Updates

The Biocidal Products (Health and Safety) (Amendment) Regulations 2022

Jurisdiction: Great Britain

Commencement: 31st December 2022

Amends: GB Retained: Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products

Mini Summary

The GB Retained: Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products details the rules for the authorisation of biocidal products placed on the market in Great Britain. Following the UK leaving the European Union (EU), this EU Regulation has been incorporated directly (with amendments) into domestic law in Great Britain (GB). This entry describes the GB version of the Biocides Regulation. There is a separate entry for the remaining EU version of the Regulation. (N.B. The EU version also applies in Northern Ireland.)

Duties

Various duties apply.

 

Amendment

Article 26 (Applicable procedure) and Article 29 (Submission and validation of applications) are amended.

The competent authority* must inform applicants** of any fees payable by 31st December 2027.

*The competent authority is:

  • for England, the Secretary of State;
  • for Scotland, the Scottish Ministers; and
  • for Wales, the Welsh Ministers.

**Applicants refers to applicants of any application:

**Relevant category B products are any product containing an active substance listed in the Simplified Active Substance List.

Authorisation and evaluation of applications

The competent authority must consider the results of the comparative assessment* before authorising an application for products containing an active substance.*Comparative assessment is a comparison of the biocidal product with other authorised biocidal products.

The competent authority must decide whether to authorise applications that were validated in accordance with Article 19 by 31st December 2027. This applies only to applications that were validated before 31st December 2026.

The competent authority must authorise any application by 31st December 2027 if:

  • the application was accepted before 2nd October 2027; and
  • the competent authority is satisfied the application meets the conditions set out in Article 25.

N.B. The deadline may be extended if the competent authority requires additional information on an application.

An application must be rejected if the applicant fails to submit the required information.

Minor technical changes are made to Article 89. The deadline by which the competent authority must authorise applications concerning biocidal products is extended to:

Transitional measures for applications

Transitional measures are added for applications made under the simplified procedure. These apply to applications:

  • made to the competent authority before IP completion day;
  • made under Article 4a of Regulation (EU) 414/2013; and
  • for which an authorisation decision was not made before IP completion day.

Applicants must resubmit the application and any supporting data to the competent authority by 31st January 2023.

The competent authority must reject any application which does not meet the requirements set out in Article 95FA.

Link to full government text

 

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