Directive 2003/36/EC of the European Parliament and of the Council of 26 May 2003 amending, for the 25th time, Council 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 (substances classified as carcinogens, mutagens or substances toxic to reproduction — c/m/r) (Text with EEA relevance)
Date: 2003-05-26
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, carcinogenic substance, consumer protection, dangerous substance, labelling, marketing restriction, public health, toxic substance

L 156/26

EN

Official Journal of the European Union

25.6.2003

DIRECTIVE 2003/36/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 26 May 2003

amending, for the 25th time, Council 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 (substances classified as carci-
nogens, mutagens or substances toxic to reproduction — c/m/r)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,

(5)

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),

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),

(6)

Whereas:

(1)

(2)

(3)

(4)

Council Directive 76/769/EEC (4), lays down restrictions
on the marketing and use of
certain dangerous
substances and preparations.

The measures provided for in this Directive fall within
the framework of the action plan in Decision No 646/
96/EC of the European Parliament and of the Council of
29 March 1996 adopting an action plan to combat
cancer within the framework for action in the field of
public health (1996 to 2000) (5).

In order 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 (6), establishes,
in the
form of an appendix concerning points 29, 30 and 31
of Annex I to Directive 76/769/EEC, a list containing
substances classified as carcinogenic, mutagenic or toxic
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.

(1) OJ C 126 E, 28.5.2002, p. 398.
(2) OJ C 221, 17.9.2002, p. 8.
(3) Opinion of the European Parliament of 11 June 2002 (not yet
published in the Official Journal), Council Common Position of 21
January 2003 (OJ C 64 E, 18.3.2003, p. 6) and European Parliament
Decision of 10 April 2003 (not yet published in the Official
Journal).

(4) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Commis-

sion Directive 2002/62/EC (OJ L 183, 12.7.2002, p. 58).

(5) OJ L 95, 16.4.1996, p. 9. Decision repealed on 31 December 2002

by Decision No 1786/2002/EC (OJ L 271, 9.10.2002, p. 1).

(6) OJ L 365, 31.12.1994, p. 1.

Directive 94/60/EC envisaged that the said list would be
extended shortly 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 laws,
regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous
substances (7), which lists substances classified as carcino-
genic, mutagenic or toxic to reproduction of category 1
or 2.

Commission Directive 2001/59/EC (8), which adapted to
technical progress for the 28th time Council Directive
67/548/EEC, and more particularly Annex I thereto, lists
two substances newly classified as carcinogenic category
1, 19 substances newly classified as carcinogenic cate-
gory 2, five substances newly classified as mutagenic
category 2, one substance newly classified as toxic to
reproduction category 1 and 16 substances newly classi-
fied as toxic to reproduction category 2.

(7)

Those substances should be added to the list in the
appendix to Annex I to Directive 76/769/EEC.

(8)

(9)

The risks and advantages of the substances newly classi-
fied, by Directive 2001/59/EC, as carcinogenic, muta-
genic and toxic to reproduction of category 1 or 2 have
been taken into account.

This Directive shall 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 (9), 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 (10),

(7) OJ L 196, 16.8.1967, p. 1. Directive as last amended by Commis-

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

(8) OJ L 225, 21.8.2001, p. 1.
(9) OJ L 183, 29.6.1989, p. 1.
(10) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Council

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

25.6.2003

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Official Journal of the European Union

L 156/27

HAVE ADOPTED THIS DIRECTIVE:

Article 1

The substances listed in the Annex to this Directive shall be
added to those substances listed in the appendix concerning
points 29, 30 and 31 of Annex I to Directive 76/769/EEC. The
substances listed in the Annex to this Directive in point 1(c)
shall be deleted from list 2 of point 29 of Annex I to Directive
76/769/EEC.

2. When Member States adopt these measures, they shall
contain a reference to this Directive or shall 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 day of its publica-
tion in the Official Journal of the European Union.

This Directive is addressed to the Member States.

Article 4

Article 2

1. Member States shall adopt and publish the laws, regula-
tions and administrative provisions necessary to comply with
this Directive by 25 June 2004. They shall forthwith inform
the Commission thereof.

