Commission Implementing Regulation (EU) 2025/1928 of 25 September 2025 concerning the authorisation of a preparation of lutein-rich extract of Tagetes erecta L. as a feed additive for turkeys for fattening

Official Journal EN of the European Union L series 2025/1928 26.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1928 of 25 September 2025 concerning the authorisation of a preparation of lutein-rich extract of Tagetes erectaL. as a feed additive for turkeys for fattening (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 an authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of lutein-rich extract of Tagetes erecta L. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of a preparation of lutein-rich extract of Tagetes erectaL. as a feed additive for use in feed for turkeys for fattening, requesting that additive to be classified in the category ‘sensory additives’ and in the functional group ‘colourants (ii), substances which, when fed to animals, add colours to food of animal origin’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 18 September 2024(2)that, under the proposed conditions of use, the additive is safe for the target species, for consumers and for the environment. Regarding user safety, it concluded that the lutein-rich extract of Tagetes erectaL. is irritant to skin and eyes and any exposure is considered a risk. The Authority further concluded that the substance has the potential to colour the skin of turkeys for fattening at the proposed conditions of use. (5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in the assessment carried out regarding the methods of analysis of lutein-rich extract of Tagetes erectaL. as a feed additive in the context of the previous authorisation are valid and applicable for the current application. However, the Reference Laboratory subsequently updated the evaluation report submitted in the context of the previous authorisation, in order to take account of scientific and technological developments and to ensure a better suitability of the methods of analysis for official controls. The Authority verified the amended report on the methods of analysis of lutein as a feed additive submitted by the Reference Laboratory(3). (6) In view of the above, the Commission considers that the preparation of lutein-rich extract of Tagetes erectaL. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. As regards the methods of analysis, account should be taken of the updated evaluation report of the Reference Laboratory. Accordingly, the use of that substance as a feed additive should be authorised. 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. (7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal2024; 22(10):e9027, https://doi.org/10.2903/j.efsa.2024.9027. (3) Minutes of the meeting of 28-29 January 2025 of the Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), accessible at: https://www.efsa.europa.eu/sites/default/files/2025-02/feedap250128-29_m.pdf. ELI: http://data.europa.eu/eli/reg_impl/2025/1928/oj 1/4EN OJ L, 26.9.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants (ii), substances which, when fed to animals, add colours to food of animal origin’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex. Article 2 Entry into force This Regulation shall enter into force on the twentieth day following that 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, 25 September 2025. For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1928/ojANNEX Minimum Maximum Identification content content Species or End of period number of Composition, chemical formula, Maximum Additive category of Other provisions of the feed description, analytical method age mg total carotenoids/kg animal authorisation additive complete feed with 12 % moisture content Category: sensory additives. Functional group:colourants: (ii) substances which, when fed to animals, add colours to food of animal origin 2a161bii Lutein-rich extract Additive composition Turkeys 80 1. In the directions for use of 16 October Preparation of lutein-rich extract of for the additive and 2035 Tagetes erectaL. with total carotenoids fattening premixtures, the storage ≥ 0,5 % conditions and stability to heat treatment shall be Benzene ≤ 2 mg/kg indicated. Hexane ≤ 290 mg/kg 2. The mixture of lutein-rich extract with other Solid or liquid form authorised carotenoids shall Characterisation of the active substance not exceed a total Lutein from a saponified extract of carotenoids content of Tagetes erectaL. (dried flowers petals) 80 mg/kg of complete feed. obtained via extraction with hexane 3. For users of the additive and and saponification: premixtures, feed business — Total carotenoids (TC): ≥ 60 g/kg operators shall establish — Lutein ≥ 75 % of total operational procedures and carotenoids (TC) organisational measures to — Zeaxanthin ≥ 4 % of total address potential risks carotenoids (TC) resulting from their use. Chemical formula: C H O Where those risks cannot be 40 56 2 CAS number 127-40-2 (lutein) eliminated by such CAS number 144-68-3 (zeaxanthin) procedures and measures, CoE number: 494 the additive and premixtures shall be used with personal skin and breathing protective equipment. ELI: http://data.europa.eu/eli/reg_impl/2025/1928/oj 3/4 OJ L, 26.9.2025 ENMinimum Maximum Identification content content Species or End of period number of Composition, chemical formula, Maximum Additive category of Other provisions of the feed description, analytical method age mg total carotenoids/kg animal authorisation additive complete feed with 12 % moisture content Analytical method(1) For the determination of lutein, zeaxanthin and total carotenoids in the feed additive: — High performance liquid chromatography (HPLC) with spectrophotometry – FAO JECFA monograph ‘lutein from Tagetes erecta’, Combined Compendium for Food Additive Specifications For the determination of total carotenoids (including lutein) in premixtures and compound feed: — Reversed-phase high performance liquid chromatography (HPLC) coupled to UV detection – EN 17550 (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa- evaluation-reports_en. 4/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1928/oj EN OJ L, 26.9.2025