Common Position (EC) No 17/2001 of 12 March 2001 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 Directive of the European Parliament and of the Council amending for the 21st 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)
Date: 2001-03-12
Institutions: Council of the European Union
Subjects: approximation of laws, carcinogenic substance, dangerous substance, marketing restriction, public health

15.5.2001

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Official Journal of the European Communities

C 142/1

I

(Information)

COUNCIL

COMMON POSITION (EC) No 17/2001

adopted by the Council on 12 March 2001

with a view to adopting Directive 2001/(cid:133)/EC of the European Parliament and of the Council
amending for the 21st time Council Directive 76/769/EEC of (cid:133) 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)

(2001/C 142/01)

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),

(4)

Having regard to the opinion of
Committee (2),

the Economic and Social

Acting in accordance with the procedure laid down in Article
251 of the Treaty (3),

Whereas:

(1)

(2)

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).

(3)

In order to improve health protection and consumer
safety, substances classified as carcinogenic, mutagenic

(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 and European Parliament Decision of (cid:133) (not yet
published in the Official Journal).

(4) OJ L 95, 16.4.1996, p. 9.

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
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.

substances

classified

as

Directive 94/60/EC provides that the Commission will
to the European Parliament and Council a
submit
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
labelling of dangerous substances (7), which contains
substances classified as carcinogenic, mutagenic or toxic
to reproduction of category 1 or 2.

Commission Directive 97/69/EC of 5 December 1997
Directive
adapting

twenty-third

time

the

for

(5)

(6)

(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).
(7) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

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

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Official Journal of the European Communities

15.5.2001

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

1.

In the introduction, the note R below shall be added:

(cid:145)R. The classification as a carcinogen need not apply to
fibres with a length weighted geometric mean diameter less
than two standard errors greater than 6 lm(cid:146).

2. The substances listed in the Annex to this Directive shall
listed in the Appendix

be added to those substances
concerning points 29 and 31.

Article 2

The risks and advantages of
the substances newly
classified, by Directives 97/69/EC and 98/73/EC, as
carcinogenic to category 2 or toxic to reproduction of
category 2 have been taken into account.

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

later than (*). They shall

(7)

(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 (3), and individual directives
based
Council Directive
particular
90/394/EEC of 28 June 1990 on the protection of
workers
to
carcinogens at work (sixth individual Directive within
Directive
the meaning
89/391/EEC (4),

related to exposure

from the

thereon,

Article

16(1)

risks

of

of

in

HAVE ADOPTED THIS DIRECTIVE:

Article 1

They shall apply those provisions from (cid:133) (**).

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
publication in the Official Journal of the European Communities.

into force on the day of

its

Article 4

This Directive is addressed to the Member States.

Done at (cid:133)

For the European Parliament

For the Council

The President

Annex I to Directive 76/769/EEC shall be amended as follows.

The President

(1) OJ L 343, 13.12.1997, p. 19.
(2) OJ L 305, 16.11.1998, p. 1.
(3) OJ L 183, 29.6.1989, p. 1.
(4) OJ L 196, 26.7.1990, p. 1. Directive as last amended by Directive

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

from the date of entry into force of

this

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

Directive.

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ANNEX

Point 29 (cid:151) Carcinogens: category 2

Name of substance

Index number

EC number

CAS number

Notes

4-chloroanilin

612-137-00-9

203-401-0

106-47-8

Refractory ceramic fibres; special purpose fibres,
with the exception of those specified elsewhere in
Annex I
[man-made
to Directive 67/548/EEC;
vitreous (silicate) fibres with random orientation
with alkaline oxide and alkali earth oxide (Na2O+
K2O+CaO+ MgO+BaO) content less or equal to
18 % by weight]

650-017-00-8

R

Point 31 (cid:151) Toxic to reproduction: category 2

Name of substance

Index number

EC number

CAS number

6-(2-Chlorethyl)-6(2-methoxyethoxy)-2,5,7,10-tetraoxa-
6-silaundecan; etacelasil

014-014-00-X

253-704-7

37894-46-5

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STATEMENT OF THE COUNCIL’S REASONS

I.

INTRODUCTION

1. On 6 January 2000 the Commission presented a proposal (1) for a European Parliament and
time Council Directive 76/769/EEC relating to
substances and preparations

Council Directive amending for
restrictions on the marketing and use of certain dangerous
(substances classified as carcinogens, mutagens or substances toxic to reproduction).

the 21st

The proposal is based on Article 95 of the Treaty.

2. The European Parliament approved the Commission proposal on 14 November 2000 (2).

The Economic and Social Committee delivered its opinion on 10 October 2000 (3).

3. On 12 March 2001, the Council adopted its Common Position in accordance with Article 251 of

the Treaty.

II. OBJECTIVE

4. The objective is to add to Annex I to 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

5. For reasons of clarity, the Council felt compelled to introduce an amendment specifying that the
classification as a carcinogen need not apply to fibres with a length weighted geometric mean
diameter less two standard errors greater than 6 microns.

The Council also agreed, for reasons of clarity, to add to the list the full identification of refractory
ceramic fibres.

IV. CONCLUSION

6. The Council feels that the suggested amendments are faithful to the intention of the Commission’s

proposal, which has been approved by the European Parliament.

(1) OJ C 116 E, 26.4.2000, p. 54.
(2) OJ C (cid:133).
(3) OJ C 140, 15.5.2000, p. 1.