Specific data required for risk assessment of flavourings
Article 10
1. In addition to data to be provided pursuant to Article 5, information shall be provided on: (a) the manufacturing process; (b) specifications; (c) where applicable, information on particle size, particle size distribution and other physicochemical characteristics; (d) where applicable the existing authorisations and evaluations; (e) the proposed uses in food and proposed normal and maximum use levels in the categories according to the Union list or in a more specified type of product within the categories; (f) the data on dietary sources; (g) the dietary exposure assessment; (h) the biological and toxicological data. 2. As regards to the biological and toxicological data, referred to in point (h) of paragraph 1, the following core areas shall be covered: (a) examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE); (b) genotoxicity; (c) subchronic toxicity, where applicable; (d) developmental toxicity, where applicable; (e) chronic toxicity and carcinogenicity data, where applicable.