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.