MODIFIED PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF HEALTH: HUMAN GENOME ANALYSIS: ( 1990 - 1991 )

action programme,genetic engineering,public health,research and development,scientific progress

action programme
genetic engineering
public health
research and development
scientific progress

COMMISSION OF THE EUROPEAN COMMUNITIES

COM (89) 532 final - SYN 146

Brussels, 13 November 1989

MODIFIED PROPOSAL FOR A COUNCIL DECISION

Adopting a specific research and technological development programme

in the field of health:

Human Genome Analysis: (1990-19S1)

(Presented by the Comrussion in accordance with

Article 149, paragraph 3 of the EEC Treaty)

*

- 2 -

Explanatory Memorandum

A. The first reading of the "Proposal for a Council Decision adopting a

specific research programme in the field of health: Predictive Medicine:

Human Genome Analysis (1989 - 1991)"(*) was carried out by the European

Parliament during the part-session from 13 - 17 February 1989. The essential message of the 38 amendnents adopted by the Parliament is as

follows: "The technical content of the research programme proposed by the

Commission is justified, but care must be taken to see that individual

rights are protected and respected while it is being carried out. Furthermore, it is essential to guarantee that throughout the programme

the ethical, social and legal problems which may arise out of applications

of ever more precise knowledge of the human genome are examined and

debated. This debate should also identify the limits beyond which such

applications would become unacceptable by society". B. The expression "Predictive Medicine" is no longer used in the title of the

programme. It has reverted to "Human Genome Analysis", which corresponds

to reality since the main aim is to increase our knowledge of human

genetics. However, it is possible that this type of research, which will

certainly lead to improvements in the treatment of patients suffering from

certain diseases of genetic origin, will also lead subsequently to

applications in predictive medicine. But the social acceptability of such

applications must first be carefully evaluated. The modified proposal is drafted in such a way as to guarantee the respect

both of rules accepted by or acceptable to our democratic society and of

the integrity and dignity of the person, not only while the programme is

running but also in its medium- and long-term consequences. The clear affirmation of the respect for the integrity and dignity of the

person has consequences of which several aspects are defined in the

modified proposal. The consequences both for the individual and for

society of the application of the results obtained by research on the

human genome must be analysed at the same time as the research is being

(*) COM(88) 424 final, 20 July 1988

- 3 -

carried out. Possible abuses must be identified, as must, where

appropriate, recommended national or Community legislative measures. This

task will be carried out by the Commission assisted by a high-level

committee which it will set up for this purpose, representing different

areas of science, law, philosophy and ethics, together with

representatives of patients* associations. The term "eugenics" which is contained in amendment no. 10 lacks

precision. For this reason it is not used directly in the proposal. The

approach described above guarantees the exclusion from the programme of

any tendency towards a type of eugenics which would involve the

"selection" of the human species by genetic means. This guarantee is

further strengthened by the explicit exclusion of all research seeking to

modify human genetic heritage by the alteration of germ cells, in

accordance with Parliament's request (amendments nos. 21 and 33). But the

modified proposal goes further: it excludes all intervention at any stage

in the development of the embryo which might lead to hereditary changes. This technical possibility is indeed conceivable, and it must be rejected. Protection is guaranteed of the confidentiality of information gained

during the research and of the anonymity of those concerned. The prenormative nature of the scientific data acquired, to be available

to legislative authorities in particular, is highlighted. Lastly, progress reports on the research and on studies of ethical, social

and legal problems will be submitted annually to the Council and the

European Parliament, and measures will be taken to keep the public fully

informed of the Community action. C. As far as the European Parliament*s amendments are concerned:

- amendnents Nos. 1, 3, 4, 7, 11, 12, 16, 17, 21, 22, 23, 28, 32, 33, 35

and 36 have been incorporated in the modified proposal. Amendnents 21

and 33 have been supplemented to clarify the exclusion of all work

seeking to "select" the human species. - 4 -

the intentions expressed in amendments nos. 5, 6, 8, 9, 10, 13, 20, 25,

26 and 41 are incorporated in the modified proposal in different terms,

sometimes regrouped or at places in the text other than those foreseen

in the amendments. amendments nos. 14, 15, 18, 19, 24, 27, 29, 30, 31, 34, 39 and 44

(budgetary amendment) are not incorporated in the proposal. However,

the modified proposal expresses the ideas contained in some of these

amendments, especially nos. 14, 15, 18, 19, 27, 29, 30 and 39. - 5 -

MODIFIED PROPOSAL FOR A COUNCIL DECISION

Adopting a specific research and technological development programme

in the field of health:

Human Genome Analysis: (1990-1991)

(Presented by the Commission in accordance with

Article 149, paragraph 3 of the EEC Treaty)

THE COUNCIL OF THE EUROPEAN COMMUNITIES

Having regard to the Treaty establishing the European Economic Community, and

in particular to Article 130 Q (2) thereof,

Having regard to the proposal from the Commission(*),

In cooperation with the European Parliament(2),

Having regard to the opinion of the Economic and Social Committee^),

Whereas Article 130 K of the Treaty stipulates that the framework programme

shall be implemented through specific programmes developed within each

activity;

Whereas by its Decision of 28 September 1987(4) the Council has adopted a

framework programme of Community research and technological development

(1987-1991), in which it provided for activities to be undertaken in the

field of healthj

h OJ H*

2) OJ N°

3) OJ N° C 56/47, 6. 3. 1989

4) OJ N° L 302, 24. 10. 87, p. 1

- 6 -

Whereas, for the evaluation of each specific programme and the selection of

Community actions, the framework programme sets out criteria among which is

that of contributing to the strengthening of the economic and social

cohesion of the Community, consistent with the pursuit of scientific and

technical quality;

Whereas two successive pluriannual programmes of research and training of the

European Economic Coniminity in the field of biotechnologies(5), of which the

second is still in progress, have shown the possibility and usefulness of a

Cormunity action promoting the utilization of modern biology for scientific

and industrial purposes;

Whoreas the framework programme has foreseen in its activity "Quality of

life" under the "Health" line 1. 1, the initiation of new activities relating

to the development of knowledge of the human genome;

Whereas a specific programme to study the human genome is therefore necessary

and, in particular, it is necessary to:

develop and spread the basic technologies concerning the study of the

human genome, with the intention of improving knowledge of matters of

medical importance,

improve the resolution of the human genetic map and to refine the

physical map by the creation of ordered clone libraries, as a basis for

locating genes of medical importance and for a better general

understanding of gene function, and

organise networks and coordination, on a European and international

scale, of researchers from all disciplines working in this field;

Whereas the carrying out of the above-mentioned goals requires the

undertaking at Community level of actions aiming at:

filling some existing gaps in scientific and technological knowledge, and

encouraging cooperation between European research institutions with a

view to furthering the development of existing technologies while

5) OJ N° L 375, 20. 12. 1981, p. 1; OJ N° L 83, 25. 3. 1985, p. 1

- 7 -

promoting all research sectors capable of generating new lines of

research;

Whereas, simultaneously, measures will be taken to promote cooperation

between the Community programme and similar ones developed in non-Member

States or by international organizations;

Whereas the right to a genetic identity forms part of the integrity and the

dignity of an individual, and this principle is recognized in the

constitutions and laws of Member States and in the Community legal system as

forming part of the fundamental rights for which respect is ensured;

Whereas the results which can be achieved from human genome research require

the development of an integrated approach taking into account ethical, social

and legal aspects of their possible applications and the need to avoid any

improper use of those results;

Whereas there are good grounds for guaranteeing the right of an individual

in complete possession of the facts to choose whether or not to be informed

of his genetic characteristics;

Whereas, in the absence of clear standards and provisions concerning possible

developments in the field of genome analysis, there may be a risk on the one

hand that attempts are made to intervene in the human genome in order to

make the modifications so obtained hereditary, and on the other hand that

genetic analyses are carried out for monitoring purposes which may have a

profound effect on social life; whereas there are, accordingly, good grounds

for taking the necessary steps to preclude unacceptable developments,

particularly as regards predictive medicine;

Vfoereas, furthermore, it is necessary to develop during the course of the

programme the prenormative aspects arising from human genome analysis by

establishing a reliable scientific data set which could provide a basis for

political authorities to establish sound,, clear and responsible regulations;

Whereas the Scientific and Technical ResearchCommittee (CREST) was consulted

on the following measures,

HAS ADOPTED THIS DECISION:

- 8 -

Article 1

A specific research and technological development programme for the European

Economic Community in the field of Human Genome Analysis, as defined in the

Annex, is hereby adopted for a period of two years commencing on 1 January

1990. Article 2

The amount deemed necessary as the financial contribution from the Community

for the execution of the programme is 15 million ECU, including costs of a

staff of two persons. Article 3

Detailed rules for the implementation of the programme are set out ia the*?

Annex. Article 4

1. The Commission shall send to the Council and to the European Parliament

an annual report on the progress of the programme. 2. In the second year of the programme implementation, the Commission shall

undertake a review of the programme and it shall send the results of this

review to the Council and to the European Parliament, together, if

necessary, with any proposals for modification or prolongation of the

programme. 3. An evaluation of the results achieved shall be carried out by independent

experts and published in the form of a communication to the Council and

to the European Parliament. 4. The above-mentioned reports shall be established taking account of the

objectives and evaluation criteria set out in the Annex to this decision

and in conformity with the provisions of Article 2, paragraph 2 of

Decision 87/516/Euratom, EEC. - 9 -

Article 5

The Commission shall be responsible for the implementation of the programs. It shall be assisted in its execution by an advisory committee, hereinafter

called "the committee", composed of representatives of Member States and

chaired by a representative of the Commission. Article 6

1. The Commission shall submit to the committee a draft of the measures to

be taken. The conrtittee shall give its opinion within a period set by the

chairman according to the urgency of the matter, decided by a vote if

necessary. 2. The opinion shall be recorded in the report of the meeting; moreover,

each Member State shall have the right to have its own opinion recorded

in the report. 3. The Commission shall take due note of the opinion given by the committee. It shall inform the committee of the procedures through which that

opinion was taken into consideration. Article 7

The procedures laid down in Article 6 shall apply in particular to:

the contents of the calls for proposals;

the assessment of the proposed projects and the estimated amount of the

Community's contribution to themj

departures from the general rules governing Community participation set

out in the Annex;,

the participation

in any project by non-Coramunity organizations and

enterprises referred to in Article 8(2);

the measures to be undertaken to evaluate the programme;

arrangements for the dissemination, protection and exploitation of the

results of research carried out under the programme. Article S

1. The Commission is authorized, in conformity with Article 130 N of the EEC
Treaty, to negotiate agreements with non-member States and international
in
o r g a n i z a t i o n s, p a r t i c u l a r ly with non-member S t a t es taking part

