Even as we enter a crucial week for EU-UK trade negotiations, the shape of regulation for biocides and biocidal products on the future market of Great Britain is already well mapped out. Given that there is still a good deal of confusion in the industry (and many market participants are still in 'wait and see' mode), this blog looks at what we already know, so that businesses can start planning for 1 January 2021.
The most important message is that from the end of the implementation period (currently set at 11pm UK time on 31 December 2020), there will be two, separate, independent markets, where for decades there has been one Single Market. The trade negotiators are discussing access between these two markets, but nothing on the negotiating table will change the fundamentals of a two market system. Businesses need to act now to preserve market access into both the EU and the GB market. In particular:
- From day one, the regime in the UK, applicable for access to the market of Great Britain, will be a 'copy and paste' replication of the EU Biocidal Products Regulation, with the necessary tweaks to ensure it operates effectively;
- Under the Northern Ireland Protocol, the NI market will be governed by EU BPR, but there are arrangements (currently before UK parliament) to facilitate GB-NI trade;
- The UK's Health and Safety Executive (HSE) will fulfil the role of the EU's European Chemicals Agency (ECHA) and the Secretary of State will take over some of the responsibilities held by the European Commission;
- Before the end of the transition period, UK based suppliers on the Article 95 List need to protect ongoing access to the EU market through the appointment of a representative in the EU-27 and communicating the details to the European Chemicals Agency (ECHA) through a 'request for correction';
- UK based holders of authorisations will need to transfer them to an entity established in the EU through an administrative change requiring prior notification before implementation;
- Access to the new GB market will be maintained through transition provisions in the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (due to be further amended through the draft Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 currently before UK parliament): in short, existing active substance approvals and biocidal product authorisations that were in place before the end of the transition period will continue to be valid until their normal expiry date but, as the HSE will not have access to the ECHA database, there are provisions to require the holder to provide scientific and technical information to the HSE over time (and each market participant will need to understand the timeframes applicable to them).
- Ensuring access to the necessary scientific and technical data for the GB market is therefore an important consideration, just as it is for the GB version of the REACH regulation (see for example our blog here).
With less than two months to go until the end of the implementation period, steps to ensure continued market access for both the EU and the GB market must start now.
It is true that one of the big issues for the negotiation is the 'level playing field': in other words, the degree to which the UK and the EU will commit to matching environmental (and other) standards under the parallel regulatory regimes. As today's media coverage makes clear, both sides are still some way apart on this. This will of course have an impact on the future of biocides regulation, which is concerned with the protection of human health and the environment. However, even if the basic standards remain the same, the regulatory regime for biocidal products requires a number of independent scientific and technical judgements made by competent authorities, and it is hard to imagine that identical judgement calls will be made on each side of the North Sea. As such, 'divergence by decision-making' is highly probable.
Add to this the fact that it is stated government policy that environmental regulation can and should change ("there is no point leaving the EU to keep everything the same", as the UK Environment Secretary George Eustice put it this summer) and it becomes clear that market participants for biocidal products and active substances need to keep a close eye on both the GB market and the EU market in the future.
But there is no agreement on a mechanism on maintaining similar baseline environmental, labour and social standards in the years to come. The UK insists it will not tie itself to the Brussels rulebook.