Proposal for a Directive of the European Parliament and of the Council amending, for the twenty-fifth 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)
Date: 2002-02-12
Institutions: European Commission
Subjects: approximation of laws, carcinogenic substance, consumer protection, dangerous substance, domestic market, marketing standard, toxic substance

C 126 E/398

EN

Official Journal of the European Communities

28.5.2002

Proposal for a Directive of the European Parliament and of the Council amending, for the
twenty-fifth 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)

(2002/C 126 E/18)

(Text with EEA relevance)

COM(2002) 70 final — 2002/0040(COD)

(Submitted by the Commission on 12 February 2002)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF
THE EUROPEAN UNION,

reproduction and preparations containing them should not
be placed on the market for use by the general public.

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

Having regard to the proposal from the Commission,

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

Acting in accordance with the procedure laid down in Article
251 of the Treaty (1),

Whereas:

(1) Council Directive 76/769/EEC (2) lays down restrictions on
the marketing and use of certain dangerous substances and
preparations.

(2) 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) (3), which has been extended until the end of 2002
by Decision No 521/2001/EC.

(3) In order to improve health protection and consumer safety,
substances classified as carcinogenic, mutagenic or toxic to

(1) Opinion of the European Parliament of 14 November 2000 (not yet
published in the Official
Journal), Council Common Position of
12 March 2001 (OJ C 142, 15.5.2001, p. 1) and European
Parliament Decision of 16 May 2001.

(2) OJ L 262, 27.9.1976, p. 201. Directive as last amended by
Commission Directive 2001/91/EC (OJ L 286, 29.10.2001, p. 27).
(3) OJ L 95, 16.4.1996, p. 9. Decision as amended by Decision

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

(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 (4) 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 should
not be placed on the market for use by the general public.

(5) 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 relating to the classification,
packaging and labelling of dangerous substances, which
contains substances classified as carcinogenic, mutagenic
or toxic to reproduction of category 1 or 2 (5).

(6) Commission Directive 2001/59/EC, which was adopted on
6 August 2001 and adapted to technical progress for the
and more
twenty-eighth time Directive 67/548/EEC,
particularly Annex I
two substances
newly classified as carcinogenic category 1, nineteen
substances newly classified as carcinogenic category 2,
five substances newly classified as mutagenic category 2,
one substance newly classified as toxic to reproduction
category 1 and sixteen substances newly classified as
toxic to reproduction category 2.

thereto, contains

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

in the

(8) The risks and advantages of the substances newly classified,
by Commission Directive 2001/59/EC, as carcinogenic,
mutagenic and toxic to reproduction of category 1 or 2
have been taken into account.

(4) OJ L 365, 31.12.1994, p. 1.
(5) OJ L 196, 16.8.1967, p. 1. Directive as

last amended by

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

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Official Journal of the European Communities

C 126 E/399

(9) 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 the 28 June 1990 on the protection of workers from the
risks related to exposure to carcinogens at work (Sixth
individual Directive within the meaning of Article 16(1)
of Directive 89/391/EEC) (2),

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.

Article 2

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive no later than 31 December 2002 [nine
its entry into force]. They shall
months after the date of
forthwith inform the Commission thereof.

They shall apply those provisions from 31 March 2003 [twelve
months after the date of the entry into force of this Directive].

2. When Member States adopt these 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
made.

Article 3

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

(1) OJ L 183, 29.6.1989, p. 1.
(2) 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).

Article 4

This Directive is addressed to the Member States.

