mean any veterinary \n\nproduct\" shall mean any pharmaceuticai \n\nmedicinal product prepared in \n\naccordance with a homeopathic \n\npreparation prepared in accordance with \n\na homeopathic manufacturing procedure \n\nmanufacturing procedure described by \n\ndescribed by the European \n\nthe European Pharmacopoeia, or in \n\nPharmacopoeia, or in the absence \n\nthe absence thereof, by the official \n\nthereof, by the official pharmacopoeia \n\npharmacoposia of a Member State. of a Member State. Homeopathic preparations are produced \n\nHomeopathic preparations are produced \n\nfrom products, substances or \n\nfrom products, substances or \n\ncompositions called homeopathic stocks \n\ncompositions called homeopathic stocks \n\nby successive dilutions. by successive dilutions and \n\npotentiation. A homeopathic medicinal \n\nproduct may also contain a number of \n\ndifferent components. - 12 -\n\nHomeopathic preparations may contain, \n\nwith the exception of catalysts, only \n\nhomeopathic stocks, in a minimum of \n\n1:10. Articles 2, 3, 4, 5, 6 and 7 unchanged \n\nOriginal proposa \n\nAmended proposa \n\nArt icle 8 \n\nAn application for a simplified \n\nAn application for a simplified \n\nregistration submitted by the person \n\nregistration submitted by the person \n\nresponsible for marketing may cover \n\nresponsible for marketing may cover \n\na series of preparations derived from \n\na series of preparations derived from \n\nthe same homeopathic stock. The \n\nthe same homeopathic stock or stocks. following documents shall be included \n\nThe following documents shall be \n\nwith the application in order to \n\nincluded with the application in order \n\ndemonstrate, in particular, the \n\nto demonstrate, in particular, the \n\npharmaceutical quality and the batch \n\npharmaceutical quality and the batch \n\nto batch consistency of the products \n\nto batch consistency of the products \n\nconcerned : \n\nconcerned : \n\nscientific name of the homeopathic \n\nscientific name of the homeopathic \n\nstock, together with a mention of \n\nstock or stocks, together with a \n\nthe various routes of administration, \n\nmention of the various routes of \n\npharmaceutical forms and dilut Ions \n\nadministration, pharmaceutical forms \n\nto be registered; \n\nand strengths to be registered; \n\ndossier described how the stock is \n\ndossier describing how the \n\nobtained and controlled, and \n\nhomeopathic stock/stocks is/are \n\nJustifying its homeopathic nature, \n\nobtained and controlled, and \n\non the basis of an adequate \n\nhomeopathic bibliography; \n\nJustifying its/their homeopathic \n\nnature, on the basis of an \n\nadequate homeopathic bibliography; \n\n\f- 13 -\n\nmanufacturing and control file \n\n- manufacturing and control file \n\nfor each pharmaceutical form and \n\nfor each pharmaceutical form and \n\na description of the method of \n\na description of the method of \n\ndilution; \n\nd iI ut i on and potent I at ion; \n\nmanufacturing authorization for \n\n- manufacturing authorization for \n\nthe preparations concerned; \n\nthe preparations concerned; \n\ncopies of any registrations or \n\ncopies of any registrations or \n\nauthorizations obtained for the \n\nauthorizations obtained for the \n\nsame preparations in other Member \n\nsame preparations in other Member \n\nStates; \n\nStates; \n\none or more specimens or mock-ups \n\none or more specimens or mock-ups \n\nof the sales presentation of the \n\nof the sales presentation of the \n\npreparations to be registered. preparations to be registered; \n\ndocuments quaranteeing the safety \n\nof the preparation and, in the case \n\nof veterinary medicinal products \n\nintended for administration to food-\n\nproducing animals, quaranteeing the \n\nabsence of harmful residues. Original proposal \n\nAmended proposal \n\n- 14 -\n\nArt icle 9 \n\nHomeopathic veterinary medicinal \n\nHomeopathic veterinary medicinal \n\nproducts other than those referred \n\nproducts other than those referred \n\nto in Article 7 shall be authorized \n\nto in Article 7 shall be authorized \n\nand labelled in accordance with the \n\nand labelled in accordance with the \n\nprovisions of Articles 5 to 15 of \n\nprovisions of Articles 5 to 15 of \n\nDirective 81/851/EEC, including the \n\nDirective 81/851/EEC, including the \n\nprovisions concerning proof of \n\nprovisions concerning proof of \n\ntherapeutic effect, and shall be \n\ntherapeutic effect, and shall be \n\nlabelled in accordance with the \n\nlabel led pursuant to the provisions \n\nprovisions of Articles 43 to 50 of \n\nof Articles 43 to 50 of Directive \n\nDirective 81/851/EEC. 81/851/EEC, in accordance with the \n\nbasic principles and special nature \n\nof homeopathic or anthroposophlcal \n\nmedicine. Article 10, paragraphs 1 and 2 unchanged \n\nArticle 10 (3) (new) \n\n3. Not later than 31 December 1995 \n\nthe Commission shall present a \n\nreport to the Council and to the \n\nEuropean Parliament concerning \n\nthe operation of this