Data required for risk management of food enzymes
Article 9
1. The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6 of Regulation (EC) No 1332/2008. 2. In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on: (a) the identity of the food enzyme, including reference to the specifications; (b) the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied; (c) the effect of the food enzyme on the final food; (d) why the use would not mislead the consumer; (e) the proposed normal and maximum use levels where applicable; (f) the dietary exposure assessment, as described in the Authority’s guidance document on food enzymes ( 13 ) .