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Brussels, 20 January 2012
Statement by Commissioner Potočnik on the new Regulation on biocides
Environment Commissioner Janez Potočnik welcomed the boost to human health and environmental protection brought by the adoption of the new Biocides Regulation in the European Parliament yesterday. Thanks to the combined efforts of the European Parliament, the Council and the Commission, the new Regulation will significantly increase the safety and simplify the authorisation procedure of biocidal products used and placed on the market in the European Union.
Environment Commissioner Janez Potočnik said: "The vote is another step towards ensuring that only safe products are made available and that the most dangerous substances are kept out of our market. The simplification of authorisation procedures will bring considerable economic benefits to European companies while ensuring a high level of environmental protection for citizens."
The new Regulation simplifies and streamlines the requirements for approving active substances and authorizing products to enter the EU market. The total cost savings for the industry, to be achieved through more efficient product authorisation, data sharing and data requirements are estimated to be €2.7 billion over a period of 10 years.
The new provisions also reduce animal testing by making data sharing compulsory and encouraging a more flexible and intelligent approach to testing. A dedicated IT platform (the Register for Biocidal Products) will be used for submitting applications as well as recording decisions and disseminating information to the public.
The new Regulation is also the first piece of legislation to integrate the new Commission definition on nanomaterials.
The text is a major breakthrough for the internal market with the creation of an EU-wide authorisation for biocidal products, which will allow industry to directly place their products on the entire EU market.
The European Chemicals Agency (ECHA) will provide a strong scientific and technical back-up to the Commission and the Member States under this new Regulation. The agency's tasks will include the assessment of applications for the Union authorisation of biocidal products. The total number of opinions to be delivered by ECHA is expected to grow from 80 in 2014 to 300 in 2020.
The text of the Regulation is the outcome of an informal agreement between Parliament and the Council, reached in late 2011. The negotiation process involved very close co-operation between the Commission and the other institutions.
Following endorsement in the Parliament yesterday, the new Regulation is now expected to be approved by EU Ministers in the Council. The Regulation is expected to apply from 1 September 2013.
Directive 98/8/EC of the European Parliament and of the Council on the placing on the market of biocidal products was adopted in 1998. According to the Directive, Member States had to transpose the rules before 14 May 2000 into national law. The Biocidal Product Directive aims to harmonise the European market for biocidal products and their active substances. At the same time it aims to provide a high level of protection for humans, animals and the environment. 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 Regulation endorsed today by the European parliament in second reading will repeal and replace the current Directive 98/8/EC.