Directive. Article 11 unchanged \n\n\fISSN 0254-1475 \n\nCOM(91)313final \n\nDOCUMENTS \n\nEN \n\n03 \u00b05 \u00b06 \n\nCatalogue number : CB-CO-91-353-EN-C \n\nISBN 92-77-74898-2 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/9727de12-0f86-4ca3-9b43-995d6c6eec3c", "title": "AMENDMENT TO THE PROPOSAL FOR A COUNCIL DIRECTIVE WIDENING THE SCOPE OF DIRECTIVE 81/851/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES ON VETERINARY MEDICINAL PRODUCTS AND LAYING DOWN ADDITIONAL PROVISIONS ON HOMEOPATHIC VETERINARY MEDICINAL PRODUCTS", "langIdentifier": "ENG", "mtypes": "pdf,pdfa1b,print", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_directive_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "alternative medicine,approximation of laws,labelling,marketing standard,veterinary medicinal product", "workIds": "celex:51991PC0313(02),comnat:COM_1991_0313(02)_FIN,oj:JOC_1991_244_R_0011_01", "eurovoc_concepts": ["alternative medicine", "approximation of laws", "labelling", "marketing standard", "veterinary medicinal product"], "url": "http://publications.europa.eu/resource/cellar/9727de12-0f86-4ca3-9b43-995d6c6eec3c", "lang": "eng", "formats": ["pdf", "pdfa1b", "print"], "text": "COMMISSION OF THE EUROPEAN COMVTUNITIES \n\nC0M(91) 313 final - SYN 251 and 252 \n\nBrussels, 2 August 1991 \n\nsilt \n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directives 65/65/EEC and 75/319/EEC on the \n\napproximation of the laws of the Member States on medicinal \n\nproducts and laying down additional provisions on \n\nhomeopathic medicinal products \n\nSYK 251 \n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directive 81/851/EEC on the approximation of \n\nthe laws of the Member States on veterinary medicinal products \n\nand laying down additional provisions on homeopathic \n\nSYN 252 \n\nveterinary medicinal products \n\n(presented by the Commission pursuant to Article 149(3) \nof the EEC-Treaty) \n\n\f- 2 -\n\nEXPLANATORY MEMORANDUM \n\nAt its plenary session on 13 June 1991, the European Parliament, on first reading \n\nof the co-operation procedure, gave its opinion upon two proposals for Directives \n\nrelating to homeopathic medicines for human and veterinary use - COM(90)72 of \n\n22. 03. 90, SYN 251-252. The Commission has decided, in accordance with Article 149, paragraph 3 of the EEC \n\nTreaty, to amend its proposals in order to incorporate into the text 17 out of the \n\n28 amendements adopted by the Parliament. The primary aims of the amendments accepted by the Commission are : \n\n- to avoid the distortion of competition between manufacturers \n\n- to maintain the principle of a free choice of therapies \n\n- to assimilate anthroposophic medicines as homeopathic medicines when described \n\nin an off I cal pharmacopoeia \n\n- to introduce appropriate references to homeopathic and anthroposophic \n\nprinciples. - 3 -\n\nBy contrast, the Commission rejected other amendments for three principal reasons. Certain of the amendments go far beyond the limits of those proposals which deal \n\nwith the free movement of medicines, for example; training for and engaging in \n\nprofessional practice, and the way in which the cost of medicines to the patient \n\nis met by public funding. Some amendments show excessive partiality towards particular medical traditions, \n\nbearing in mind that the Commission must remain neutral in the debate between \n\n\"conventional\" and \"alternative\" medicine. Other amendments would widen excessively the scope of the simplified registration \n\nprocedure (Article 7 ), to the extent that a full marketing authorization \n\n(Article 9) would become an exception to the normal rule. It is worth recalling that since 1965 throughout the Community the normal basis \n\nfor a marketing authorization has been three standard criteria (quality, safety \n\nand efficacy) leading the competent authorities to undertake an evaluation of the \n\nrisks and benefits expected of the medicament in question. 4 -\n\nHowever, the simplified registration procedure, in the form proposed by the \n\nCommission, constitutes rather an administr\u00e2tive notification, adequate for \n\nhomeopathic medicines which do not present any known risk by virtue of their \n\nmethod of administration (oral) and the low concentration of their active \n\nconstituents, which is fixed at less than one part per million. Manufacturing \n\nquality can be verified from the dossier supplied. The other routes of administration described by the pharmacopoeias, especially \n\ninjectibles, or stronger concentrations of active constituents, can, in certain \n\ncases, expose patients to potential risks and necessitate because of this a more \n\ncomprehensive authorization procedure based upon an evaluation of the risks and \n\nbenefits by the competent authorities in accordance with the provisions of \n\nArticle 9. - 5 -\n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directives 65/65/EEC and 75/319/EEC on the \n\napproximation of the laws of the