Article 95 Data Protection for Biocides Set to Expire in 2026
At the end of 2025, a major change will reshape the European biocides market. The data protection period for certain active substances listed under Article 95 of the Biocidal Products Regulation (BPR) is set to expire.
This change affects many companies that rely on protected study data to maintain their market access in the European Union.
What Happens After December 31, 2025
According to Article 95(5) of the BPR, all data protection periods for substance/product-type combinations not yet approved under the Review Programme will end on 31 December 2025.
This means dossiers for active substances still awaiting approval will lose protection, even though their evaluations continue until 2030.
So far, only about half of all active substance and product-type combinations have been approved. The rest could soon become open for competitors without the need to pay compensation to the original data owners.
Free Access for New Market Players
From 1 January 2026, new companies—both within and outside the EU—may enter the market through an Article 95 listing without paying data-sharing fees.
This “free-riding” scenario could significantly disrupt the biocides sector for years.
Industry experts expect uncertainty to last until at least 2030, when the Review Programme is scheduled to conclude. This instability might delay investment, limit innovation, and discourage new R&D projects for safer and more sustainable biocidal substances.
Industry Reactions and Calls for Extension
Some Member States, including Belgium, France, Italy, and the Netherlands, have urged the European Commission to extend data protection.
They warn that losing access to approved biocides could endanger public health and environmental safety.
They argue that companies that invested heavily in substance approvals may also face unfair competition from newcomers using their data for free. Without protection, many manufacturers might withdraw applications, reducing the number of available active substances and biocidal products on the EU market.
What Comes Next
The European Commission plans to review these issues under the BPR REFIT evaluation, expected to conclude by the end of 2026.
Possible adjustments to the rules on data protection are being discussed, but no final decisions have been made.
For now, companies should monitor developments closely, evaluate their portfolios, and consider how to position themselves in the post-2025 biocides landscape.
At Nordiik, we help businesses navigate these regulatory transitions, assess strategic opportunities, and stay compliant with the evolving EU Biocidal Products Regulation. Contact us!
Source: ECHA
