Vertebrate testing in support of applications for active substance approval or product authorisation under the Biocidal Products Regulation (528/2012)
In order to reduce in vivo testing on vertebrate animals, the Biocidal Products Regulation (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 this Regulation (article 62(1)), with data sharing being a paramount requirement under articles 62-63.
To meet this duty (following the entry into force of BPR on 1st September 2013), Applicants considering undertaking in vivo testing on vertebrate animals to support an application for active substance approval or product authorisation, must submit a written request and justification to ECHA prior to the testing being commissioned. This is to ensure that in the first instance the test is not a repeat of one that has already been performed.
In the case where such tests or studies have already been submitted to ECHA or a Competent Authority, ECHA will communicate details of the data submitter/data owner to the prospective Applicant so an agreement on using the tests or studies can be reached (with suitable compensation agreed – as set out in article 63).
Once it has been established that a proposed in vivo test on vertebrates will not duplicate an existing test, a robust justification must be provided indicating why the test is necessary, ie why it represents a last resort. It is recommended that the Applicant provides detailed justification for planning to undertake in vivo testing on vertebrates to the Competent Authority that they intend to submit an application containing such tests to.
Submissions to the UK CA
If an application submitted to the UK CA (for active substance approval or product authorisation) contains an in vivo test on vertebrate animals conducted after 1st September 2013, it is required that this application:
- will be supported by correspondence showing that ECHA has been appropriately consulted. The correspondence should include a statement to indicate that the test is not a duplicate of one that is already available. If there is no evidence that ECHA has been contacted regarding a test conducted after 1st September 2013, the test will not be accepted and so, the application may be deemed incomplete. In addition, this issue will be formally raised with HSE’s Biocides Compliance team; and
- will contain a robust justification stating why the test was necessary, ie why it represents a last resort. It is recommended that once it has been established that a proposed in vivo test on vertebrates will not be a repeat, the Applicant consult with the proposed evaluating Competent Authority to ensure there is agreement regarding the justification for the proposed test and that any test undertaken is conducted using the most appropriate protocol to fulfil the data requirement.
Pesticides/Plant Protection Products
Please note this position applies only to biocides. For information on vertebrate studies to support an application under Regulation (EC) No. 1107/2009, please consult the HSE pesticides website.