Article 6 Specific data required for risk assessment of food additives

the identity and characterisation of the additive, including the proposed specifications and analytical data;

where applicable, the particle size, particle size distribution and other physicochemical characteristics;

the manufacturing process;

presence of impurities;

the stability, reaction and fate in foods to which the additive is added;

where applicable, the existing authorisations and risk assessments;

proposed normal and maximum use levels in F1... food categories F2..., or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;

a dietary exposure assessment;

the biological and toxicological data.

toxicokinetics;

subchronic toxicity;

genotoxicity;

chronic toxicity/carcinogenicity;

reproductive and developmental toxicity.