Legal provisions of COM(2008)618 - Amendment of Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain time periods

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dossier COM(2008)618 - Amendment of Directive 98/8/EC concerning the placing of biocidal products on the market as regards the extension of certain ...
document COM(2008)618 EN
date September 16, 2009

Contents

Article 1 - Amendments

Directive 98/8/EC is hereby amended as follows:

1.Article 12 is amended as follows:

(a)paragraph 1(c)(i) is replaced by the following:

‘(i)until 14 May 2014 for any information submitted for the purposes of this Directive, except where such information is already protected under existing national rules relating to biocidal products. In such cases, the information shall continue to be protected in that Member State until the expiry of any remaining period of data protection provided for under national rules, but not beyond 14 May 2014 or, if applicable, not beyond the date to which the transitional period referred to in Article 16(1) is extended in accordance with Article 16(2);’;

(b)paragraph 2(c)(i) is replaced by the following:

‘(i)until 14 May 2014 for any information submitted for the purposes of this Directive, except in the case where data are already protected according to existing national rules relating to biocidal products, in which case such data shall be protected in that Member State until the expiry of any remaining period of data protection provided for under those national rules, but not beyond 14 May 2014 or, if applicable, not beyond the date to which the transitional period referred to in Article 16(1) is extended in accordance with Article 16(2);’;

2.Article 16 is amended as follows:

(a)paragraph 1 is replaced by the following:

‘1.   By way of further derogating from Articles 3(1), 5(1), 8(2) and 8(4), and without prejudice to paragraphs 2 and 3 of this Article, a Member State may, until 14 May 2014, continue to apply its current system or practice of placing biocidal products on the market. If a decision to include an active substance in Annex I or IA sets a later date for compliance with Article 16(3) than 14 May 2014, this derogation shall continue to apply for products including that active substance until the date set in that decision. A Member State may, in particular, in accordance with its national rules, authorise the placing on the market in its territory of a biocidal product containing active substances not listed in Annex I or IA for that product type. Such active substances must be on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d).’;

(b)paragraph 2 is amended as follows:

(i)the first subparagraph is replaced by the following:

‘2.   Following the adoption of this Directive, the Commission shall commence a 14-year work programme for the systematic examination of all active substances already on the market on the date referred to in Article 34(1) as active substances of a biocidal product for purposes other than those defined in Article 2(2)(c) and (d). Regulations shall provide for the establishment and implementation of the programme, including the setting of priorities for the evaluation of the different active substances and a timetable. Those regulations, designed to amend non-essential elements of this Directive by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4). Not later than two years before completion of the work programme, the Commission shall forward to the European Parliament and to the Council a report on progress achieved with the programme. Depending upon the conclusions of the report, it may be decided to extend the transitional period referred to in paragraph 1 and the 14-year period of the work programme for a period of no more than two years. That measure, designed to amend non-essential elements of this Directive, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 28(4).’;

(ii)in the second subparagraph the words ‘During that 10-year period’ are replaced by the words ‘During that 14-year period’.

Article 2 - Transposition

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 14 May 2010. They shall forthwith inform the Commission thereof.

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.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3 - Entry into force

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4 - Addressees

This Directive is addressed to the Member States.