(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 authorisation. Article 10(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2) and Article 4 of the same Regulation for the authorisation of a new use of an additive.

(2)

Ethyl ester of β-apo-8’-carotenoic acid was authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for poultry belonging to the functional group ‘colourants, including pigments’, under the heading ‘carotenoids and xanthophylls’. The additive 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 Articles 4 and 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and the re-evaluation of ethyl ester of β-apo-8’-carotenoic acid as feed additive for chickens for fattening, laying hens and minor poultry species for laying and for fattening. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants’. 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 8 March 2016 (3) and of 12 November 2019 (4) that, under the proposed conditions of use, ethyl ester of β-apo-8’-carotenoic acid does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that ethyl ester of β-apo-8'-carotenoic acid is not an irritant to skin and eyes, and not a dermal sensitiser. On the inhalation toxicity of ethyl ester of β-apo-8’-carotenoic acid, the Authority cannot conclude on the risk of users by inhalation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health. The Authority further concluded that the additive concerned is effective in adding colour to food of animal origin. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the European Union Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5)

As regards the use in water for drinking, the Commission considers that the simultaneous use of the additive in water for drinking and feed is difficult to manage, as there are maximum levels established for safety reasons and there are also other additives containing xanthophylls and carotenoids that may be used in feed. The simultaneous use of ethyl ester of β-apo-8’-carotenoic acid in water for drinking and feed increases the ways of administration and the risk to exceed the maximum levels authorised for additives containing carotenoids and xanthophylls. Consequently, the use in water for drinking should be denied.

(6)

The assessment shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of ethyl ester of β-apo-8’-carotenoic acid should be authorised as specified in the Annex to this Regulation.

(7)

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 allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(8)

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