Amendments to Biocidal Products Regulation as regards the extension of certain data protection periods (Omnibus X)

Regulation (EU) 2026/1165 amends Regulation (EU) No 528/2012 on the making available on the market and use of biocidal products. It extends the protection of certain data submitted under the review programme for existing biocidal active substances, where approval decisions had not been adopted by 7 June 2018. The Regulation is relevant to the European Economic Area (EEA).

Extended Data Protection

The Regulation extends until 31 December 2030 the data protection periods for all data concerning active substance/product-type combinations for which no approval decision was adopted by 7 June 2018 under the review programme.

Previously, the protection periods for the data concerned ended on 31 December 2025. The extension reflects delays in the review programme, including delays linked to the generation and assessment of data required under scientific criteria for endocrine-disrupting properties, evolving technical guidance and additional data requirements.

The extended period is intended to allow review programme participants that own the data to obtain compensation for the costs of generating the data requested by Member States’ evaluating competent authorities. It applies to all data in the relevant applications, including data submitted after the initial application.

Re-protection and compensation

The Regulation allows the protected status of the data concerned to be restored, notwithstanding the general rule that expired data protection periods cannot start again.

The data were unprotected from 1 January 2026 to 15 June 2026. Data owners may claim compensation for access to their data from substance suppliers or product suppliers that both benefited from the absence of protection and were included, during that period, in the list of eligible suppliers established under Regulation (EU) No 528/2012.

Procedure and entry into force

The Regulation was adopted under the ordinary legislative procedure. The European Parliament adopted its position on 28 April 2026 and the Council took its decision on 11 May 2026.

Published on 26 May 2026, the Regulation enters into force on 15 June 2026. It is binding in its entirety and directly applicable in all Member States.

This summary was AI-generated and human-reviewed.