Commission Implementing Regulation (EU) 2025/2513 of 11 December 2025 concerning the authorisation of copper(II)-betaine complex as a feed additive for all animal species

Official Journal EN of the European Union L series 2025/2513 12.12.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2513 of 11 December 2025 concerning the authorisation of copper(II)-betaine complex as a feed additive for all animal species (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. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of copper(II)-betaine complex. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) That application concerns the authorisation of copper(II)-betaine complex as a feed additive for all animal species, requesting that additive to be classified in the additive category ‘nutritional additives’ and in the functional group ‘compounds of trace elements’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 January 2023(2)that, under the proposed conditions of use, copper(II)-betaine complex is safe for all animal species as well as for the consumers. In regard to the environment, the Authority concluded that at the proposed use levels the substance is considered safe for the terrestrial species and the land-based aquaculture systems. The data available did not allow the conclusion to be made on the safety of the additive for marine sediment, when it is used in sea cages. The Authority also concluded that the additive exposure by inhalation is likely. The additive is irritant to eyes and non-irritant to skin. The additive is considered to be a skin and respiratory sensitiser, due to the presence of nickel. The Authority further concluded that based on the data available, the efficacy of the additive cannot be demonstrated. In its second opinion of 15 November 2023(3), the Authority concluded that the use of the additive at the proposed conditions of use in marine aquaculture does not a pose a risk to the marine sediment compartment. The Authority reiterated its previous conclusion that, based on the data available, the efficacy of the additive cannot be demonstrated. In its third opinion of 6 May 2025(4), the Authority concluded that that the additive is efficacious as a source of copper for all animal species. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (5) In view of the above, the Commission considers that copper(II)-betaine complex satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised for all animal species. 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. (6) 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: https://eur-lex.europa.eu/eli/reg/2003/1831/oj/eng. (2) EFSA Journal, 2023;21(2):7817, https://doi.org/10.2903/j.efsa.2023.7817. (3) EFSA Journal, 2023;21:e8460, https://doi.org/10.2903/j.efsa.2023.8460. (4) EFSA Journal, 2025;23:e9469, https://doi.org/10.2903/j.efsa.2025.9469. ELI: http://data.europa.eu/eli/reg_impl/2025/2513/oj 1/5EN OJ L, 12.12.2025 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, 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, 11 December 2025. For the Commission The President Ursula VON DER LEYEN 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2513/ojANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, End of period number of category of Maximum age Content of the element (Cu) Other provisions additive analytical method of authorisation the additive animal in mg/kg of complete feed with a moisture content of 12 % Category: nutritional additives. Functional group: compounds of trace elements 3b416 Copper (II)– Additive composition Bovines Before start 15 1. The additive shall be 1 January betaine Copper betaine complex with a of incorporated into feed in 2036 complex minimum content of 19 % of copper rumination the form of a premixture. and a minimum content of 36 % of betaine; Other bovines 30 2. The following information Nickel: maximum 77 mg/kg; shall be included in the Ovines 15 Solid form labelling: Caprines 35 — For feed for sheep, if ---------------------------------------------------- the level of copper in Characterisation of the active substances Piglets Up to 4 150 the feed exceeds Name: catena-[diaqua-sulphato- suckling and weeks after 10 mg/kg: ‘The level of μ2-(trimethylammonio)acetato- weaned weaning copper in this feed may copper(II)]; Piglets From 5-th 100 cause poisoning in Chemical formula: week after certain breeds of [Cu(H O) ((CH ) NCH COO)(SO )]n 2 2 33 2 4 weaning up sheep.’ Specifications: to 8 weeks — For feed for bovines Copper: minimum of 19 %; after after the start of Betaine: minimum 36 %; weaning rumination, if the level Sulphur: 9 %–12 %; of copper in the feed is Moisture: maximum 5 % Crustaceans 50 less than 20 mg/kg: Other animal 25 ‘The level of copper in Analytical methods(1) species and this feed may cause For the quantification of total copper in categories copper deficiencies in the feed additive: cattle grazing pastures — Inductively coupled plasma-atomic with high contents of emission spectrometry, ICP-AES (EN molybdenum or 15621 or EN 15510) or sulphur.’ — Atomic absorption spectrometry, AAS (ISO 6869). ELI: http://data.europa.eu/eli/reg_impl/2025/2513/oj 3/5 OJ L, 12.12.2025 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, End of period number of category of Maximum age Content of the element (Cu) Other provisions additive analytical method of authorisation the additive animal in mg/kg of complete feed with a moisture content of 12 % Category: nutritional additives. Functional group: compounds of trace elements For the quantification of total copperin 3. Users of the additive and the premixtures: premixtures, feed business — Inductively coupled plasma-atomic operators shall establish emission spectrometry, ICP-AES (EN operational procedures and 15621 or EN 15510) or appropriate organisational — Atomic absorption spectrometry, measures to address the AAS (ISO 6869) or potential risks of exposure — Inductively coupled plasma-mass by inhalation, dermal spectrometry, ICP-MS (EN 17053). contact or eyes contact, in particular due to the For the quantification of total copperin content of nickel. Where the compound feed: such risks cannot be — Inductively coupled plasma-atomic eliminated by these emission spectrometry, ICP-AES (EN procedures and measures, 15621 or EN 15510) or the additive and — Atomic absorption spectrometry, premixtures shall be used AAS (Commission Regulation (EC) with appropriate personal No 152/2009 (Annex IV-C) or ISO protective equipment, 6869) or including eyes, skin and — Inductively coupled plasma-mass breathing protection. spectrometry, ICP-MS (EN 17053). For the quantification of betainein the feed additive: — High performance liquid chromatography with refraction index detection (HPLC-RI). For the quantification of sulphurand sulphatein the feed additive: — Inductively coupled plasma-atomic emission spectrometry, ICP-AES (EN 15621). 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2513/oj EN OJ L, 12.12.2025Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, End of period number of category of Maximum age Content of the element (Cu) Other provisions additive analytical method of authorisation the additive animal in mg/kg of complete feed with a moisture content of 12 % Category: nutritional additives. Functional group: compounds of trace elements For proving the formation of copper (II) betaine complex: — Powder X-ray diffraction (XRD). (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/2025/2513/oj 5/5 OJ L, 12.12.2025 EN