UK | Revision of GB Biocidal Products Regulation Annexes II and III

 This consultation relates to the Great Britain Biocidal Products Regulation (GB BPR) (Regulation EU No 528/2012). GB BPR applies to the supply and use of biocidal products. Biocidal products are products that control harmful organisms, and include insecticides, rodenticides, wood preservatives, anti-fouling coatings on ships, disinfectants, and hand sanitisers. Biocides are essential to society to protect human health and infrastructure but can also cause risks to human and animal health and the environment if used incorrectly. GB BPR therefore aims to ensure a high level of protection for both human and animal health and the environment.

UK HSE is consulting on proposed revisions to Annexes II and III of GB BPR, which deal with the following:

Annex II – information requirements for biocidal active substances.  The Annex details the information that must be submitted by applicants who wish to apply for a biocidal active substance to be approved.

Annex III – information requirements for biocidal products.  This Annex details the information that must be submitted by applicants who wish to apply for biocidal products to be approved.

HSE is proposing to make technical updates to these Annexes which will:

1. Introduce and place emphasis on In Vitro studies rather than In Vivo studies.
2. Make new tests for endocrine disruptors part of the legal data requirements in GB BPR, rather than only being done on an ad hoc basis.
3. Change mutagenicity requirements to reflect new information.
4. Change requirements in relation to reproductive toxicity and generational studies.
5. Change the requirements to include developmental neurotoxicity studies if certain triggers are met.
6. Change the requirements to include efficacy data to support the innate activity of the active substance for the intended use.

These changes would enable:

• A reduction in animal testing
• Alignment with current guidance, and Organisation for Economic Co-operation and Development (OECD) validated tests
• Keeping up with new developments and scientific progress

The proposed reduction in animal testing will not reduce the quality of testing or safety of products, as reliable non-animal-based tests are now available to provide information which was previously only available through testing using live animals.

The changes are similar to updates made recently to data requirements in the European Union’s Biocidal Products Regulation (EU) No 528/2012.  However, there are some minor differences which HSE believes will make the requirements more proportionate for GB needs.