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

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

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

1,3-Butadiene;
Buta-1,3-diene

601-004-01-8 203-448-7 [1]

106-97-8 [1]

200-857-2 [2]

75-28-5 [2]

Notes

C, S

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

Sodium chromate

Trichloroethylene;
Trichloroethene

α-Chlorotoluene;
Benzyl chloride

004-003-00-8

215-133-1

1304-56-9

024-018-00-3

231-889-5

7775-11-3

602-027-00-9

201-167-4

79-01-6

602-037-00-3

202-853-6

100-44-7

E

E

E

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Official Journal of the European Communities

28.5.2002

Substances

Index number

EC number

CAS number

Notes

E

E

E

E

E

E

E

E

E

2,3-Dibromopropan-1-ol;
2,3-Dibromo-1-propanol

Propylene oxide;
1,2-Epoxypropane;
Methyloxirane

Phenyl glycidyl ether;
2,3-Epoxypropyl phenyl ether;
1,2-Epoxy-3-phenoxypropane

602-088-00-1

202-480-9

96-13-9

603-055-00-4

200-879-2

75-56-9

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

3,4-Dinitrotoluene

3,5-Dinitrotoluene

2,5-Dinitrotoluene

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)-ammonium]
formate

Trisodium-[4'-(8-acetylamino-3,6-disulfonato-
2-naphthylazo)-4''-(6-benzoylamino-
3-sulfonato-2-naphthylazo)biphenyl-
1,3',3'',1'''-tetraolato-O, O', O'', O''']copper(II)

609-050-00-3

210-013-5

602-01-7

609-051-00-9

210-222-1

610-39-9

609-052-00-4

210-566-2

618-85-9

609-055-00-0

210-581-4

619-15-8

611-057-00-1

400-340-3

85136-74-9

611-058-00-7

402-060-7

108225-03-2

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

—

A mixture of: N-[3-hydroxy-2-(2-methylacry-
loylamino-methoxy)propoxymethyl]-2-methyl-
acrylamide;
N-[2,3-Bis-(2-methylacryloylamino-methoxy)
propoxymethyl]-2-methylacrylamide;
Methacrylamide;
2-Methyl-N-(2-methyl-acryloylaminomethoxy-
methyl)-acrylamide;
N-(2,3-Dihydroxypropoxymethyl)-2-methyl-
acrylamide

(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]

601-004-01-8 203-448-7 [1]

106-97-8 [1]

C, S

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

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

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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]

1,3-Butadiene
Buta-1,3-diene

Propylene oxide;
1,2-Epoxypropane;
Methyloxirane

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

200-857-2 [2]

75-28-5 [2]

601-013-00-X

203-450-8

106-99-0

603-055-00-4

200-879-2

75-56-9

D

E

E

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

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

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

Substances

Index number

EC number

CAS number

Notes

Flusilazole (ISO);
Bis(4-fluorophenyl)-(methyl)-(1H-1,2,4-triazol-
1-ylmethyl)-silane

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

014-017-00-6

—

85509-19-9

014-019-00-7

403-250-2

—

E

E

Bis(2-methoxyethyl) ether

603-139-00-0

203-924-4

111-96-6

R-2,3-Epoxy-1-propanol

603-143-00-2

404-660-4

57044-25-4

E

Fluazifop-butyl (ISO);
Butyl (RS)-2-[4-(5-trifluoromethyl-
2-pyridyloxy)phenoxy]propionate

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

Methoxyacetic acid

607-312-00-1

210-894-6

625-45-6

E

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

Dibutyl phthalate;
DBP

607-317-00-9

204-211-0

117-81-7

607-318-00-4

201-557-4

84-74-2

(±) Tetrahydrofurfuryl (R)-2-[4-(6-chloroquin-
oxalin-2-yloxy)phenyloxy]propionate

607-373-00-4

414-200-4

119738-06-6

E

C 126 E/402

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Official Journal of the European Communities

28.5.2002

Substances

Index number

EC number

CAS number

Notes

Flumioxazin (ISO);
N-(7-Fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-
2H-1,4-benzoxazin-6-yl)cyclohex-
1-ene-1,2-dicarboxamide

613-166-00-X

—

103361-09-7

(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophe-
nyl)-[(1H-1,2,4-triazol-1-yl)-methyl]oxirane

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