CHAPTER IIU.K. CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Article 10U.K.Specific data required for risk assessment of flavourings

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