# 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 10: Specific data required for risk assessment of flavourings

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

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 ... categories ... 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.

---
Source: https://www.legislation.gov.uk/eur/2011/234/article/10 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-234/article-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.