Commission Implementing Regulation (EU) 2025/647 of 2 April 2025 amending and correcting Implementing Regulation (EU) 2019/913 and correcting Implementing Regulation (EU) 2022/1471 concerning the authorisation of lanthanum carbonate octahydrate, respectively with identification numbers 4d1 and 4d23, as feed additives for cats

Official Journal EN of the European Union L series 2025/647 3.4.2025 COMMISSION IMPLEMENTING REGULATION (EU) 2025/647 of 2 April 2025 amending and correcting Implementing Regulation (EU) 2019/913 and correcting Implementing Regulation (EU) 2022/1471 concerning the authorisation of lanthanum carbonate octahydrate, respectively with identification numbers 4d1 and 4d23, as feed additives for cats (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 2003on additives for use in animal nutrition(1), and in particular Articles 9(2) and 13(3) 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) The authorisation of lanthanum carbonate octahydrate was renewed for 10 years as a feed additive for cats, with identification number 4d1, by Commission Implementing Regulation (EU) 2019/913(2) (holder of authorisation: Bayer HealthCare AG). Lanthanum carbonate octahydrate was also authorised for 10 years as a feed additive for cats, with identification number 4d23, by Commission Implementing Regulation (EU) 2022/1471(3) (holder of authorisation: Porus GmbH). Both additives were erroneously referred to as a preparation in the Annexes to those Implementing Regulations. In addition, the conditions of use in the Annexes to those Implementing Regulations do not properly reflect the conclusion of the European Food Safety Authority (‘the Authority’) in its opinions of 27 September 2007(4) and 27 January 2022(5) that lanthanum carbonate octahydrate is safe and efficacious for adult cats. (3) Implementing Regulations (EU) 2019/913 and (EU) 2022/1471 should therefore be corrected accordingly. (4) In addition, Bayer HealthCare AG, the holder of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1, has submitted an application to the Commission in accordance with Article 13(3) of Regulation (EC) No 1831/2003, proposing to change the name of the holder of the authorisation for that feed additive to Elanco GmbH. (5) The proposed change of the terms of the authorisation concerning the name of the holder of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1, is purely administrative in nature and does not entail a new assessment. The Authority was informed of the application. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) 2019/913 of 29 May 2019 concerning the renewal of the authorisation of lanthanum carbonate octahydrate as a feed additive for cats and repealing Regulation (EC) No 163/2008 (holder of authorisation Bayer HealthCare AG) (OJ L 146, 5.6.2019, p. 57, ELI: http://data.europa.eu/eli/reg_impl/2019/913/oj). (3) Commission Implementing Regulation (EU) 2022/1471 of 5 September 2022 concerning the authorisation of lanthanum carbonate octahydrate as a feed additive for cats (holder of authorisation Porus GmbH) (OJ L 231, 6.9.2022, p. 113, ELI: http://data.europa.eu/ eli/reg_impl/2022/1471/oj). (4) EFSA Journal (2007) 542. (5) EFSA Journal 2022;20(2):7168. ELI: http://data.europa.eu/eli/reg_impl/2025/647/oj 1/5EN OJ L, 3.4.2025 (6) To allow Elanco GmbH to exploit its marketing rights in accordance with Article 9(6) of Regulation (EC) No 1831/2003, it is necessary to change the terms of the authorisation concerned by indicating its name as the holder of the authorisation for lanthanum carbonate octahydrate as a feed additive for cats, with identification number 4d1. (7) Implementing Regulation (EU) 2019/913 should therefore be amended accordingly. (8) Since safety reasons do not require the immediate application of the modifications to the conditions of the authorisations of lanthanum carbonate octahydrate for cats, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the correction of Implementing Regulations (EU) 2019/913 and (EU) 2022/1471 and the amendment to Implementing Regulation (EU) 2019/913. (9) 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 Correction and amendment to Implementing Regulation (EU) 2019/913 The Annex to Implementing Regulation (EU) 2019/913 is replaced by Annex I to this Regulation. Article 2 Correction to Implementing Regulation (EU) 2022/1471 The Annex to Implementing Regulation (EU) 2022/1471 is replaced by Annex II to this Regulation. Article 3 Transitional measures 1. The substance specified in Annexes I and II and premixtures containing that substance, which are intended for cats and which are produced and labelled before 23 October 2025 in accordance with the rules applicable before 23 April 2025may continue to be placed on the market and used until the existing stocks are exhausted. 