They shall apply those provisions from 25 December 2004.

Done at Brussels, 26 May 2003.

For the European Parliament

The President

P. COX

For the Council

The President

G. DRYS

L 156/28

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Official Journal of the European Union

25.6.2003

ANNEX

The Appendix to Annex I to Directive 76/769/EEC is amended as follows:

1. the lists under the heading ‘Point 29 — Carcinogens’ are amended as follows:

(a) in the list for category 1, the following are added:

Substances

Index number

EC number

CAS number

Notes

Butane [containing ≥0,1 % Butadiene (203-
450-8)] [1]

Isobutane
(203-450-8)] [2]

[containing ≥0,1 % Butadiene

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

200-857-2 [2]

75-28-5 [2]

1,3-Butadiene; buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

(b) in the list for category 2, the following are added:

Substances

Index number

EC number

CAS number

Notes

Beryllium oxide

004-003-00-8

215-133-1

1304-56-9

Sodium chromate

024-018-00-3

231-889-5

7775-11-3

Trichloroethylene; trichloroethene

602-027-00-9

201-167-4

79-01-6

α-Chlorotoluene; benzyl chloride

602-037-00-3

202-853-6

100-44-7

2,3-dibromopropan-1-ol;
propanol

2,3-dibromo-1-

602-088-00-1

202-480-9

96-13-9

Propylene oxide; 1,2-epoxypropane; methy-
loxirane

603-055-00-4

200-879-2

75-56-9

Phenyl
ether; 2,3-epoxypropyl
phenyl ether; 1,2-epoxy-3-phenoxypropane

glycidyl

603-067-00-X

204-557-2

122-60-1

Furan

603-105-00-5

203-727-3

110-00-9

R-2,3-epoxy-1-propanol

603-143-00-2

404-660-4

57044-25-4

(R)-1-chloro-2,3-epoxypropane

603-166-00-8

424-280-2

51594-55-9

2,3-dinitrotoluene

609-050-00-3

210-013-5

602-01-7

3,4-dinitrotoluene

609-051-00-9

210-222-1

610-39-9

3,5-dinitrotoluene

609-052-00-4

210-566-2

618-85-9

2,5-dinitrotoluene

609-055-00-0

210-581-4

619-15-8

6-hydroxy-1-(3-isopropoxypropyl)-4-
methyl-2-oxo-5-[4-(phenylazo)phenylazo]-
1,2-dihydro-3-pyridinecarbonitrile

(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-
sulfonato-7-naphthylamino)-1,3,5-triazin-
2,4-diyl)bis[(amino-1-methylethyl)-ammo-
nium] formate

611-057-00-1

400-340-3

85136-74-9

611-058-00-7

402-060-7

108225-03-2

E

E

E

E

E

E

E

E

E

E

E

E

25.6.2003

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Official Journal of the European Union

L 156/29

Substances

Index number

EC number

CAS number

Notes

Trisodium-[4'-(8-acetylamino-3,6-disulfo-
nato-2-naphthylazo)-4''-(6-benzoylamino-3-
sulfonato-2-naphthylazo)biphenyl-
1,3',3'',1'''-tetraolato-O, O', O'', O''']cop-
per(II)

611-063-00-4

413-590-3

—

Phenylhydrazine [1]

612-023-00-9

202-873-5 [1]

100-63-0 [1]

E

Phenylhydrazinium chloride [2]

200-444-7 [2]

59-88-1 [2]

Phenylhydrazine hydrochloride [3]

248-259-0 [3]

27140-08-5 [3]

Phenylhydrazinium sulphate (2:1) [4]

257-622-2 [4]

52033-74-6 [4]

616-057-00-5

412-790-8

—

N-[2,3-Bis-(2-methyla-

A mixture of: N-[3-hydroxy-2-(2-methyla-
cryloylamino-methoxy)propoxymethyl]-2-
methylacrylamide;
cryloylamino-methoxy)propoxymethyl]-2-
methylacrylamide; methacrylamide;
2-
methyl-N-(2-methyl-acryloylaminomethoxy-
methyl)-acrylamide;
N-2,3-dihydroxypro-
poxymethyl)-2-methylacrylamide

