Recently, the Council of the European Union and the European Parliament formally adopted a draft regulation to amend the Biocidal Products Regulation (Regulation (EU) No 528/2012, or BPR), extending the data protection periods for existing biocidal active substances. Under the new rules, the data protection period originally scheduled to expire on December 31, 2025, will be extended to December 31, 2030. This amendment aims to strike a balance between the interests of data owners and other market participants, while ensuring fair competition in the biocides market.
In late 2025, the EU proposed extending the data protection periods for existing active substances to allow more time for the finalization of the review programme.
The core amendments of the new regulation include the following key points:
1. Extension of Data Protection Periods:
o For active substance/product-type combinations for which a decision on approval had not been adopted by June 7, 2018, the data protection period is extended from December 31, 2025, to December 31, 2030.
o This extension applies to all relevant data, including newly generated data submitted since June 7, 2018.
2. Compensation Mechanism:
o Between January 1, 2026, and the date of entry into force of the new regulation, the data concerned were unprotected. The new regulation allows data owners to claim fair compensation from substance or product suppliers who benefited from this absence of protection and were included in the Article 95 list during that period.
3. Regulatory Amendments:
o The act amends Articles 60 and 95 of the Biocidal Products Regulation, clarifying the scope of the extended data protection periods and the compensation mechanism.
The amendments provide data owners with a longer timeframe for economic returns, helping to compensate for the high costs of generating data. However, it also delays market entry for other participants, such as alternative suppliers, thereby impacting market competition. The European Commission plans to conduct a full evaluation of the Biocidal Products Regulation during 2026-2027, and companies should closely monitor potential future changes.
This extension of data protection periods reflects the EU’s ongoing efforts to balance market competition with the rights of data owners. The new regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union. Companies must promptly adjust their compliance strategies to meet these new regulatory requirements. Moving forward, as the EU further evaluates biocidal regulations, the industry may face additional changes; stakeholders are advised to continuously monitor policy developments and prepare accordingly.
