CHAPTER II

CONTENT, DRAFTING AND PRESENTATION OF AN APPLICATION

Specific data required for risk assessment of food additives
Article 6
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.
Word in Art. 6(1)(g) 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(3)(a) (with reg. 23)
Words in Art. 6(1)(g) 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(3)(b) (with reg. 23)