Guidance for submission for food additive evaluations

This guidance document refers to the applications for authorisation of a new food additive or to a modification of an already authorised food additive, combining in a single document the description of the data requirements and their context, and also a description of the risk assessment paradigm applied. The document is arranged in four main sections: chemistry and specifications, existing authorisations and evaluations, proposed uses and exposure assessment, and toxicological studies. Assessment of the exposure to food additives is based on information on known or anticipated human exposure to the proposed additive or toxicologically relevant components of the additive from food, and any other potential dietary sources. For the toxicological studies, this guidance describes a tiered approach which balances data requirements against the risk, taking into consideration animal welfare by adopting animal testing strategies in line with the 3-Rs (replacement, refinement, reduction). This tiered approach for toxicological studies consists of 3 tiers, for which the testing requirements, key issues and triggers are described. According to this tiered approach, a minimal dataset applicable to all compounds has been developed under Tier 1, while Tier 2 testing, generating more extensive data, will be required for compounds which are absorbed and/or demonstrate (geno) toxicity in Tier 1 tests. Tier 3 should be performed on a case-by-case basis taking into consideration all the available data, to elucidate specific endpoints needing further investigation of findings in Tier 2 tests. This guidance document replaces the previous guidance document by the Scientific Committee for Food published in 2001. (C) European Food Safety Authority, 2012