Regulation of Biocides in the UK – Update from the HSE
At Kerona Scientific’s virtual Biocides Symposium in February, Dr Nicola Gregg, Head of Biocides Operational Policy at HSE UK, spoke about the new Biocidal Products Regulation in Great Britain. The new GB regime reflects the framework of the EU BPR, but the two systems operate independently. Since the UK exited the EU it no longer has access to ECHA IT tools or data stored in ECHA systems. This means that for a product to remain under consideration in GB, applications and data must be resubmitted to the HSE. This also means companies must be established in the UK in order to be listed on the Article 95 list and obtain product authorisation.
Under continuity arrangements, active substance approvals and biocidal product authorisations in force before 31/12/2020 can remain until their expiry date. Great Britain transferred the EU’s Article 95 list but any Article 95 listings after 31/12/2020 need a specific submission into GB. To remain on the Article 95 list in GB, businesses must submit a supporting dossier or letter of access as submitted to ECHA to be established in the UK within two years of the end of the Transition Period which runs until 31/12/2022.
Under the Northern Ireland protocol (NIP), biocidal products supplied in Northern Ireland are subject to the EU BPR. The HSE acts as the competent authority on behalf of HSE NI. Northern Ireland accepts mutual recognitions, Union Authorisations and simplified notifications from EU Member States but can’t act as a lead Member State. For Article 95 listing in NI, companies must be established in the EU/EEA/CH or NI. The UK Government is committed to ‘unfettered access’ for NI goods moving to the rest of the UK.
The recent activities of the HSE include dealing with resubmissions (there are over 200 product application resubmissions), and for establishment applications, nearly 4,000 authorised products are potentially affected. Other activities include Union Authorisations being changed to GB National Authorisations, new applications, new UK Authorised Products Lists (separate for GB and NI), tracking EU decisions and deadlines that impact NI, preparing new application forms and templates for GB and NI in accessible formats, and new website information.
Kerona Scientific can help you with biocide registrations in the UK. Please contact our biocides team at email@example.com
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