Have your say: HSE opens consultation on proposed changes to GB BPR Data Requirements
Earlier this month, the Health and Safety Executive (HSE) opened a 2-month consultation period on proposed changes to active substance and product data requirements under the Great Britain Biocidal Products Regulation (Regulation EU No 528/2012 also known as the ‘GB BPR’).
The proposed revisions - which aim to reduce the need for animal testing and better align data requirements with current guidance and OCED test methods - will:
- place emphasis on use of In Vitro studies over In Vivo studies;
- make tests for endocrine disruptors part of the legal data requirements, in place of only being needed on an ad hoc basis;
- revise mutagenicity data requirements to reflect new information;
- revise the data requirements for addressing reproductive toxicity and generational studies;
- revise the data requirements to include developmental neurotoxicity studies when certain triggers are met;
- revise the data requirements to include efficacy data to support the activity of the active substance for the intended use.
Whilst the proposals are similar to revisions made to EU BPR that came into effect last April (Regulation 2021/525), the changes would introduce some divergence between GB and EU BPR data requirements, these being:
- Additional developmental neurotoxicity studies on rats: HSE propose that additional development neurotoxicity testing on rats will only be necessary if neurotoxicity or thyroid toxicity in adult experimental animals occurs or the active substance interacts with molecules in the central nervous system of the target organism. This differs from the EU data requirements where such testing is a core data requirement.
- Efficacy data and treated articles: For active substance evaluations, HSE consider that data to support efficacy claims for treated articles is unnecessary and propose that active substance data requirements need only efficacy data on the innate activity of the active substance itself. This position differs from the EU BPR where the active substance data requirements include the need for efficacy data to support claims on treated articles.
- 5-batch analysis of active substance technical material: The GB BPR amendments will revise the wording adopted in the EU BPR to make it clear that analytical information required for in situ generated active substances must include information on any impurities that may be present in the technical material.
This divergence between the GB and EU BPRs may not necessarily have major implications for biocides businesses in these instances as the proposed changes are not introducing additional data requirements and testing in GB compared to requirements already in place under the EU BPR. It is, however, further evidence of how the UK is willing for GB regulatory frameworks to diverge from equivalent EU law, where deemed appropriate and necessary to meet specific needs and conditions within Great Britain.
HSE proposes that the revisions – subject to the outcomes of the consultation – would take effect from Autumn 2023 with a 12-month transitional period, after which the revised data requirements would be mandatory for any new application received under the GB BPR.
The current consultation will close on 14th March 2023. To have your say on the proposed revisions to the GB BPR click here.