Projects & Resources

Biocides - Council's approval on extension of data protection periods

SUMMARY
Today, the Council gave its final approval to revised biocides rules under Regulation (EU) No 528/2012, extending certain data protection periods until 31 December 2030 for biocidal active substances and products placed on the market.


MORE INFORMATION

  • Regulation (EU) No 528/2012, which governs the approval of biocidal active substances and the authorization and placing on the market of biocidal products, establishes a data protection regime for information submitted in support of approvals of active substances and product-types.
  • Under this framework, data protection applied until 31 December 2025, with the objective of ensuring fair compensation for data owners participating in the review program while preventing undue market exclusivity.
  • To maintain the intended balance between remuneration for data owners and the gradual opening of the market, the protection period has been extended to 31 December 2030.
  • The extension ensures that companies remain appropriately compensated for the scientific data generated in the context of the ongoing review of active substances and avoids any gap in protection that would otherwise have arisen after the previous expiry date.
  • The measure is part of the “Omnibus X” legislative package under the EU’s simplification agenda, which seeks to reduce administrative costs and regulatory burdens.

NEXT STEPS
The legislative act will be published in the Official Journal of the EU in the coming days and will enter into force 20 days after its publication.