Amendment BPR for Data Protection: Extension Enters into Force
- 5 hours ago
- 3 min read
On 15 June 2026, Regulation (EU) 2026/1165 entered into force, amending the Biocidal Products Regulation (BPR) and extending data protection for certain active substance dossiers until 31 December 2030. The amendment addresses a long-standing concern arising from delays in the Review Programme for existing active substances and restores protection that had expired at the end of 2025.
The full text of the Regulation is available on EUR-Lex and can be accessed here: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202601165.
What Changed?
Under the previous version of Article 95(5) of the BPR, data protection for many Review Programme dossiers expired on 31 December 2025. As a result, from 1 January 2026, alternative suppliers could rely on previously protected data when applying for inclusion on the Article 95 list without obtaining a Letter of Access (LoA) or sharing the costs incurred by the data owner.
Regulation (EU) 2026/1165 changes this position by extending data protection until 31 December 2030 for active substance/product-type combinations for which an approval decision had not been adopted by 7 June 2018. The legislator considered that many of these dossiers required substantial additional data generation following the introduction of the endocrine disruptor criteria in 2018 and due to evolving regulatory requirements and guidance. The extension is intended to preserve incentives for data generation while recognising the significant delays in the completion of the Review Programme.
Importantly, the extension applies to all data within the relevant dossiers rather than only to newly generated studies, providing a simpler and more predictable framework for both data owners and applicants.
Impact on Article 95 Applications
The practical consequence is that, from 15 June 2026, companies seeking inclusion on the Article 95 list can no longer freely rely on these dossiers.
ECHA has confirmed that Article 95 applications making reference to an existing dossier without a Letter of Access will only be accepted where all applicable data protection periods have expired. In practice, applicants must ensure that:
the relevant data is no longer protected under Article 60(2) of the BPR; and
the data is no longer protected under Article 95(5), including the new extension introduced by Regulation (EU) 2026/1165.
Where protection remains in place, applicants must obtain a Letter of Access or submit their own alternative dossier.
ECHA has also clarified that renewal data may create additional protection obligations. Even where the original approval dossier is no longer protected, applicants may still require a Letter of Access to protected data generated in support of a renewal application.
The January - June 2026 “Gap Period”
One of the most interesting aspects of the amendment is how it deals with the period between 1 January and 15 June 2026.
During this six-month period, the original Article 95(5) protection had expired, and the new Regulation had not yet entered into force. ECHA reported that more than 90 applications were processed during this interval, demonstrating the immediate practical impact of the temporary absence of data protection and the commercial interest in obtaining Article 95 listings.
To address this situation, the legislator introduced an exception to the normal BPR principle that expired protection periods cannot restart. Article 60 was amended specifically to allow the affected data to become protected again. In addition, data owners may claim compensation from substance suppliers or product suppliers that benefited from the absence of protection and were included on the Article 95 list between 1 January and 15 June 2026.
This compensation mechanism is likely to be closely monitored by industry, as it introduces a novel situation in which suppliers may face post-registration claims relating to access to data relied upon during the temporary lapse of protection.
Looking Ahead
The amendment provides greater certainty for companies that have invested in maintaining Review Programme dossiers and generating additional studies requested during the evaluation process. At the same time, it re-establishes the need for Article 95 applicants to carefully assess the protection status of the data on which they intend to rely.
With ECHA now applying the revised rules and a broader evaluation of the BPR expected during 2026–2027, companies should review their Article 95 strategies, data access arrangements and ongoing applications to ensure continued compliance and avoid delays in market access.
Author: Barbara Dhoop, Regulatory Affairs Manager - Biocides