- 10 -

European cooperation in the field of scientific and technical research

(COST) and with countries which have concluded scientific and technical

framework cooperation agreements with the Community, with a view to

associating them fully or partially with the programme. 2. VThere framework agreements for scientific and technical co-operation

between European non-Member States and the European Communities have been

concluded, organizations and enterprises established in those countries

may, on the basis of the criterion of mutual benefit, become partners in

a project undertaken within the programme. Article 9

This Decision is addressed to the Member States. Done at

,. 1989

For the Council,

The President

- 11 -

ANNEX

for a specific research programme in the field of health:

Human Genome Analysis

1. OBJECTIVES

Use and improvement of new biotechnologies in the study of the human genome

for a better understanding of the mechanisms of genetic function, as well as

the prevention and treatment of human diseases. In the pursuit of these

objectives, optimal cooperation will be sought with the programmes of non-

member States and international organizations. At the same time measures will be taken to develop an integrated approach to

the ethical, social and legal aspects of possible applications of results

obtained through the programme to ensure that they are not misused and also,

with prenormative aspects in mind, to establish a set of bioethical

principles to be followed in the developments to come. Alteration of germ cells or any stage of embryo development with the aim of

modifying human genetic characteristics in a hereditary manner is excluded

from the programme objectives. 2. TECHNICAL CONTENT

Precompetitive Ccmnunity research, setting up and reinforcement of networks

of European laboratories, and training, intended to allow the use of modern

technologies for the study and setting up of the human genetic map as well as

possible medical applications of the knowledge gained. The research described below will require the use of data-processing

facilities for the handling of data, and the development of integrated

databases to serve European networks. 2. 1 IMPROVEMENT OF THE HUMAN GENETIC MAP

- 12 -

Establishment of a Europe-based network, extending worldwide, for the

collection and mapping of the DNA of large families, in order to provide

research scientists with well-characterized genetic material and sets of

probes to determine the location of the relative positions of genes on the

chromosomes. 2. 2 SETTING UP OF ORDERED CLONE LIBRARIES OF HUMAN DNA

Setting up of a European network of laboratories working on establishing

overlapping clone libraries, and support for limited sequencing of cDNA. 2. 3 IMPROVEMENT OF THE METHODS AND BASIS FOR THE STUDY OF THE HUMAN GENOME

New biochemical reagents (restriction enzymes, etc. ). Improvement of methods

for the detection and localization of genetic markers (techniques for

labelling DNA probes, amplification of genes, etc. ). Development of new

vectors for the cloning of large DNA fragments and of procedures for the

transfection of chromosomes. Development of model systems for the

reproducible and stable expression of medically important genes both in vivo

and in vitro aimed at the well-being of patients. Development of new

computer software for the storage and manipulation of data from genome

sequencing and mapping. 2. 4 TRAINING

Setting up of a training programme to assist with the technology transfer of

molecular genetics methods, in particular to Member States in which these

techniques are currently underdeveloped. 3. BPU34ENTATION

3. 1 The programme shall be implemented through cost-shared or marginal cost

contracts, support to centralized facilities and networks, training

contracts, training grants, courses, consultations with national experts,

organization of study-group meetings, participation in seminars and

symposia, publications, studies, dissemination of results to all

interested groups, and organization of public presentations. - 13 -

Community participation will be up to a maximum of 50% in the case of

cost-shared contracts and could reach 100% in other cases. Participants may be research institutions, universities, private

enterprises, or combinations of them, located in Member States or in the

non-member States referred to in Article 7, or competent organizations in

a position to make a significant contribution. Projects must be carried out by participants from more than one country,

and include at least one participant from one Member State. Fellows coming from non-^nember States will be accepted in the training

programme, provided that they meet the required conditions and that their

costs are covered from other sources, such as other Community programmes

or actions which support fellows coming from developing countries. The contracts concluded by the Commission will govern the rights and the

obligations of each party, in particular the means of distribution,

protection and exploitation of the results of the research. 3. 2 The drawing up of research contracts can only take place if the

contracting parties undertake to abstain from all research seeking to

modify the genetic constitution of human beings by alteration of germ

cells or of any stage of embryo development which may make these

alterations hereditary. The contracts shall regulate the granting of licences arising out of

research projects and in particular there shall be no right to exploit on

an exclusive basis any property rights in respect of human DNA. In

addition, the Commission shall reserve the right to publish the results

of the research performed within the scope of the contracts. The contracts will guarantee that the members of the families

participating in the studies referred to in paragraph 2. 1 above will be

fully informed about and have consented to the use and study of their

DNA. The contracts will also guarantee complete protection of the

confidentiality and anonymity of the personal data, obtained in the

programme. - 14 -

3. 3 The Commission will ensure that during the execution of the programme

there will be wide-ranging and in-depth discussions of the ethical,

social and legal aspects of human genome analysis and that possible

misuses will be identified regarding applications of the results obtained

or of future developments of that research. It will ensure that the far-

reaching consequences of the research will be evaluated in a responsible

manner, and will submit to the Council and to the European Parliament an

annual report, possibly with legislative recommendations arising as much

from the research policy angle as frcm the legal one. To this end, the

Commission will obtain advice from experts in different fields of

science, law, philosophy and ethics, together with representatives of
patients1 associations. 4. EVALUATION CRITERIA

The Communication from the Commission to the Council relating to the

evaluation of Community research and development programmes(°) states that

the objectives and milestones for each research programme have to be set out

in verifiable and, where possible, quantitative form. These reference marks

are listed below:

4. 1 The long-term objective of this programme is to contribute to a better

understanding of the mechanisms of genetic function as well as to the

fight against human diseases arising from genetic variation (including

genetic diseases sensu stricto and many common diseases with a genetic

component, such as heart disease and cancer), through early diagnosis,

prevention, and improvement of prognosis and therapy. The Commission

proposes to achieve this objective by:

- the management of networks of laboratories set up around European

facilities for (a) the improvement of the human genetic map and (b) the

setting up of ordered clone libraries of human DNA, either of the

complete genome or of selected chromosomes, together with cDNA

sequencing;

6) OJ N° C 14, 20. 1. 87, p. 5

- 15 -

- the launching of a programme of precompetitive research aiming at

improvement of the methods and basis for the study of the human genome;

- the setting up of a programme of training to increase the distribution

of modern genetic technologies in Europe, and to improve technological

know-how in European laboratories;

- the promotion of cooperation with non-member States and international

organizations. 4. 2 The primary short-term objective is that the programme should succeed in

establishing the above-mentioned European networks of laboratories in the

fields of:

- the human genetic map

- ordered clone libraries of human DNA and cDNA sequencing

- improvement of the methods and basis for the study of the human genome,

all using data-processing facilities for data-handling and developing

integrated data bases. These objectives should be verifiable in 1991. 4. 3 Particular objectives to be attained within two years of the programme

implementation are as follows:

4. 3. 1 Concerning the human genetic map:

- the present total of 40 well-studied large families which form the

basis for the genetic map should be increased to 60 families;

- genetic material frem these families, and DNA probes, should be made

available to the European laboratories concerned while respecting the

individual rights of those families;

- a central facility should be identified to pool the results and

establish an improved genetic map at the 1 to 5" centimorgan level,

and an integrated databank should be set up. - 16 -

4. 3. 2 The strategies for setting up ordered clone libraries of human DNA

should be compared and a better approach defined; facilities for

maintaining the stocks of cloned DNA fragments should be established,

and the available clones dispatched to interested European

labofa" tories. 4. 3. 3 Substantial improvements should be obtained in the following research

fields to improve the methods and the basis for the study of the human

genome:

- New reagents, such as restriction enzymes,

- Methodology for cloning large DNA fragments and for the transfection of

chromosomes,

- Gene vectors adapted to human somatic cells in vitro,

- Ifethodology for the detection of a particular gene in a cell,

- Localization, cloning and sequencing of new genps, especially those

which are disease-related,

- New computer software for the storage, collation and analysis of DNA

sequence data. 4. 4 In addition, the programme should ensure that the following general

criteria are met:

4. 4. 1 That throughout the execution of the programme, the ethical, social and

legal aspects of human genome analysis should be the subject of wide-

ranging and in-depth discussions, and possible abuses of the results or

later developments of the work should be identified; principles for

their utilization and control should be proposed. 4. 4. 2 That the drawing up of research contracts shall presuppose that the

contracting parties undertake to abstain from all research seeking to

nodify the genetic constitution of human beings by alteration of germ

cells or of any stage of embryo development which may make these

alterations hereditary. - 17 -

4. 4. 3 The members of the families taking part in the studies mentioned in

paragraph 2. 1 must have been informed and given their consent, and the

confidentiality and anonymity of personal data must be ensured. 4. 4. 4 That the development and the application of somatic gene therapy are

not provided for within the framework of the present programme. 4. 4. 5 That actual or potential medical applications should be facilitated. 4. 4. 6 That potential opportunities for commercial developments should be

obtained. 4. 4. 7 That the overall technological standard of the participating European

laboratories must have been improved. 4. 4. 8 That taking account of the results of Community, national or commercial

research activities in human genetics, the evaluation panel should

consider whether the human genome analysis has contributed to the

development of the results of the said activities in regions of the

Community other than those in which the research was conducted. The

evaluation panel should also ascertain whether cooperation with non-

member States and international organizations has indeed been achieved

and whether this cooperation has had positive results. •

-AS-

FICHE FINANCIERE
PROGRAMME ANALYSE PU CENOME HUMAIN

Les points 1 à 4 de la fiche financière originale de la proposition
COH<88)424 restent inchangés. 5. INCIDENCE FINANCIERE PE L'ACTION SUR LES CREP1TS D'INTERVENTION

(Y conprls les dépenses de personnel (l agent de catégorie A, 1
agent
les dépenses de fonctionnement
administratif et technique). catégorie

C) et

de

5. 1. Çoftt tOtll M m U lU tPUtt 11 dUTéi «lYllMto
5. 2. Part dans la financement
• du budget communautaire
- des budgets nationaux et )
- d'autres secteurs au

niveau national

). )

5. 3. Echéancier plurlannuel du budget cosmunautalre

5. 3. 1. Crédits d'engagement en Millions d'Ecua

Personnel
Fonctionnement
Contrats et bourses

looo»

0,21
0,20
12,09

îooi

0. 21
0,25
2,04

Total

12,5

2,5

^ »i° Ecus

15 Mio Ecus

15 Mio Ecus

TSiïâL

0,42
0,45
14,13

15,00

5. 3. 2. Crédita de paiement en Million* d'Ecua

1000»

