Feed additives are substances, or preparations, which are intentionally added to feed or water in order to satisfy the nutritional needs of animals, favourably affect the characteristics of feed and animal products, and favourably affect animal production, performance or welfare.
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. 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.
We can support you in the safety assessment of feed additives with a range of solutions and services:
- Strategy definition for the hazard assessment of feed additives
- Database search and expert review of experimental toxicological data
- Alert profiling
- Identification and assessment of toxicologically relevant structural alerts to understand toxicity mechanism and mode of action
- Read-across predictions