Explanatory Memorandum to COM(2013)288 - Amendment of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market

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1. CONTEXT OF THE PROPOSAL

The proposal relates to the recently adopted Regulation (EU) No 528/2012 ('the Biocidal Products Regulation'), which has not yet become applicable. An analysis of the Biocidal Products Regulation has shown that certain provisions will lead to unforeseen consequences.

The main problem identified is that the transitional rules of the Biocidal Products Regulation will introduce an un-intended market freeze of up to eleven years for articles treated with biocidal substances which are legal on the EU market, but which have not yet been evaluated at EU level. Other un-intended market barriers for certain companies have also been identified. Finally, the Biocidal Products Regulation fails to define a protection period for data relating to those products with the most favourable risk profile.

1.

RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS



Stakeholders and experts have been consulted in several meetings of the expert group named Competent authorities for biocidal products. The proposal has received broad support in those meetings.

2.

LEGAL ELEMENTS OF THE PROPOSAL



The proposal contains provisions that will remove market barriers for suppliers of new articles treated with biocidal products and for a large number of suppliers of biocidal active substances. It also defines the protection periods for the data relating to those biocidal products with the best profile.