Specific data required for risk assessment of food enzymes
Article 8
1. In addition to data to be provided pursuant to Article 5, information shall be provided on: (a) name(s), synonyms, abbreviations and classification(s); (b) Enzyme Commission Number; (c) the proposed specifications, including the origin; (d) the properties; (e) the reference to any similar food enzyme; (f) the source material; (g) the manufacturing process; (h) the stability, reaction and fate in foods in which the food enzyme is used; (i) where applicable the existing authorisations and evaluations; (j) the proposed uses in food and, where applicable, the proposed normal and maximum use levels; (k) the dietary exposure assessment; (l) the biological and toxicological data. 2. As regards to the biological and toxicological data, referred to in point (1) of paragraph 1, the following core areas shall be covered: (a) subchronic toxicity; (b) genotoxicity.