2. Compound feed and feed materials containing the substance specified in Annexes I and II, which are intended for cats and which are produced and labelled before 23 April 2027 in accordance with the rules applicable before 23 April 2025may continue to be placed on the market and used until the existing stocks are exhausted. 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/647/ojEN OJ L, 3.4.2025 Article 4 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, 2 April 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/647/oj 3/5ANNEX I Minimum Maximum Identifica- content content tion Name of the Species or Composition, chemical formula, Maximum End of period of number of holder of Additive category Other provisions description, analytical method age mg of additive/kg of authorisation the feed authorisation of animal complete feedingstuff with a additive moisture content of 12 % Category: zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine) 4d1 Elanco Lanthanum Additive composition Cats — 1 500 7 500 1. In the directions for use of the 25 June 2029 GmbH carbonate Lanthanum carbonate octahydrate additive and premixtures, the octahydrate At least 85 % lanthanum carbonate storage conditions and stability to octahydrate as active substance. heat treatment shall be indicated. 2. The additive shall only be fed to Characterisation of the active substance adult cats. Lanthanum carbonate octahydrate 3. In the directions for use of the La 2(CO 3) 3*8H 2O additive, the following shall be CAS number 6487-39-4 indicated: Analytical method(1) ‘For adult cats. Avoid simultaneous use of feeds For the quantification of carbonate with high level of phosphorus.’. in the feed additive: Union method, 4. For users of the additive and introduced by Commission premixtures, feed business Regulation (EC) No 152/2009(2). operators shall establish For the quantification of lanthanum operational procedures and in the feed additive and compound organisational measures to address feed: Inductively coupled plasma- potential risks resulting from their atomic emission spectrometry (ICP- use. Where those risks cannot be AES). eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. (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. (2) Commission Regulation (EC) No 152/2009 of 27 January 2009laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/ 2009/152/oj). 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/647/oj EN OJ L, 3.4.2025ANNEX II Minimum Maximum Identifica- content content tion Name of the Species or Composition, chemical formula, Maximum End of period of number of holder of Additive category Other provisions description, analytical method age mg of additive/kg of authorisation the feed authorisation of animal complete feedingstuff with a additive moisture content of 12 % Category: zootechnical additives. Functional group: other zootechnical additives (decrease in phosphorous excretion via urine) 4d23 Porus Lanthanum Additive composition Cats — 1 500 7 500 1. In the directions for use of the 26 September GmbH carbonate Lanthanum carbonate octahydrate additive and premixtures, the 2032 octahydrate having at least 85 % lanthanum storage conditions and stability to carbonate octahydrate as active heat treatment shall be indicated. substance. 2. The additive shall only be fed to Solid form. adult cats. 3. In the directions for use of the Characterisation of the active substance additive, the following shall be Lanthanum carbonate octahydrate indicated: La 2(CO 3) 3*8H 2O ‘For adult cats. CAS number 6487-39-4 Avoid simultaneous use of feeds Analytical method(1) with high level of phosphorus.’. 4. For users of the additive and For the quantification of carbonate premixtures, feed business in the feed additive: Union method, operators shall establish introduced by Commission operational procedures and Regulation (EC) No 152/2009(2). organisational measures to address For the quantification of potential risks resulting from their lanthanum in the feed additive and use. Where those risks cannot be compound feed: Inductively eliminated by such procedures and coupled plasma-atomic emission measures, the additive and spectrometry (ICP-AES). premixtures shall be used with personal breathing protective equipment. (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. (2) Commission Regulation (EC) No 152/2009 of 27 January 2009laying down the methods of sampling and analysis for the official control of feed (OJ L 54, 26.2.2009, p. 1, ELI: http://data.europa.eu/eli/reg/ 2009/152/oj). ELI: http://data.europa.eu/eli/reg_impl/2025/647/oj 5/5 OJ L, 3.4.2025 EN