Proposal for a Directive of the European Parliament and of the Council 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)
Date: 2001-05-14
Institutions: European Commission
Subjects: carcinogenic substance, dangerous substance, health policy, marketing restriction, public health, reprography, toxic substance

31.7.2001

EN

Official Journal of the European Communities

C 213 E/263

Proposal for a Directive of the European Parliament and of the Council 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 (cid:151) c/m/r)

(2001/C 213 E/14)

(Text with EEA relevance)

COM(2001) 256 final (cid:151) 2001/0110(COD)

(Submitted by the Commission on 14 May 2001)

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,

Having regard to the opinion of
Committee,

the Economic and Social

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

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) The European Parliament and the Council adopted on
29 March 1996 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) (1).

(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 (2) establishes, in the form of an

Appendix concerning points 29, 30 and 31 of Annex I to
Directive 76/769/EEC (3),
containing substances
a
classified as carcinogenic, mutagenic or toxic to repro-
duction of category 1 or 2. Such substances and prep-
arations 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
a
and Council
submit
proposal
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
relating to the classification, packaging and labelling of
substances
dangerous
classified as carcinogenic, mutagenic or toxic to repro-
duction of category 1 or 2.

substances (4), which

contains

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 (5), and more particularly
to technical progress, contains 20
Annex I
substances newly classified as carcinogenic, mutagenic or
toxic to reproduction category 1 or 2, and Commission
Directive 2000/32/EC of 19 May 2000 adapting to
the twenty-sixth time Council
technical progress
Directive 67/548/EEC (6), and more particularly Annex I
thereto,
contains 2 substances
newly classified as carcinogenic, mutagenic or toxic to
reproduction 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.

to technical progress,

for

(7) The risks and advantages of the substances newly classified,
by Directives 98/98/EC and 2000/32/EC, as carcinogenic,
mutagenic and toxic to reproduction of category 1 or 2
have been taken into account.

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

Directive 99/77/EC (OJ L 207, 6.8.1999, p. 18).

the laws,

(4) Council Directive 67/548/EEC of 27 June 1967 on the approxi-
mation of
regulations and administrative provisions
relating to the classification, packaging and labelling of dangerous
substances (OJ L 196, 16.8.1967, p. 1). Directive as last amended by
Directive 99/33/EC of
the European Parliament and Council of
10 May 1999 (OJ L 199, 30.7.1999, p. 57).

(1) OJ L 95, 16.4.1996, p. 9.
(2) OJ L 365, 31.12.1994, p. 1.

(5) OJ L 355, 30.12.1998, p. 1.
(6) OJ L 136, 8.6.2000, p. 1.

C 213 E/264

EN

Official Journal of the European Communities

31.7.2001

(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:

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.

Article 2

after the date of its entry into force]. They shall forthwith
inform the Commission thereof.

They shall apply those provisions from 1 January 2003 [18
months after the date of the entry into force of this Directive].

2. When Member States adopt those provisions, they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
Member States shall determine how such reference is to be
made.

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.

1. Member States shall adopt and publish the laws, regu-
lations and administrative provisions necessary to comply
with this Directive no later than 31 July 2002 [one year

Article 4

This Directive is addressed to the Member States.

(1) OJ L 183, 29.6.1989, p. 1.
(2) OJ L 196, 26.7.1990, p. 1.

31.7.2001

EN

Official Journal of the European Communities

C 213 E/265

Point 29 (cid:151) Carcinogens: category 2

ANNEX

Cobalt dichloride

Cobalt sulphate

Cadmium fluoride

Chrysene

Benzo[e]pyrene

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]; dinitro-
toluene, 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

609-049-00-8

210-106-0

606-20-2

Hydrazine-tri-nitromethane

609-053-00-X

414-850-9

(cid:151)

Azobenzene

611-001-00-6

203-102-5

103-33-3

based

dyes; 4,4’-diarylazo-
azo
o-Dianisidine
3,3’-dimethoxybiphenyl dyes with the exception
of
to
those mentioned elsewhere in Annex I
Directive 67/548

611-029-00-9

o-Tolidine based
biphenyl dyes, with the exception of
elsewhere in Annex I to Directive 67/548

dyes; 4,4’-diarylazo-3,3’-dimethyl-
those mentioned

611-030-00-4

(cid:151)

(cid:151)

(cid:151)

(cid:151)

1,4,5,8-Tetraaminoanthraquinone;
Blue 1

C.I. Disperse

611-032-00-5

219-603-7

2475-45-8

Point 30 (cid:151) 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 (cid:151) 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

2-Methoxypropanol

603-106-00-0

216-455-5

4,4’-isobutylethylidenediphenol; 2,2-bis
droxyphenyl)-4-methylpentane

(4’-hy-

604-024-00-8

401-720-1

556-52-5

1589-47-5

6807-17-6

2-Methoxypropyl acetate

607-251-00-0

274-724-2

70657-70-4

Tridemorph (ISO); 2,6-dimethyl-4-tridecylmor-
pholine

613-020-00-5

246-347-3

24602-86-6

Cycloheximide

613-140-00-8

200-636-0

66-81-9