[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 16.9.2005

COM(2005) 434 final

1999/0238 COD

OPINION OF THE COMMISSION

pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a

DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

amending for the twenty-second time Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles)

1. INTRODUCTION

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out its opinion below on the amendments proposed by Parliament.

2. BACKGROUND

3. Date of the Commission decision: 10 November 1999

4. Date of transmission to Parliament and Council: 10 November 1999

5. Opinion of the Economic and Social Committee: 1 March 2000

6. Date of the opinion of the first reading in Parliament: 6 July 2000

7. Date of adoption of the common position: 4 April 2005 (unanimity)

8. Date of the opinion of the second reading: 5 July 2005

9. PURPOSE OF THE PROPOSAL

The Commission made a first proposal to amend Directive 76/769/EEC on 10 November 1999 (COM (1999) 577 final) to introduce a ban on the use of six phthalates in toys and childcare articles intended to be put in the mouths of children under the age of three.

In the subsequent discussions, the Council decided to wait for the results of a series of comprehensive risk assessments under Council Regulation (EEC) 793/93 on the evaluation and control of risks of existing substances which had been initiated in the meantime. From these risk assessments, new scientific data has now become available.

In addition to the proposal for a permanent limitation, the Commission in 1999 adopted temporary measures under Commission Decision 1999/815/EC on the basis of article 9 of Directive 92/59/EEC of the Council banning the use of 6 phthalates in toys and childcare articles intended to be put in the mouths of children under the age of three years. The Commission has been renewing these temporary bans by extending the duration of Decision 1999/815/EC on a regular (3 monthly / 6 monthly) basis. Member States have also adopted differing limitations on phthalates in toys and childcare articles.

For all parties involved, including industry, the instability of the legal situation and the variation found in the internal market are creating difficulties. A stable legal situation should therefore be created as soon as possible.

10. OPINION OF THE COMMISSION ON THE AMENDMENTS BY THE EUROPEAN PARLIAMENT

Amendments accepted by the Commission

The Commission can accept in full all 4 amendments adopted by the European Parliament. They are the result of a compromise package agreed between the European Parliament and the Council with a view to the adoption of the Directive in second reading. The amendments are in line with the objectives of the Commission’s proposal and maintain the balance of interests achieved in the common position.

The amendments to the Common Position mainly refer to the extension of the restriction of the three phthalates DINP, DIDP and DNOP to all toys that can be placed in the mouth by children. In addition, the definition of childcare articles was extended to include the word "hygiene", and the Commission was asked to also review other applications, notably medical devices.

The conclusion of the compromise package has been facilitated by two declarations which the Commission made during the July 2005 Plenary session (see annex).

11. CONCLUSION

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out

above.

ANNEX

Declarations by the Commission:

Guidance document (already made at Competitiveness Council on 24 September 2004):

As soon as the Directive relating to restrictions on the marketing and use of phthalates in toys and childcare articles (22nd amendment of Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous preparations) is adopted, the Commission, in consultation with Member States’ experts responsible for the management of Directive 76/769/EEC and stakeholders, will prepare a guidance document in order to facilitate the implementation of the Directive. The document will address in particular the provisions on restrictions of certain substances in toys and childcare articles intended for children insofar as they concern the condition "which can be placed in the mouth" as specified in the annex to the Directive.

In the context of this work, the aspects related to "accessible" plasticised material and "handheld" toys will be examined.

Fragrances

The Commission confirms its intention to address the issue of fragrances in toys in the framework of the revision of the Directive on the Safety of Toys. This will have the advantage of identifying what falls within the scope of “fragrances”, consider the appropriate measures to deal with the risks identified and ensure consistency with the other legislative provisions of the said Directive.