Biocides vertebrate testing
To reduce in vivo testing on vertebrate animals, the GB Biocidal Products Regulation (GB BPR) requires that such tests should only be conducted as a last resort and that testing on vertebrates shall not be repeated for the purposes of GB BPR.
Determining if data exists
Before undertaking any in vivo testing on vertebrate animals for the purposes of GB BPR (for example to fulfil a data requirement), you must follow the steps on data sharing under GB BPR.
This ensures that your proposed in vivo test on vertebrates will not duplicate an existing test.
If HSE holds the data you need, you should follow the required steps to allow that data to be used on your behalf.
If no vertebrate data exists
If HSE does not hold the data you need, new tests involving vertebrates should only be conducted as the last available option to meet data requirements for your GB BPR application.
You should ensure all the other data sources have been exhausted before you commission any new vertebrate tests.
HSE has developed detailed guidance on how to address the toxicology data requirements for the authorisation of biocidal products, in line with the provisions of Article 62 of GB BPR on minimising animal testing when unnecessary.
In addition, before commissioning new tests involving vertebrates, you must contact HSE with a robust justification for the test. If the justification is found acceptable, the correspondence between you and HSE can be included in your GB BPR application.
If you submit an application containing new vertebrate data for active substance approval or product authorisation under GB BPR and we consider your justification is not acceptable, the data will not be accepted, and your application may be rejected.
To consult HSE about your proposed justification for conducting vertebrate studies for GB BPR, the prospective applicant or company acting on their behalf should submit a completed English language consultation form to [email protected].
Companies may wish to mark emails as confidential as appropriate. Please note that your form may be returned if it is incomplete.
Only the consultation form should be submitted by email.
All other relevant documentation and data must be submitted via the HSE Secure File Sharing Service, including:
- evidence that you have contacted HSE to determine whether we already hold such studies
- evidence that HSE confirmed we do not hold such studies
Using the HSE Secure File Sharing Service
- Once we have received and processed your consultation form, you will be sent a link to upload the files associated with the relevant consultation - please do not use the link to upload files related to other consultations or applications.
- Links will be sent out Monday to Friday and are valid for 5 working days. I the link expires before you are able to upload your files, please email [email protected] to request a new link.
- Please ensure you comply with the terms and conditions of using the HSE Secure File Sharing Service, these will be included in the email alongside the link.
- Please check the spam settings on your email account to ensure our emails are not going to your junk folder.
GB applications containing new vertebrate data
When submitting an application for active substance approval or product authorisation in GB that contains a test on vertebrate animals conducted after 1 September 2013, you must provide the following:
- evidence that you contacted, prior to the commissioning of the test, either:
- HSE - for tests commissioned after 31 December 2020
- European Chemicals Agency (ECHA) - for tests commissioned prior to 01 January 2021
- confirmation that HSE or ECHA, as applicable, did not hold such vertebrate tests
- a robust justification demonstrating why the test was necessary, such as why it represented a last resort and that all other data sources had been exhausted. Where you have contacted us prior to commissioning the test you can provide the correspondence showing that HSE agreed with your justification
If there is no evidence that HSE or ECHA, as applicable, has been contacted regarding a test conducted after 1 September 2013, the data will not be accepted, and your application may be rejected.
Enforcement action may also be taken as this is a breach of the law.