Common Position (EC) No 45/2002 of 3 June 2002 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting a Directive of the European Parliament and of the Council amending for the 23rd 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: 2002-06-03
Institutions: Council of the European Union
Subjects: animal breeding, approximation of laws, dangerous substance, environmental protection, health policy, marketing restriction, plant propagation, public health

20.8.2002

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Official Journal of the European Communities

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 45/2002

adopted by the Council on 3 June 2002

with a view to the adoption of a Directive 2002/. . ./EC of the European Parliament and of the
Council of . . . amending for the twenty-third 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)

(2002/C 197 E/01)

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 Commission (1),

Having regard to the opinion of the Economic and Social
Committee (2),

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1) 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.

(2) On 29 March 1996 the European Parliament and the
Council adopted 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) (4).

(3) 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.

(4) Directive 94/60/EC of the European Parliament and of the
Council of 20 December 1994 amending for the fourteenth
time Directive 76/769/EEC (5) establishes, in the form of an
Appendix concerning points 29, 30 and 31 of Annex I to
Directive 76/769/EEC (6), a
containing substances
classified as carcinogenic, mutagenic or toxic to repro-
duction of category 1 or 2. Such substances and prep-
arations containing them should not be placed on the
market for use by the general public.

list

(5) Directive 94/60/EC provides that

to the European Parliament
to extend this list not

the Commission will
submit
a
and Council
later than six months
proposal
after publication of an adaptation to technical progress of
Annex I to Council Directive 67/548/EEC of 27 June 1967
on the approximation of the laws, regulations and adminis-
trative provisions relating to the classification, packaging
and labelling of dangerous substances (7), which contains
substances classified as carcinogenic, mutagenic or toxic
to reproduction of category 1 or 2.

thereto,

(6) Commission Directive 98/98/EC of 15 December 1998
adapting to technical progress for the twenty-fifth time
Council Directive 67/548/EEC (8), and more particularly
Annex I
to technical progress, contains 20
substances newly classified as carcinogenic, mutagenic or
toxic to reproduction of category 1 or 2, and Commission
Directive 2000/32/EC of 19 May 2000 adapting to
technical progress
twenty-sixth time Council
Directive 67/548/EEC (9), and more particularly Annex I
thereto,
to technical progress, contains two substances
newly classified as carcinogenic, mutagenic or toxic to
reproduction of category 1 or 2. These substances should
be added to points 29, 30 and 31 of the Appendix to
Annex I to Directive 76/769/EEC.

the

for

(1) OJ C 213 E, 31.7.2001, p. 263.
(2) OJ C 311, 7.11.2001, p. 7.
(3) Opinion of the European Parliament of 5 February 2002 (not yet
published in the Official
Journal), Council Common Position of
4 June 2002 and Decision of the European Parliament of . . . (not
yet published in the Official Journal).

(4) OJ L 95, 16.4.1996, p. 9. Decision as last amended by Decision

No 521/2001/EC (OJ L 79, 17.3.2001, p. 1).

(5) OJ L 365, 31.12.1994, p. 1.
(6) OJ L 262, 27.9.1976, p. 201. Directive as last amended by
Commission Directive 2001/91/EC (OJ L 286, 30.10.2001, p. 27).
(7) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).

(8) OJ L 355, 30.12.1998, p. 1. Directive as amended by Commission

Decision 2000/368/EC (OJ L 136, 8.6.2000, p. 108).

(9) OJ L 136, 8.6.2000, p. 1.

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(7) The risks and advantages of the substances thus newly

classified have been taken into account.

necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

(8) 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 work (1), and individual directives
based thereon, in particular Council Directive 90/394/EEC
of 28 June 1990 on the protection of workers from the
risks related to exposure to carcinogens at work (2),

HAVE ADOPTED THIS DIRECTIVE:

They shall apply these measures from . . . (**)

2. When Member States adopt these measures, they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
The methods of making such reference shall be laid down by
Member States.

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 1

Article 4

The substances listed in the Annex shall be added to those
listed in the Appendix, under points 29, 30 and 31
respectively, of Annex I to Directive 76/769/EEC.

This Directive is addressed to the Member States.

Article 2

Done at . . .

1. Member States shall adopt and publish not later than
regulations and administrative provisions
. . . (*)

the laws,

For the European Parliament

The President

For the Council

The President

(1) OJ L 183, 29.6.1989, p. 1.
(2) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive

1999/38/EC (OJ L 138, 1.6.1999, p. 66).

(*) 12 months after the entry into force of this Directive.

(**) 18 months after the entry into force of this Directive.

