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• The progress of the revision process
• Commission proposal
• Questions and Answers about the proposal
• Impact Assessment
• Background information
• Press releases and speeches

The progress of the revision process

First reading

The European Parliament voted in the first reading on 22 September 2010. The legislative resolution and the amendments adopted can be found here.

The Council adopted its position at the first reading on 21 June 2011. The adopted text is available here.

The Commission Communication on the Council position at the first reading was adopted on 11 August 2011. The text of the Communication is available here.

Second reading

The draft recommendations for the Parliament's position at the second reading are available here.

More information on the decision-making process related to this proposal can be found on Prelex.

Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products was adopted on 22 May 2012. It will repeal and replace Directive 98/8/EC, and will be applicable as of 1 September 2013.

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:

• Questions and Answers on the new Biocides Regulation

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:

• Assessing the Impact of the Revision of Directive 98/8/EC concerning the Placing of Biocidal Products on the Market
• Study on the impacts of the implementation of Directive 98/8/EC on biocidal products
• Study on impacts of possible measures to manage articles or materials treated with biocides
• Report on the evaluation of the implementation of Directive 98/8/EC and progress report on the work programme

 

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:

• Timing and principal objectives
• Outline and progress of the Impact Assessment
• Simplified procedures and data requirements
• Data protection and data sharing
• Product authorisation and fees
• Articles treated with biocidal products

 

Press releases and speeches

12 June 2009: Commission acts to make biocides safer