Data required for risk management of food additives
Article 7
1. The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6(1) of Regulation (EC) No 1333/2008. 2. In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on: (a) the identity of the food additive, including reference to the existing specifications; (b) the function and technological need for the level proposed in each of the food categories or products for which authorisation is requested and an explanation that this can not be reasonably achieved by other economically and technologically practical means; (c) the investigations on the efficacy of the food additive for the intended effect at the use level proposed; (d) advantages and benefit for the consumer. The applicant shall take into account the requirements laid down in Article 6(2) of Regulation (EC) No 1333/2008; (e) why the use would not mislead the consumer; (f) proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories; (g) the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned; (h) the amount of the food additive present in the final food as consumed by the consumer; (i) analytical methods allowing the identification and quantification of the additive or its residues in food; (j) where applicable, the compliance with the specific conditions for sweeteners and for colours as laid down in Articles 7 and 8 of Regulation (EC) No 1333/2008.