- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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)
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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 F1... categories F2... 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.
Textual Amendments
F1Word in Art. 10(1)(e) omiited (1.4.2025) by The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(5)(a) (with reg. 23)
F2Words in Art. 10(1)(e) omitted (1.4.2025) by virtue of The Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (S.I. 2025/361), regs. 1(2), 10(5)(b) (with reg. 23)
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