Division 10.1.2 Effects on terrestrial vertebrates other than birds

Possible risks to vertebrate species other than birds shall be investigated except when the test substance is included in plant protection products used, for example, in enclosed spaces and wound-healing treatments where vertebrate species other than birds will experience neither direct nor secondary exposure.

Experimental testing of vertebrates shall only be carried out where the data required for risk assessment cannot be derived from the data generated in accordance with the requirements set out in Section 5 and 7 of Part A of the Annex to Regulation (EU) No 283/2013.

An acute and reproductive risk assessment for terrestrial vertebrates other than birds shall be conducted in accordance with the relevant risk quotient analysis.