Common Position (EC) No 8/2003 of 21 January 2003 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 Decision 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) (Text with EEA relevance)
Date: 2003-01-21
Institutions: Council of the European Union
Subjects: approximation of laws, carcinogenic substance, consumer protection, dangerous substance, marketing restriction, reprography, toxic substance

C 64 E/6

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Official Journal of the European Union

18.3.2003

COMMON POSITION (EC) No 8/2003

adopted by the Council on 21 January 2003

with a view to adopting Directive 2002/. . ./EC of the European Parliament and of the Council of
. . . 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)

(2003/C 64 E/02)

(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 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) Council Directive 76/769/EEC (4) 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) (5).

(3) 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.

(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 (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.

(5) Directive 94/60/EC envisaged that the said list would be
extended shortly after publication of an adaptation to
to Council Directive
technical progress of Annex I
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 carci-
nogenic, mutagenic or toxic to reproduction of category
1 or 2.

for

(6) Commission Directive 2001/59/EC (8) which adapted to
technical progress
the twenty-eighth time Council
Directive 67/548/EEC, and more particularly Annex I
thereto, lists two substances newly classified as carcinogenic
category 1, nineteen substances newly classified as carci-
nogenic 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.

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

in the

(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
Journal), Council Common Position of
(not

published in the Official
21 January 2003 and European Parliament Decision of . . .
yet published in the Official Journal).

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

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

(6) OJ L 365, 31.12.1994, p. 1.
(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 225, 21.8.2001, p. 1.

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(9) This Directive shall apply 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 (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.

with this Directive by . . . (*). They shall forthwith inform the
Commission thereof.

They shall apply those provisions from . . . (**).

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 publi-
cation. 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 publi-
cation in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at . . .

Article 2

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply

For the European Parliament

For the Council

The President

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 Council

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

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

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

ANNEX

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

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

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

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-me-
thyl-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

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

E

E

E

E

E

E

E

E

E

E

E

E

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Official Journal of the European Union

C 64 E/9

Substances

Index number

EC number

CAS number

Notes

Trisodium-[4'-(8-acetylamino-3,6-disulfona-
to-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

—

A mixture of: N-[3-hydroxy-2-(2-methyla-
cryloylamino-methoxy)propoxymethyl]-
2-methylacrylamide;
N-[2,3-Bis-(2-methylacryloylamino-
methoxy)propoxymethyl]-2-methylacryla-
mide;
Methacrylamide;
2-Methyl-N-(2-methyl-acryloylaminome-
thoxymethyl)-acrylamide;
N-(2,3-Dihydroxypropoxymethyl)-2-me-
thylacrylamide

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

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]

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

CE number

CAS number

Notes

Sodium chromate

024-018-00-3

231-889-5

7775-11-3

E

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

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

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

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

Notes

C, S

D

E

E

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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

CE 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

CE number

CAS number

Notes

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

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

014-017-00-6

—

85509-19-9

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

603-143-00-2

404-660-4

57044-25-4

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

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

Dibutyl phthalate;
DBP

(±) Tetrahydrofurfuryl (R)-2-[4-(6-chloro-
quinoxalin-2-yloxy)phenyloxy]propionate

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

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

607-317-00-9

204-211-0

117-81-7

607-318-00-4

201-557-4

84-74-2

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

616-052-00-8

200-842-0

75-12-7

N-Methylacetamide

616-053-00-3

201-182-6

79-16-3

N-Methylformamide

616-056-00-X

204-624-6

123-39-7

E

E

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 12 February 2002, the Commission presented a proposal for a European Parliament and Council
Directive amending for the 25th 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 11 June 2002 (2).

3. The Economic and Social Committee delivered its Opinion on 29 May 2002 (3)

4. On 21 January 2003, 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 of 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 spring 2002. The Council's Common Position is

in substance identical to the Commission's proposal.

2. On 11 June 2002, the European Parliament adopted 5 amendments, proposing to extend the
restrictions to articles and requesting the Commission to present proposals to this effect by the
end of 2002. In addition, the Parliament proposed to end the exemption for CMR substances in
cosmetics.

3. As concerns amendments 5 and 3 + 6, second part, the Council, in general, shares the concern of the
European Parliament in relation to CMR substances in articles/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 articles 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
these amendments by the Parliament and has rejected them.

(1) OJ C 126 E, 28.5.2002, p. 398.
(2) OJ: not yet published.
(3) OJ C 221, 17.9.2002, p. 8.

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Finally, it should be noted that the issue of chemicals in products will be adressed in the context of
the development of a new chemicals policy. It is the view of the Council that the envisaged
measures
the
in the new chemicals policy will considerably improve the effectiveness of
management of risks relating to dangerous substances, including CMR substances in articles.

4. In relation to amendments 1, 2 and 3 + 6, first part, the Council agrees with the aim of the Parliament
of ensuring that the CMR substances restricted under the Dangerous Substances Directive should be
subject to the same restrictions in cosmetic products. However, the Council is of the opinion that
CMR substances in cosmetics should be dealt with in the framework of the Cosmetics Directive
(Directive 76/768/EEC) and therefore cannot accept the amendments proposed by the Parliament.

It should be recalled that in the context of the 7th amendment of the Cosmetics Directive, the
Parliament and the Council have, subject to final approval, agreed that all CMR substances, category
1 and 2, should be banned.