Making available on the market and use of biocidal products: conditions for access to the market

PURPOSE: to amend 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.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.

BACKGROUND: an analysis of Regulation (EU) No 528/2012 on Biocidal Products has shown that certain provisions will lead to unforeseen consequences. The main problem identified is that the transitional rules of the Regulation will introduce an unintended 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 unintended market barriers for certain companies have also been identified. Furthermore, the Biocidal Products Regulation fails to define a protection period for data relating to those products with the most favourable risk profile.

IMPACT ASSESSMENT: the Commission did not undertake an impact assessment. The proposal has received the broad support of stakeholders and experts.

LEGAL BASIS: Article 114 of the Treaty on the Functioning of the European Union.

CONTENT: this proposal seeks to amend the recently adopted Regulation (EU) No 528/2012 on Biocidal Products which has not yet come into force. It 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.

BUDGETARY IMPACT: the proposal has no impact of the budget of the European Union.