Directive 2001/41/EC of the European Parliament and of the Council of 19 June 2001 amending, for the twenty-first 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, as regards substances classified as carcinogens, mutagens or substances toxic to reproduction
Date: 2001-06-19
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, carcinogenic substance, dangerous substance, marketing restriction, public health, toxic substance

L 194/36

EN

Official Journal of the European Communities

18.7.2001

DIRECTIVE 2001/41/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 19 June 2001

amending, for the twenty-first 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, as regards substances
classified as carcinogens, mutagens or substances toxic to reproduction

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),

(6)

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)

(2)

(3)

(4)

(5)

Article 14 of the Treaty provides for the establishment
of an area without internal frontiers in which the free
movement of goods, persons, services and capital
is
ensured.

On 29 March 1996 the European Parliament and the
Council adopted Decision 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).

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
fourteenth time Directive 76/769/EEC (5) establishes, in
the form of an Appendix concerning points 29, 30 and
to Directive 76/769/EEC (6), a list
31 of Annex I
containing substances classified as carcinogenic, muta-
genic or toxic to reproduction in category 1 or 2. Such
substances and preparations 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 relating to the classification, packaging and label-
ling of
substances (7), which contains
substances classified as carcinogenic, mutagenic or toxic
to reproduction in category 1 or 2.

dangerous

the

Commission Directive 97/69/EC of 5 December 1997
adapting for
twenty-third time Directive 67/
548/EEC, and more particularly Annex I thereto, to tech-
nical progress, contains one substance newly classified as
carcinogenic in category 2 and Commission Directive
98/73/EC (8) of 18 September 1998 adapting for the
twenty-fourth time Directive 67/548/EEC (9), and more
to technical progress,
particularly Annex 1 thereto,
contains one substance newly classified as carcinogenic
in category 2 and one substance newly classified as toxic
to reproduction in category 2. These substances should
be added to the Appendix concerning points 29 and 31
of Annex I to Directive 76/769/EEC.

The risks and advantages of the substances newly classi-
fied, by Directives 97/69/EC and 98/73/EC, as carcino-
genic in category 2 or toxic to reproduction in category
2 have been taken into account.

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 (10), and individual directives
in particular Council Directive 90/
based thereon,
394/EEC of 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) (11),

(7)

(8)

HAVE ADOPTED THIS DIRECTIVE:

Article 1

(1) OJ C 116 E, 26.4.2000, p. 54.
(2) OJ C 140, 18.5.2000, p. 1.
(3) 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.
(4) OJ L 95, 16.4.1996, p. 9.
(5) OJ L 365, 31.12.1994, p. 1.
(6) OJ L 262, 27.9.1976, p. 201. Directive as

last amended by

Commission Directive 1999/77/EC (OJ L 207, 6.8.1999, p. 18).

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

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

sion Directive 2000/33/EC (OJ L 136, 8.6.2000, p. 90).

(8) OJ L 343, 13.12.1997, p. 19.
(9) OJ L 305, 16.11.1998, 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 Council

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

18.7.2001

EN

Official Journal of the European Communities

L 194/37

1. In the introduction, the Note R below shall be added:

‘Note R:
The classification as a carcinogen need not apply to fibres
with a length weighted geometric mean diameter, less two
standard errors, greater than 6µm.’

2. The substances listed in the Annex to this Directive shall be
added to those substances listed in the Appendix concerning
points 29 and 31.

Article 2

1.
The Member States shall adopt and publish the laws,
regulations and administrative provisions necessary to comply
with this Directive not later than 18 July 2002. They shall
forthwith inform the Commission thereof.

They shall apply those provisions from 18 January 2003.

2. When Member States adopt those provisions, they shall
contain a reference to this Directive or be accompanied by
such 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 day following that
of its publication in the Official Journal of the European Communi-
ties.

Article 4

This Directive is addressed to the Member States.

Done at Luxembourg, 19 June 2001.

For the European Parliament

For the Council

The President

N. FONTAINE

The President

M. WINBERG

ANNEX

Point 29 — Carcinogens: category 2

Substances

Index number

EC number

CAS number

Notes

4-chloraniline

612-137-00-9

203-401-0

106-47-8

those specified elsewhere in Annex I

Refractory ceramic fibres; Special Purpose Fibres, with the
to
exception of
Directive 67/548/EEC; [Man-made vitreous (silicate)
fibres
with random orientation with alkaline oxide and alkali earth
oxide (Na
less or
O + K
2
equal to 18 % by weight]

O + CaO + MgO + BaO) content
2

650-017-00-8

R

Point 31 — Toxic to reproduction: category 2

Substances

Index number

EC number

CAS nummer

Notes

6-(2-chloroethyl)-6(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-
silaundecane; etacelasil

014-014-00-X

253-704-7

37894-46-5