Amendments to Biocidal Products Regulation as regards the extension of certain data protection periods (Omnibus X)
The European Parliament adopted by 591 votes to 54, with 8 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods.
The European Parliament adopted its position at first reading, taking over the Commission's proposal.
As a reminder, the proposal, which is part of the Commission's omnibus simplification package, aims to modify Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, in order to address specific concerns which have been expressed by Member States competent authorities on biocidal products and economic operators regarding the expiry of the protection of certain data by 31 December 2025 in accordance with that Regulation.
It is proposed that all data protection periods for active substance/product-type combinations for which a decision on the approval has not been adopted in accordance with Regulation (EU) No 528/2012 by 7 June 2018, shall end on 31 December 2030.
By extending data protection periods, the proposal aims to better encourage innovation and investment in biocidal products, particularly where data production is costly and time-consuming. This amendment promotes the smooth functioning of the internal market and integrates the regulatory framework for biocidal products into the broader context of EU simplification.
Data owners may claim compensation for access to their data for the period from 1 January 2026 to the date of entry into force of this amending Regulation from a substance supplier or product supplier having benefitted from the absence of protection and having been included in the list referred to in Article 95 of Regulation (EU) No 528/2012 during that period.