COMMISSION IMPLEMENTING REGULATION (EU) 2021/420

of 9 March 2021

correcting Implementing Regulation (EU) 2020/1097 concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

(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 by Commission Implementing Regulation (EU) 2020/1097 (3) concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying.

(3) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 3 April 2019 (4) that the maximum proposed use level of 80 mg total carotenoids/kg of complete feed for lutein-rich and lutein/zeaxanthin extracts is safe for poultry for fattening (except turkeys), minor poultry for fattening, poultry for laying (except turkeys) and minor poultry for laying. By mistake, the heading of the sixth and seventh columns of the Annex to Implementing Regulation (EU) 2020/1097 refers to ‘mg of active substance of kg of complete feedingstuff with a moisture content of 12 %’. That reference is not correct as the EFSA opinion refers to the ‘total carotenoids’. It is therefore appropriate to correct the heading of the sixth and seventh columns of the table in the Annex to that Implementing Regulation to reflect the wording appearing in the EFSA opinion of 3 April 2019.

(4) The references to ‘poultry for fattening (except turkeys)’ and ‘poultry for laying, (except turkeys)’ have been modified to ‘chickens for fattening’ and ‘laying hens’. This change does not affect or modify the categories of animals currently authorised, as the term ‘poultry’ covers turkeys for laying and fattening, chickens for fattening and laying hens. Therefore, it is more appropriate to refer directly to chickens for fattening and laying hens.

(5) The EFSA opinion also indicated that the maximum use level of the lutein/zeaxanthin extract is 80 mg total carotenoids/kg of complete feed in poultry for fattening (except turkeys), minor poultry for fattening, poultry for laying (except turkeys) and minor poultry for laying. In addition, the EFSA opinion stated that in breeding minor poultry the maximum level should not exceed 50 mg total carotenoids/kg complete feed, considering the toxicological potential of zeaxanthin on reproduction. The EFSA opinion further stated that, since the breeding husbandry in minor poultry species does not differentiate between laying and breeding, it cannot be excluded that the additive contained in a layer diet would be given to minor breeding poultry. By mistake, the table in the Annex to Implementing Regulation (EU) 2020/1097 set the maximum level of carotenoids of lutein/zeaxanthin extract for poultry for fattening (except turkeys), minor poultry for fattening, poultry for laying (except turkeys) and minor poultry for laying at 50 mg total carotenoids/kg feed, while this level should apply only to minor poultry for laying, to prevent any misuse on breeding animals. The rest of the poultry categories should have a maximum level of use of 80 mg total carotenoids/kg of complete feed.

(6) Implementing Regulation (EU) 2020/1097 should therefore be corrected.

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

HAS ADOPTED THIS REGULATION:

Article 1 The Annex to Regulation (EU) 2020/1097 is replaced by the Annex to this Regulation.

Article 2 This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 9 March 2021. For the Commission The President Ursula VON DER LEYEN

(1) OJ L 268, 18.10.2003, p. 29.

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3) Commission Implementing Regulation (EU) 2020/1097 of 24 July 2020 concerning the authorisation of lutein-rich and lutein/zeaxanthin extracts from Tagetes erecta as feed additives for poultry (except turkeys) for fattening and laying and for minor poultry species for fattening and laying (OJ L 241, 27.7.2020, p. 23).

(4) EFSA Journal 2019; 17(5):5698.