1001

1002

1993

I P J AL

Personnel
Fonctionnement
Contrats et bourses

0,21
0,20
3,79

0,21
0,25
5,54

•
-
3,10

*
-
1,70

0,42
0,43
14,13

Total

4,2

6,0

3,10

1,70

15,00

* Ces montants figurent à 1*APB 90 - Ht sont aujeti à modification

au cours de la procédure budgétgalre en cours. ISSN 0254-1475

COM(89) 532 final

DOCUMENTS

EN

05

Catalogue number : CB-CO-89-485-EN-C

ISBN 92-77-54138-5

Office for Official Publications of the European Communities
L-2985 Luxembourg


Conclusions of the Council and the ministers for health meeting within the Council of 13 November 1989 on the implementation of coordinated measures for preventing drug addiction and coping with drug addicts

Council of the European Union,Representatives of the Governments of the Member States

drug addiction,information network,public awareness campaign,reintegration into working life,social rehabilitation,therapeutics

drug addiction
information network
public awareness campaign
reintegration into working life
social rehabilitation
therapeutics


PROPOSAL FOR A COUNCIL DIRECTIVE CONCERNING MUNICIPAL WASTE WATER TREATMENT

action programme,industrial pollution,pollution control measures,urban area,wastewater,water treatment

action programme
industrial pollution
pollution control measures
urban area
wastewater
water treatment

COMMISSION OF THE EUROPEAN COMMUNITIES

C0MC89) 518 final

Brussels, 13 November 1989

Proposal for a

COUNCIL DIRECTIVE

concerning municipal waste water treatment

Il

(presented by the Commission)

&*v <n/-^

EXPLANATORY MEMORANDUM

I. Introduction

In 1988, initiatives were taken towards a new and more
effective Community water policy. The European Council
at Hannover invited the Commission and the Counci I to

intensify their efforts to combat and prevent air and
in its
water pollut ion. The Environment CounciI

—~'"'Hiso I ut i on of 28 June 1988 invited the Commission to

subm i t proposa i s for measures requI red at Commun i ty I eve I
for the treatment of municipal sewage, In the I ight of
the conclusions of the Community water Policy Ministerial
Seminar in Frankfurt on 27 and 28 June 1988. I J. The need for a directive

The general concern for municipal waste water quality is
due to the environmental detrimental effect of their
effluents which in many cases are not sufficiently
treated to avoid pollution. Uiithin the Community there
ars more discharges of municipai waste water than from

3 _

any other source. The volume of these discharges varies
depending on whether the discharges are from small
villages of a few hundred people or from cities of
several mill ions. Discharges are made to all parts of the Community's
aquatic environment to seas, estuaries, rivers, lakes and
streams. A survey undertaken for the Commission in 1984 showed
about 30,000 municipal waste water treatment plants in 10
Member States, of which over 1200 received waste water
from populations of greater than 50. 000, and at least 32
from cities of more than half a million. However, in
general terms only about 45% of the total organic load
was treated at that time. The detrimental effects of municipal waste waters are
self-evident in many of the Community waters. At the
most superficial level, the discharge of untreated
municipal waste waters can cause obnoxious conditions and
so reduce the amenity value of rivers, lakes, estuaries
and coasts. In freshwater, the reduction of dissolved
oxygen, the introduction of ammonia and high loads of
suspended solids can seriously reduce the ecological
quality, thus affecting a wide range of natural flora and
fauna including fish. The reduction in water quality can
also seriously affect water intended for abstraction and
human consumpt ion. In the sea, mun ic ipa I waste water
d i scharges can make waters unsu i tab Ie for bath i ng and
she I IfIsh cu11ivation. Nor should the industrial contribution to municipal waste
waters be overlooked. For historical reasons, industrial
wastes, many without preliminary treatment, drain into
collecting systems and are carried to municipal waste
water treatment plants. As a consequence, discharges
from municipal waste water treatment plants even after

i
I

- 3 -

treatment are not always satisfactory, and sewage sludge

is not of a qua I ity suitable for recyc I ing or for

disposal. 11 shou Id a I so be noted that over the I ast decade,

eutrophication has become a major problem in Community

waters, especially in seawater and in some rivers and

lakes. *ïh»3 proposal for a directive related to municipal

waste water treatment plants, together with the already

proposed directive concerning the protection of fresh,

coastal and marine waters against pollution caused by

nitrates from diffuse s o u r c e s ^ ), provides, inter aiiâ,

an opportunity for the Community to take action to

control the discharge of the two major nutrients

(nitrogen and phosphorus) which are responsible for

eutrophication. The need

for Community

action

is

reinforced by the transfrontier movement of nutrients,

both in freshwater and the seas. III. Proposed Commun Ity Act ion

A. Requirements for discharges from treatment plants

The proposed directive lays down minimum requirements for

the treatment of municipal waste water and for the

disposal of sludge. Because of the varied assimilative

capacity of the waters into which treated waste waters

are discharged, It is proposed that the receiving waters

be classified into three types. It is proposed that in

general, secondary

(biological) treatment

will

be

required as a minimum level of treatment. in more

sensitive areas, additional treatment will be required to

misât specific environmental needs, such as reduction of

nutrlsnts (for uihlcn there are specific provisions)

roductI on of bactsr)o, Gtc. [ )) 0. ë~ 0 54, 5. 5,19^9»

a-
t|

-

5

- 4 -

On the question of discharges to coastal waters, the
Comm i ss i on be Ii eves that in pr i nc i pIe, all mun i c i pa I
waste water discharged to marine waters should be given a
h i gh degree of treatment. However, if it can be proved through comprehensive
studies that, in zones with favourable hydrographie
conditions, discharges of waste water after primary
treatment can satisfy the relevant water quality
directives and other environmental requirements, such
treatment could be given to these municipal waste waters. B. Particular industrial discharges

The directive also seeks to control the discharge of
industrial waste waters which are of a nature similar to
municipal waste water and which do not enter municipal
waste water treatment plants before discharge to the
was
environment. The
i nappropr i ate to requ i re Member States to i ntroduce what
might be costly measures to control municipal waste
waters while ignoring discharges of comparable waste
waters from industrial sources, particularly where these
dIscharges occur near to one another. Commission

that

felt

it

- 5 -

C. Disposal of sludges at sea

The Commission also thinks that the discharge of sewage
sludge to sea by pi pel ine or by ship should be phased
out. In addition, from the time of the notification of
the d i rectIve, Member States are requ i red to ma i nta i n a
standstill on the amounts of sludge disposed to sea, and
to reduce the amounts of toxic, persistent and
bioaccumuIabIe substances present. It should be stressed
that the riparian Member States of the North Sea have
already subscribed to such a commitment in the framework
of the second International Conference for the Protection
of the North Sea. D. The proposed Committee

National practices related to municipal waste water
treatment vary widely within the Community. The
Commission has therefore considered in the directive only
the main provisions for municipal waste water treatment,
and is proposing that certain details can best be dealt
with by a Regulatory Committee (which can also meet as an
advIsory Comm i ttee). The Comm i ttee cou Id dea I w I th matters such as gu i de Ii nes
for the design of collecting systems, the quality of
industrial waste water entering municipal systems,
identification of sensitive areas, methods and frequency
of sampling, the monitoring of the environment subject to
municipal waste water discharges, or sludge disposal to
sea and the report i ng system and nat i onaI programmes. E. Nat IonaI programmes

It should be underlined that the whole proposal has been
conceived
of
mind
'subs Id i arIty'. Th i s means that act i on shouId be taken

principle

bearing

the

in

- 6 -

at a Commun i ty I eve I when th i s is necessary to ach i eve
the objectives set out in Article 130 R of the Treaty. In the circumstances, the key for the implementation of
the proposed directives will be the obligation for Member
States to establish National programmes, to regularly
update them and to provide information to the Commission. Formats to present this information in the most efficient
(and the least possible burocratic) way will be set up by
the Commission with the assistance of the above mentioned
Committee. Such a procedure will provide the possibility
of having an "ex-ante" assessment of the national
programmes as we I I as a continuous monitoring of the
progress made in their achievement. F. Access of the public to information

The information to be provided by the Member States about
the implementation of the directive and on its impact on
the env i ronment will perm i t the Comm i ssI on to pub Ii sh a
report at intervaIs. However, Member States will also be
required to make available to the public information on
the operation and monitoring of treatment plants and on
the discharges. Such
information should be made
ava I Iab Ie in a form whIch is both access ib Ie and
comprehensive, in line with the orientation of the
Commission's proposal for a Council Directive on the
freedom of access to information on the environment (O. J. C 335 of 30. 12. 1988, p. 5). G. TraIninq

The proposed directive will lead to the construction or
improvement of many waste water treatment pI ants, some of
a high level of sophistication. There will be a
requirement for staff to deal with design, construction,
operation and the provision of technical/seientific
support. For some States, the demand for skilled staff
will far outstrip the resources available, and they wiil

- 7 -

need to Increase the i r tra i n i ng faciIi t i es at a I I I eve I s
to overcome these difficulties. It is therefore proposed
that Member States shouId ass ist each other. In
add i 11 on, the CommIss i on wI I I a I so i nst i gate and promote
any i n11 i at i ves in th i s field. - 8-

Proposal for a
COUNCIL DIRECTIVE
concerning municipal waste water treatment

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic
Community, and in particular Article 130s thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the Economic and Social
Committee,

Whereas, the Council Resolution, of 28 June 1988 (1) invited
the Commission to submit proposals for measures required at any
level for the treatment of municipal sewage;

Whereas pollution due to insufficient treatment of waste water
in one member State often influences other member States'
waters; and therefore in accordance with article 13OR (4),
action at Community levels is necessary;

Whereas to prevent the environment from being adversely affected by
the disposal of insufficiently-treated municipal waste water,
there is a general need for secondary treatment of municipal
waste water;

it

Whereas
s t r i n g e nt treatment and whereas in some l e ss s e n s i t i ve marine
areas a primary treatment could be considered appropriate;

is necessary in s e n s i t i ve areas to require more

i n d u s t r i al waste water entering c o l l e c t i ng systems as

Whereas
well as the d i s p o s al of waste water and sludge from municipal
waste water treatment p l a n ts should be s u b j e ct to
a u t h o r i s a t i o n;

s i m i l ar requirements for treatment, as those for

Whereas
municipal waste water, should be applied for d i r e ct discharges
of
i n d u s t r i al waste water, when the i n d u s t r i al waste water
of a nature s i m i l ar to municipal waste water;

is

Whereas the r e c y c l i ng of sludge should be encouraged; whereas when sludge
is used f or a g r i c u l t u r al purposes use is
Council D i r e c t i ve 86/278/EEC ( 2 ); whereas the d i s p o s al of sludge at sea
should be phased o u t;

in c o n f o r m i ty w i th

take place

to

it

is necessary

Whereas
r e c e i v i ng waters and land, to control treatment p r o c e s s es and to
ensure t h at the discharge of waste water does not adversely
a f f e ct the environment;

to monitor

treatment

plants,

(1) 0J No C 209, 9. 8. 1 9 8 8, p. 3. (2) 0J No L 1 8 1, 4. 7. 1 9 8 6, p. 6. - 9 -