(c) in the list for category 2, the following are deleted:

Substances

Index number

EC number

CAS number

Notes

Butane [containing ≥ 0,1% Butadiene (203-
450-8)] [1]

Isobutane
(203-450-8)] [2]

[containing ≥ 0,1% Butadiene

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C,S

200-857-2 [2]

75-28-5 [2]

1,3-Butadiene; buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

2. under the heading ‘Point 30 — Mutagens’ in the list for category 2, the following are added:

Substances

Index number

EC number

CAS number

Notes

Sodium chromate

024-018-00-3

231-889-5

7775-11-3

E

Butane [containing ≥ 0,1 % Butadiene (203-
450-8)] [1]

Isobutane [containing ≥ 0,1 % Butadiene
(203-450-8)] [2]

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

20-857-2 [2]

75-28-5 [2]

1,3-Butadiene buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

Propylene oxide; 1,2-epoxypropane; Methy-
loxirane

603-055-00-4

200-879-2

75-56-9

1,3,5-tris-[(2S and 2R)-2,3-epoxypropyl]-
1,3,5-triazine-2,4,6-(1H,3H,5H)-trione

616-091-00-0

423-400-0

59653-74-6

D

E

E

3. the lists under the heading ‘Point 31 — Toxic to reproduction’ are amended as follows:

(a) in the list for category 1, the following is added:

Substances

Index number

EC number

CAS number

Notes

2-bromopropane

602-085-00-5

200-855-1

75-26-3

E

L 156/30

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Official Journal of the European Union

25.6.2003

(b) in the list for category 2, the following are added:

Substances

Index number

EC number

CAS number

Notes

(ISO);

Flusilazole
(methyl)-(1H-1,2,4-triazol-1-ylmethyl)-
silane

bis(4-fluorophenyl)-

014-017-00-6

—

85509-19-9

of: 4-[[bis-(4-fluorophenyl)-
1-

A mixture
methylsilyl]methyl]-4H-1,2,4-triazole;
[[bis-(4-fluorophenyl)methyl-silyl]methyl]-
1H-1,2,4-triazole

014-019-00-7

403-250-2

—

Bis(2-methoxyethyl) ether

603-139-00-0

203-924-4

111-96-6

R-2,3-epoxy-1-propanol

603-143-002

404-660-4

57044-25-4

Fluazifop-butyl
(RS)-2-[4-(5-
trifluoromethyl-2-pyridyloxy)phenoxy]pro-
pionate

(ISO); butyl

Vinclozolin (ISO); N-3,5-Dichlorophenyl-5-
methyl-5-vinyl-1,3-oxazolidine-2,4-dione

607-304-00-8

274-125-6

69806-50-4

607-307-00-4

256-599-6

50471-44-8

E

E

E

Methoxyacetic acid

607-312-00-1

210-894-6

625-45-6

E

Bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl)
phthalate; DEHP

607-317-00-9

204-211-0

117-81-7

Dibutyl phthalate; DBP

607-318-00-4

201-557-4

84-74-2

tetrahydrofurfuryl

(+/-)
quinoxalin-2-yloxy)phenyloxy]propionate

(R)-2-[4-(6-chloro-

Flumioxazin
(ISO);
dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-
benzoxazin-6-yl)cyclohex-1-ene-1,2-dicar-
boxamide

N-(7-Fluoro-3,4-

(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluoro-
phenyl)-[(1H-1,2,4-triazol-1-yl)-methyl]ox-
irane

607-373-00-4

414-200-4

119738-06-6

E

613-166-00-X

—

103361-09-7

613-175-00-9

406-850-2

106325-08-0

N, N-Dimethylacetamide

616-011-00-4

204-826-4

127-19-5

Formamide

N-methylacetamide

N-methylformamide

616-052-00-8

200-842-0

75-12-7

616-053-00-3

201-182-6

79-16-3

616-056-00-X

204-624-6

123-39-7

E

E