One year on – the impact of Brexit on the UK biocides sector
At the end of 2020, TSG published a paper to address some of the concerns United Kingdom (UK) and European Union (EU) businesses were likely to have at the end of the Brexit transition period once chemical regulations changed in the UK.
One year after Brexit, our biocides regulatory experts look at some of the current and future challenges of trading in the UK.
Meeting the GB BPR deadlines
2021 was the year of meeting important GB Biocidal Product Regulation (BPR) deadlines. From pending applications to maintain access to the GB market, to new applications and renewals for products ‘grandfathered’ over from the EU BPR to GB BPR, to establishment in the UK, TSG’s biocides specialists helped companies overcome any hurdles and navigate the new system smoothly.
Looking forward, the next key deadline is 31 December 2022 by when GB BPR Article 95 resubmissions of data need to be made.
Whilst GB BPR mirrors the EU BPR as much as possible, some changes have already been seen – obvious ones linked to procedures as well as the more challenging ones concerning differences between the status of active substances.
The submission of biocides applications can no longer be made with the EU central hub R4BP3. Applications to the UK’s Health & Safety Executive (HSE) must initially be made by completing specific forms which are then submitted by email. Once processed, a link to upload the relevant application files on the HSE Secure File Sharing Service is sent. Despite some initial delays in receiving the links, the system performs well in transferring the dossiers.
While HSE is yet to confirm the exact details of its review programme to evaluate existing biocidal active substances in GB (expected to start in Q2 2023), differences between the status of substances in the EU and GB began to appear in 2021, for instance:
- Certain active substance/PT combinations are no longer being supported under GB BPR
- While Didecyldimethylammonium chloride (DDAC) CAS No 7173-51-5 will be ‘approved’ in the EU in PTs 3 and 4 on 1 November 2022, it is still ‘under review’ under GB BPR
- Citric Acid CAS No 77-92-9, already approved for use in PT 2 on 1 March 2018, was assessed by ECHA as not giving rise to concern and added to Annex I in Category 6 on 29 March 2021. It is not listed on the GB ‘Simplified Active Substance List’
- Esbiothrin CAS No 260359-57-7 in PT 18 is listed on the ‘Open invitations’ document for companies to take over the role of participant under GB BPR
For the review of approval of active substances, we expect to see a difference in the approach between ECHA and the HSE as well as possible divergence in decisions made.
It is therefore essential for companies, mainly biocidal product formulators, to regularly check the GB BPR list of active substances in case active substance/PT combinations are no longer supported or decisions are made on active substance approval.
Current and future challenges trading in the UK
Trading outside of the EU has been challenging and frustrating for business owners, both in the chemicals industry and across other sectors. Whilst the initial hurdles have been overcome, additional difficulties are foreseen that will affect biocides.
Active substance availability and Article 95 listing
Active substance and product suppliers on the EU Article 95 List on 31 December 2020 were automatically included on the GB Article 95 List. However, action is needed and by 31 December 2022 suppliers must resubmit the dossier or Letter of Access (LoA) supporting the EU Article 95 listing to HSE to remain on the list. Based on the existing invitations to take over the role of participant for active substance/PT combinations, more active substances may not be supported which will reduce the choice in substances in addition to possibly less suppliers.
Letters of Access
With new LoA required for GB BPR purposes, data sharing negotiations are a major focus for this now separate market area.
Different processes in place
Companies will now see their biocidal products under two separate regulatory streams under EU BPR and GB BPR and with potentially different outcomes to contend with. This is already proving to be an administrative mountain that companies need to climb.
Northern Ireland (NI)
NI remains an interesting topic. EU BPR still applies in NI (with HSE acting as the Competent Authority), thereby creating the need for a ‘GB BPR’ instead of a ‘UK BPR’. Whilst the theoretical approach and the various routes to market are clear, how this unfolds in practice remains to be seen. An important point is that having a legal entity within NI (registered office, headquarters, or permanent business establishment) opens parallel opportunities within the EU and GB for biocides.
Complications that industry must contend with as part of the UK's exit from the EU do not finish with GB BPR. UKCA (UK Conformity Assessed) marking, GB CLP (Classification, Labelling and Packaging Regulation) and UK REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals regulation) are other regulations that directly impact on biocidal products.
Challenges to face will be divergence between regulations, from harmonised CLP requirements across the EU and GB to labelling issues in general, especially with regards to NI. UK REACH will affect co-formulants in biocidal products; and with DEFRA as the Competent Authority, differences in approach – such as the way ‘substances of very high concern’ are dealt with – are expected.
While 2021 was the year for mainly resubmitting and testing the new administrative system for GB BPR, the cost of maintaining compliance in two regulatory regimes, and the impact on the biocide and chemical industry in general, is yet to come.
With the UK government currently planning to introduce a Brexit Freedoms Bill allowing the removal of legislation of EU origin, divergences will become more obvious between chemical regulations in the EU and UK. Until then, confusion may arise such as the recent uncertainty of applicability in GB of Annex VIII of the CLP on harmonised information relating to emergency health response.
How can TSG Consulting help?
Whatever challenges GB BPR may bring, TSG’s team of experienced biocides consultants are committed to guiding companies through the changing regulations. With offices in the UK, and former HSE employees embedded in our teams, we are well-placed to understand the new regulations, communicate with the UK authorities and support companies with their biocide dossier resubmissions or new applications, as well as other regulations applying to chemicals.
Get in touch at [email protected] if you’d like an informal chat with our biocides team.