Proposal for a European Parliament and Council Directive amending for the 17th time 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 (96/C 383/01) (Text with EEA relevance) COM(96) 513 final - 96/0252 (COD)

(submitted by the Commission on 28 October 1996)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 100 (a) thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee,

Acting in accordance with the procedure referred to in Article 189 (b) of the Treaty,

Whereas measures should be adopted for the achievement of the internal market; whereas the internal market is an area without internal frontiers in which the free movement of goods, persons, services and capital is guaranteed;

Whereas work on the internal market should also gradually improve the quality of life, health protection and consumer safety; whereas the measures proposed by this Directive are in line with the Council resolution of 9 November 1989 on future priorities for relaunching consumer protection policy (1);

Whereas the Council and the Representatives of the Governments of the Member States, meeting within the Council, adopted Decision 90/238/Euratom, ECSC, EEC (2) concerning a 1990 to 1994 action plan in the context of the 'Europe against Cancer` programme; whereas the Council has decided on the continuation of this action plan by the Decision 93/362/EEC (3).

Whereas 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;

Whereas the European Parliament and Council Directive 94/60/EC (4) of 20 December 1994 amending for the 14th time Directive 76/769/EEC (5) 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 introduces a list in the form of an appendix to points 29, 30 and 31 of Annex I to Directive 76/769/EEC containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2, which may not be used in substances and preparations placed on the market for sale to the general public;

Whereas Directive 94/60/EC requires that the Commission presents to the European Parliament and Council a proposal to extend this list within six months after publication of an adaptation to technical progress of Annex I to Directive 67/548/EEC (6) containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2;

Whereas the risks and advantages of the substances newly classified as carcinogenic, mutagenic and toxic to reproduction of category 1 or 2 have been considered.

Whereas the Commission Directive 93/101/EC (7) of 11 November 1993 adapting to technical progress for the 20th time Annex I to Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and the Commission Directive 94/69/EC (8) of 19 December 1994 adapting the same Annex to technical progress for the 21st time contain over 800 substances newly classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2; whereas these substances should be added to the appendix to points 29, 30 and 31 of Annex I to Directive 76/769/EEC.

Whereas for reasons of transparency and clarity the appendix to points 29, 30 and 31 of Annex I to Directive 76/769/EEC should be replaced by a consolidated appendix to these points;

Whereas this Directive does not affect Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC (9) and individual directives based thereon, in particular Directive 90/394/EEC (10),

HAVE ADOPTED THIS DIRECTIVE:

Article 1

The appendix to points 29, 30 and 31 of Annex I to Directive 76/769/EEC is replaced by the Annex to this Directive.

Article 2

1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive no later than one year after the date of its adoption and shall forthwith inform the Commission thereof.

They shall apply these provisions as from 1 March 1999.

2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such reference to the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

Article 3

This Directive is addressed to the Member States.

(1) OJ No C 294, 23. 11. 1989, p. 1.

(2) OJ No L 137, 30. 5. 1990, p. 31.

(3) OJ No L 150, 22. 6. 1993, p. 43.

(4) OJ No L 365, 31. 12. 1994, p. 1.

(5) OJ No L 262, 27. 9. 1976, p. 201, Directive as last amended by Directive 94/60/EC (OJ No L 365, 31. 12. 1994, p. 1).

(6) OJ No 196, 16. 8. 1967, p. 1/67, Directive as last amended by Commission Directive 94/69/EC (OJ No L 381, 31. 12. 1994, p. 1).

(7) OJ No L 13, 15. 1. 1994, p. 13.

(8) OJ No L 381, 31. 12. 1994, p. 1.

(9) OJ No L 183, 29. 6. 1989, p. 1.

(10) OJ No L 196, 26. 7. 1990, p. 1.

APPENDIX

Foreword

Explanations of headings of columns

Name of the substance:

The name is the same as used for the substance in Annex I of Directive 67/548/EEC on classification, packaging and labelling of dangerous substances. Whenever possible dangerous substances are designated by their Einecs (European Inventory of Existing Commercial Chemical Substances) of Elincs (European List of Notified Chemical Substances) names. Other entries not listed in Einecs or Elincs are designated using an internationally recognized chemical name (e.g. ISO, IUPAC). An additional common name is included in some cases.

Index number:

The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are listed in the Appendix according to this index number.

EEC-number:

In the European Inventory of Existing Commercial Chemical Substances (Einecs) an identification code has been defined for the substance. The code starts at 200-001-8.

For new substances notified under the Directive 67/548/EEC an identification code has been defined and published in the European List of Notified Chemical Substances (Elincs). The code starts at 400-010-9.

CAS-number:

Chemical Abstracts Service (CAS) number has been defined for substances to help in their identification.

Notes:

The full text of the notes can be found in the foreword of Annex I of Directive 67/548/EEC.

Notes for the purposes of this Directive are defined as follows:

Note J:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

Note K:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-butadiene (Einecs No 203-450-8).

Note L:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO extract as measured by IP 346.

Note M:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w benzo[a]-pyrene (Einecs No 200-028-5).

Note N:

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen.

Note P:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w benzene (Einecs No 200-753-7).

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