#32026R1165EU extends data protection periods for biocidal active substances
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This regulation extends certain data protection periods under the EU biocidal products framework. It responds to delays in the EU review programme for existing biocidal active substances, where many national authorities have not completed assessments within the expected timelines. The change mainly affects companies that supported active substance reviews, companies seeking to rely on existing data for biocidal product approvals, and regulators handling these files. Businesses in the biocides sector should check whether the extended protection affects access to data, authorisation strategies, costs, or timing for market entry.
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Key Changes
- Extends certain data protection periods for existing biocidal active substance and product-type combinations
- Addresses delays in the EU review programme for existing biocidal active substances
- Gives review programme participants longer protection for data used in active substance assessments
Obligations
What this law requires
For active substance/product-type combinations for which no approval decision had been adopted under Article 89(1), third subparagraph, of Regulation (EU) No 528/2012 by 7 June 2018, treat all related data protection periods as continuing until 31 December 2030 rather than ending on 31 December 2025.
Do not rely on the general rule that expired data protection periods cannot restart where the special Article 95(5) extension applies to covered biocidal active substance/product-type combinations.
Substance suppliers or product suppliers included on the Article 95 list between 1 January 2026 and 15 June 2026 after benefitting from the absence of data protection should be prepared to pay compensation if data owners claim compensation for access to the data during that period.