The Impact of a ‘no-deal’ Brexit on Biocidal Products Regulation
The 31st October 2019 remains as the current deadline for the United Kingdom to leave the European Union, with or without a deal in-place. Businesses need to be aware of the potential impacts a ‘no-deal’ Brexit could have on their current and future Biocidal products registered under BPR.
Businesses in the chemical industry are faced with continued uncertainty as the UK and EU are yet to agree on the terms of the departure.
If a withdrawal agreement can be reached before the end of October, an implementation period will follow, where UK-EU trade will be able to continue on the same terms as now until this period comes to an end. However, there is a very real possibility that no such deal will be agreed, forcing a scenario where the UK will look to establish its own separate system for biocidal product registrations, UK BPR. Companies wishing to register their biocidal products in both the EU/EEA and the UK will have to complete the registration process for both the EU BPR and UK BPR systems.
The UK competent authority, HSE, have issued guidance for business which outlines plans for the UK regulation of biocidal products during both an implementation period and in the event of a no-deal scenario, along with the necessary measures businesses will need to take in order to be prepared.
UK BPR - Maintaining Continued Access to the UK Market Under a 'no deal' Brexit
- There would be a separate system where companies wishing to apply for an active substance approval or a biocidal product authorisation in the UK would apply to HSE rather than ECHA.
- Biocidal product authorisations and active substance approvals currently valid in the UK would remain valid after Brexit until its normal expiry date.
- The UK will also look to establish its own version of the Article 95 list for approved active substances and suppliers. This UK version of the list would include companies already on the EU list, but they may need to provide supporting information to HSE, and will have to establish themselves in the UK within 2 years.
Further information regarding specific situations can be found in the ‘no-deal scenario table’ for biocidal products published by HSE at https://www.hse.gov.uk/brexit/biocides-no-deal-scenario-table.pdf.
Ongoing Applications Through The Current BPR System
- Any ongoing UK national biocidal product applications would be unaffected and processing would proceed as usual through HSE. Similarly, applications which do not involve the UK will not be affected.
- Any ongoing EU-wide biocidal product applications (such as mutual recognition or union authorisation) would require an additional application, for example an application being processed by the UK would need an additional application to the EU and vice versa, with the original application proceeding as usual.
EU BPR - Maintaining Continued Access to the EU Market Under a 'no deal' Brexit
- Biocidal product authorisation and active substance approval applications under EU BPR will proceed as normal if being assessed in the EU, but will not be valid in the UK.
- Under EU BPR, suppliers have to either be located in the EU or have an appointed EU-based representative to be listed in the Article 95 list. This includes Non-EU companies already listed, who will need transfer their representative to the EU if currently in the based in the UK.
- The European Chemicals Agency (ECHA) has published further advice online outlining the actions UK, EU and non-EU businesses will need to take to ensure continued compliance and maintain access to the EU market.
Enviresearch is here to help
During this period of uncertainty, Enviresearch can offer expert regulatory advice and support to minimise the impact of Brexit on your business operations. We will continue to provide assistance with the preparation of active substance and biocidal product dossiers to support registrations under the existing EU framework, alongside the new UK national system if put in place.