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:

**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:

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:

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.

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Jurisdiction: EU & Northern Ireland

Commencement: 9th November 2021

Amends:

Mini Summary
Regulation (EU) 528/2012 concerning the making available on the market and use of biocidal products concerns the making available on the market and use of biocidal products (‘Biocidal Products Regulation’) sets out the requirements which apply to biocidal products. The Regulation primarily concerns those manufacturers, importers, etc. who wish to place biocidal products on the market.

Biocidal products are products which are designed to control, by chemical or biological means (but not solely by physical means) harmful organisms which include not only pathogens, but also some vermin, fish and birds. Biocidal products contain one or more ‘active substances’ which act on the harmful organisms.

Before placing a harmful product on the market in an EU Member State, the person who wishes to place it on the market must ensure that:

The Biocidal Products Regulation is directly acting in all EU Member States.

There are several routes by which a product may become authorised. A product may be authorised in one Member State but this does not automatically allow the product to be placed on the market in other Member States – it is therefore important to ensure that the correct process has been followed if the product is to be placed on the market in other Member States.

Users must use biocidal products in accordance with any labelling and conditions which apply to the product (which information should be made available with the product). Users do not need to apply for authorisation.
Amendment

The expiry date of the approval of creosote (active substance*) for use in biocidal products of product-type 8 (wood preservatives) is postponed to 31st October 2022. 

*An active substance is defined as a substance or micro-organism (including viruses) that has a general or specific action against harmful organisms or on plants, parts of plants or plant products.

There are no changes in duties for organisations.

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