# Commission Regulation (EU) No 234/2011 of 10 March 2011 implementing Regulation (EC) No 1331/2008 of the European Parliament and of the Council establishing a common authorisation procedure for food additives, food enzymes and food flavourings (Text with EEA relevance), Article 9: Data required for risk management of food enzymes

Extent: E+W+S+N.I.

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 ... .

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Source: https://www.legislation.gov.uk/eur/2011/234/article/9 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-234/article-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.