Article 10 Specific data required for risk assessment of flavourings

the manufacturing process;

specifications;

where applicable, information on particle size, particle size distribution and other physicochemical characteristics;

where applicable the existing authorisations and evaluations;

the proposed uses in food and proposed normal and maximum use levels in F1... categories F2... or in a more specified type of product within the categories;

the data on dietary sources;

the dietary exposure assessment;

the biological and toxicological data.

examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE);

genotoxicity;

subchronic toxicity, where applicable;

developmental toxicity, where applicable;

chronic toxicity and carcinogenicity data, where applicable.