Following the Brexit on 31 December 2020, Great Britain is no longer part of the EU scheme for regulating biocidal products. The existing EU Biocidal Products Regulation (EU BPR) has been transformed to Great Britain Biocidal Product Regulation (GB BPR). However, most aspects of the EU BPR will continue in the same way under the GB BPR.

Here are a few updates on the GB BPR:

Table 1 

Ref: https://www.youtube.com/watch?v=BlremnIINIs&feature=youtu.be

• Ongoing active substance approvals and product authorizations will remain valid in GB and Northern Ireland (NI) until their expiry dates. (subject to establishment requirements)
• NI continues to follow the EU
• The EU and the UK negotiations have no impact on the biocides

• Establishment Rules: 

  • GB BPR requires authorization holders to be established in the UK (including NI)
  • EU BPR requires authorization holders to be established in the EU/EEA. An NI authorization holder must be established in the EU/EEA/NI

• Consequences of Establishment Rules:

  • To change the authorization, applicants must submit  an ‘Admin change’ application available in the Health and Safety Executive (HSE) website.
  • One (01) year transition period will be provided for products that are already authorized in the GB market.
  • Timelines will be provided by the HSE for resubmissions in GB.
  • Authorization for new products will be provided based on the applications.
  • For market-entry in both GB and NI, – two (2) sets of certificates are issued with both the addresses mentioned on the product label.

• Transitional Arrangements: 

  • Ongoing active substances and product applications must be resubmitted to the HSE by:
    • 31 March 2021, where the UK stands as the lead
    • 29 June 2021, where the UK is not the lead
  • A new application form from the HSE website must be used
  • Highlight and justify the data gaps
  • No automatic non-approval decisions

• Routes to the UK Market for Products:

  For GB:

  • Apply to the HSE as per the GB BPR or
  • Apply to the HSE via unfettered access (once the product is authorized in NI)

  For NI:

  • Apply to the HSE as per the EU BPR (national or MR) or
  • Apply to the ECHA for a Union Authorization under EU BPR

• Submissions or Resubmissions of Applications and Dossiers to GB:

  • Download the relevant application from the HSE website
  • Fill in the form and submit to the HSE via eMail
  • An upload link with a validity of five (5) days will be sent, where you must upload the files specific to the application

Hence, authorization holders must be established as per Table 1 and be aware of the deadlines issued by the HSE. Adhering to the Regulatory deadlines is quite complex and requires clear-cut knowledge of the regional Regulatory frameworks. Consult an expert for compliance. Stay informed. Stay updated.