Extension of Data Protection Under the EU Biocidal Products Regulation: Key Regulatory Insights for Companies

In December 2025, the European Commission published a targeted legislative proposal under its Food and Feed Safety Simplification Omnibus. One of its most relevant elements for the biocides sector is a proposed amendment to Regulation (EU) No 528/2012 (the Biocidal Products Regulation, or BPR), extending certain data protection periods for active substances still undergoing review.

This initiative responds to long-standing concerns raised by industry and Member State authorities and has direct implications for companies supporting active substances, data owners, alternative suppliers, and product authorisation applicants.

Background: Why This Amendment Was Needed

Under the BPR, approval of biocidal active substances requires extensive scientific data demonstrating safety for human health, animal health, and the environment. These data packages are costly to generate and are therefore protected for a defined period to allow data owners to recover their investment.

Article 95(5) of the BPR currently provides that data protection for certain existing active substance/product-type combinations expires on 31 December 2025, regardless of whether the regulatory review has been completed. This “hard stop” was originally intended to balance fair compensation for data owners with increased market access and competition over time.

However, the EU review programme for existing biocidal active substances, initiated more than two decades ago, has experienced significant and repeated delays. Completion is now scheduled for 31 December 2030. Key drivers of these delays include limited resources in Member State authorities, evolving technical guidance, and, critically, the introduction of new scientific criteria for identifying endocrine-disrupting properties in 2018. These criteria triggered the need for additional, often expensive, studies well after original data submissions.

As a result, many companies were required to generate new data without the prospect of adequate protection if the original 2025 cut-off remained unchanged.

What the Commission Is Proposing

The proposal seeks to realign data protection rules with the reality of the extended review programme. In practical terms, it would:

• Extend data protection until 31 December 2030 for all active substance/product-type combinations that were still under review on 7 June 2018.

• Apply the extension to all data within the relevant dossiers, without distinguishing between older and newly generated studies, ensuring administrative simplicity and legal clarity.

• Introduce a derogation allowing protection to be reinstated even if it temporarily lapsed after 1 January 2026.

• Allow data owners to claim compensation from substance or product suppliers that benefited from the absence of protection during the interim period.

This results in a maximum protection period of approximately 11–12 years for data generated since 2018, broadly consistent with the standard data protection framework under the BPR.

Balancing Innovation and Competition

Stakeholder feedback highlighted diverging perspectives. Data owners and industry associations warned that allowing protection to expire amid regulatory delays would create free-rider risks, discourage investment in new studies (including vertebrate testing), and undermine supply security. Some Member State authorities supported extending protection at least for endocrine disruptor-related data.

Conversely, alternative suppliers and SME representatives cautioned that prolonged protection could limit competition, increase costs, and complicate data-sharing negotiations.

The Commission’s proposal reflects a compromise: it preserves incentives for data generation and regulatory compliance while maintaining the original objective of Article 95(5) to avoid disproportionate or perpetual exclusivity.

What This Means for Companies

For companies active in the biocides sector, the proposal provides:

• Greater legal certainty for data owners who have invested in additional studies during a delayed review process.

• Continued relevance of letters of access and compensation negotiations beyond 2025.

• Reduced risk of immediate, uncompensated data reuse by competitors.

• A clearer regulatory framework pending the broader evaluation of the BPR announced for 2026–2027.

Next Steps

The proposal will now be examined by the European Parliament and the Council under the legislative procedure. Until it enters into force, companies should carefully assess their data protection strategies, Article 95 positioning, and contractual arrangements.

We will continue to monitor legislative developments closely and provide updates on timelines, implementation details, and strategic implications for substance suppliers and product authorisation holders.

If you would like to discuss how this proposal may affect your portfolio or data protection strategy, please contact our regulatory team.

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Author: Barbara DHOOP

Reference:

Simplification Omnibus Package 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: https://food.ec.europa.eu/document/download/d8c35be0-ecc9-432b-a645-fd363681f5d3_en?filename=horiz_omnibus_reg_com-2025-1020-1-p1.pdf