Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE amending for the 21st time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogens, mutagens or substances toxic to reproduction - c/m/r)
Date: 2000-01-06
Institutions: European Commission
Subjects: approximation of laws, consumer protection, dangerous substance, public health

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 06.01.2000
COM(1999) 746 final

2000/0006 (COD)

Proposal for a

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE

amending for the 21st time Council Directive 76/769/EEC relating to restrictions
on the marketing and use of certain dangerous substances and preparations
(substances classified as carcinogens, mutagens or substances toxic to
reproduction - c/m/r)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1.

INTRODUCTION AND CONTEXT

the laws,

(on the approximation of

European Parliament and Council Directive 94/60/EC1 amending for the 14th time
Directive 76/769/EEC2
regulations and
administrative provisions of the Member States relating to restrictions on the
marketing and use of certain dangerous substances and preparations) adds a list of
substances classified as category 1 or 2 carcinogens, mutagens or substances toxic to
reproduction (c/m/r) to Annex I of Directive 76/769/EEC. It stipulates that these
substances may not be used in substances or preparations placed on the market for
sale to the general public. The c/m/r-classification of these substances has been
defined in Annex I of Directive 67/548/EEC3 on classification, packaging and
labelling of dangerous substances. This Annex is regularly updated by way of
adaptation to technical progress.

Directive 94/60/EC also imposes on the Commission the obligation to submit further
proposals to the European Parliament and Council to add additional c/m/r substances
to Annex I of Directive 76/769 no later than six months after the publication of new
classifications as c/m/r (categories 1 and 2) in the framework of Council Directive
67/548/EEC. The European Parliament and Council Directive 97/56/EC4, 16th
to Directive 76/769/EEC, updates and consolidates the Appendix of
amendment
c/m/r-substances to Annex I to the Directive.

Commission Directive 97/69/EC5 (23rd adaptation) added 1 substance newly classified
as carcinogenic category 2 to Annex I of Directive 67/548/EEC and Commission
Directive 98/73/EC6
(24th adaptation) added 1 substance newly classified as
carcinogenic category 2 and 1 substance newly classified as toxic for reproduction
category 2. It is proposed to add these substances to the appendix to points 29 and 31.

2.

JUSTIFICATION FOR PROPOSAL AND CONSIDERATIONS OF
SUBSIDIARITY

What are the objectives of the proposal in relation to the Community’s obligations ?

Within the framework for action in the field of public health, the European Parliament
and the Council have adopted an action plan to combat cancer (Decision N° 646/967).
Due to the fact that use of chemicals by consumers cannot be controlled safety can
only be ensured by prohibiting use by consumers of c/m/r substances and

1

2

3

4

5

6

7

OJ L 365, 31.12.1994, p. 1.
OJ L 262, 27.9.1976, p. 201, Directive as last amended by Directive 94/60/EC (OJ L 365,
31.12.1994, p. 1).
OJ L 196, 16.8.1967, p. 1/67, Directive as last amended by Commission Directive 94/69/EC
(OJ L 381, 31.12.1994, p. 1).
OJ L 333, 4.12.1997, p. 1.
OJ L 343, 13.12.1997, p. 19.
OJ L 305, 16.11.1998, p. 1.
OJ L 95, 16.4.1996, p. 9.

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preparations. Following the adoption of the Directive 94/60/EC the Commission is
required to propose Directives prohibiting use by consumers of substances newly
classified as c/m/r categories 1 or 2.

The objectives of the proposal are to preserve the Internal Market and to protect the
health of the consumers.

Does the initiatives arise out of an exclusive Community competence or a shared
competitiveness ?

The action to preserve the Internal Market for dangerous substances falls within the
exclusive competence of the Community. This competence was established by
Council Directive 76/769/EEC.

What are the courses of action available to the Community ?

The only course of action available is a proposal for an amendment to Directive
76/769/EEC, the twenty-first amendment, providing for harmonised rules on the use
of substances and preparations classified as category 1 or 2 c/m/r’s.

Are uniform rules necessary ? Is it not sufficient
implemented by Member States ?

to establish targets to be

The proposed 21st amendment establishes uniform rules for the circulation of
substances and preparations classified as c/m/r. It also guarantees high level of
protection of health and safety of consumers. The proposed 21st amendment is the
only way to meet these goals. Targets would be insufficient.

3.

RATIONALE OF THE PROPOSAL

The proposed 21st amendment would extend the appendix of c/m/r substances to
Annex I to Directive 76/769 by adding the substances classified as c/m/r category 1 or
category 2 in the 23rd and 24th adaptations to technical progress of Directive
67/548/EEC. Use by consumers of all these substances is thus prohibited.

4.

COSTS AND BENEFITS

4.1.

Costs

None of the 3 substances is known to be placed on the market for consumer uses.
Refractory ceramic fibres could however, although extremely rare and unlikely, be
obtained by the general public for hobby use. The proposed Directive should not pose
any problems to the industry or trade.

4.2.

Benefits

The proposed ban will ensure that the carcinogenic substances and preparations are
not placed on the market for consumer use either now or in the future. The benefit of
the proposal is to protect the health of consumers.

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5.

PROPORTIONALITY

The 21st amendment would yield benefits in terms of protecting the health of
consumers. This would be achieved at no costs.

6.

CONSULTATIONS PERFORMED IN RPEPARING THE DRAFT 21ST
AMENDMENT

Advice on the preparation of the proposal was sought through several meetings
involving experts from Member States and industry. Industry, represented by CEFIC
(European Chemical Industry Council) and CERAME-UNI did not oppose the
proposal, in so far as it does not concern articles containing the substances.

7.