Member States on medicinal \n\nproducts and laying down additional provisions on \n\nSYN 251 \n\nhomeopathic medicinal products \n\n(Presented by the Commission in accordance with article 149, \n\nparagraph 3 of EEC Treaty) \n\nOriginal proposal \n\nAmended proposal \n\nTitles and visas unchanged \n\nFirst recital \n\nWhereas differences currently existing \n\nWhereas differences currently existing \n\nbetween the provisions laid down by \n\nbetween the provisions laid down by \n\nlaw, regulation or administrative \n\nlaw, regulation or administrative \n\naction in the Member States may hinder \n\naction in the Member States may hinder \n\ntrade in homeopathic medicinal \n\ntrade in homeopathic medicinal \n\nproducts within the Community; \n\nproducts within the Community and thus \n\nlead to discrimination and distorsion \n\nof competition between manufacturers of \n\nthese products; \n\n2nd recital unchanged \n\nRecital 2a (new) \n\nWhereas freedom of choice with regard \n\nto therapy needs to be safeguarded; \n\nwhereas, despite considerable dif \n\nferences in the status of alternative \n\nmedicines in the various Member States, \n\npatients should be guaranteed free \n\naccess to the therapy of their choice, \n\nprovided all precautions are taken to \n\nensure the quality and safety of \n\nproducts; \n\n3rd recital unchanged \n\n\fOriginal proposal \n\nAmended proposa \n\n- 6 -\n\nFourth recital \n\nWhereas homeopathic medicine is \n\nWhereas homeopathic medicine is \n\nofficially recognized in certain \n\nofficially recognized in certain \n\nMember States but is only tolerated \n\nMember States but is only tolerated \n\nin other Member States; whereas, \n\nin other Member States; \n\ntherefore, it is appropriate to \n\nrecognize certain national homeopathic \n\ntraditions without imposing them \n\nthroughout the Community; \n\n5th, 6th and 7th recitals unchanged \n\nEighth recital \n\nWhereas, having regard to the \n\nWhereas, having regard to the \n\nparticular characteristics of these \n\nparticular characteristics of these \n\nmedicinal products, such as their \n\nmedicinal products, such as their ' \n\nvery low content of active principles \n\nvery low content of active principles \n\nand the difficulty of applying to them \n\nand the difficulty of applying to them \n\nthe conventional statistical methods \n\nthe conventional statistical methods \n\nrelating to clinical trials, it is \n\nrelating to clinical trials, it is \n\nappropriate to provide a simplified \n\nappropriate to provide a simplified \n\nregistration system for those \n\nregistration system for those \n\ntraditional homeopathic medicinal \n\ntraditional homeopathic medicinal \n\nproducts which are placed on the market \n\nproducts which are placed on the market \n\nwithout specific therapeutic \n\nwithout specific therapeutic \n\nindications in a preparation which \n\nindications in a preparation and dosage \n\ndoes not present a risk for the patient; \n\nwhich does not present a risk for the \n\npatient; \n\n9th recital unchanged \n\n\f- 7 -\n\nOriginal proposal \n\nAmended proposal \n\nArt \n\nicle 1 \n\nFor the purposes of this Directive \n\nFor the purposes of this Directive \n\n\"homeopathic medicinal product\" shall \n\n\"homeopathic medicinal product\" shall \n\nmean any medicinal product prepared in \n\nmean any pharmaceutical preparation \n\naccordance with a homeopathic manufac \n\nprepared in accordance with a \n\nturing procedure described by the \n\nhomeopathic manufacturing procedure \n\nEuropean Pharmacopoeia, or in the \n\ndescribed by the European \n\nabsence thereof, by the official \n\nPharmacopoeia, or in the absence \n\npharmacopoeia of a Member State. thereof, by the official pharmacopoeia \n\nof a Member State. For the purposes of this Directive \n\nanthroposophical medicinal products \n\ndescribed by an official pharmacopoeia \n\nshall be treated as equivalent to \n\nhomeopathic medicinal products. Homeopathic preparations are \n\nHomeopathic preparations are produced \n\nproduced from products, substances \n\nfrom products, substances or composi \n\nor compositions called homeopathic \n\ntions called homeopathic stocks by \n\nstocks by successive dilutions. successive dilutions and potentiation. A homeopathic medicinal product may \n\nalso contain a member of different \n\ncomponents. A homeopathic preparation may contain, \n\nwith the exception of catalysts, only \n\nhomeopathic stocks in a minimum \n\ndilut ion of 1:10. Articles 2, 3, 4, 5 and 6 unchanged \n\nArticle 7, paragraph 1 unchanged \n\nArticle 7 (2) \n\nSeventh indent a (new) \n\n- a sentence advising the user to \n\nconsult a competent therapist whilst \n\nusing the medicinal product if the \n\nif the symptoms persist. Rest of the article unchanged \n\n\fOriginal proposal \n\nAmended proposa \n\n- 8 -\n\nArticle 8, introductory phrase and first three indents \n\nAn application for a simplified \n\nAn application for a simplified \n\nregistration submitted by the person \n\nregistration submitted by the person \n\nresponsible for marketing may cover \n\nresponsible for marketing may cover \n\na series of preparations derived from \n\na series of preparations derived from \n\nthe same homeopathic stock. The \n\nthe same homeopathic stock or stocks. following documents shall be included \n\nThe following documents shall be \n\nwith the application in order to \n\nincluded with the application in order \n\ndemonstrate, in particular, the \n\nto demonstrate, in particular, the \n\npharmaceutical quality and the batch \n\npharmaceutical quality and the batch \n\nconsistency of the products concerned : \n\nconsistency of the products concerned \n\nscientific name of the homeopathic \n\n- scientific name of the homeopathic \n\nstock, together with a mention of \n\nstock or stocks, together with a \n\nthe various routes of administra \n\nmention of the various routes of \n\ntion, pharmaceutical forms and \n\nadministration, pharmaceutical forms \n\ndilut ions to be registered; \n\nand strengths to be registered; \n\ndossier describing how the \n\n- dossier describing how the \n\nhomeopathic stock is obtained and \n\nhomeopathic stock or stocks is/are \n\ncontrolled, and Justifying its \n\nobtained and controlled, and \n\nhomeopathic nature, on the basis \n\nJustifying its homeopathic nature, \n\nof an adequate homeopathic biblio \n\non the basis of an adequate homeopa \n\ngraphy; \n\nthic or anthroposophical bib Iio-\n\ngraphy; \n\nmanufacturing and control file \n\n- manufacturing and control file \n\nfor each pharmaceutical form and \n\nfor each pharmaceutical form and \n\na description of the method of \n\na description of the method of \n\ndilut ion; \n\ndilution and potent iat ion; \n\nRest of the article unchanged \n\n\fOriginal proposal \n\nAmended proposal \n\n- 9 -\n\nArticle 9 (1) \n\n1. Homeopathic medicinal products \n\n1. Homeopathic and antroposophical \n\nother than those referred to in \n\nmedicinal products other than those \n\nArticle 7 shall be authorized and \n\nreferred to in Article 7 shall be \n\nlabel led in accordance with the \n\nauthorized and labelled pursuant to \n\nprovisions of Articles 5 to 21 of \n\nthe provisions of Articles 5 to 21 of \n\nDirective 65/65/EEC and Articles 1 \n\nDirective 65/65/EEC and Articles 1 \n\nto 7 of Directive 75/319/EEC, \n\nto 7 of Directive 75/319/EEC, \n\nincluding the provisions concerning \n\nincluding the provisions concerning \n\nproof of therapeutic effect. proof of therapeutic effect, in \n\naccordance with the basic principles \n\nand special nature of homeopathic or \n\nanthroposophlcal medicine. Article 9(2) unchanged \n\nArticle 10 (1) and (2) unchanged \n\nArticle 10 (3) (new) \n\n3. Not later than 31 December 1995 the \n\nCommission shall present a report to \n\nthe Council and to the European \n\nParliament concerning the operation of \n\nthis Directive. Article 11 unchanged \n\n\f- 10 -\n\nAmendment to the proposal for a \n\nCOUNCIL DIRECTIVE \n\nwidening the scope of Directive 81/851/EEC on the approximation of \n\nthe laws of the Member States on veterinary medicinal products \n\nand laying down additional provisions on homeopathic \n\nSYN 252 \n\nveterinary medicinal products \n\n(presented by the Commission in accordance with Article 149, \n\nparagraph 3 of the EEC Treaty) \n\nOriginal proposal \n\nAmended proposal \n\nFirst recital \n\nWhereas differences currently \n\nWhereas differences currenlty \n\nexisting between the provisions laid \n\nexisting between the provisions laid \n\ndown by law, regulation or administra \n\ndown by law, regulation or administra \n\ntive action by the Member States may \n\ntive action in the Member States may \n\nhinder trade in homeopathic medicinal \n\nhinder trade in homeopathic medicinal \n\nproducts within the Community; \n\nproducts within the Community and thus \n\nlead to discrimination and distorsion \n\nof competition between manufacturers of \n\nthese products; \n\n2nd recital unchanged \n\nRecital 2a (new) \n\nWhereas freedom of choice with \n\nregard to therapy needs to be \n\nsafeguarded; \n\n3rd recital unchanged \n\nFourth recital \n\nWhereas homeopathic medicine is \n\nWhereas homeopathic medicine is \n\nofficially recognized in certain \n\nofficially recognized in certain \n\nMember States but is only tolerated \n\nMember States but is only tolerated \n\nin other Member States; whereas, \n\nin other Member States; \n\ntherefore, it is appropriate to \n\nrecognize certain national homeopathic \n\ntraditions without imposing them \n\nthroughout the Community; \n\n5th, 6th and 7th recitals unchanged \n\n\fOriginal proposal \n\nAmended proposal \n\n- 11 -\n\nEighth \n\nrecital \n\nWhereas, having regard to the \n\nWhereas, having regard to the \n\nparticular characteristics of these \n\nparticular characteristics of these \n\nmedicinal products, such as their \n\nmedicinal products, such as their \n\nvery low content of active principles \n\nvery low content of active principles \n\nand the