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Guidance on data sharing in the UK for EU Regulation (528/2012)

In line with recent policy developments in REACH and the Regulation on the placing of plant protection products on the market, sharing of vertebrate animal studies in exchange for equitable compensation becomes mandatory under the EU Biocide Regulation 528/2012 (EU BPR). This is expected to save costs and animal lives by prohibiting the duplication of these studies.

General points

In order to avoid animal testing, testing on vertebrates for the purposes of the new Regulation must only be carried out as a last resort. Testing on vertebrates must not be repeated for the purposes of EU BPR.

Anyone intending to carry out new tests involving vertebrates must send a written request to ECHA asking whether such tests have already been submitted to ECHA or a competent authority (CA) in connection with a previous application under EU BPR or the Biocidal Products Directive (BPD). For new tests involving non vertebrates prospective applicants may send a similar written request to ECHA, though it is not mandatory for non vertebrate tests.

If relevant tests have already been submitted to the ECHA or a CA, ECHA will provide details of the data submitter and data owner to the prospective applicant. The data submitter will then facilitate contact between the prospective applicant and the data owner.  If the data is still under data protection the prospective applicant  must for vertebrate tests and may for non vertebrate tests request all the technical and scientific data related to the tests as well as the right to refer to these data when submitting an application under EU BPR.

Compensation for data sharing

If such a request is made, the prospective applicant and the data owner should make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant. Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.

If an agreement is reached the data owner will make all the data concerned available to the prospective applicant or will give them permission to refer to the data when submitting an application under EU BPR.

If no agreement is reached in relation to tests or studies involving vertebrate tests the prospective applicant must inform ECHA and the data owner, at the earliest one month after the prospective applicant receives the name and address of the data submitter from ECHA. Within 60 days of being informed, ECHA will give the prospective applicant permission to refer to the data on vertebrates, provided the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs involved. If the prospective applicant and the data owner cannot agree, national courts will decide the share of the cost that the prospective applicant has to pay the data owner.

An appeal may be brought against the decisions of ECHA.

Updated 2013-06-26