Whereas information of the general public by publication of
reports and the public accessibility of all information
and monitoring data related to municipal waste water treatment
plants is of great importance;

Whereas the establishment and the presentation to the Commission
of national programmes by Member States will help
ensure the coordination of the necessary measures to be taken
to achieve the aims of this Directive;

Whereas, in order to improve and accelerate practical
implementation of this Directive, the technical content of the
Annexes must, where appropriate, be speedily elaborated or
amended and whereas, in order to facilitate application of the
measures required for this purpose, provision should be made
for a uniform procedure establishing close cooperation between
the Member States and the Commission ;

Whereas, in order further to facilitate implementation of this
Directive, provision should equally be made for a
committee to assist the Commission, in an advisory capacity, on
any matter falling within the Commission's powers of
implementation which the Commission may submit to this
committee;

Whereas it is useful that the Commission
help Member States assist
training for staff and exchange of technical/scientific
information to improve the efficiency of municipal waste water
treatment;

each other in the provision of

measures to

take

Whereas Member States may take more stringent measures than
those provided for under this Directive,

HAS ADOPTED THIS DIRECTIVE :

- 10 -

Article 1

This Directive concerns the provision of municipal waste water
treatment and related matters. The objective of the Directive is to prevent the environment
from being adversely affected by municipal waste water
discharges. The definitions of the terms given in Annex I shall apply for the purposes
of this Directive. Article 2

Article 3

1. Member States shall ensure that, by 31 December 1998,

all municipalities are provided with collecting systems for
municipal waste water. 2. Collecting

systems described

satisfy
r e q u i r e m e n ts of Annex II (A). These r e q u i r e m e n ts may be
e l a b o r a t ed or amended
in Article 18. in paragraph 1 shall

in accordance with the procedure laid down

the

A r t i c le 4

1. Member

States

s h a ll

ensure

t h a t,

m u n i c i p al
b e f o re
an

e q u i v a l e nt

waste

d i s c h a r ge

e n t e r i ng

water
be
p r o c e s s,

s u b j e ct
in

by
c o l l e c t i ng

31 December 1998,
s h a ll
or

t r e a t m e nt

systems

to

secondary

t he

f o l l o w i ng

c i r c u m s t a n c e s:

- for d i s c h a r g es to fresh water and e s t u a r i es from
m u n i c i p a l i t i es r e p r e s e n t i ng 2,000 p. e. or more;

- for d i s c h a r g es to c o a s t al waters from m u n i c i p a l i t i es

r e p r e s e n t i ng 10,000 p. e. or more;

2. D i s c h a r g es from m u n i c i p al w a s te w a t er t r e a t m e nt p l a n ts

in paragraph 1 shall

described
of Annex II B. These r e q u i r e m e n ts may be e l a b o r a t ed or
amended in accordance with the procedure laid down in Article 18. the relevant

satisfy

requirements

3. The load expressed in p. e. s h a ll be c a l c u l a t ed on the b a s is
of t he maximum d a i ly load e n t e r i ng t he treatment p l a nt
during t he year excluding unusual s i t u a t i o ns such as t h o se
due to heavy r a i n. A r t i c le 5

1. Member States s h a ll by 31 December 1991 i d e n t i f y,
to c r i t e r ia

paragraph 2, s e n s i t i ve areas according
Annex

I I I. f or

the p'. ;eposes of
in

'. nid down

2. Member

by

States

shall
waste

t h a t,
entering

ensure
1998, municipal
water
s y s t e ms s h a ll b e f o re d i s c h a r ge
s u b j e ct to more s t r i n g e nt t r e a t m e nt than t h at d e s c r i b ed
A r t i c le 4 in t he f o l l o w i ng c i r c u m s t a n c e s:
-

f or d i s c h a r g es to f r e sh w a t er and e s t u a r i e s,
m u n i c i p a l i t i es r e p r e s e n t i ng 2 , 0 00 p. e. or more;
f or d i s c h a r g es to c o a s t al w a t e r s,
r e p r e s e n t i ng 1 0 , 0 00 p. e. or more. i n to s e n s i t i ve a r e as be

31 December
collecting

from m u n i c i p a l i t i es

from

-

in

3. Member s t a t es s h a ll e n s u re t h at t he
s e n s i t i ve a r e as a re r e v i e w ed at
y e a r s. i d e n t i f i c a t i o ns of
i n t e r v a ls of no more than 4

4. D i s c h a r g es from m u n i c i p al w a s te water t r e a t m e nt p l a n ts

in paragraph 2 shall

described
of Annex II B. These r e q u i r e m e n ts may be e l a b o r a t ed or
amended in accordance with the procedure laid down in Article 18. relevant

satisfy

the

requirements

A r t i c le 6

1. Member States may i d e n t i fy by 31 December 1 9 9 1, for the purposes of

paragraph 2,
I I I. in Annex

l e s s - s e n s i t i ve areas according to c r i t e r ia

l a id down

2. Municipal w a s te w a t er d i s c h a r g es to c o a s t al w a t e rs s i t u a t ed
less

in paragraph 1, may be subjected

in areas described
stringent treatment than prescribed

to
in A r t i c le 4 providing t h a t:

- such d i s c h a r g es r e c e i ve at
- comprehensive s t u d i es
n ot a d v e r s e ly a f f e ct

t he environment. l e a st primary

t r e a t m e n t;

i n d i c a te t h at such d i s c h a r g es w i ll

3. Member S t a t es s h a ll e n s u re t h at t he
s e n s i t i ve a r e as a re r e v i e w ed at
y e a r s. l e ss
i d e n t i f i c a t i o ns of
i n t e r v a ls of no more than 4

A r t i c le 7

shall

waste

water

States

ensure

Member
municipal
entering
s h a ll b e f o re d i s c h a r ge be s u b j e ct to a p p r o p r i a te t r e a t m e n t,
t he f o l l o w i ng c i r c u m s t a n c e s:
-

f or d i s c h a r g es to f r e s h w a t er and e s t u a r i es
m u n i c i p a l i t i es r e p r e s e n t i ng
f or d i s c h a r g es to c o a s t al w a t e rs from m u n i c i p a l i t i es

l e ss than 2 , 0 00 p. e. ;

by
collecting

systems

from

t h a t,

31 December 1998,

in

-
r e p r e s e n t i ng

l e ss than 1 0 , 0 00 p. e. - 12 -

Article 8

Where waters within the area of jurisdiction of a Member
State are adversely affected by discharges of municipal
waste water from another Member State, the Member State
whose waters are affected may notify the other Member State
and the Commission of the relevant facts. In such cases, the Member State from which the discharges
originate shall take action to identify the relevant
discharges in its country and shall take action as if the
affected waters were within its area of jurisdiction. Article 9

Member States shall ensure that the municipal waste water
treatment plants described in Articles 4, 5, 6 and 7 are
designed and constructed to maintain
under all normal climatic conditions. When designing the
plants, seasonal variations of the load shall be taken into
account. sufficient performance

Article 10

shall

ensure

t h a t,

before

31 December

1- Member

States
i n d u s t r i al

1991,
waste
c o l l e c t i ng s y s t e ms and m u n i c i p al w a s te w a t er
p l a n ts a re s u b j e ct to p r i or a u t h o r i s a t i on by t he competent
a u t h o r i t y. t r e a t m e nt

enters

which

water

2. A u t h o r i s a t i o ns s h a ll s a t i s fy

t he r e q u i r e m e n ts of Annex II C. These r e q u i r e m e n ts may be e l a b o r a t ed or amended in accordance
with the procedure laid down in Article 18. 3. Competent a u t h o r i t i es s h a ll a l so e n s u re t h at

t he

authorisations
other relevant Community Directive. referred

to

in paragraph 1 comply with any

4. Competent authorities shall ensure that authorisations are

reviewed at intervals of no more than 4 years in order to be
able, inter alia, to implement other international
commitments. Article 11

1. Competent

a u t h o r i t i es

shall

31 December 1998,
s l u d ge from m u n i c i p al w a s te w a t er
to a u t h o r i s a t i o n. s u b j e ct

the disposal

ensure
of

t h a t,
waste water
t r e a t m e nt p l a n ts

and of
is

before

? A u t h o r i s a t i o ns of d i s c h a r g es from m u n i c i p al w a s te v / a t er

treatment plants made pursuant
c o n d i t i o ns
B. T h e se r e q u i r e m e n ts may be e l a b o r a t ed or amended
acccrdance w i th

to paragraph 1 shall

l a id down in A r t i c le 18. t he r e l e v a nt r e q u i r e m e n ts of Annex

to s a t i s fy

the procedure

in

contain

II

- 13 -

3. Competent authorities shall insure that authorisations are

reviewed at intervals of no more than 4 years. Article 12

s h a ll

Member States
i n d u s t r i al waste waters which
- are of a n a t u re s i m i l ar
- do not enter municipal waste water treatment p l a n ts

to m u n i c i p al waste w a t e r,

31 December

ensure

b e f o re

t h a t,

1998,

before discharge to r e c e i v i ng waters,

s h a ll be considered for the purpose of t h is Directive as
to the relevant
municipal waste waters and be s u b j e ct
p r o v i s i o ns of t h is Directive. A r t i c le 13

1. Sludge arising from waste water treatment shall be recycled

whenever possible. When used for agricultural purposes,
use shall take place in conformity with the
provisions of Directive 86/278/EEC. Disposal routes shall
minimise the effects on the environment. 2. Member States shall, before 31 December 1998, eliminate the disposal
of sludge to sea by dumping from ships, by discharge from pipelines,
or by other means. 3. Until the elimination of disposal mentioned in paragraph 2,

Member States shall ensure that:
- the total amount of dry matter present in sludge disposed

of at sea does not increase,

- the amounts of toxic, persistent or bioaccumulable

materials contained therein
to comply inter alia with any relevant international
commitments. progressively reduced

are

Article 14

1. Competent authorities shall monitor:

- discharges from municipal waste water treatment plants to
verify compliance with the requirements of Annex II B;

