COMMISSION DIRECTIVE 2006/50/EC
of 29 May 2006
amending Annexes IVA and IVB to Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular Article 29 thereof,
Whereas:
(1)
Annexes IVA and IVB to Directive 98/8/EC set out the requirements for the dossiers to be submitted by applicants for, respectively, inclusion of an active substance consisting of micro-organisms including viruses and fungi in Annex I or IA to that Directive, and authorisation of a biocidal product based on preparations of such micro-organisms including viruses and fungi.
(2)
It is necessary to adapt Annexes IVA and IVB to Directive 98/8/EC to technical progress and to developments in related legislation, in particular Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (2) and Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (3), in order to provide a better basis for carrying out the risk assessments for micro-organisms and the biocidal products containing them. In addition, there have been scientific and technical developments within the field of microbiology and biotechnology. Providing for a similar structure of the data requirements in the framework of Directive 98/8/EC with those of Directive 91/414/EEC will facilitate the work of applicants submitting dossiers within both legal frameworks and the work of the Member States authorities evaluating such dossiers. It is therefore appropriate to update the data requirements for micro-organisms including viruses and fungi currently contained in Directive 98/8/EC and to align them as far as possible with those established in the framework of Directive 91/414/EEC.
(3)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products.
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes IVA and IVB to Directive 98/8/EC are replaced by the text set out in the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 January 2008 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
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
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 29 May 2006.