Regulatory Developments

UK HSE Announces March 31, 2021, and June 29, 2021, Deadlines for Businesses under UK BPR

March 9, 2021

The United Kingdom (UK) Health and Safety Executive (HSE) published an HSE Biocides eBulletin on March 8, 2021, announcing upcoming deadlines for businesses under the Great Britain (GB) Biocidal Products Regulation (GB BPR). As of January 1, 2021, HSE no longer has access to the European Union’s (EU) information technology (IT) systems to access applications (including the data dossiers) previously submitted under those systems. Businesses must therefore resubmit applications for product authorizations and active substance approvals to HSE to be evaluated under GB BPR.

The following deadlines apply for resubmission of GB product authorizations (including renewals) and active substance approval (including renewals) to HSE:

  • March 31, 2021, for resubmission of any application where the UK was, at any time prior to January 1, 2021:
     
    • Evaluating the Union or National product authorization application (including renewal) as the reference Member State (rMS); or
       
    • The evaluating Competent Authority (eCA) for an active substance approval/renewal application.
       
  • June 29, 2021, for resubmission of any application where, prior to January 1, 2021, the UK was:
     
    • A concerned Member State (cMS) for the UK/EU product authorization application (including renewal, mutual recognition);
       
    • The rMS or cMS for the same biocidal product application (UK/EU) or any application to change an authorization; or
       
    • Not the evaluating eCA for an active substance approval/renewal application.
       

Businesses can consult HSE’s fact sheets to determine which deadline is relevant for their applications. Applicants must resubmit the full original application and any additional data gathered or generated since the original submission in IUCLID format. HSE will charge no fees for receiving and handling the resubmissions, but the regular fees will be charged for the evaluation of the resubmitted applications and data. The fee schedule is available on HSE’s website.

Commentary

The UK’s status as a “third country” from the EU perspective has consequences on the regulation of biocide products in the UK. The UK’s loss of access to the EU’s databases and IT systems generates burdens and obligations for companies wishing to continue doing business in post-Brexit UK. To secure continued access to the UK market, companies must be aware of applicable compliance deadlines, must ensure the availability of and legal access to the information they must resubmit, and must be prepared to pay the additional costs associated with obtaining data rights and the evaluation of the data by HSE.


 
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