- amounts and composition of sludges. 2. Competent authorities shall monitor waters subject to

discharges from municipal waste water treatment plants and
direct discharges according to Article 12 to verify that the
environment is not adversely affected. 2. In the case of a discharge subject to the provisions of

Article 6 and in case of a disposal of sludges subject to
the provisions of Article 13, Member States shall monitor
and carry out any other relevant studies to verify that the
discharge or disposal do not adversely affect the
environment. - 14 —

4. I n f o r m a t i on c o l l e c t ed by competent a u t h o r i t i es
with paragraphs 1, 2 and 3 and other
be r e t a i n ed by t he Member S t a te and made a v a i l a b le to
Commission w i t h in 3 months of r e c e i pt of a r e q u e s t. information

relevant

shall
t he

in complying

5. Guidelines on monitoring mentioned

e l a b o r a t ed f o l l o w i ng t he procedure

in paragraphs 1, 2 and 3 may be
l a id down in A r t i c le 1 8. A r t i c le 15

1. Member

States

shall

that, before 31 December

ensure
information

1991, the following
waste water treatment plants is made available to the public
promptly upon request, and in a form which is accessible and
comprehensible :
- a catalogue, where necessary supplemented by maps, to

related to municipal

enable a particular discharge or location to be traced,
including the type of treatment given;

- authorisations for the discharges from municipal waste

water treatment plants to receiving waters or to land, and
for the disposal of sludge to sea;

- results of the monitoring of discharges from municipal
waste water treatment plants, and of the amount and
composition of sludge;

- results of the monitoring of waters subject to discharges
from municipal waste water treatment plants, and of sea
areas subject to the disposal of sludge. 2. The detailed arrangements for the provision of information
described in paragraph 1 shall be determined by the competent
authorities. 3. in the case of the third indent of paragraph 1, the local public

shall also be informed in the most appropriate way, for
example by publication in local newspapers, by bill-posting
in public places, or at the offices of the relevant
operating body. 4. Member States shall ensure that every year, the relevant
authorities publish and disseminate a situation report on
the disposal of municipal waste water and sludge in their
area. These reports shall be transmitted to the Commission
by the Member States as soon as they are published. Article 16

1. Member States s h a ll e s t a b l i s h, b e f o re 31 December 1 9 9 1, a
implementation of

t h is D i r e c t i v e. programme f or

t he

2. Member States

s h a l l,

b e f o re

31 December

1 9 9 1, p r o v i de

the Commission w i th

i n f o r m a t i on on the programme. 3. Member S t a t es s h a ll p r o v i de t he Commission by 30 June each

y e ar w i th an update of t he

i n f o r m a t i on d e s c r i b ed

in paragraph 2

- 15 -

4. The

information

described

in

paragraphs ?. and 3 s h a ll be prepared

on the basis of Annex IV. This Annex as well as formats for
the provision of t h is information may be elaborated or
l a id down in A r t i c le 18. t he orocedure
amended in accordance w i th

D. Member States shall keep and make available any further

relevant information requested by the Commission. 0. The Commission shall review and assess the information

ralaced to this Directive and publish a report at intervals. Article 17

1. A Regulatory Committee, hereinafter called "the Committee'',

is hereby s«^t up to bring about the elaborations and
amendments providec* for in Articles 3, 4, 5, 10, 11 and 16. It
shall be composed of the representatives of the Member
States and chaired hy the representative of the Commission. 2. The Committee shall equally assist the Commission on any other
matter which the Commission may submit to the Committee. The
Committee shall act in those circumstances in an advisory
capacity and proceed without a vote. 3. The Committee shall adopt its own rules of procedure. Article 18

i. Where the procedure laid down in this Article is to be

followed, the matter shall be referred to the Committee by
its chairman. 2. The representative of the Commission shall submit to the

on

its

opinion

deliver

Committee a draft of the measures to be taken. The Committee
shall
tim« limit which the chairman may lay down according to the
urgency of the matter. The opinion shall be delivered by the
majority laid down in Article 148 (2) of the Treaty in the
case of decisions which the Council is required to adopt on
a proposal from the Commission. The votes of the
representatives of the Member States within the Committee
shall be weighted in the manner set out in that Article. The
chairman shall not vote. the draft withir. a

3. (a) the Commission shall adopt the measures envisaged if
they are in accordance with the opinion of the
Committee. (b) If the measures envisaged are not in accordance with the
opinion of the Committee, or if no opinion is delivered,
the Commission shall, without delay, submit to the
Council a proposal relating to the measures tn be taken. The Council shall act by a qualified majority. (c) iff on the expiry of ^hree months from the date of referral to

thr- council, the Council has not acted, the proposed measures
shall be adopted by the f. ommirsion. - 16 -

Article 19

Where appropriate, one or more Member States may individually
or jointly take more stringent measures than those provided for
under this Directive. Article 20

1. Member States shall ensure that those responsible for the
design, construction, operation and technical/scientific
support of municipal waste water treatment plants and
related equipment are properly qualified to undertake their
duties. 2. To that end, the Commission may consult the Committee on

measures to help Member States to assist each other in the
provision of training of staff at all levels and any other
initiative which will promote an improvement of the
performance of municipal waste water treatment plants and
related equipment. Article 21

1. Member States shall bring into force the laws, regulations

and administrative provisions necessary to comply with this
Directive no later than 31 December 1991. They shall forthwith inform
the Commission thereof. 2. Member States shall communicate to the Commission the texts
of the main provisions of national law which they adopt in
the field governed by this Directive. 3. The provisions adopted pursuant to paragraph 1 shall make

express reference to this Directive. This Directive is addressed to the Member States. Article 22

Done at

For the CounciI

I

À,'

&
I
I

!

(

I
î
j

- 1 7-

ANNEX I

For the purpose of this directive:

DEFINITIONS

1) "Appropriate treatment" means: treatment of municipal waste

water by a process which after discharge allows the
receiving waters to meet the objectives of this or any
other relevant Community directive. 2)

"Collecting system" means: a system of conduits which
collects and conducts municipal waste water to a municipal
waste water treatment plant. \ "Domestic waste water" means: waste water originating from

households and being predominantly of human origin. 4) "Sutrophic" means: the enrichment of water by nutrients,

especially compounds of nitrogen and phosphorus, causing an
accelerated growth of algae and higher forms of plant life
to produce an undesirable disturbance to the balance of
organisms and to the quality of the water concerned. 5) "Industrial waste water" means: waste water other than

domestic waste water and urban run off water. 6) "Municipalitv" means: an area of sufficiently concentrated

habitat where it is practicable for municipal waste water
to be collected and conducted to a municipal waste water
treatment plant. 7) "Municipal waste water" means: the mixture of domestic

waste water, industrial waste water and urban run off water
entering collecting systems. 8) "Municipal waste water treatment plant" means: an

installation which treats municipal waste water before
discharge to receiving waters or land. 9) "p. e. (population equivalent)" means: the organic

degradable load having a 5 day Biochemical Oxygen Demand
(BOD 5) of 60 g 02. 10) "Primary treatment" means: treatment of municipal waste
water by a physical process involving settlement of
suspended organic solids, or other processes in which the 5
day BOD of the incoming waste water is reduced by 20 to
40%. 11) "Secondary treatment" means: treatment of municipal waste

water by a process involving biological treatment with a
secondary settlement. 12) "Sludge" means residual sludge, whether treated or

untreated, from municipal waste water treatment plants, or
septic tanks. - 18 -

ANNEX II

REQUIREMENTS FOR MUNICIPAL WASTEWATER

A. Collecting systems

Collecting systems shall take into account existing and future
waste water treatment requirements. The design of collecting systems shall be undertaken according
to the best technical knowledgek notably regarding:

- Volume and characteristics of municipal waste water. - Prevention of leaks. - Limitation of pollution of receiving waters due to storm
water overflows or malfunction of wastewater treatment
plants. -~*

v. *

"f
4

~~

B. Discharge from municipal waste water treatment plants to

receiving waters

1. Discharges from municipal waste water treatment plants

subjected to treatment according to article 4 and 5 shall
meet the requirements for composition and percentage
reduction of the parameters shown in Table 1. 2. Discharges from municipal waste water treatment plants to
those sensitive areas which are subject to eutrophication,
shall meet the reguirements for composition and percentage
reduction of the parameters shown in Table 2. 3. More stringent requirements or requirements for additional
parameters than those shown in Tables 1 and/or 2 shall be
applied where required to ensure that the receiving waters
satisfy any other relevant directives. 4. Wastewater treatment plants shall be designed or modified so
that representative samples of the incoming waste water and
of treated effluent can be obtained before discharge to
receiving waters. - 19 -

C. Industrial vaste water

Industrial waste water entering collecting systems and
municipal waste water treatment plants shall be subject to such
pre-treatment as is required in order to:

- protect the health of staff working in collecting systems and

treatment plants,

- ensure that collecting systems, waste water treatment plants

and associated equipment are not damaged,

- ensure that the operation of the waste water treatment plant

and the treatment of sludge are not impeded,

- ensure that discharges from the treatment plants do not

adversely affect the environment, or prevent receiving water
from complying with other Community Directives,

- allow sludge to be disposed of safely to other media. •5fc, •

Table 1: Requirements for discharge from municipal waste water treatment plants subject to

Article 4 and 5. The value for average concentration or the percentage of reduction
shall be applied. PARAMETERS

EXPRESSION OF

RESULTS

MAXIMUM
DAILY AVERAGE
CONCENTRATION

PERCENTAGE
OF REDUCTION

REFERENCE METHOD OF
MEASUREMENT

Biochemical oxygen
demand (B0D5 at
20 °C) without
nitrification
(1)

mg/1 o2

25

70-90

Determination of dissolved
oxygen before and after
five-day incubation at
20'C + 1°C, in complete
darkness. Addition of a
nitrification inhibitor

Chemical oxygen
demand (COD)

Total suspended
solids

mg/1 02

mg/1

100

30

75 (2)

Potassium
dichromate method

- Filtering through a

0,45 jam. filter
membrane. Drying at 105CC and
weighing. - Centrifuging (for at

least 5 mins with mean
acceleration of 2 800
to 3 200 g ), drying at
105°C weighing. (1) This parameter can be replaced by another parameter : Total Organic Carbon (TOC) or Total Oxygen
Demand (TOD) if a relationship can be established between BOD5 and the substitute parameter. The relationship shall be controlled every 6 months. (2) Minimum percentage of reduction. Table 2: Requirements for discharges from municipal waste water treatment plants to those sensitive
areas which are subject to eutrophication. One or both parameters may be applied depending
of the local situation. PARAMETERS

