Regulation (EC) No. 1831/2003 provides the application procedure for their authorisation in Europe.
Based on the EFSA Guidance on the safety of feed additives for consumers, data submitted should allow an assessment of the safety for consumers exposed to food derived from animals given feed or water containing the additive, considering: i) the metabolic fate (ADME) and residues of the additive in the target species and laboratory animals, ii) the potential toxicity of the additive, iii) consumer exposure resulting from the consumption of food derived from animals exposed to the highest proposed use level of the additive.
The basic set of toxicological studies includes studies on genotoxicity and subchronic oral toxicity. Based on these results, there could be an indication to perform chronic oral toxicity, reproduction toxicity including prenatal developmental toxicity, and carcinogenicity studies.
In silico studies, such as read-across studies, can be proposed to improve understanding of toxicity mechanisms and to compare the toxicity of parent substance with its metabolites.