COMMON POSITION (EC) No 29/94 adopted by the Council on 16 June 1994 with a view to adopting European Parliament and Council Directive 94/. . ./EC of . . . amending for the 13th 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 (94/C 244/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Comittee (2),

Acting in accordance with the procedure referred to in Article 189b of the Treaty (3),

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 (4);

Whereas the Council and the Representatives of the Governments of the Member States, meeting within the Council, adopted Decision 90/238/Euratom, ECSC, EEC (5) concerning a 1990 to 1994 action plan in the context of the 'Europe against Cancer` programme;

Whereas the substances which appear in Annex I to Directive 67/548/EEC (6) and are classified as carcinogens category 1 or 2 many cause cancer; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public;

Whereas the substances which appear in Annex I to Directive 67/548/EEC and are classified as mutagens category 1 or 2 may cause heritable genetic damage; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public;

Whereas the substances which appear in Annex I to Directive 67/548/EEC and are classified as toxic for reproductive purposes category 1 or 2 may cause birth defects; whereas to improve health protection such substances and preparations containing them should not be placed on the market for use by the general public;

Whereas, for reasons of transparency and clarity, such substances should be referred to using a recognized nomenclature, preferably that of the Iupac (International Union of Pure and Applied Chemistry); whereas Annex I to Directive 67/548/EEC ('List of dangerous substances`) is regularly updated by way of technical progress; whereas the Commission will submit to the European Parliament and the Council, no later than six months after publication of such adaptation to technical progress in the Official Journal of the European Communities, a proposal for a Directive governing the substances newly classified as carcinogenic in categories 1 and 2, mutagenic in categories 1 and 2, and toxic for reproductive purposes in categories 1 and 2, so as to update this Directive;

Whereas the said proposal from the Commission will take account of the risks and advantages of the substances newly classified as well as of the Community legislative provisions on risk analysis;

Whereas Annex I to Directive 67/548/EEC lays down individual concentration limits for such substances and, in the absence of such limits, Table VI of Annex I to Directive 88/379/EEC (7), lays down general concentration limits which apply to such substances contained in preparations;

Whereas creosote, as defined in the Annex to this Directive, may be damaging to health because of its content of known carcinogens; whereas for these reasons the use of creosote in wood treatment and the marketing and use of creosote-treated wood should be limited;

Whereas some of the components of creosote are poorly degradable and deleterious to certain organisms in the environment; whereas these components may enter the environment as a result of the use of treated wood;

Whereas some chlorinated solvents present a danger to health and should not be marketed to the general public in substances and preparations;

Whereas the restrictions on the use of creosote in wood treatment, on the marketing and use of creosote-treated wood and on the marketing and use of chlorinated solvents laid down by this Directive take into account the current state of knowledge and techniques regarding safer alternatives;

Whereas restrictions already adopted by certain Member States on the marketing and use of the substances mentioned above or the preparations containing them directly affect the establishment and functioning of the internal market; whereas it is therefore necessary to approximate the laws of the Member States in this field and consequently amend Annex I to Council Directive 76/769/EEC (8);

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

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is hereby amended as set out in the Annex hereto.

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 . . . (11*).

2. When Member States adopt these measures, they shall contain a reference to this Directive or shall be accompanied by such 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 is addressed to the Member States.

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ No C 157, 24. 6. 1992, p. 6.

(2) OJ No C 332, 16. 12. 1992, p. 8.

(3) Opinion of the European Parliament of 19 January 1994 (OJ No C 44, 14. 2. 1994, p. 2), Council Common Position of . . . (not yet published in the Official Journal) and Decision of the European Parliament of . . . (not yet published in the Official Journal).

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

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

(6) OJ No L 196, 16. 8. 1967, p. 1, Directive as last amended by Commission Directive 91/632/EEC (OJ No L 338, 10. 12. 1991, p. 23).

(7) OJ No L 187, 16. 7. 1988, p. 14, Directive as last amended by Commission Directive 93/18/EEC (OJ No L 104, 29. 4. 1993, p. 46).

(8) OJ No L 262, 27. 9. 1976, p. 201, Directive as last amended by Commission Directive 91/659/EEC (OJ No L 363, 31. 12. 1991, p. 36).

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

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

(11*) Six months after the date of adoption.

ANNEX

The following is added to Annex I to Directive 76/769/EEC:

>TABLE>

APPENDIX

Point 29 - Carcinogens

List 1, category 1

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List 2, category 2

>TABLE>

Point 30 - Mutagens

List 3, category 1

No substances classified in this category

List 4, category 2

>TABLE>

Point 31 - Toxic for reproduction

List 5, category 1

>TABLE>

List 6, category 2

>TABLE>

(1*) The name 'Warfarin` is not authorized in France

STATEMENT OF THE COUNCIL'S REASONS

I. Introduction

1. On 18 June 1992 the Commission submitted a proposal based on Article 100a of the Treaty, amending for the 13th 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.

2. The European Parliament delivered its opinion on 27 October 1993 and 19 January 1994. The Economic and Social Committee delivered its opinion on 22 October 1992.

In the light of those opinions the Commission submitted an amended proposal on 29 March 1994.

3. On 16 June 1994 the Council adopted its common position in accordance with Article 189b of the Treaty.

II. Purpose

The purpose of the proposal is to restrict the placing on the market and use of three types of substances and preparations which present a danger for consumer health and for the environment. These are:

(a) carcinogens, mutagens and substances toxic for reproductive purposes;

(b) creosote and its derivatives;

(c) chlorinated solvents.

III. Analysis of the common position

The Commission incorporated into its amended proposal all the amendments proposed by the European Parliament.

The Council basically went along with the amended Commission proposal. It did, however, insert a number of clarifications of a formal rather than of a substantive nature into the text of those amendments. Hence:

- the two new recitals proposed in amendments Nos 12 and 13 of 19 January 1994, which make provision for recourse to the procedure referred to in Article 189b of the Treaty for any amendment to this Directive following a revision or updating of Annex I to Directive 67/548/EEC containing new carcinogens, mutagens and substances toxic for reproductive purposes, have been merged into a single recital, for the sake of clarity, with no change whatsoever to its content,

- in points 29, 30 and 31, right-hand column, the safety advice to be indicated on the labelling, proposed by amendment No 16 of 19 January 1994, has been partially replaced by the safety phrase S.53, so as to take into account the safety instructions laid down in Commission Directive 93/21/EEC (1) adapting Council Directive 67/548/EEC to technical progress,

- under point 31, left hand column, the term 'teratogen` has been replaced by 'toxic for reproductive purposes` and the risk phrase R.47 has been replaced by the risk phrases R.60 and R.61. These are merely technical adjustments intended once again to take Commission Directive 93/21/EEC into account.

The Council introduced two other amendments to the Commission proposal:

- a new recital supplementing the merged recitals mentioned above, providing that the Commission will take account, in its proposals, of the risks and advantages of the substances newly classified in Annex I to Directive 67/548/EEC, as well as of risk analysis (recital No 8 of the common position),

- an amendment to the date of application of the Directive. The three months provided for in the proposal for application of the provisions necessary to comply with the Directive have been extended to six months. The Council considers that three months are not enough for withdrawing from the market all the substances and preparations covered by the Directive (Article 2 (1) of the common position).

IV. Conclusion

The Council is of the opinion that the amendments and clarifications made to the Commission's amended proposal will contribute to the Directive's objectives of protecting consumers and the environment, by facilitating effective implementation and aligning the technical instructions with the other Community provisions in that sector.

(1) OJ No L 110 A, 4. 5. 1993, p. 1.