EXPRESSION OF
RESULTS

MAXIMUM
AVERAGE
CONCENTRATION

MINIMUM
PERCENTAGE
OF REDUCTION

REFERENCE METHOD OF

MEASUREMENT

Total
phosphorus

mg/1 P

Total
nitrogen

mg/1 N

1

(1)

10

(2)

80

80

Molecular adsorption
Spectrophotometry

Molecular adsorption
Spectrophotometry

I

(1) Daily average concentration. (2) Annual average concentration; daily average should not exceed 20 mg/1

- 22 -

ANNEX III

CRITERIA FOR IDENTIFICATION OF SENSITIVE AND LESS SENSITIVE
AEEAS

A. Sensitive areas

A water body shall be identified as a sensitive area if it
falls into one of the following groups:

(a) natural freshwater lakes, other freshwater bodies,

estuaries, coastal waters and seas which are found to be
eutrophic or which in a short time may become eutrophic if
protective action is not taken. The following elements shall be taken into account when
considering which nutrient should be reduced by further
treatment:

(i) Lakes and streams reaching lakes/reservoirs/closed

bays which are found to have a poor water exchange,
whereby accumulation may take place. In these areas,
the removal of phosphorus should be included unless it
can be demonstrated that the removal will have no
effect on the level of eutrophication. Where
discharges from large municipalities are made, the
removal of nitrogen may also be considered. (ii) Estuaries, bays and other coastal waters and seas
which are found to have a poor water exchange, or
which receive large quantities of nutrients. Discharges from small municipalities are usually of
minor importance in those areas, but for large
municipalities, the removal of phosphorus and nitrogen
should be included unless it can be demonstrated that
the removal will have no effect on the level of
eutrophication. (b) Surface freshwaters intended for the abstraction of

drinking water which could contain more than 50 mg/1
nitrate if protective action is not taken. (c) Areas where treatment according to Article 4 is inadequate

to protect the environment or to allow the use of water for
specific purposes, or where further treatment than that
prescribed in Article 4 is necessary to fulfil Council
Directives, and other international commitments. (d) Areas of high ecological quality due to the flora and fauna

present and other areas which are important from a
scientific or nature protection point of view. B. Less sensitive areas

A marine water body or area can be identified as a less
sensitive area if the discharge of waste water does not
adversely affect the environment due to morphology,
hydrology or specific hydraulic conditions which exist in
that area. When identifying less sensitive areas, Member States shall
take into account the risk that the discharged load may be
transferred to adjacent areas where it can cause detrimental
environmental effects. Member States shall recognise the
presence of sensitive areas outside their national
jurisdiction. The following elements shall be taken into consideration
when identifying less sensitive areas:

a. Open bays and other coastal waters and seas with a good

water exchange and not subject to eutrophication or oxygen
depletion or which are considered unlikely to become
eutrophic or to develop oxygen depletion due to the
discharge of municipal waste water. b. Coastal marine areas which do not require a high level of
municipal waste water treatment due to the specific use of
that area. -24-

ANNEX IV

REPORTING OF NATIONAL PROGRAMMES

The Commission shall elaborate the methods and formats to be
adopted for reporting the national programmes. The following points should be taken into consideration:

1. Member States shall summarise the existing arrangements for
municipal waste water treatment and their future actions to
implement this directive. 2. The programme shall give brief details of the national

strategy including major schemes and time tables for the
actions as well as any other relevant information. The
timetable shall deal with periods of 5 years. 3. Information shall be given on costs of the programme

indicating capital investments and operating costs for the
collection, treatment and disposal of municipal waste water
and sludge. 4. Identification of sensitive areas as well as less sensitive
areas including a short explanation. The location of the
areas shall be shown on maps. 5. A short overview of the actual loads of municipal waste

water discharged to fresh water, estuaries, coastal waters
and land. Where insufficient data exist, estimates should be
made using available information. 6. Any other matters which the Commission considers will assist

the implementation of this directive. 7. Whenever possible use should be made of tables, maps and
other means of simplifying the presentation of data. £

2f

FINANCIAL 8TATBAENT

1. Budget head i ng

Chapter A 25
Item A 2510

2. Title of Project: Proposal for a Council Directive
concerning Municipal Waste UJater
Treatment

3. LegaI bas i s

Description and justification of project

See the annexed proposal for a Council directive

Proposed cI ass i fI cat i on of expend i ture

Non-compuIsory expend i ture

Type of expenditure and method of calculation

6. 1 Type of expenditure

- costs related to the organisation of two annual

meetings of the regulatory/advisory committee;

6. 2 Method of calculation

Two participants per Member State, Two meetings of
two days per year (Travel expenses)

Financial implications for operating appropriations
(including staffing). 7. 1 Total cost over the period proposed: 20. 000 ECU per

year (estimate). 7. 2 Proportion (%) of the total cost of the operation

to be financed from the Community budget:

100%

Telephone: direct tins 23

telephone exchange 239 11 11 - Telex COMEU 8 21877 - Telegraphic oddreee 0TACUR Bruxelles - T«l«fox 235 01 44

Rue de lo Loi 200 - B-104» Brussels - Belgium

;• ; - 2 4-

7. 3

TImetabIe

- from 1991

7. 3. 1. Commitment appropriations (in ECU)

8. The necessary credits will be requested in the norma

budgetary procedure of com i ng years. 1
i

2>

COMPETITIVENESS AND EMPLOYMENT IMPACT STATEMENT RELATED TO THE
PROPOSED DIRECTIVE ON MUNICIPAL WASTE WATER TREATMENT

I. What is the main reason for introducing the measure ?

Request by the Council Resolution 88/C209/02 of 28 June
1988, for Community legislation to deal with municipal
waste water. II• Features of the businesses in question:

Not applicable as the directive will require construction
or extension of waste water treatment plants operated by
local authorities. III. What direct obligations does this measure impose on

businesses ?

No direct obligations placed on businesses. IV. What indirect obligations are local authorities likely to

impose on businesses ?

Only indirect obligations imposed by local authorities are

a) tighter controls on industrial wastes entering

municipal waste water collecting systems,

b) the requirement that industries producing waste waters

comparable to municipal waste waters (e. g. breweries)
which discharge directly to receiving waters, should be
treated in a similar manner to that required for
municipal waste waters. Many of the industrial wastes entering municipal waste
water systems described in a) are already subject to the
requirements of the Dangerous Substances Directives, but
these are not always implemented by Member states. Z2

The proposed directive will require Member States to
observe these requirements more thoroughly. Many of the
industrial wastes described in b) are already subject to
controls to ensure that the receiving waters satisfy other
water quality directives (Drinking Water, freshwater fish,
etc. )

V. Are there any special measures in respect of SMEs ?

No. VI. What is the likely effect on the competitiveness of

businesses and on employment ?

The proposals are unlikely to affect the competitiveness
of businesses. With regard to employment, the effect is
likely to be positive, as there will be a substantial
programme of investment in the design, construction and
operation of new municipal waste water treatment systems. Increased employment will take place at professional,
technical, scientific and operative levels. The greatest
increase is likely to take place in Southern countries,
where relatively fewer municipal waste water treatment
systems already exist. The proposed directive promotes the
development of training programmes, and the Commission may
submit measures to assist Member States in the provision
of training. VII. Have both sides of industry been consulted ?

No. 4

%

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*
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*

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t

ISSN 0254-1475

COM(89) 518 final

DOCUMENTS

EN

15

|
t
]

I

Catalogue number : CB-CO-89-477-EN-C

ISBN 92-77-53924-0

Office for Official Publications of the European Commuiaities

L-2985 Luxembourg


Council Directive 89/622/EEC of 13 November 1989 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the labelling of tobacco products

approximation of laws,consumer information,labelling,smoking,tobacco industry

approximation of laws
consumer information
labelling
smoking
tobacco industry


Commission Regulation (EEC) No 3403/89 of 13 November 1989 amending Regulation (EEC) No 2159/89 laying down detailed rules for applying the specific measures for nuts and locust beans as provided for in Title IIa of Council Regulation (EEC) No 1035/72

guarantee,leguminous vegetable,nut,producer organisation,production improvement,working capital

guarantee
leguminous vegetable
nut
producer organisation
production improvement
working capital


Commission Regulation (EEC) No 3389/89 of 10 November 1989 re-establishing the levying of customs duties on gelatines and derivatives thereof falling within CN code 3503 00 10 originating in Pakistan to which the preferential tariff arrangements set out in Council Regulation (EEC) No 4257/88 apply

Pakistan,food additive,tariff preference,tariff quota

Pakistan
food additive
tariff preference
tariff quota


PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING FOR THE TENTH TIME DIRECTIVE 76/769/EEC ON THE APPROXIMATION OF THE LAWS, REGULATIONS AND ADMINISTRATIVE PROVISIONS OF THE MEMBER STATES RELATING TO RESTRICTIONS ON THE MARKETING AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS

approximation of laws,cadmium,dangerous substance,marketing,metal pollution

approximation of laws
cadmium
dangerous substance
marketing
metal pollution

COMMISSION OF THE EUROPEAN COMMUNITIES

C0M(89) 548 final - SYN 224

Brussels/!!} November 1989

Proposal for a

COUNCIL DIRECTIVE

amending for the tenth time Directive 76/769/EEC on the approximation

of the laws, regulations and administrative provisions of the Member States

relating to restrictions on the marketing and use of

certain dangerous substances and preparations

(presented by the Commission)

Explanatory «eooraudui

1. Kim of the Directive

This is the restriction of the marketing and use of certain dangerous

substances and preparations. It will contribute to:

- improved protection of man and of environment,

- improved functioning of the internal market through the imposition

of the same restrictions throughout this area without internal

frontiers. ?. Factors taken into consideration

The following factors were taken into consideration when the proposal for

a Directive was being drawn up:

- cadmium pollution poses a complex and difficult problem since it is a

"multimedia" form of pollution, affecting all environmental sectors. Cadmium may be emitted into the environment at numerous points in the

production, manufacturing, use and waste disposal processes. Some twenty legal acts concerning cadmium have been published in the

Official Journal: clear evidence of the importance attached to it;

- in April 1987 the Commission presented to the Council an action

programme on environmental pollution by cadmium. In response to that

Communication, on 25 January 1908 the Council adopted Resolution

88/C 30/01 on a Community action programme to combat environmental

pollution by cadmium. The Resolution stresses the major elements of the

strategy for cadmium control in the interests of the protection of

health and the environment. These elements concern the limitation of

the uses of cadmium to cases where suitable alternatives do not exist,

stimulation of research and development, collection and recycling of

products containing cadmium, for example batteries, and development of

a strategy designed to reduce cadmium input in soil;

