GB BPR extends biocidal data rights to 2030
Manufacturers and importers of disinfectants, preservatives and repellents have been handed a longer exclusivity window. The UK has amended Article 95 of the GB Biocidal Products Regulation so that data protection for active substance and product‑type pairs still awaiting an approval decision will now end on 31 December 2030. The instrument was made on 24 November, laid on 25 November, and takes effect on 30 December 2025.
Why this matters is straightforward. Under Article 95, businesses that funded the studies for an active substance can control access to their data for a set period. Competitors who wish to rely on that dossier must secure a letter of access and share costs. Extending the end date defers the point at which late entrants can rely on those data without paying, shifting market entry maths for private‑label and challenger brands.
The changes are targeted and technical but carry clear commercial effects. First, the cross‑reference in Article 95(3) is updated to the current review programme, Commission Delegated Regulation (EU) No 1062/2014, which lists the existing active substances under evaluation. Second, paragraph 5 now fixes 31 December 2030 as the cut‑off for data protection where no approval decision has yet been issued. In other words, the transitional data rights run five years longer than previously set.
Geography matters. These Regulations extend to England, Wales and Scotland. Northern Ireland continues to follow the EU BPR, so suppliers active across the UK need to check status on both the GB and EU lists maintained by the Health and Safety Executive. Portfolio planning should assume dual tracking where products are sold in NI.
For early movers who invested in data, the extension supports a longer payback period and potentially stronger pricing power in tenders through to 2030. For would‑be entrants, it delays low‑cost reliance on existing dossiers, which could push out private‑label timelines and increase the need for letters of access. Cash costs will remain front‑loaded in negotiations with data owners while the protection window remains open.
A quick reading guide helps. Annex II to Regulation 1062/2014 is the master list for the review programme-think of it as the roster of active substance/product‑type combinations working towards approval decisions. The UK amendment pins the Article 95 data protection end‑date to 31 December 2030 for those combinations that still lack a decision by the UK Secretary of State (or pre‑Brexit, by the European Commission). Suppliers should map their portfolios against that Annex II list to see where the extra years bite.
Consider a typical SME scenario. A contract manufacturer supplying PT2 disinfectant wipes plans a Q2 2026 launch under a retailer’s brand. Previously, they modelled dossier access costs falling away after December 2025. Under the new timetable, they should expect to keep paying for data reliance-either via an existing letter of access or a fresh negotiation-until 2030 unless an approval decision arrives and resets obligations earlier under the main regime.
What to do now comes down to housekeeping and pricing discipline. Regulatory teams should confirm each active substance’s status on the HSE lists for GB and, where relevant, NI; renew any time‑limited letters of access; and document evidence of cost‑sharing offers. Commercial teams should bake higher dossier access costs into 2026 price lists, revisit bid validity periods, and include regulatory change clauses in new supply contracts.
One line in the Explanatory Note will raise eyebrows: no full impact assessment was produced on the basis that no significant impact is foreseen. For SMEs, the extension clearly shifts cashflow and may delay entry for copycat lines. It is manageable-but only if finance directors re‑profile approvals budgets, and procurement teams avoid assuming post‑2025 access will be free.
Key dates are locked. The rules take effect on 30 December 2025; the extended end‑date runs to 31 December 2030 for combinations still awaiting a decision. Signed by Minister of State Stephen Timms, the instrument tidies the legal cross‑references and, more importantly for suppliers, resets the clock on data access economics. Treat Q1 2026 as the window to refresh your compliance plan and your pricing model.