(fra kommisjonsforordningen)

(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC. 

(2) The substance indigo carmine was authorised under the name ‘indigotine’ without a time limit in accordance with Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group ‘colourants, including pigments’, under the heading ‘other colourants’. It was also authorised without a time limit as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules’. That substance was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003. 

(3) In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of indigo carmine as a feed additive for cats, dogs and ornamental fish. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants: substances that add or restore colour in feedingstuffs’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. 

(4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 28 April 20153 and 27 June 20244 that indigo carmine (purity of at least 85% colouring matter) is safe for cats and dogs at levels up to 250 mg/kg complete feed, and for ornamental fish up to 1000 mg/kg complete feed. The Authority concluded that it would be prudent to regard users as being at risk of inhalation exposure to dust from the additive and that in the absence of information on the inhalation toxicity of indigo carmine, such exposure is regarded as hazardous. Indigo carmine is not an irritant to skin and eyes but it should be considered a potential skin and respiratory sensitiser in humans. Indigo carmine is effective in adding colour to feedingstuffs for dogs, cats and ornamental fish. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. 

(5) In view of the above, the Commission considers that indigo carmine satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised as specified in the Annex to this Regulation. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive. 

(6) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substance concerned, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,