- measures to restrict the use of cadmium taken individually by the

Member States. These may constitute barriers to trade and have a direct

effect on the establishment and operation of the internal market;

- scientific and technical data on the existence of substitutes less

hazardous both for man and the environment. 3. Comments on the proposed restrictions

Cadmium and its compounds are substances that are dangerous for man and

the environment; it is therefore necessary to regulate their marketing. This proposal for a Directive falls within the context of Council

Directive 76/769/EEC. The following principles were incorporated in the

drafting:

- the ban on the use of cadmium affects three areas of application -

pigments, stabilizers and plating - but the purpose of the ban differs

in each case. In the case of pigments, polymers (basic products) are covered. The

Directive contains a list of polymers which may no longer be coloured

by pigments containing cadmium. In the case of stabilizers, products or articles are covered. In the case of cadmium-plating. sectors or applications are covered. By a process of elimination, any substance not included in the lists is

permitted;

- the date for putting the Directive into effect may vary according to

product. Some manufacturers need time to adapt their production to

these conditions;

- in certain circumstances, notably for reasons of safety and

reliability, it may be essential to use cadmium. A general derogation

clause is provided for that reason;

-the Directive is not applicable in certain cases, notably where other

directives contain further special provisions;

- implementation of the Combined Nomenclature (Council Regulation (EEC)

No 2658/87 of 23 July 1987, as amended, on the tariff and statistical

nomenclature and on the Common Customs Tariff: OJ L 256, 7. 9. 1987). •"S

It has emerged in many cases from discussions with national experts that

the definition of the products or applications covered by the Directive

poses a very thorny problem. To overcome that it is proposed to include

with the products or applications, where possible, the corresponding CN

code number. The CN code numbers corresponding to the proposed definition are

therefore indicated in brackets after each product or application. The CN

subheadings are Community subdivisions to the harmonized system

nomenclature. The first six digits of the code numbers relate to the

harmonized system nomenclature, while the next two digits identify the CN

subheadings required. With a view to establishing an operative system, a recital concerning

technical and technological progress in relation to substitutes for

cadmium and its compounds has been included in the proposal. This

reference to progress, which meshes with the context of Council

Resolution 88/C 30/01, is set out in Article 2 of the proposal. A. Conformity with the Treaty

As is clear from section 3 above, this proposal is intended to afford

a high Level of protection for both persons and the environment and

is therefore in conformity with Article 100A (3) of the Treaty. The proposal does not call for any special provisions of the kind

referred to in Article 8c of the Treaty. 5. Consultation of the sector concerned

The proposal for a Directive was drawn up in consultation with a

group of national experts on public health and environmental

protection as well as representatives of the various sectors of

industry concerned. 6. Consultation of the European Parliament and the Economic and Social

Committee

In compliance with Article 100A of the Treaty, the cooperation

procedure with the European Parliament is applicable. The Economic

and Social Committee has to be consulted. u

Proposal for a

COUNCIL DIRECTIVE

amending for the tenth time Directive 76/769/EEC on the approximation of

the laws, regulations and administrative provisions of the Member States

relating to restrictions on the marketing and use of certain dangerous

substances and preparations. THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Havind regard to the Treaty establishing the European Economic Community,

and in particular Article 100a thereof,

1
Having regard to the proposal from the Commission,

In cooperation with the European Parliament,

Having regard to the opinion of the Economic and Social Committee,

1 0J No

2 OJ No

3 OJ No

S

- 2 -

Whereas measures should be adopted for the progressive establishment of the

internal market by 31 December 1992; whereas the internal market is an area

without

internal frontiers in which the free circulation of goods,

persons, services and capital is guaranteed;

4

Whereas t he Council Resolution of 25 January 1988" invites the Commission to pursue

without delay. the development of specific measures for a Community action

programme to combat environmental pollution by cadmium; whereas human

health also has to be protected and an overall strategy that in particular

restricts the use of cadmium and stimulates research into substitutes

should therefore be implemented;

Whereas the restrictions on the use of cadmium and its compounds laid down

by this Directive take into account the current state of knowledge and

techniques regarding substitutes; whereas it would be advisable to reassess

the situation in the light of the development of knowledge and techniques;

Whereas restrictions already adopted by certain Member States on use and

marketing of the above mentioned substances or preparations containing them

have a direct effect on the establishment and functioning of the internal

market; whereas it is therefore necessary to approximate the laws of the

Member States in this field and thus to amend the Annex to Council

Directive 76/769/EEC , as last amended by Directive

/

/EEC ,

HAS ADOPTED THIS DIRECTIVE:

4 OJ No C 30, 4. 2. 1988, p. 1-

5 0J No L 262, 27. 9. 1976, p. 201

6 OJ No L

G

- 3 -

' Article 1

Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex

hereto. Article 2

Owing to the development of knowledge and techniques in respect of substitutes

for cadmium, the Council shall reassess the situation within seven years of

adoption of this Directive on the basis of a report drawn up by the Commission. Article 3

1. Member States shall bring into force the laws, regulations and administrative

provisions necessary to comply with this Directive no later than 30 June 1991

and shall forthwith inform the Commission thereof. 2. Member States shall communicate to the Commission no later than 31 December

1990 the text of the basic provisions of national law which they adopt in

the field covered by this Directive. 3. The provisions adopted pursuant to paragraph 1 shall make express reference

to this Directive. Article A

This Directive is addressed to the Member States. Done at Brussels

For the Council

•\

ANNEX

The following point is hereby added to Annex I to Directive 76/769/EEC:

"Cadmium (CAS No. 7440-43-9) and its compounds

1. 1. Shall not be used to give colour to finished products manufactured

from the substances and preparations listed below. Such finished products, whatever their use or intended final purpose,

shall not be placed on the market if their cadmium content (expressed

as Cd metal) exceeds 0. 01 X by weight. - polyvinyl chloride (PVC) ••••%"

(3904 10) (3904 21)

(*)

- polyurethane (PUR)

- low-density polyethylene (Id PE), with the

exception of low-density polyethylene used

(3904 22)

(3909 50)

for the production of coloured masterbatch

(3901 10)

- cellulose acetate (CA)

(3912 11) (3912 12)

- cellulose acetate butyrate (CAB)

(3912 11) (3912 12)

- epoxy resins

(3907 30)

1. 2. Shall also be covered by this provision from (five years from adoption

of this Directive) :

a) the finished products manufactured from the following substances

and preparations :

- melamine - formaldehyde (MF) resins

- urea - formaldehyde (UF) resins

- unsaturated polyesters (UP)

- polyethylene terephthalate (PET)

- polybutylene terephthalate (PBT)

(3909 20)

(3909 10)

(3907 91)

(3907 60)

- transparent/general-purpose polystyrene

(3903 11) (3903 19)

- acrylonitrile methylmethacrylate (AMMA)

- cross-1 inked polyethylene (VPE)

- high-impact polystyrene

- polypropylene (PP)

(3902 10)

(*)

(l° Council Regulation (EEC) No 2658/87 of 23 July 1987, on the tariff ?nd statis

tical nomenclature and on the common customs tariff: 0J No L 256, 7. 9. 1987, p. 1

- 2 ~

b) paints

(3208) (3209)

J (*)

However, if the paints have a high zinc content, their residual

concentration of cadmium should be as low as possible and at all

events not exceed 0,1 % by weight. 1. 3. However, this provision shall not apply to products to be

coloured for safety reasons. 2. 1. Shall not be used to stabilize the finished products listed below

manufactured from polymers or copolymers of vinyl chloride

Such finished products shall not be placed on the market if their

cadmium content (expressed as Cd metal) exceeds 0. 01 % by weight. - packaging materials (bags, containers,

(3923 29 10)

bottles, lids)

(3920 41) (3920 42)

(*)

- office or school supplies

(3926 10)

- fitting for furniture, coachwork or

the like

- articles of apparel and clothing

accessories (including gloves)

- floor and wall coverings

(3926 30)

(3926 20)

(3918 10)

- impregnated, coated, covered or laminated

(5903 10)

textile fabrics

- imitation leather and morocco-leather goods

(4202)

- gramophone records

- tubes and pipes and their fittings

(8524 10)

(3917 23)

- swing doors

- vehicles for road transport (interior,

exterior, underbody)

- coating of steel sheet used in construction

or in industry

- insulation for electrical wiring

&

-3 -

This provision shall enter into force on (three years from the adoption

of this Directive). 2. 2. However, this provision shall not apply to finished

products using stabilizers with cadmium for safety reasons. 3. Within the meaning of this Directive, cadmium plating means any

deposit or coating of metallic cadmium on a metallic surface. 3. 1. Shall not be used for plating metallic products or components of the

products used in the sectors/applications listed below. Such cadmium-ptated finished products or components- of these products

shall not be placed on the market where they are used in i-

a) equipments and machinery for

- food production

- agriculture

cooling and freezing

printing and book-binding

(*)

(8210)

(8417 20)

(8419 81)

(8421 11)

(8421 22)

(8422)

(8435) (8437) (8438)

(8476 11)

(8419 31)

(8424 81)

(8432) (8433)

(8434) (8436)

(8418)

(8440)

(8442)

(8443)

Jo

- 4 -

b) equipment and machinery for the production of :

- household goods

- furniture

- sanitaryware

- central heating and

air conditioning plant

(*)

(7321)

(8421 12)

(8450)

(8509)

(8516)

(8465) (8466)

(9401) (9402)

(9403) (9404)

(7324)

(7322)

(8403) (8404)

(8415)

or in the products manufactured in the sectors listed under b)

3. 2. Shall be covered by this provision from (five years from adoption of

this Directive) products or components of products intended for use

in:. _

a) equipment and machinery for the production of :

- paper and board

- textiles and clothing

(*)

(8419 32)

(8439)

(8441)

(8444)

(8445) (8447)

(8448) (8449) (8451)

(8452)

b) equipment and machinery for the production of :

- industrial handling

(8425) (8426) (8427)

- road and agricultural vehicles

- rolling stock

- vessels

(8428)

(8429)

(8430)

(8431)

(chapter 87)

(chapter 86)

(chapter 89))

or in the products manufactured in the sectors listed under b ). (*)

\K

y

3. 3. However, this provision shall not apply to:

- products and components of the products used in the aerospace,

mining, offshore and in nuclear sectors whose applications require high

safety standards and in safety devices in road and agricultural

vehicles, rolling stock and vessels;

