Specific data required for risk assessment of food additives
Article 6
1. In addition to data to be provided pursuant to Article 5, information shall be provided on: (a) the identity and characterisation of the additive, including the proposed specifications and analytical data; (b) where applicable, the particle size, particle size distribution and other physicochemical characteristics; (c) the manufacturing process; (d) presence of impurities; (e) the stability, reaction and fate in foods to which the additive is added; (f) where applicable, the existing authorisations and risk assessments; (g) proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories; (h) a dietary exposure assessment; (i) the biological and toxicological data. 2. As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered: (a) toxicokinetics; (b) subchronic toxicity; (c) genotoxicity; (d) chronic toxicity/carcinogenicity; (e) reproductive and developmental toxicity.