difficulty of applying to them \n\nand the difficulty of applying to them \n\nthe conventional statistical methods \n\nthe conventional statistical methods \n\nrelating to clinical trials, it is \n\nrelating to clinical trials, it is \n\nappropriate to provide a simplified \n\nappropriate to provide a simplified \n\nregistration system for those \n\nregistration system for those \n\ntraditional homeopathic veterinary \n\ntraditional homeopathic veterinary \n\nmedicinal products which are placed \n\nmedicinal products which are placed \n\non the market without specific \n\ntherapeutic indications in a \n\npreparation which does not present \n\na risk for the animal or the consumer \n\nof animal products; \n\non the market without specific \n\ntherapeutic indications in a \n\npreparation and dosage which does not \n\npresent a risk for the animal or the \n\nconsumer of animal products; \n\n9th recital unchanged \n\nArt icle 1 \n\nFor the purposes of this Directive \n\nFor the purposes of this Directive \n\n\"homeopathic veterinary medicinal \n\n\"homeopathic veterinary medicinal \n\nproduct\" shall mean any veterinary \n\nproduct\" shall mean any pharmaceuticai \n\nmedicinal product prepared in \n\naccordance with a homeopathic \n\npreparation prepared in accordance with \n\na homeopathic manufacturing procedure \n\nmanufacturing procedure described by \n\ndescribed by the European \n\nthe European Pharmacopoeia, or in \n\nPharmacopoeia, or in the absence \n\nthe absence thereof, by the official \n\nthereof, by the official pharmacopoeia \n\npharmacoposia of a Member State. of a Member State. Homeopathic preparations are produced \n\nHomeopathic preparations are produced \n\nfrom products, substances or \n\nfrom products, substances or \n\ncompositions called homeopathic stocks \n\ncompositions called homeopathic stocks \n\nby successive dilutions. by successive dilutions and \n\npotentiation. A homeopathic medicinal \n\nproduct may also contain a number of \n\ndifferent components. - 12 -\n\nHomeopathic preparations may contain, \n\nwith the exception of catalysts, only \n\nhomeopathic stocks, in a minimum of \n\n1:10. Articles 2, 3, 4, 5, 6 and 7 unchanged \n\nOriginal proposa \n\nAmended proposa \n\nArt icle 8 \n\nAn application for a simplified \n\nAn application for a simplified \n\nregistration submitted by the person \n\nregistration submitted by the person \n\nresponsible for marketing may cover \n\nresponsible for marketing may cover \n\na series of preparations derived from \n\na series of preparations derived from \n\nthe same homeopathic stock. The \n\nthe same homeopathic stock or stocks. following documents shall be included \n\nThe following documents shall be \n\nwith the application in order to \n\nincluded with the application in order \n\ndemonstrate, in particular, the \n\nto demonstrate, in particular, the \n\npharmaceutical quality and the batch \n\npharmaceutical quality and the batch \n\nto batch consistency of the products \n\nto batch consistency of the products \n\nconcerned : \n\nconcerned : \n\nscientific name of the homeopathic \n\nscientific name of the homeopathic \n\nstock, together with a mention of \n\nstock or stocks, together with a \n\nthe various routes of administration, \n\nmention of the various routes of \n\npharmaceutical forms and dilut Ions \n\nadministration, pharmaceutical forms \n\nto be registered; \n\nand strengths to be registered; \n\ndossier described how the stock is \n\ndossier describing how the \n\nobtained and controlled, and \n\nhomeopathic stock/stocks is/are \n\nJustifying its homeopathic nature, \n\nobtained and controlled, and \n\non the basis of an adequate \n\nhomeopathic bibliography; \n\nJustifying its/their homeopathic \n\nnature, on the basis of an \n\nadequate homeopathic bibliography; \n\n\f- 13 -\n\nmanufacturing and control file \n\n- manufacturing and control file \n\nfor each pharmaceutical form and \n\nfor each pharmaceutical form and \n\na description of the method of \n\na description of the method of \n\ndilution; \n\nd iI ut i on and potent I at ion; \n\nmanufacturing authorization for \n\n- manufacturing authorization for \n\nthe preparations concerned; \n\nthe preparations concerned; \n\ncopies of any registrations or \n\ncopies of any registrations or \n\nauthorizations obtained for the \n\nauthorizations obtained for the \n\nsame preparations in other Member \n\nsame preparations in other Member \n\nStates; \n\nStates; \n\none or more specimens or mock-ups \n\none or more specimens or mock-ups \n\nof the sales presentation of the \n\nof the sales presentation of the \n\npreparations to be registered. preparations to be registered; \n\ndocuments quaranteeing the safety \n\nof the preparation and, in the case \n\nof veterinary medicinal products \n\nintended for administration to food-\n\nproducing animals, quaranteeing the \n\nabsence of harmful residues. Original proposal \n\nAmended proposal \n\n- 14 -\n\nArt icle 9 \n\nHomeopathic veterinary medicinal \n\nHomeopathic