- electrical contacts in any sector of use on account of the reliability

required of the apparatus on which they are installed. '•

rv
i. Impact on competitiveness and employment

I. Principle grounds for introducing the measure

In the framework of Directive 76/769/EEC relating to restrictions on

the marketing and use of certain dangerous substances and

preparations, a proposal for a Directive has been prepared by the

Commission with the aim of limiting the use of cadmium. This proposal for a directive must be regarded in the perspective

of :

- the other existing European legislations to control the imput of

cadmium in the environment

- the communication presented by the Commission to the Council in

April 1987 for a proposed action programme on environmental

pollution by cadmium (COM (87) 165 final). - The Council Resolution of 25 January 1988 (88/C30/01 of 4/2/88)

which invites the Commission to continue without delay the

elaboration of specific measures concerning and Community action

programme to combat environmental pollution by cadmium. The Council Resolution also underlines the major elements of a

strategy for cadmium control in the interests of the protection of

human health and the environment. These elements are the limitation

of the uses of cadmium where suitable alternatives do not exist,

the stimulation of research and development; the collection and

recycling of products containing cadmium. jft

-2-

- an existing legislation in Denmark which is in force since 1st

January 1984 and prohibits the manufacture and importation of

products containing cadmium. - a project of decree in the Netherlands concerning cadmium

prohibition in products notified to the Commission in the framework

of Directive 83/189/EEC on 26 April 1987. This project has been

already published in the Netherlands official journal but the law

is not effectively enforced. 11- Characteristics of the firms concerned

The directive is trying to put in balance the industrial areas where

the use of cadmium is essential and the potential risks for the

environment. The obvious first step, in order to define some

realistic restrictions on the limitation of cadmium and its

compounds, was to look at the distribution of cadmium users and to

make a distinction between the major areas and the less important

ones. The available data has allowed us to see the proportion of cadmium

end-uses in the European countries. Plating and pigments have the

same order of percentage (24-29 %) whereas stabilizers represent the

half of that percentage (12 %) The part occupied by batteries

represents nearly 1/3 of the total cadmium consumed. However the

batteries are being investigated separately in the frame of another

directive and therefore would not be tackled 'in the present

directive. On the basis of the above data only the three following sectors :

- pigments

- stabilizers

- plating

have been tackled by the present proposal for a Directive. ^

-3-

Are there regional concentrations

The laws of prohibition on cadmium already adopted by some Member

States had as result to close their markets to goods coming from

other member States. At the door of the Internal Market of 1992 such situations could be

harmful and therefore the Commission has decided to make all the

necessary efforts to harmonize the legislations of the member States

in this field. This would have a positive impact to the industry

concerned all over Community. III. Direct obligations on firms

All the products which appear in the lists covered by this Directive

must satisfy its provisions, from the date of its entry into force. Prohibitions on application of cadmium would result to a consequent

need for alternatives. This could have a number of cost implications,

the most obvious of which but by no means the most significant is

the direct cost of new formulations for these alternatives. Other

factors

must

also

be

considered

notably

the

performance

characteristics of the alternatives and its harmlessness to man and

the environment. However, it is the view of the EEC industry concerned that it is

feasible that practical substitutes to cadmium for most of the use

areas covered by the proposal exist or are already employed. In all the three sectors mentioned above intensive research has led

to the development; of substitutes which could be considered as

equivalent to cadmium. Furthermore at the present time and in the three sectors concerned

the major substitution would appear to have already taken place. IV. Obligations which may be imposed indirectly on firms by local

authorities. p

-4-

The directive will be applied in each Member States on the basis of

the transposition of its provisions

into national Law local

authorities may impose additional requirements only if these do not

adversely affect the trade of the products concerned and on the basis

of paragraph d) of the Article 100 A of the Single European Act. V. Are there any special measures applicable to small and medium - sized

firms ?

No. These

firms

in

the

three

sectors

concerned

(pigments/stabilizers/plating) should also comply with the provisions

provided for under the directive. However, despite of the fact that

the directive bans the marketing of specific products containing

cadmium a transition period of 3-5 years has been granted to allow

industry and more particular SME and PME to adapt their manufacturer

process to the new conditions. VI. What is the likely effect

- on the competitiveness of undertakings ?

The powerful advantage given by the directive to the European

Industry concerned as regards the harmonization of the legislations

concerning restrictions on the uses of cadmium is that after the

date of entry into force of the directive it will no longer be

possible to impede the free movement of the products which do not

appear in the lists of banned products on the internal market. However this directive does not apply to exports of products

containing cadmium to Third countries. On the other hand any EEC legislation treats imports into the

Community in an identical manner to EEC production and this also

allows the European industry to compete fairly with those trading

nations who export to the Community market. P

-5-

There is currently a reliable method to detect the presence of

cadmium in products. - on employments

As for employment the effects of such restrictions

are very

difficult to quantity and would vary according to the applications

involved. It is however noticeable that the implementation of the

directive

should

result

in a general

improvement

in the

competitiveness

of

the European

Industry concerned with a

consequent beneficial effect on the labour market. VII. Have both sides of industry been consulted ?

Industry's concern regarding the prohibition of uses of cadmium was

tackled with attention. Useful contacts have been taken with the

representatives of industries concerned by the project in order to

discuss the critical industrial areas which could be affected by such

a directive. The approach adopted was to discuss the restrictions on

the application of cadmium on case by case basis allowing a more

complete discription of the industrial sectors involved. The result

was the establishment of lists of banned products accepted by both

sides. A group of national experts was also directly and actively involved

in the preparation of this proposal. j\

ISSN 0254-1475

COM(89) 548 final

DOCUMENTS

EN

05

Catalogue number : CB-CO-89-538-EN-C

ISBN 92-77-55053-8

Office for Official Publications of the European Communities
L-2985 Luxembourg


RE-EXAMINED PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH AND TECHNOLOGICAL DEVELOPMENT PROGRAMME IN THE FIELD OF BIOTECHNOLOGY ( 1990 - 1994 ) - BRIDGE ( BIOTECHNOLOGY RESEARCH FOR INNOVATION, DEVELOPMENT AND GROWTH IN EUROPE )

EU research policy,biotechnology,research programme

EU research policy
biotechnology
research programme

COMMISSION OF THE EUROPEAN COMMUNITIES

C0MC89) 545 final - SYN 182

Brussels, 10 November 19&9

' - ^ S ^l

«^•jj^-i^jS^fc^

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Re-examined proposal f or a

COUNCIL DECISION

adopting a specific research and technological development

programme in the f i e ld of biotechnology

(1990 - 1994)

B R I D GE

(Biotechnology Research for Innovation,

Development and Growth in Europe)

(presented by the Commission pursuant to A r t i c le 149. 2(d)

of the EEC Treaty)

EXPLANATORY flEHORANOUH

(fe^rVf

1. On 1 1 October 1909 the European Parliament in its second reading of t;h<?

BRIDGE proposai (COM(00)806) adopted two amendments to the Common
Position. Pursuant to Art. 149 2d of the EEC Treaty, the Commission takes as a
basis for its re-exarained proposal the Common Position with one
exception: the Commission modifies the text of the Common Position by
taking into account the substance of parliamentary amendment n° 2
concerning deliberate release. In countries where no regulations or guidelines governing deliberate
release currently exist, the Commission believes that it is necessary in
the implementation of the programme to place responsibility upon project
proposers and to have an active involvement of national authorities in
order to ensure safety. Therefore, the Commission modifies the third
paragraph of the implementation section of Action I in Annex I of the
Common Position by requiring that project proposers, planning to ini
tiate release experiments, "obtain
consent" of the
competent authorities and not "ascertain that there is no objection". This modification falls in line with terminology agreed in pending
deliberate release legislation proposed by the Commission (C0H(88)160
final). the written

3. Comment of the Commission on the amendment of Parliament not accepted bv

the Commission
As regards the first part of amendment n° 1, whilst the Commission has
undertaken to include in all future specific RDT programme proposals a
provision concerning the relationship between the term "amount deemed
necessary", the budgetary procedure and the interinstitutional agreement
on budgetary discipline it considers untimely the introduction of any
such provision for proposals already submitted as this could delay the
adoption of the programmes concerned. The Commission cannot accept the second part of amendment n° 1 because
the amounts to be allocated to different research areas are to be deci
ded by the budgetary authority and not by the legislature. Dependent
upon the availability of budgetary means, the Commission intends to
commit at least 3 MECU to the third paragraph of the implementation
section of Action II. 4. The text of the re-examined proposal is to be found at Annex I. The
text of the amendment of Parliament, which is not accepted by the
Commission, is to be found at Annex II. ANNEX 1

The Commission modifies the Common Position (Annex 1,

Action I, Implementation, third paragraph) as follows:

Participants in a project conducted as a shared-cost action
may be industrial enterprises, including small and medium
enterprises, research institutions, universities or combina
tions of them, established in the Community or in those
European third countries which have concluded framework
agreements in scientific and technical co-operation with the
Community. Pending the implementation of the provisions of a
possible Council Directive on deliberate release into the
environment of genetically modified organisms, proposals
selected will have to conform, in the country where the
release experiment is to take place, to relevant safety
regulations or guidelines; in those countries where no such
regulations or guidelines have been developed, the project
proposers planning to initiate release experiments will
obtain the written consent from the competent authorities
concerned. /. •^y^^^^P^ÊM'^^^^ÊÊh1:

-••••'. 'M--•••-'••*£ •'^v,1ij^^. :*#iV-

ANNEX 2

Amendment n° 1 of the European Parliament

Article Z, third and,fourth
paragraphs (new) •

the context

procedure. to
propose

In
budgetary
shall
authority

Each year,
annual
the
Commission
these
budgetary
appropriations be entered
the
programme on the basis of the real
needs of
financial
year and the financial estimates as
t he
f e a t u r ed
Institutional Agreement. reference

I n t e r-

that

the

for

in

allocated

s o d a ! - s c i e n ce s

A minimum of 5% of the total BRIDGE
to
s h a ll
be
budget
research projects 1n th«
parallel
of
form
r«s«<rc*i
the possible effect» o f _ih$. Into
technologies and techftjgmt
generic
the BfrJPQf,
to be
supported unàer
s o c i a l - s c i e n c es
programme. research
sub-
the BRIOCE
programme w i t h in
programme with I ts own budget of not
l e ss than S m ECU. shall be a separate

The

c DN51

1 6. 1 0. 89

ISSN 0254-1475

COM(89) 545 final

DOCUMENTS

16

EN *

Catalogue number : CB-CO-89-504-EN-C

ISBN 92-77-54411-2

Office for Official Publications of the European Communities
L-2985 Luxembourg. J*3"?A