COMMON POSITION (EC) No 12/94 adopted by the Council on 4 March 1994 with a view to adopting a European Parliament and Council Directive 94/. . ./EC of . . . amending for the 14th 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 137/07)

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 Committee (2),

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

Whereas Article 7a of the Treaty establishes an area without internal frontiers in which the free movement of goods, persons, services and capital is ensured;

Whereas work on the internal market should 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;

Whereas the presence of nickel in certain objects coming into direct and prolonged contact with the skin may cause sensitization of humans to nickel and may lead to allergic reactions; whereas for these reasons the use of nickel in such objects should be limited;

Whereas one Member State has already introduced a set of control measures on its territory to counteract nickel sensitization and nickel allergy and a second Member State plans to introduce on its territory a different set of control measures; whereas there is therefore a risk of barriers to trade;

Whereas the test methods to be used in demonstrating conformity with this Directive should be defined and published before the Directive is implemented; whereas these test methods should be the subject of a European standard;

Whereas limitations already adopted or planned by certain Member States on the use of nickel directly affect the completion and functioning of the internal market; whereas it is therefore necessary to approximate the laws of the Member States in this field and consequently to amend Annex I to Directive 76/769/EEC (3),

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is hereby supplemented as provided for in the Annex hereto.

Article 2

1. Member States shall adopt the laws, regulations and administrative provisions necessary to comply with this Directive not later than six months after publication by the Commission in the Official Journal of the European Communities, of the standards adopted by the European Committee for Standardization (CEN) on all the test methods used in demonstrating the conformity of the products with this Directive, or six months after the adoption of this Directive if that date is later than the former, so that:

- six months after the expiry of one or other of those periods, whichever is applicable, no manufacturer or importer may place on the market products which fail to comply with this Directive,

- 18 months after the expiry of one or other of those periods, whichever is applicable, products which fail to comply with this Directive cannot be sold or made available to the final consumer, unless they have been placed on the market before the expiry of the period in question.

They shall forthwith inform the Commission thereof.

2. When Member States adopt the measures referred to in paragraph 1, 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 the 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 116, 27. 4. 1993, p. 10.

(2) OJ No C 304, 10. 11. 1993, p. 2.

(3) OJ No L 262, 27. 9. 1976, p. 201. Directive as last amended by Directive 91/339/EEC (OJ No L 186, 12. 7. 1991, p. 64).

ANNEX

'28. Nickel CAS No 7440-0-20 EINECS No 2311114 and its compounds

May not be used:

1. in post assemblies which are inserted into pierced ears and other pierced parts of the human body during epithelization of the wound caused by piercing, whether subsequently removed or not, unless such post assemblies are homogeneous and the concentration of nickel - expressed as mass of nickel to total mass - is less than 0,05 %;

2. in products intended to come into direct and prolonged contact with the skin such as:

- earrings,

- necklaces, bracelets and chains, anklets, finger rings,

- wrist-watch cases, watch straps and tighteners,

- rivet buttons, tighteners, rivets, zippers and metal marks, when these are used in garments

if the rate of nickel release from the parts of these products coming into direct and prolonged contact with the skin is greater than 0,5 ìg/cm²/week;

3. in products such as those listed in point 2 above where these have a non-nickel coating unless such coating is sufficient to ensure that the rate of nickel release from those parts of such products coming into direct and prolonged contact with the skin will not exceed 0,5 ìg/cm²/week for a period of at least two years of normal use of the product.

Furthermore, products which are the subject of points 1, 2 and 3, may not be placed on the market unless they conform to the requirements set out in those points'.

STATEMENT OF THE COUNCIL'S REASONS

I. Introduction

1. On 4 March 1994 the Council, acting by a qualified majority, adopted a common position on the above proposal, using Article 100a of the Treaty as a legal basis. The Italian delegation voted against adoption of the common position.

2. The Commission submitted the original proposal to the Council on 16 April 1993. The European Parliament and the Economic and Social Committee delivered their opinions on 27 October and 22 September 1993 respectively. Drawing on these opinions, the Commission submitted an amended proposal on 1 December 1993.

II. Aim

The Directive seeks to protect consumers against the allergic reactions likely to be caused in certain nickel-sensitive people by jewellery and personal items coming into contact with their skin. It seems that the number of sensitized persons, especially young people, is on the increase in Europe.

III. Opinion of the European Parliament and amended proposal

The European Parliament tabled three amendments to the Commission's original proposal:

- the first sought to delay the entry into force in order to allow manufacturers and especially retailers more time to clear stocks of the products affected,

- the second concerned the publication by the Commission of the methods to be used for certifying compliance with the Directive's provisions, and

- the third replaced the ban on certain products by a requirement to label them.

The Commission incorporated the first two amendments in its amended proposal. It did not see fit to adopt the third one, on the ground that labelling would be insufficient to protect the health of consumers.

The Council has essentially taken over the Commission's amended proposal.

- Parliament's first two amendments have been incorporated by the Council. However, in order to ensure that tests are available, the Council has decided to make their publication a condition for the entry into force of the Directive. It is further specified that the tests have been adopted by the CEN, which ensures that they are valid and homogeneous throughout the Community (Article 2 (1)).

- Regarding the third amendment, namely replacement of points 2 and 3 of the Annex by a labelling requirement, the Council has followed the Commission's amended proposal, on the ground that labelling alone is insufficient to attain the Directive's objectives. However, the Council has decided to simplify the illustrative list of products covered by the ban in point 2 of the Annex by removing buttons and spectacle frames. Also, in point 3 the period of normal use of the products has been reduced from three years to two. (Annex, points 2 and 3).

IV. Analysis of other points in the common position

In addition to the amendments described in Section III, the Council has made two amendments to the preamble to the common position:

1. the citations have been altered to take account of the entry into force of the Treaty on European Union, and in particular of Article 189b of the Treaty establishing the European Community;

2. the fifth recital relating to test methods has been slightly amended to take account of the new wording of Article 2 (1).

V. Conclusion

The Council believes that all the adjustments made to the amended proposal with the Commission's agreement are intended to strengthen the Directive's objectives, protect consumers and facilitate efficient implementation of the Directive by means of homogeneous and reliable tests.