# 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 6: Specific data required for risk assessment of food additives

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 identity and characterisation of the additive, including the proposed specifications and analytical data;
(b) where applicable, the particle size, particle size distribution and other physicochemical characteristics;
(c) the manufacturing process;
(d) presence of impurities;
(e) the stability, reaction and fate in foods to which the additive is added;
(f) where applicable, the existing authorisations and risk assessments;
(g) proposed normal and maximum use levels in ... food categories ..., or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;
(h) a dietary exposure assessment;
(i) the biological and toxicological data.
2. As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered:
(a) toxicokinetics;
(b) subchronic toxicity;
(c) genotoxicity;
(d) chronic toxicity/carcinogenicity;
(e) reproductive and developmental toxicity.

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Source: https://www.legislation.gov.uk/eur/2011/234/article/6 (the official version)
Page: https://openlegislation.uk/eu-regulation-2011-234/article-6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.