Directive 2003/34/EC of the European Parliament and of the Council of 26 May 2003 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: 2003-05-26
Institutions: Council of the European Union, European Parliament
Subjects: carcinogenic substance, consumer protection, dangerous substance, labelling, marketing restriction, public health, toxic substance

L 156/14

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Official Journal of the European Union

25.6.2003

DIRECTIVE 2003/34/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 26 May 2003

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission (1),

(5)

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

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3), in the light of the joint text approved by
the Conciliation Committee on 17 March 2003,

Whereas:

to reproduction of category 1 or 2. Such substances and
preparations containing them 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 Council Directive 67/548/EEC of 27 June
1967 on the approximation of the laws, regulations and
administrative provisions relating to the classification,
substances (7),
packaging and labelling of dangerous
which contains substances classified as carcinogenic,
mutagenic or toxic to reproduction of category 1 or 2.

(1)

(2)

(3)

(4)

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.

(6)

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).

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. The Commission should submit as soon
as possible a proposal to prohibit the use of products
containing such substances, when there is scientific
evidence that
they are released from these products
leading to exposure of, and risk to, 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 (5) establishes,
in the
form of an Appendix concerning points 29, 30 and 31
of Annex I to Directive 76/769/EEC (6), a list containing
substances classified as carcinogenic, mutagenic or toxic

(8)

(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 (OJ C 284
E, 21.11.2002, p. 88), Council Common Position of 3 June 2002
(OJ C 197 E, 20.8.2002, p. 1) and Decision of the European Parlia-
ment of 10 October 2002 (not yet published in the Official Journal).
Decision of the European Parliament of 27 March 2003 and Council
Decision of 8 April 2003.

(4) OJ L 95, 16.4.1996, p. 9. Decision repealed by Decision No 1786/
2002/EC of the European Parliament and of the Council (OJ L 271,
9.10.2002, 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 Directive
2003/11/EC of the European Parliament and of the Council (OJ L
42, 15.2.2003, p. 45).

Commission Directive 98/98/EC of 15 December 1998
adapting to technical progress for the 25th time Council
Directive 67/548/EEC (8), which in particular adapts
Annex I thereto, 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 for the
26th time Council Directive 67/548/EEC (9), which in
particular
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.

adapts Annex

contains

thereto,

I

(7)

The risks and advantages of the substances thus newly
classified have been taken into account.

This Directive is to apply without prejudice to Commu-
nity 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 (10), and individual directives
in particular Council Directive 90/394/
based thereon,
EEC of 28 June 1990 on the protection of workers from
the risks related to exposure to carcinogens at work (11),

(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.
(10) OJ L 183, 29.6.1989, p. 1.
(11) 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).

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Official Journal of the European Union

L 156/15

HAVE ADOPTED THIS DIRECTIVE:

Article 3

Article 1

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

Article 2

1. Member States shall adopt and publish not later than 15
July 2004 the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
inform the Commission thereof.

This Directive shall enter into force on the 20th day following
that of its publication in the Official Journal of the European
Union.

Article 4

This Directive is addressed to the Member States.

They shall apply these measures from 15 January 2005.

Done at Brussels, 26 May 2003.

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.

For the European Parliament

The President

P. COX

For the Council

The President

G. DRYS

L 156/16

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Official Journal of the European Union

25.6.2003

Cobalt dichloride

Cobalt sulphate

Cadmium fluoride

Chrysene

Benzo[e]pyrene

ANNEX

Point 29 — Carcinogens: category 2

Substances

Index number

EC number

CAS number

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

601-049-00-6

205-892-7

218-01-9

192-97-2

1464-53-5

556-52-5

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

603-060-00-1

215-979-1

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

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'-dimethoxybiphenyl dyes
with the exception of those mentioned elsewhere in Annex I to Directive
67/548/EEC

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

611-029-00-9

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

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

603-063-00-8

209-128-3

603-106-00-0

216-455-5

2,2-bis

(4'-hydroxyphenyl)-4-methyl-

604-024-00-8

401-720-1

556-52-5

1589-47-5

6807-17-6

607-251-00-0

274-724-2

70657-70-4

Cadmium fluoride

Cadmium chloride

2,3-Epoxypropan-1-ol; glycidol

2-Methoxypropanol

4,4'-isobutylethylidenediphenol;
pentane

2-Methoxypropyl acetate

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