From 31 January 2020, the United Kingdom is no longer part of the European Union, and since then a transition period has begun, lasting until 31 December 2020. This period is intended to introduce all the necessary measures to implement Brexit from 1 January 2021, the date on which new national regulations will come into force. These are still being finalized but are broadly comparable to the European regulations currently in place.
According to Regulation 528/2012 on the making available on the market and use of biocidal products, approved suppliers of substances or products listed under Article 95 must be established in the EU or have a nominated representative within the EU.
For all approved suppliers based in or represented by a UK entity, it will therefore be necessary to nominate a representative based in the EU before the end of the transition period to avoid being removed from the Article 95 list.
Once the UK leaves the EU, the HSE (Health and Safety Executive) will become the Competent Authority for all matters related to biocides.
Approvals for active substances and products granted up to that point will remain valid after the UK’s exit from the EU until their normal expiry date (provided that, for product authorisations, the company is established in the UK within 12 months of the exit date).
If applications have been submitted to the HSE before the exit date but no decision has been made regarding the authorisation or approval, it is expected that the supporting data must be resubmitted to the HSE within deadlines yet to be defined. This is necessary so that the HSE can continue assessing the applications and make a valid decision in the UK after losing access to the EU databases containing the information supporting these applications. If these deadlines are not met, the applications will be cancelled and the affected products withdrawn from the market (with a phase-out period allowed for the disposal of existing stocks).
TEAM mastery is able to support our clients with all regulatory procedures arising from the UK’s exit from the EU.