Commission Implementing Regulation (EU) 2025/1782 of 9 September 2025 concerning the authorisation of a preparation of chromium chelate of DL-methionine as a feed additive for salmonids (holder of authorisation: Zinpro Animal Nutrition Europe, Inc.)

Official Journal EN of the European Union L series 2025/1782 10.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1782 of 9 September 2025 concerning the authorisation of a preparation of chromium chelate of DL-methionine as a feed additive for salmonids (holder of authorisation: Zinpro Animal Nutrition Europe, Inc.) (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 chromium chelate of DL-methionine (‘the preparation’). 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 the preparation as a feed additive for salmonids, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘other zootechnical additives’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 February 2025(2)that, under the proposed conditions of use, the preparation is safe for the target species, consumers and the environment. It also concluded that the preparation is not a skin or eye irritant but is considered a skin and respiratory sensitiser, while inhalation and dermal exposure are considered a risk. The Authority further concluded that the preparation may have the potential to be efficacious in improving the performance of salmonids, despite noting that one study showed a worse feed-to-gain ratio compared to the control when fed to salmons at the highest proposed use level. It did not consider that there is a need for specific requirements of post-market monitoring. (5) The Reference Laboratory set up by Regulation (EC) No 1831/2003 considered that the conclusions and recommendations reached in a previous assessment concerning another application for the authorisation of the same additive and verified by the Authority in its opinion of 30 January 2020(3) are valid and applicable for the current application. In accordance with Article 5(4), point (a), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required. (6) In view of the above, the Commission considers that the preparation of chromium chelate of DL-methionine satisfies the conditions as provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that preparation 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 Journal2025;23:e9310, https://doi.org/10.2903/j.efsa.2025.9310. (3) EFSA Journal2020;18(2):6026, https://doi.org/10.2903/j.efsa.2020.6026. (4) Commission Regulation (EC) No 378/2005 of 4 March 2005 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the duties and tasks of the Community Reference Laboratory concerning applications for authorisations of feed additives (OJ L 59, 5.3.2005, p. 8, ELI: http://data.europa.eu/eli/reg/ 2005/378/oj). ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj 1/5EN OJ L, 10.9.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, 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, 9 September 2025. For the Commission The President Ursula VON DER LEYEN 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1782/ojANNEX Minimum Maximum Identifica­ content content Name of the Species or tion number Composition, chemical formula, Maximum End of period of holder of Additive category of Other provisions of the feed description, analytical method age mg additive/kg of complete authorisation authorisation animal additive feedingstuff with a moisture content of 12 % Category: zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d30 Zinpro Chromium Additive composition Salmonids — 200 600 1. In the directions for 30 September Animal chelate of Preparation of: use of the additive 2035 Nutrition DL-methio­ and premixtures, the — Chromium chelate of Europe, Inc nine storage conditions DL-methionine: 1,8 to and stability to heat 2,2 % (≥ 1 000 mg Cr(III)/kg treatment shall be additive) indicated. — Iron coloured microtracer coated with tartrazine and shellac: 270 particles /g 2. For users of the additive additive and premixtures, feed Impurities: business operators — Nickel ≤ 1,33 mg/kg additive shall establish Solid form. operational procedures and Characterisation of the active organisational substance measures to address Chromium chelate of potential risks DL-methionine: resulting from their — [CH S(CH ) CH(NH ) use. Where those 3 22 2 COO] Cr(III) risks cannot be 3 — chromium-DL-2-amino- eliminated by such 4-(methylthio)butanoic acid procedures and measures, the Analytical method(1) additive and — For the determination of premixtures shall be total chromium in the feed used with personal additive: Inductively coupled breathing and skin plasma coupled with mass protective spectrometry (ICP-MS) equipment. ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj 3/5 OJ L, 10.9.2025 ENMinimum Maximum Identifica­ content content Name of the Species or tion number Composition, chemical formula, Maximum End of period of holder of Additive category of Other provisions of the feed description, analytical method age mg additive/kg of complete authorisation authorisation animal additive feedingstuff with a moisture content of 12 % — For the determination of methionine in the feed additive: Ion-exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS) — For proving the chelated structure of the feed additive: Mid-infrared (IR) spectrometry together with the determination of total chromium and methionine in the feed additive — For the determination of inclusion rate of the microtracer into the feed additive preparation: Enumeration of colour coated particles of the microtracer — For the determination of total chromium in premixtures: Inductively coupled plasma coupled to atomic emission spectrometry (ICP-AES) 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj EN OJ L, 10.9.2025Minimum Maximum Identifica­ content content Name of the Species or tion number Composition, chemical formula, Maximum End of period of holder of Additive category of Other provisions of the feed description, analytical method age mg additive/kg of complete authorisation authorisation animal additive feedingstuff with a moisture content of 12 % — For the determination of added chromium / chromium chelate of DL-methionine in premixtures and compound feed: Enumeration of colour coated particles of the microtracer present at fixed mass ratio in the feed additive preparation (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 ELI: http://data.europa.eu/eli/reg_impl/2025/1782/oj 5/5 OJ L, 10.9.2025 EN