Revision of Directive
Commission proposal
On 12 June 2009, the European Commission adopted a proposal for a Regulation concerning the placing on the market and use of biocidal products (COM(2009)267). The proposed Regulation will repeal and replace the current Directive 98/8/EC concerning the placing of biocidal products on the market.
The objective of the proposal for a Regulation concerning the placing on the market and use of biocidal products (COM(2009)267) is to improve the functioning of the internal market in biocidal products while maintaining the high level of the environmental and human health protection. The proposal will build on the principles laid down in Directive 98/8/EC, in particular the two-tier authorisation process: firstly, the inclusion of the active substance in Annex I and secondly, the authorisation of the biocidal product. The proposed regulation is scheduled to enter into force on 1 January 2013.
Presentation of the Commission's proposal is available here.
Questions and Answers about the proposal
In order to facilitate the reading of the legislative proposal, the Commission prepared a document which outlines the main changes in form of questions and answers:
Impact Assessment
The proposal of the Commission is accompanied with the impact assessment (SEC(2009)773). The impact assessment looked at the different policy options in five policy areas:
- Scope
- Product authorisation
- Data sharing
- Data requirements
- Fees charged by the Member States.
In preparing the impact assessment, the Commission relied on the following studies:
Background information
On 8 October 2008, the Commission published a report on the implementation of Directive 98/8/EC submitted to the Council in accordance with Article 18(5) of the Directive. This report highlighted the complexity of the legal framework laid down in Directive 98/8/EC and the resulting costs of compliance with its requirements, in particular the costs of compiling a dossier in support of the inclusion of an active substance. The proposal of the Commission aims, therefore, to addresses the weaknesses identified in the implementation report and anticipate issues which may arise at the product authorisation stage.
A wider consultation of stakeholders has been organised through a conference in Brussels on 23 May 2008 (see agenda). Representatives from industry and national governments were informed about the key issues for the revision, on which you can find more information in the presentations below:
Press releases and speeches
12 June 2009: Commission acts to make biocides safer |
