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Chemicals: Biocides & Brexit

  • United Kingdom
  • Brexit
  • Diversified industrials - Chemicals

11-05-2017

To date it’s been REACH which has hogged the headlines as a Single Market regulation which merits special Brexit-related consideration. However, the Biocidal Products Regulation (BPR) is another EU regulation which will also be converted into UK law on Brexit. You may wonder how difficult this can be, but it presents its own particular challenges.

Like REACH, many aspects of the BPR depend on the involvement of EU institutions. For example, it is the European Commission which decides whether or not to approve an active substance which is in the EU Review Programme for a particular product type (as set out in Annex V BPR).

The European Chemicals Agency (ECHA) too plays a significant role. One example is the work of its Biocidal Products Committee (BPC), which includes carrying out peer reviews in the evaluation process for active substances under the EU Review Programme. The BPC also prepares the ECHA opinion on matters such as Union approval of a biocidal product, which is submitted to the European Commission for its final decision.

Unlike REACH, there is a system of dual approval for a biocidal product under the BPR which adds additional complexity in the Brexit context. First the active substances in it must be approved by the European Commission (e.g. through the EU Review Programme). Secondly the biocidal product itself must be approved either by the regulator of the relevant Member State and/or the European Commission in the case of Union approval. However, whilst the active substance in a biocidal product remains subject to the Review Programme (and potentially longer under the three year transition period provided for in the BPR), local laws of individual Member States continue to apply to that biocidal product. This remains the situation for a number of biocidal products.

So, how will this play out on Brexit?

A key issue for UK BPR is whether the UK will continue to recognise substances already approved by the European Commission and the EU Review Programme generally, in the sense of deeming active substances approved under the EU Review Programme to be approved for the purposes of UK BPR. This is relevant not only to biocidal products which businesses propose to supply or use in the UK, but also to treated articles which are placed on the UK market. The question though is whether this will be acceptable politically when one of the twelve principles guiding the UK Government in delivering Brexit is “taking control of our own laws”.

Alternatively HSE could reconsider active substance applications considered to date by the European Commission. HSE could also pick up the evaluation of any active substances currently in the EU Review Programme when an application is made for product approval under UK BPR. This would be potentially a huge increase in HSE’s workload, and a possible doubling of work.

Equally what happens to active substances still under evaluation by HSE, as the relevant competent authority, when the UK leaves the EU? The European Commission may require them to be handed over to another Member State for evaluation on Brexit or it may be happy for HSE to continue its evaluation of those substances post Brexit, on a transitional basis. Equally, HSE may look to keep all or some of them, particularly if the active substance in question is relevant to biocidal products in the UK.

Whatever happens, the UK looks set to lose its current insights and input into biocidal regulation at EU level when the UK leaves the EU. It will lose its seat at the EU table post Brexit, along with its right of UK representation on Member State Committees, including the BPC and The Forum for Exchange of Information on Enforcement.

For example if HSE does decide to make its own assessments of active substances in lieu of the European Commission through the EU Review Programme, it will be making scientific and technical decisions without the benefit of the peer review carried out by the BPC. Divergent law and standards between the EU and the UK is a real risk. The reality is that compliance with EU regulation will be a prerequisite for trade with the “new” EU and vice versa, and two sets of compliance costs would be an additional burden for industry. At the very least, the UK risks always being “behind the curve”.

From a practical perspective, ECHA’s R4BP 3, the central online hub through which all biocides applications are made will need to be replaced with an equivalent system. This is likely to take time, and as part of the exit negotiations, the UK may look to incorporate some transitional provisions into the withdrawal agreement, allowing a continued role for/access to ECHA at least in the short term. The Government has rejected an unlimited transitional status. It has however indicated that it is open, on an issue by issue basis, to considering a phased process of implementation to allow businesses time to plan and prepare for new arrangements.

Next steps?

For businesses, the priority is to consider now what biocidal products may be affected by Brexit, and what specific issues will need to be addressed. There could be Article 95 BPR to consider. Data access arrangements may need to be reviewed, both existing and new, as data access may be limited to the BPR. The requirements of other applicable chemicals regulation should also be kept in mind. For example, there are multiple challenges for biocidal products where the non-active substances are also subject to REACH, itself a complex regulation - see our Brexit and chemicals compliance briefing here. In particular the need for any 2018 REACH registrations should be taken into account in your overall strategy.

Many questions on biocides regulation remain currently unanswered, but are likely to move up the agenda as the clock ticks towards Brexit. It’s important for industry to lobby trade associations to share concerns with the UK Government and with EU institutions, and to stress the importance of a harmonised approach to biocides regulation (and other chemicals regulation including REACH and CLP) across the UK and the “new” EU.

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