Mr Mark McGregor (Department for the Economy): Committee Chair and Committee members, I am grateful for the opportunity to brief you this morning on the EU biocidal products regulation, specifically the expiry of certain regulatory data protections under article 95. You will have received your written briefing pack. Unfortunately, the explanatory memorandum was not available until this morning, so it was not included in the pack. An updated pack of written documents, including the explanatory memorandum, will be lodged with the Committee later today. I have been engaging with the Health and Safety Executive of Great Britain, which is responsible for the explanatory memorandum, so I am able to provide oral evidence today.
Article 95 of the biocidal products regulation governs access to regulatory data submitted in support of active substance approvals and product authorisations. The datasets, which include toxicological, ecotoxicological and efficacy studies, are costly to generate and are protected for defined periods. That protection underpins a system of letters of access and compensation that allows data owners to recover costs when others rely on their studies.
Under article 95(5), protection of a defined category of datasets expired on 31 December 2025. However, the EU review programme for existing active substances has been extended and is now scheduled to run until 31 December 2030. The European Commission identified that as a misalignment. In effect, the data protection period has ended, while the regulatory review process continues for a further five years: that is an acknowledged gap period. Importantly, the EU institutions' procedural information explicitly recognises that that creates a gap period from 1 January 2026. Until any amending legislation is adopted and applied, the affected datasets are no longer protected under the regulation.
Stakeholder concerns about the practical implications include industry stakeholders describing the risk of "free riding" arising from the gap, meaning that competitors might be able to rely on existing studies to support their own article 95 listings or dossiers without compensating the data owner, at least during the gap period. That weakens data owners' bargaining position for letters of access and undermines the cost-recovery model that incentivises investment in high-quality regulatory data. For other economic operators, including alternative suppliers and new entrants, the position is also uncertain. The Commission's proposal indicates an intention to introduce a compensation mechanism to address such reliance during the gap.
The Commission has brought forward targeted amendment COM/2025/1020 to address the issue. The proposal seeks to extend the relevant article 95 data protection to 31 December 2030, aligning protection with the revised end date of the review programme. It also seeks to address the interim period from 1 January 2026 until the amended provisions apply, with the stated aim of avoiding uncompensated reliance during that window. Until that proposal is adopted and applied, however, the gap remains live.
Divergence considerations for Northern Ireland are particularly relevant because Great Britain has already amended its domestic regime to extend the article 95 protection to 31 December 2030. That means that there is divergence between Great Britain and the EU and Northern Ireland, with protection extended in Great Britain but expired in the EU and Northern Ireland during the legislative gap. That divergence adds complexity for businesses operating across both regimes and is being closely monitored by regulators.
If adoption of the proposal is delayed, the unprotected period will continue, data owners will remain exposed to uncompensated reliance and other businesses will face ongoing uncertainty as to future liabilities. If the proposal were not to be adopted, the gap would become the steady state. The affected data would remain unprotected for the remainder of the review programme with continued risks to investment incentives, market behaviour and regulatory alignment.
There is a recognised and acknowledged period that began on 1 January 2026 during which certain regulatory datasets under the biocidal products regulation are no longer protected in the EU and Northern Ireland. That creates real commercial and regulatory risks for data owners in particular and legal uncertainty for other operators. The Commission's proposal is intended to resolve that, but, until it is adopted and applied, the exposure remains live.
I trust that that overview is helpful to the Committee. I am happy to take questions.