Adopted text
Amendments to Biocidal Products Regulation as regards the extension of certain data protection periods
TA-10-2026-0117 · P10_TA(2026)0117 · PE786.759
- Adopted in plenary on · Adopted 591–54–8 · See the decision →
- Full procedure 2025/0408
✦ In short · AI summary of this text, generated 6 Sept 2026
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Parliament's amended version of the proposed regulation extends data protection periods for biocidal products under Regulation (EU) No 528/2012.¶¶ It sets new rules for when data protection periods apply and how they are calculated for active substance approvals.
Key points
- Extends the data protection period for the first approval of an active substance from 10 to 15 years.¶
- Allows an additional 5-year extension if the applicant submits a complete dossier for a new active substance within two years of the first approval.
- Requires that data protection periods start from the date of the first approval decision.
- Applies the extended periods to applications pending on the entry into force of this regulation.
Who is affected
- Companies applying for approval of active substances for biocidal products benefit from longer data exclusivity.¶
- Competitors seeking to rely on existing data face longer waits before access.
Figures and deadlines
- 10 years¶
- 15 years
- 5-year extension
- two years
Legal basis: Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union¶