On December 16, 2025, the European Commission proposed an amendment to the Biocidal Products Regulation (Regulation (EU) No 528/2012) to extend the data protection period for existing active substances under review until December 31, 2030. This proposal aims to address delays in the review programme for biocidal active substances while balancing the interests of data owners and other market participants.

Background and Rationale

Under the current regulation, data protection for existing biocidal active substances is set to expire on December 31, 2025. However, the review programme for these substances has faced significant delays due to factors such as resource constraints in Member States, data quality issues, and evolving technical guidance. The programme, originally scheduled for completion in 2010, has now been extended to December 31, 2030.

Additionally, new data requirements, particularly those related to endocrine-disrupting (ED) properties introduced in 2018, have further delayed evaluations. The proposed extension seeks to ensure fair returns on investments made by data owners while maintaining market competition and innovation incentives.

Key Provisions of the Proposal

The proposal includes the following main elements:

1. Extension of Data Protection Period:

• Data protection for active substance/product-type combinations under review as of June 7, 2018, will be extended until December 31, 2030.

• The extension applies to all relevant data, not limited to those related to ED properties.

2. Interim Data Protection Gap and Compensation Mechanism:

• From January 1, 2026, until the new regulation enters into force, data will temporarily lose protection.

• Data owners may claim compensation from substance or product suppliers who benefit from the absence of protection during this period.

3. Regulatory Amendments:

• Amendments to Article 95(5) of the Biocidal Products Regulation to define the scope of the extended protection and establish compensation mechanisms.

Impact on the Industry

The proposed changes are expected to have the following implications for the biocidal products industry:

• Protection for Data Owners: The extended protection period will provide data owners with a longer timeframe to recoup their investments, particularly for costly studies required to meet new scientific standards.

• Market Competition: By discouraging "free-riding" behavior, the proposal aims to foster innovation and ensure fair competition in the market.

• Potential Cost Implications: Extended data protection may increase costs for alternative suppliers, potentially impacting downstream product pricing.

Compliance Recommendations

For Data Owners:

• Identify data eligible for extended protection and assess potential compensation claims.

• Prepare for negotiations regarding data sharing and compensation mechanisms.

For Non-data holding substance suppliers:

• Evaluate compliance risks associated with using unprotected data during the interim period.

• Account for potential compensation costs in supply chain and pricing strategies.

• Monitor legislative developments and implementation details.

This proposal reflects the European Commission's efforts to balance regulatory simplification with the protection of industry interests. While the proposal requires approval from the European Parliament and Council, its adoption would significantly impact the compliance landscape for biocidal products. Companies are advised to assess the potential implications and prepare strategies to ensure compliance and competitiveness under the revised framework.

Looking ahead, the European Commission plans a comprehensive evaluation of the Biocidal Products Regulation in 2026-2027, which may lead to further adjustments to data protection rules. Industry stakeholders should remain vigilant and proactive in their compliance planning.