On January 17, 2023, the Health and Safety Executive (HSE) began a public consultation on changes to the data requirements in the Great Britain (GB) Biocidal Products Regulation (GB BPR). GB BPR applies to the supply and use of biocidal products. Biocidal products are products that control harmful organisms, and include insecticides, rodenticides, wood preservatives, anti-fouling coatings on ships, disinfectants, and hand sanitizers. HSE is consulting on proposed revisions to Annexes II and III of GB BPR, which address the information requirements for biocidal active substances and the information requirements for biocidal products. Comments are due March 14, 2023.
Background
According to the Consultation Document, after the European Union (EU) Exit Transition period ended, the European Commission (EC) published Regulation 2021/525, which amended Annexes II and III of the EU Biocidal Products Regulation (EU BPR). HSE specialists were involved in developing the EU BPR while the United Kingdom (UK) was still a member of the EU. The EU BPR came into force in 27 EU countries and Northern Ireland with effect from April 15, 2022. As this date came after the end of the Brexit Transition Period, the changes did not apply in GB.
Proposed Changes to GB BPR
HSE proposes to make technical updates to the Annexes that will:
- Introduce and place emphasis on in vitro studies rather than in vivo studies;
- Make new tests for endocrine disruptors part of the legal data requirements in GB BPR, rather than only being done on an ad hoc basis;
- Change mutagenicity requirements to reflect new information;
- Change requirements in relation to reproductive toxicity and generational studies;
- Change the requirements to include developmental neurotoxicity studies if certain triggers are met; and
- Change the requirements to include efficacy data to support the innate activity of the active substance for the intended use.
According to HSE, these changes would enable:
- A reduction in animal testing;
- Alignment with current guidance and Organisation for Economic Co-operation and Development (OECD) validated tests; and
- Keeping up with new developments and scientific progress.
HSE notes that the proposed reduction in animal testing will not reduce the quality of testing or safety of products, as reliable non-animal-based tests are now available to provide information that was previously available only through testing using live animals. HSE states that these changes are similar to updates made recently to data requirements in the EU’s BPR (Regulation (EU) No 528/2012). According to HSE, there are some minor differences that HSE believes will make the requirements more proportionate for GB needs, however.
Subject to comments submitted during the consultation, HSE proposes making the changes take legal effect in fall 2023, with a 12-month transitional period after which the new requirements would become mandatory from that point for any new evaluations starting from that point onwards (even if the application had been received prior to that point). HSE states that it will still accept data generated under the current requirements where the data are considered “scientifically adequate” for the purposes of evaluation, however, including data generated for compliance with the EU BPR.
Commentary
Most of the proposed changes to the GB BPR align well with current requirements under the EU BPR. Evaluating the efficacy data for treated articles at the product stage instead of the active substance stage, as is now the case under the EU BPR, seems more appropriate and efficient because the form and formulation of treated articles varies and affects efficacy.
Consideration of developmental neurotoxicity as an additional data requirement that is triggered by certain observations in the required core data sets leverages the advances in scientific knowledge about key events that are associated with developmental neurotoxicity to assure safety while limiting the routine, required use of additional live animals. This proposed GB BPR approach is an example of limiting additional animal testing to circumstances that are known to be associated with the potential for developmental neurotoxicty, and to explore that potential further when warranted by the required core data. This represents departure from a rigid, check box approach to consideration of the available, scientifically robust information before requiring the use of experimental animals and suggests that GB could be more open than the EU to incorporating new alternative methods (NAM) into its processes for evaluation of substances under the GB BPR.
HSE considers the differences between its proposed GB BPR revisions to be minor, well aligned with the evolution of scientific knowledge, and at lower cost than the EU BPR requirements. While it is clear that a data package that is sufficient for compliance with the EU BPR will be sufficient for compliance with the GB BPR, whether a GB BPR package generated according to the proposed revisions will be acceptable for compliance with the EU BPR is uncertain.