Biocides: What you'll need to do in a no deal scenario
The UK would establish an independent standalone biocidal products regime.
The UK would put in place a stable regulatory framework for biocidal products from the point of exit, by retaining the BPR and its subsidiary regulations in national law using the provisions of the EU Withdrawal Act. At the time of exit, the national regime would be essentially the same as the current EU framework, with changes made only where they are required to enable the regime to operate effectively in a national context.
This would ensure continued levels of protection for human health and the environment and give certainty to UK businesses putting biocidal products on the market.
Implications for business
HSE would continue to act as the competent authority for the UK on behalf of the Secretary of State and the devolved administrations, building on its existing capacity and capability.
Companies wishing to apply for an active substance to be approved or for a biocidal product to be authorised in the UK would apply to HSE, instead of ECHA. Active substance approvals and biocidal product authorisations would be UK-specific. Companies wishing to apply for active substance approvals or product authorisations in the EU-27, the European Economic Area (EEA) (Norway, Iceland and Liechtenstein), and Switzerland, would continue to apply to ECHA.
HSE would take on the functions that ECHA currently performs, where these are still relevant in the UK. For example, HSE would co-ordinate the UK-specific active substance evaluation process, in liaison with the various administrations of the UK, and would undertake technical equivalence assessments (determining whether a new source of an active substance, or material produced by a different manufacturing process, is sufficiently similar to one that has already been evaluated, so that the evaluation conclusions remain valid).
HSE would introduce its own processes and systems for receiving and processing applications. Companies would use these instead of ECHA’s systems. In the longer term HSE would build an IT system for handling applications, with interim arrangements for receiving and processing applications put in place from exit day while it is developed.
Companies may need to submit information to HSE previously submitted to ECHA
HSE would store the information and data required to support biocidal product authorisations and active substance approvals, replacing ECHA’s databases. To enable HSE to operate the biocides authorisation regime on a UK-only basis, companies may need to submit supporting data or other information to HSE that had previously been submitted to ECHA. This would be the same information as was previously submitted and HSE would not impose additional charges.
Authorisations and approvals valid in the UK will remain valid
If you hold a biocidal product authorisation that is valid in the UK on exit day, it would remain valid in the UK after exit day until its normal expiry date. Active substance approvals would also remain valid until their normal expiry date.
If you have a biocidal product being processed by HSE on exit day, HSE would, where possible, continue to process this to grant a national authorisation. HSE would, however, need to ask you to re-submit the information supporting original application to enable it to complete its evaluation.
If you have an application being processed by another country in the EU, EEA or Switzerland on exit day as part of an EU-wide authorisation process (for example, a mutual recognition or union authorisation application), you would need to re-apply to the UK for a national authorisation. However, the date of your original application would be recognised for the purposes of meeting any application submission deadlines.
Article 95 list
A UK version of the EU list of approved active substance suppliers (the so-called ‘Article 95’ list) would be established. It would operate the same way as the current EU list. Companies already on the EU list would, on exit day, be included in the UK’s list. However, to remain on the list they would need to submit supporting information to HSE. This would be the same information as was submitted to ECHA, for example, an active substance dossier or a letter of access. Companies would also have to ensure they are established in the UK. A two-year phase-in period would be provided to give businesses time to meet these requirements.
Authorisation holders would need to be established in the UK
Under the BPR authorisation holders have to be established in the EU, the EEA or Switzerland. In the standalone national regime, authorisation holders would need to be established in the UK. There would be a phase-in period to give businesses time to make any necessary arrangements.
These arrangements will ensure there would be minimal changes at the time of exit from the current system, and that the transition will be as smooth for businesses as possible.
Scenario table to help you prepare
This scenario table sets out a number of actions and dates that your company would need to investigate so that you can prepare for a ‘no-deal’ scenario.