Darren Abrahams Tom Gillett Hannah Widemann February 27 2023 Consultation on substantive revision of data requirements under GB Biocidal Products Regulation Steptoe LLP | Environment & Climate Change - United Kingdom Darren Abrahams, Tom Gillett, Hannah Widemann Environment & Climate Change IntroductionComparison with EU rulesKey differences to EU BPR changesNext stepsCommentIntroductionThe UK Health and Safety Executive (HSE) is seeking the views of interested parties, until 14 March 2023, on proposed revisions to the data requirements of the EU Biocidal Products Regulation(1) (BPR) as it applies for the Great Britain (GB) market.The proposed changes relate primarily to the information that must be submitted by applicants for biocidal active substance approvals and product authorisations under Annexes II and III of the GB BPR.The proposed changes to the GB BPR are designed to:increase emphasis on the use of in vitro studies rather than in vivo studies to reduce vertebrate testing, on the basis that technical advancements have resulted in the availability of more reliable non-vertebrate tests;make new tests for endocrine disruptors an intrinsic part of the data requirements;change requirements in relation to mutagenicity, reproductive toxicity and generational studies, and developmental neurotoxicity; andchange the requirements for efficacy data.Comparison with EU rulesThe proposed changes largely mirror the new rules adopted by the European Union in October 2020 under Commission Delegated Regulation (EU) 2021/525,(2) and under which changes to the Annex II and III data requirements have applied since 15 April 2022 (with voluntary application by applicants possible as of 15 April 2021). Since these new EU rules were not operative at the end of the Brexit transition period, they were not automatically copied across into UK law under the European Union (Withdrawal) Act 2018 – although they do apply in Northern Ireland.However, the HSE has confirmed that there will be substantive differences from the EU rules, which the HSE believes will make the requirements "more proportionate for GB needs". This creates an interesting dynamic, particularly since HSE specialists were involved in work on Commission Delegated Regulation (EU) 2021/525 while the United Kingdom was still a member of the European Union. It should also be noted that the HSE anticipates that a data package generated for the purposes of EU BPR compliance would also suffice for compliance with (an amended) GB BPR.Key differences to EU BPR changesIn the consultation document, the HSE highlights the following differences to the changes introduced to the EU BPR by Commission Delegated Regulation (EU) 2021/525:Clarification that analytical information required for in situ generated active substances (ie, active substances generated or released at the point of use from other chemicals) includes information on any additional impurities that may be present. Information on impurities is also required for other active substances (ie, those not generated in situ). Therefore, this does not appear to be an effort by the United Kingdom to seek a substantively different approach from the European Union, and is perhaps instead evidence of the benefit of having an opportunity to review the enacted EU legislative drafting and amend any perceived errors or ambiguities accordingly.In relation to efficacy data, Annex II of the EU BPR requires data to support claims made about treated articles, whereas the proposed changes to GB BPR will only require efficacy data for the innate activity of the active substance under Annex II. The HSE has confirmed that it considers that the European Union's requirement for efficacy data for treated articles at the active substance evaluation stage to be unnecessary, and that it is more appropriate to consider efficacy in detail at the full product stage (as is already the case). While not expressly stated in the consultation documents, this divergence from the requirements under the EU BPR may well be a reaction to the recent case law of the EU General Court,(3) in which the Court was called upon to clarify the principles applicable to efficacy assessment of active substances and treated articles.The EU changes to Annex II make additional developmental neurotoxicity testing on rats part of the core data set. In contrast, the proposed changes for GB BPR would make this part of the additional data set, which is only requested when triggered by the occurrence of neurotoxicity or thyroid toxicity (including changes in thyroid hormones) in adult experimental animals, or a biocidal mode of action targeting molecules in the nervous system of the target organism. Given that a developmental neurotoxicity is normally only encountered in situations where at least one of these triggers has been met, and that these studies involve vertebrate animals, the HSE considers that this more targeted approach is appropriate as opposed to requiring this test in every case.Otherwise, it appears that the current proposals align with the changes introduced in the EU. Such changes include, for example, a new tiered-testing approach. The tiered-testing approach anticipates that some studies (eg, extended one-generation reproductive or prenatal developmental toxicity studies), which are in certain cases standard information requirements under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation, may also be required under the BPR.While data sharing within each of these parallel chemical regimes is subject to mandatory rules, the requirements do not extend to mandatory sharing of data between regimes. Nevertheless, it is anticipated that the new GB BPR tiered-testing requirements may ultimately drive further discussions and negotiations between data owners and potential data accessors. Technical and legal support should be called upon when entering into such negotiations (which should preferably be conducted by written communications).Next stepsIn terms of timeframe, and subject to views elicited in the consultation, the HSE intends for the proposed changes to take legal effect in Autumn 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). However, data that had been generated under the current requirements would still be accepted where it is considered scientifically adequate for the purposes of evaluation.CommentIn general terms, the HSE proposal appears to confirm that the United Kingdom intends to follow the European Union's lead towards a more integrated approach to endocrine disrupting properties in chemicals regulation. However, as in the European Union, there is no sign that the identification of endocrine disruptors will lead to simple determinations about what to do next when risk assessments are carried out. The stage is set for further disagreements.For further information on this topic please contact Darren Abrahams, Tom Gillett or Hannah Wideman at Steptoe by telephone (+44 20 7367 8000) or email ([email protected], [email protected] or [email protected]). The Steptoe website can be accessed at www.steptoe.comEndnotes(1) Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.(2) Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products, C/2020/6771, OJ L 106, 26 March 2021, page 3–28.(3) In joined cases T 122/20 and T 123/20 Sciessent LLC v Commission.