veterinary medicinal \n\nproducts other than those referred \n\nproducts other than those referred \n\nto in Article 7 shall be authorized \n\nto in Article 7 shall be authorized \n\nand labelled in accordance with the \n\nand labelled in accordance with the \n\nprovisions of Articles 5 to 15 of \n\nprovisions of Articles 5 to 15 of \n\nDirective 81/851/EEC, including the \n\nDirective 81/851/EEC, including the \n\nprovisions concerning proof of \n\nprovisions concerning proof of \n\ntherapeutic effect, and shall be \n\ntherapeutic effect, and shall be \n\nlabelled in accordance with the \n\nlabel led pursuant to the provisions \n\nprovisions of Articles 43 to 50 of \n\nof Articles 43 to 50 of Directive \n\nDirective 81/851/EEC. 81/851/EEC, in accordance with the \n\nbasic principles and special nature \n\nof homeopathic or anthroposophlcal \n\nmedicine. Article 10, paragraphs 1 and 2 unchanged \n\nArticle 10 (3) (new) \n\n3. Not later than 31 December 1995 \n\nthe Commission shall present a \n\nreport to the Council and to the \n\nEuropean Parliament concerning \n\nthe operation of this Directive. Article 11 unchanged \n\n\fISSN 0254-1475 \n\nCOM(91)313final \n\nDOCUMENTS \n\nEN \n\n03 \u00b05 \u00b06 \n\nCatalogue number : CB-CO-91-353-EN-C \n\nISBN 92-77-74898-2 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}
+{"cellarURIs": "http://publications.europa.eu/resource/cellar/67b7f3c1-d97f-438e-b0e8-296269da8185", "title": "PROPOSAL FOR A COUNCIL REGULATION ( EEC ) ON IMPORTS OF FRUIT AND VEGETABLES FROM CERTAIN COUNTRIES AFFECTED BY CHOLERA", "langIdentifier": "ENG", "mtypes": "pdf", "workTypes": "http://publications.europa.eu/ontology/cdm#act_preparatory,http://publications.europa.eu/ontology/cdm#proposal_act,http://publications.europa.eu/ontology/cdm#proposal_regulation_ec,http://publications.europa.eu/ontology/cdm#resource_legal,http://publications.europa.eu/ontology/cdm#work", "authors": "European Commission", "date": "1991-08-02", "subjects": "South America,fruit,health control,import licence,tropical disease,vegetable", "workIds": "celex:51991PC0311,comnat:COM_1991_0311_FIN", "eurovoc_concepts": ["South America", "fruit", "health control", "import licence", "tropical disease", "vegetable"], "url": "http://publications.europa.eu/resource/cellar/67b7f3c1-d97f-438e-b0e8-296269da8185", "lang": "eng", "formats": ["pdf"], "text": "COMMISSION OF THE EUROPEAN COMMUNITIES \n\nC0M(91) 311 final \n\nBrussels, 2 August 1991 \n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\non imports of fruit and vegetables from certain countries \n\naffected by cholera \n\n(presented by the Commission) \n\n;u^ \n\n\f- 2 -\n\nEXPLANATORY MEMORANDUM \n\nOn 19 March 1991 the Commission adopted Decision 91/147/CEE1 adopting \n\nprotective measures against cholera affecting imports of fruit and \n\nvegetables from Peru. Since then the epidemic has spread to neighbouring countries and there \n\nis a possibility that the whole of South America will be affected. It is planned to repeal the provisional measures adopted by \n\nDecision 91/147/EEC. Since no suitable action can be taken under the \n\ncommon agricultural policy to tackle the risks to the European fruit \n\nand vegetable consumer, it is necessary for the Council to act under \n\nthe common trade policy in order to protect consumer health and \n\npreserve the unity of the market without unduly affecting trade with \n\nthird countr ies. The attached Regulation sets requirements for importation of fresh and \n\nprocessed fruit and vegetables liable to be contaminated with cholera \n\nvibr io. it lists the South American regions affected by cholera to which \n\nthe protective measures apply (Annex I); \n\nmakes importation of products from these areas subject to \n\npresentation of a certificate issued by a recognized health \n\nauthority carrying certain information (Article 2(1), Annex II and \n\nM l ); \n\nexempts from these requirements certain products carrying no risk \n\nof infection (Article 2(2), Annex IV); \n\nimposes additional requirements in view of the health situation in \n\ncertain third countries. 1 OJ No L 73, 23. 3. 1991, p. 35. - 3 -\n\nThe Community may send inspectors to the affected regions (Article 3 ). When products are imported Member States must check the certification \n\nor if under Article 2(2) a certificate is not required check that the \n\nrequirements of Annex IV are met (Article 4 ). If the competent authorities of Member States in which products are to \n\nbe consumed find cholera vibrio when making a sample check the \n\nCommission and the other Member States are to be informed (Article 5 ). The Regulation is framed so as to enable the Commission to adopt the \n\nrules of application needed and adjust the annexes rapidly and \n\nfrequently as the changing situation dictates. To this end an ad hoc \n\nCommission regulatory committee will be set up (Article 6 ). The initial period of application of Regulation will be two years. _ 4 -\n\nProposal for a \n\nCOUNCIL