CONFORMITY WITH THE TREATY

This proposal is intended to facilitate a high level of protection of health of the
consumers and is therefore in conformity with Article 95§3 of the Treaty.

The proposal does not call for any special provisions of the kind referred to in Article
15 of the Treaty.

It is in conformity with Article 5.

8.

CONSULTATION OF THE EUROPEAN PARLIAMENT AND THE
ECONOMIC AND SOCIAL COMMITTEE

In compliance with Article 95 of the Treaty, the Codecision Procedure with the
European Parliament is applicable. The Economic and Social Committee has to be
consulted.

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2000/0006 (COD)

Proposal for a

EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE

amending for the 21st time Council Directive 76/769/EEC relating to restrictions
on the marketing and use of certain dangerous substances and preparations
(substances classified as carcinogens, mutagens or substances toxic to
reproduction - c/m/r)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN
UNION,

Having regard to the Treaty establishing the European Community, and in particular
Article 95 thereof,

Having regard to the proposal from the Commission8,

Having regard to the opinion of the Economic and Social Committee9,

Acting in accordance with the procedure laid down in Article 251 of the Treaty10,

Whereas :

(1)

(2)

(3)

(4)

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10

11

Under article 14 of the Treaty an area without internal frontiers is to be
established in which the free movement of goods, persons, services and capital
is ensured.

The European Parliament and the Council adopted on 29 March 1996 Decision
No 646/96/EC adopting an action plan to combat cancer within the framework
for action in the field of public health (1996 to 2000)11.

To improve health protection and consumer safety, substances classified as
carcinogenic, mutagenic or toxic to reproduction and preparations containing
them should not be placed on the market for use by the general public.

Directive 94/60/EC of the European Parliament and of the Council of 20
December 1994 amending for the 14th 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

OJ C
OJ C
Opinion of the European Parliament of
OJ L 95, 16.4.1996, p. 9.

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dangerous substances and preparations12 establishes,
in the form of an
Appendix concerning points 29, 30 and 31 of Annex I
to Directive
76/769/EEC13, a list containing substances classified as carcinogenic,
mutagenic or toxic to reproduction of category 1 or 2. Such substances and
preparations should not be placed on the market for use by the general public.

Directive 94/60/EC provides that the Commission will submit to the European
Parliament and Council a proposal to extend this list not later than six months
after publication of an adaptation to technical progress of Annex I to Directive
67/548/EEC14, which contains
carcinogenic,
mutagenic or toxic to reproduction of category 1 or 2.

classified as

substances

the 23rd

adapting for

Commission Directive 97/6915
time Directive
67/548/EEC, and more particularly Annex I thereto, to technical progress,
contains 1 substance newly classified as carcinogenic category 2 and
Commission Directive 98/73/EC16 adapting for
time Directive
67/548/EEC, and more particularly Annex 1 thereto, to technical progress,
contains 1 substance newly classified as carcinogenic category 2 and 1
substance newly classified as toxic to reproduction category 2. These
substances should be added to points 29 and 31 of the Appendix to Annex I to
Directive 76/769/EEC.

the 24th

The risks and advantages of the substances newly classified, by Directive
96/54/EC, as carcinogenic, mutagenic and toxic to reproduction of category 1
or 2 have been taken into account.

This Directive applies without prejudice to Community legislation laying
down minimum requirements for the protection of workers contained in
Council Directive 89/391/EEC of 12 June 1989 on the introduction of
measures to encourage improvements in the safety and health of workers at
work17, and individual directives based thereon, in particular Council Directive
90/394/EEC of the 28 June 1990 on the protection of workers from the risks
related to exposure to carcinogens at work.

OJ L 365, 31.12.1994, p. 1.
OJ L 262, 27.9.1976, p. 201. Directive last amended by Commission Directive 99/77/EC (OJ
L 207, 6.8.1999, p. 18).
Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations
and administrative provisions relating to the classification, packaging and labelling of
dangerous substances (OJ 196, 16.8.1967, p. 1). Directive as last amended by Directive
99/33/EC of the European Parliament and Council of 10 May 1999 (OJ L 199, 30.7.1999,
p. 57).
OJ L 343, 13.12.1997, p. 19
OJ L 305, 16.11.1998, p. 1.
OJ L 183, 29.6.1989, p. 1.

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(5)

(6)

(7)

(8)

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13

14

15

16

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HAVE ADOPTED THIS DIRECTIVE:

Article 1

The substances listed in Annex to this Directive shall be added to those substances
listed in the appendix concerning points 29 and 31 of Annex I to Directive
76/769/EEC.

Article 2

1.

2.

Member States
regulations and
shall adopt and publish the laws,
administrative provisions necessary to comply with this Directive no later
than 31 December 2001 [one year after the date of its entry into force]. They
shall forthwith inform the Commission thereof.

They shall apply those provisions from 1 July 2002 [18 months after the date
of the entry into force of this Directive].

When Member States adopt those provisions, they shall contain a reference
to this Directive or be accompanied by such a reference on the occasion of
their official publication. Member Sates shall determine how such reference
is to be maid.

Article 3

This Directive shall enter into force on the twentieth day following that of its
publication in the Official Journal of the European Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels,

For the European Parliament
The President

For the Council
The President

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Point 29 – Carcinogens: category 2

ANNEX

Substances

Index number

EC number

CAS
number

4-chloroaniline

612-137-00-9

203-401-0

106-47-8

Refractory ceramic fibres

650-017-00-8

Point 31 – Toxic to reproduction: category 2

Substances

Index number

EC number

CAS
number

6-(2-chloroethyl)-6(2-
methoxyethoxy)-2,5,7,10-
tetraoxa-6-silaundecane;
etacelasil

014-014-00-X

253-704-7

37894-46-5

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