Since the referendum in 2016, on whether or not the UK should leave the European Union (EU), the exact path still remains unclear regarding the regulation of biocidal products in the UK with a no deal on the cards.
The Health and Safety Executive (HSE) have provided thorough and clear guidance on how to act in the various scenarios and we should feel well assured that the whatever the eventuality, the HSE aims to ensure regulatory continuity and minimal disruption with regards to biocides in the UK, displaying an ever pragmatic approach. Nevertheless, it’s safe to say, Brexit matters, and there could be cost implications regarding UK data access, increased complexity, time delays and duplication of effort with regards to regulatory workload amongst other uncertainties.
In the absence of an EU-UK deal on exit day, and a hard Brexit occurs, draft regulations have been prepared and laid before parliament to ensure that regimes governing biocidal products can continue to operate. Using the provisions of the EU Withdrawal Act, the UK will establish a standalone biocidal products regulation, which would mean continued levels of protection for human health and the environment and provide some certainty to UK businesses placing biocidal products on the UK market.
A key point to note is that the European Chemicals Agency (ECHA) would no longer act as the ‘Agency’ on behalf of the UK and this would transfer to the HSE, who would continue to be the UK’s competent authority. For example, functions such as technical equivalence assessments would be handled by the HSE and not ECHA and the HSE will need to compose a UK fee regime for such tasks. The UK would develop its own IT system for application handling, equivalent to ECHA’s Register for Biocidal Products (R4BP), the same EU Biocidal Products Regulation (BPR) EU 528/2012 format would be acceptable.
Active substance evaluations currently being handled by the UK would be transferred to EU Member States leaving the UK to handle their own active substance evaluation procedure which could still take into consideration EU and indeed other evaluations but ultimately the UK will make its own decisions, which could be a benefit in some respects. Further, the UK would manage a UK specific list of approved active substances and suppliers, ‘the Article 95 list’ requiring resubmission of information for UK and EU companies to remain on the UK list after 29th March 2021, but normal EU expiry dates will apply in the UK to active substance approvals.
New biocidal product authorisations would be UK specific and need to be held by a UK legal entity and existing UK biocidal product authorisations will be ‘grandfathered’ into the UK regime but again a resubmission will be necessary at least at the time of any amendment, renewal or by 29th March 2020, whichever is the earlier. New Union authorisations would no longer be able to include the UK but extant Union authorisations would continue to be recognised in the UK until their expiry.
For UK national authorisation applications that are ongoing on exit day, this process should continue, however, HSE will need a resubmission by 27th June 2019 to enable completion, but no additional fees will be incurred. For ongoing applications for mutual recognition with the UK as a concerned Member State or Union authorisations that include the UK but the UK is not the lead evaluating competent authority, these applications would need to be resubmitted to the UK as new national authorisations by 25th September 2019-surely fees may be charged for new evaluations. If the UK is the lead evaluating competent authority for ongoing Union authorisations and national authorisations with associated concerned Member States for mutual recognitions, the applications will need to be resubmitted to a new EU lead evaluating competent authority and fees are likely expected there too.
There will be a UK phase-in period allowed for companies to make any necessary changes and submit the required information and data to the HSE. Please see the HSE’s no deal guidance and advice table for more depth. It’s obvious that, with calls from UK and even the EU, that there should be a British membership with ECHA, whatever the outcome.
In the case that there is a deal in place on the 29th March 2019, this should make for a smoother transition during an implementation period until 31st December 2020, with an EU-UK agreement and clear alignments therefore.
Perhaps it is now too late to worry if Brexit is really for the better or not, since after industry making their wishes clear, the fate of biocidal products regulation in the UK moving forward is now in the hands of the government; one in which we hope make decisions for the best of the country. It’s now time for industry to focus on making the best of the situation and knowing how to act, and if you are looking for further support in this area, or any other chemical regulatory matter, please do contact Philippa O’Donovan at Philippa.firstname.lastname@example.org or email@example.com.
Please also see other recent CEA articles with regards to Brexit, i.e. concerning the REACH Regulation (EC) 1907/2006. Click here.