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Point 29 — Carcinogens: category 2

ANNEX

Substances

Index number

EC number

CAS number

Cobalt dichloride

Cobalt sulphate

Cadmium fluoride

Chrysene

Benzo[e]pyrene

027-004-00-5

231-589-4

7646-79-9

027-005-00-0

233-334-2

10124-43-3

048-006-00-2

232-222-0

7790-79-6

601-048-00-0

205-923-4

218-01-9

601-049-00-6

205-892-7

192-97-2

2,2'-Bioxirane; 1,2:3,4-diepoxybutane

603-060-00-1

215-979-1

1464-53-5

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

2,4-Dinitrotoluene [1]; dinitrotoluene [2]; dinitrotoluene,
technical grade

609-007-00-9

204-450-0 [1]
246-836-1 [2]

121-14-2 [1]
25321-14-6 [2]

2,6-Dinitrotoluene

Hydrazine-tri-nitromethane

Azobenzene

609-049-00-8

210-106-0

606-20-2

609-053-00-X

414-850-9

—

611-001-00-6

203-102-5

103-33-3

o-Dianisidine based azo dyes; 4,4'-diarylazo-3,3'-dimethoxy-
biphenyl dyes with the exception of
those mentioned
elsewhere in Annex I to Directive 67/548/EEC

611-029-00-9

o-Tolidine based dyes; 4,4'-diarylazo-3,3'-dimethylbiphenyl
dyes, with the exception of those mentioned elsewhere in
Annex I to Directive 67/548/EEC

611-030-00-4

—

—

—

—

1,4,5,8-Tetraaminoanthraquinone; C.I. Disperse Blue 1

611-032-00-5

219-603-7

2475-45-8

Point 30 — Mutagens: category 2

Substances

Index number

EC number

CAS number

Cadmium fluoride

Cadmium chloride

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

2,2'-Bioxirane; 1,2:3,4-diepoxybutane

603-060-00-1

215-979-1

1464-53-5

Point 31 — Toxic to reproduction: category 2

Substances

Index number

EC number

CAS number

Cadmium fluoride

Cadmium chloride

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

2-Methoxypropanol

603-106-00-0

216-455-5

1589-47-5

4,4'-isobutylethylidenediphenol; 2,2-bis
(4'-hydroxyphenyl)-4-methylpentane

604-024-00-8

401-720-1

6807-17-6

2-Methoxypropyl acetate

607-251-00-0

274-724-2

70657-70-4

Tridemorph (ISO); 2,6-dimethyl-4-tridecylmorpholine

613-020-00-5

246-347-3

24602-86-6

Cycloheximide

613-140-00-8

200-636-0

66-81-9

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 14 May 2001, the Commission presented a proposal for a European Parliament and Council
Directive amending for the 23rd 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 — CMR) (1).

The proposal is based on Article 95 of the Treaty.

2. The European Parliament adopted its opinion at first reading on 5 February 2002 (2).

3. The Economic and Social Committee delivered its opinion on 12 September 2001 (3).

4. On 3 June 2002, the Council adopted its common position in accordance with Article 251 of the

Treaty.

II. AIM

The aim of the Commission's proposal
is to add to Annex I to Directive 76/769/EEC a list of
substances classified as category 1 or 2 carcinogens, mutagens or substances toxic to reproduction.
The proposal stipulates that these substances may not be used in substances and preparations placed on
the market for sale to the general public.

III. ANALYSIS OF THE COMMON POSITION

1. The Council has been examining the proposal since the middle of 2001. The Council's common

position is identical to the Commission's proposal.

2. On 5 February 2002, the European Parliament adopted 2 amendments, proposing to extend the
restrictions to products and requesting the Commission to present proposals to this effect before
30 June 2002.

3. In general, the Council shares the concern of the European Parliament in relation to CMR substances
in products. However, the Council cannot agree to an extension of the scope of application of the
Directive as proposed by the Parliament without basing it on scientific evaluation or a risk
assessment. According to the current legislative framework, it is for the Member States and the
Commission to determine, on the basis of a risk assessment, whether substances and preparations
and products containing them pose a risk to public health or the environment. In this respect, it
should be recalled that a very high number of CMR substances exists and that these are contained in
an indefinite number of products. A product-based approach to CMR substances would thus, under
the current legislative framework, be impossible to apply in practice.

Furthermore the Council considers that the proposed restrictions on certain CMR substances and
preparations containing them provide adequate measures to limit the use of those CMR substances,
and that these measures should be adopted without delay. Consequently, the Council cannot endorse
the two amendments by the Parliament and has rejected them.

IV. CONCLUSION

The Council considers that the measures foreseen in the common position offer a balanced solution
based on the Community risk assessment procedure, ensuring a high level of health and consumer
protection.

(1) OJ C 213 E, 31.7.2001, p. 263.
(2) Not yet published in the Official Journal.
(3) OJ C 311, 7.11.2001, p. 7.

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Further, the Council recalls the Council Conclusions on the Strategy for a Future Chemical Policy
adopted on 7/8 June 2001, in particular points 9 and 19 of these, where the Council:

— ‘Reaffirms its commitment to the development of a new chemicals policy and a new Community
system for the management of chemicals (substances and preparations) including how the issue of
chemicals in products will be addressed in legislation’;

and

— ‘Recognises that there is a need to shift to industry, including downstream users, the responsibility
to generate knowledge about chemical substances and to assess and manage the risks arising from
their use, enabling the authorities to focus on chemicals of highest priority’.

It is the view of the Council that the envisaged measures in the new chemicals policy will considerably
improve the effectiveness of the management of risks relating to dangerous substances, including CMR
substances, in products.