REGULATION (EEC) \n\non imports of fruit and vegetables from certain countries \n\naffected by cholera \n\nTHE COUNCIL OF THE EUROPEAN COMMUNITIES, \n\nHaving regard to the Treaty establishing the European Economic \n\nCommunity, and in particular Article 113 thereof, \n\nHaving regard to the proposal from the Commission, \n\nWhereas the incidence of cholera is rapidly increasing in certain parts \n\nof South America; whereas this disease is a serious threat to public \n\nhealth and can be spread by contaminated fruit and vegetables; \n\nWhereas Community experts have visited the regions in question to look \n\nat the situation and decide what safeguards are required to prevent any \n\nrisk of introduction of the disease into the Community; \n\nWhereas their findings indicate that Community measures are required; \n\nwhereas national measures have been adopted in a number of \n\nMember States on imports of fruit and vegetables from certain South \n\nAmerican countries; whereas it is incumbent on the Council therefore \n\nto adopt common rules that will protect the health of consumers, \n\nmaintain market unity without unduly affecting trade between the \n\nCommunity and third countries and prevent deflection of trade; \n\n\f- 5 -\n\nWhereas requirements to be met for imports of fruit and vegetables \n\noriginating in or consigned from regions affected by cholera should \n\ntherefore be specified; whereas the list of these regions should \n\ntherefore be determined; \n\nWhereas these requirements should not be made applicable to products \n\nthat because of their characteristics, the treatment they are given or \n\nthe length of time elapsing before they reach the Community present no \n\nhealth risk; \n\nWhereas \n\nthese requirements \n\nshould \n\nnot \n\nbe made applicable to \n\nconsignments of fruit and vegetables covered by suitable guarantees \n\nfrom the authorities of the exporting country; whereas it is necessary \n\ntherefore to specify the recognized health authorities of the countries \n\nin quest ion; \n\nWhereas Member States must be able to require presentation of health \n\ncertificates made out by the authorities of the exporting third \n\ncountry; whereas the requirements pertaining to the issuing of \n\ncertificates must be specified; \n\nWhereas experts from the Member States and from the Commission should \n\nmake checks to see whether the health safeguards offered by the third \n\ncountries concerned are effective; \n\nWhereas the special rules will apply without prejudice to normal \n\nrequirements pertaining to imports from the third countries in \n\nquest ion; \n\nWhereas documentary or identification checks, as appropriate in each \n\ncase, must be carried out on imported products when they first arrive \n\nin the Community; whereas such a check is required in order to \n\nguarantee free circulation within the Community; whereas sample checks \n\nmay also be made in the Member State of consumption to ensure the \n\nabsence of cholera vibrio; \n\n\f- 6 -\n\nWhereas a simplified procedure should be set up that will permit \n\ncontinual rapid updating of the rules in line with changes in the \n\nepidemiological situation; whereas to this end an ad hoc committee \n\nshould be set up, \n\nHAS ADOPTED THIS REGULATION: \n\nArticle 1 \n\nThis Regulation sets rules applying to imports of \n\nfruit and vegetables covered by Council Regulations (EEC) \n\nNo 1035/721 or No 827/682 \n\nprocessed fruit and vegetable products covered by Council \n\nRegulation (EEC) No 426/863 \n\noriginating in or consigned from the areas affected by cholera listed \n\nin Annex I. Art icle 2 \n\n1. Products as indicated in Article 1 shall not be admitted for import \n\nunless accompanied by an official certificate issued by a health \n\nauthority shown in Annex II, made out as specified in Annex III. 2. No certificate shall be required for products covered by Annex IV. 3. Products from third countries indicated in Annex V must meet the \n\nadditional requirements specified therein. 1 OJ No L 118, 20. 05. 1972, p. 1. 2 OJ No L 151, 30. 06. 1968, p. 16 \n\n3 OJ NO L 49, 27. 02. 1986, p. 1. - 7 -\n\nArticle 3 \n\nChecks may be made on the spot by experts from the Member States or the \n\nCommission to see whether the health protection and control guarantees \n\noffered by third countries are effective. Art icie 4 \n\nWhen products indicated in Article 1 enter the Community the competent \n\nauthorities of the Member State shall, as appropriate, check \n\nthat the certificate indicated in Article 2(1) meets the \n\nrequirements set out in Annex ill, \n\nthe identity of products exempt \n\nfrom certification under \n\nArticle 2(2). Article 5 \n\nMember States in which products are to be consumed may carry out sample \n\nexaminations on products indicated in Article 1. If cholera vibrio is \n\nfound the competent authorities shall immediately inform the Commission \n\nand the other Member States, irrespective of what is to be done with \n\nthe contaminated consignment. Article 6 \n\n1. The Commission shall be assisted by a committee composed of the \n\nrepresentatives of the Member States and chaired by the \n\nrepresentative of the Commission. - 8 -\n\n2. Detailed rules for application of this Regulation and any changes \n\nto the Annexes shall be adopted in accordance with the procedure \n\nlaid down in paragraph 3. 