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 technical progress of Annex I to Council Directive 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 carcinogenic, mutagenic or toxic to reproduction of category 1 or 2.

(6) Commission Directive 2001/59/EC(8) which adapted to technical progress for 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 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.

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

(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.

(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(9), 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(10),

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, regulations and administrative provisions necessary to comply with this Directive by...(11). They shall forthwith inform the Commission thereof.

They shall apply those provisions from...(12).

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 publication. 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 publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at...

For the European Parliament

The President

For the Council

The President

(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 published in the Official Journal), Council Common Position of 21 January 2003 and European Parliament Decision of...(not 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).

(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.

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

(10) 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).

(11) One year after the date of entry into force of this Directive.

(12) 18 months after the date of entry into force of this Directive.

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:

>TABLE>

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

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

>TABLE>

2. Under the heading "Point 30 - Mutagens" in the list for category 2, the following are added:

>TABLE>

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:

>TABLE>

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

>TABLE>

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.

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 in the new chemicals policy will considerably improve the effectiveness of the 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.

(1) OJ C 126 E, 28.5.2002, p. 398.

(2) OJ: not yet published.

(3) OJ C 221, 17.9.2002, p. 8.