Characteristics

Regulation 1107/2009 contains provisions on data sharing which aim to avoid the duplication of studies concerning plant protection products on vertebrate animals. Inquiries have to be made by the applicant at the competent authority.

The legal basis

According to Article 62 of Regulation (EC) No 1107/2009 tests and studies on vertebrates should be avoided. In addition, studies involving vertebrates should be listed in a separate list to be able to easily identify them in order to avoid the duplication of testing and to facilitate the sharing of costs and results.

In addition, The Regulation states in Article 62 (1) that: ‘testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available’.

The Regulation states that dossiers submitted for the approval of active substances and authorisation of plant protection products should include ‘for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals’ (Article 8(1)(d) and Article 33(3)(c) respectively).

Data sharing

The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way.

Consequences if the applicant doesn’t ask the Ctgb for information about animal testing

Unless the applicant can clearly demonstrate that animal testing will not be unnecessarily repeated, an application will not be taken into consideration if the dossier contains animal testing data and no information about previous testing has been acquired beforehand. Or: the Ctgb, after receiving a request to do so, has provided information about comparable animal testing data and the applicant cannot justify the need for new animal testing data. The form Request for information on animal (vertebrate) testing only concerns test on vertebrates. The applicant should have the intention to submit an application for authorisation, re-registration or change of authorisation.

Application type criteria

The form Request for information on animal (vertebrate) testing only concerns test on vertebrates. The applicant should have the intention to submit an application for authorisation, re-registration or change of authorisation.