CHAPTER IICONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Article 6Specific data required for risk assessment of food additives

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 F1... food categories F2..., 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.