HSE GB BPR legislative reform proposals
As part of a regulatory overhaul of the retained EU legislation, the HSE has launched a public consultation which will look at revising the GB BPR in an effort to reduce the barrier to entry to the GB market for industry and also hopes to reduce overall costs for industry associated with GB BPR approvals. Below we have summarised some of the key aspects of this consultation:
Changes to support the recognition of international biocide approvals and, where appropriate, product authorisations including:
Allowing the HSE to recognise foreign approvals or consider them during their own evaluations. The EU would, very likely, be automatically accepted given the ongoing similarities between GB and EU BPR - There is scope for industry to suggest other jurisdictions which could be included,
Any change in the status of a product/substance in a trusted jurisdiction could require a GB Review or trigger an ad-hoc renewal
Applicants could ask the HSE to recognise an approval, which would require a cursory review, leading to an expected 97% saving for Industry for authority fees (proposed fee of £5,000 per application rather than £160,000).
Approvals could be automatic, upon applicant request or the Secretary of State (SOS) may manually authorise products under this process with only specific grounds considered for rejection.
SOS or HSE may be given the power to request details from the applicant, for example, for underlying data or full details of the evaluation from the trusted jurisdiction.
Concerns regarding data protection and candidates for substitution would need to be carefully considered.
Removal of active substance renewal dates and calling-in active substances for review. Proposal points include:
to remove all active substance approval expiry dates and therefore remove renewal deadlines from the GB BPR process.
This would only apply to substances where a full HSE review and renewal would be required but they are considering the possibility of applying this to all products/substances.
SOS would have the power to “call in” any substance for a full re-evaluation and renewal. This may be driven by areas of particular interest, guidance changes or by the availability of new evidence. Exact details of the risk-based approach to trigger call-ins are not yet finalised.
Requiring industry to continually track information to ensure they comply with any call-in request rather than tracking a publicly available deadline.
This principle could also be applied to biocidal products - once approved, no renewal deadline but call-ins are possible. In this case, HSE would selectively call-in authorised products where there is any emerging evidence of potential risk. There is significant uncertainty regarding their intentions in this particular scenario and they are actively seeking industrial preferences.
Expanded essential use provisions
Essential use derogation can allow products which would not normally be approved to retain legal GB Market access where the active substance is considered essential to society according to criteria defined in legislation under Article 5 of GB BPR.
Criteria are stringent to avoid the option of an alternative route to BPR approval however, substances in the Review Programme (RP) have been shown to meet these criteria and have been granted essential use derogations historically.
Proposal to expand essential use to include substances outside the GB RP, as there are now many substances which were withdrawn and could be considered societally essential but not commercially viable under the costs of the GB BPR.
SOS would have power to grant essential use derogations however, current safeguards and restrictions, including the temporary nature of these approvals, would continue to apply.
Grant HSE powers to revise GB BPR and the supporting regulations
Not currently possible after 2026 under Retained EU Law act
Allow HSE to modify the GB BPR to include detailed arrangements for international recognition, amend operational matters including procedures, timeframes and information requirements, specify how the regulation will be enforced and adopt transitional provisions for any changes.
For full details of the consultation, there is a document available on the HSE website. This document can also be used as a template to prepare a response for this consultation. If you would like our expert support in preparing a response to this consultation, we would be happy to provide a proposal for this work. We would be able to tailor any response to your specific needs and regulatory situation under GB BPR. In addition to the GB BPR, this consultation also includes potential modifications to the GB CLP and PIC regulations which may also impact your products.
The deadline to submit any response under this consultation is the 18th August so if this is of interest, please let us know as soon as possible to ensure we have time to complete the preparation of this document.
If you have any further questions, please reach out to us.