3. The representative of the Commission shall submit to the committee \n\na draft of the measures to be taken. The committee shall deliver \n\nits opinion on the draft within a time limit which the chairman may \n\nlay down according to the urgency of the matter. 4. The opinion shall be delivered by the majority laid down in \n\nArticle 148(2) of the Treaty in the case of decisions which the \n\nCouncil is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the \n\ncommittee shall be weighted in the manner set out in that Article. The chairman shall not vote. 5. The Commission shall adopt the measures envisaged if they are in \n\naccordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of \n\nthe committee, or if no opinion is delivered, the Commission shall, \n\nwithout delay, submit to the Council a proposal relating to the \n\nmeasures to be taken. The Council shall act by a qualified \n\nmajor ity. 6. If, on the expiry of a period of one month from the date of \n\nreferral to the Council, the Council has not acted, the proposed \n\nmeasures shall be adopted by the Commission. - 9 -\n\nArt icle 7 \n\nThis Regulation shall enter into force on the third day following that \n\nof its publication in the Official Journal of the European Communities. It shall be valid for two years from that date. This Regulation shall be binding in its entirety and directly \n\napplicable in all Member States. Done at Brussels, \n\nFor the Council \n\nThe President \n\n\f10 -\n\nANNEX I \n\nAffected areas \n\nCountry \n\nCo IombI a \n\nEcuador \n\nAdministrative units \n\nDepartments of Narino and Cauca \n\nProvinces of Chimborazo, El Oro, \n\nEsmaraldas, Guayas, Loja and \n\nLos Rios \n\nPeru \n\nAI I provinces \n\n\f11 -\n\nANNEX I I \n\nRecognized certifying health authorities \n\nCountry \n\nCo Iomb i a \n\nName \n\n1. Instituto Nacional de la \n\nSalud (INS), Bogota \n\n2. Servicio Seccional de Salud \n\n(SSS) of the Departments of \n\nNarino (located at Tasco) and \n\nCauca (located at Popayan) \n\nEcuador \n\n1. Instituto Nacional de Higiene \n\nPeru \n\ny Medicina tropical (INHMT) \n\n\"Leopoldo Izqueta Perez\", \n\nGuayaquiI \n\n1. Centro de Cert ificaciones \n\nPesqueras (CERPER), El Callao \n\n2. Ministerio de Salud, Lima \n\n\f- 12 -\n\nANNEX I I \n\nEntries to be made on official certificates issued by recognized health \n\nauthor it ies: \n\nName of authority and if appropriate of the delegated authority or \n\nauthor it ies-, \n\nPlace of issue, number and date; \n\nDescription of consignment and type of treatment; \n\nName and address of treatment plant; \n\nAttestation that the treatment plant observes proper standards of \n\nhygiene in all handling operations and in particular that the water \n\nused is treated with chlorine; \n\nAttestation that the treatment plant is subjected to stringent \n\ninspection by officials of the recognized health authority and that \n\nall hygienic requirements for processing, presentation and \n\npackaging are complied with; \n\nThe health authority's stamp and the signature of the person or \n\npersons authorized to sign. 13 -\n\nANNEX IV \n\nA. List of products not subject to restriction \n\n1. Dried vegetables, dried leguminous vegetables, nuts and dried fruit \n\nof CN headings 0712, 0713, 0802 and 0813 respectively, and any \n\nfruit and vegetable dried to an aw value below 0. 85. 2. All fruit and vegetables transported under normal conditions, \n\nincluding moisture conditions, when the journey time is at least \n\n14 days. B. List of products given a specific treatment and not subject to \n\nrestr ict ion \n\n1. Fruit and vegetables and juices or pulps of these in hermetically \n\nsealed tins, jars and bottles heated for preservation to more than \n\n70*C throughout after sealing. 2. Fruit and vegetables in tins, jars and bottles preserved in an acid \n\nmedium of pH below 4. 5. 3. Frozen fruit and vegetables previously heat-treated to more than \n\n70*C throughout and packaged under proper hygienic conditions in \n\nthe countries concerned. - 14 -\n\nANNEX V \n\nSpecial requirements (Article 2(3)) \n\nCountry of consignment \n\nAddition requirements \n\nPeru \n\nThe certificate \n\nindicated in \n\nArticle 2(1) must be accompanied \n\nby an official numbered and \n\ndated attestation, issued by the \n\nMinistry of Health, that there \n\nis no cholera vibrio on the \n\nproducts \n\nmaking \n\nup \n\nthe \n\nconsignment. ISSN 0254-1475 \n\nCOM(91) 311 final \n\nDOCUMENTS \n\nEN \n\n03 \n\nCatalogue number : CB-CO-91-357-EN-C \n\nISBN 92-77-74972-5 \n\nOffice for Official Publications of the European Communities \nL-2985 Luxembourg"}