(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 for the authorisation of a new use of an additive.

(2)

Lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for poultry belonging to the group ‘colourants, including pigments’, under the heading ‘carotenoids and xanthophylls’. These two extracts were authorised under the common name ‘lutein’ and ‘zeaxanthin’ without any specification so the request for this two forms lutein-rich and lutein/zeaxanthin fell within the generic entries ‘lutein’ and ‘zeaxanthin’. The additives were subsequently entered in the Register of feed additives as existing products, 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 lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta in water for drinking and the re-evaluation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and for laying and minor poultry species for fattening and for laying. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’. 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 opinion of 3 April 2019 (3) that, under the proposed conditions of use, lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta do not have an adverse effect on animal health, consumer safety or the environment. It stated that the conclusion on the safety and efficacy of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta for poultry (except turkeys) for fattening and for laying can be extrapolated to minor poultry for fattening and for laying. It also concluded that the active substances are viscous substances, so operators will not be exposed by inhalation. The applicant recognises that the active substances may be irritant to skin and eyes. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human heath, in particular, as regards the users of the additive, including the use of the additives in the form of a preparation, where toxicity by inhalation or due to the potential skin/eye irritant nature of the substance cannot be excluded. The Authority further concluded that the additives concerned are 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 additives 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 lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta 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 (for lutein-rich 80 mg/kg alone or with other carotenoids or xanthophylls and for lutein/zeaxanthin 50 mg/kg alone or with other carotenoids or xanthophylls). Consequently, the use in water for drinking is denied.

(6)

The assessment shows that the conditions for authorisation for lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those additives 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 substances 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,