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 F1... .
Textual Amendments
F1Words in Art. 9(2)(f) omitted (31.12.2020) by virtue of The Food Additives, Flavourings, Enzymes and Extraction Solvents (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/860), regs. 1, 145; 2020 c. 1, Sch. 5 para. 1(1)