Commission Implementing Regulation (EU) 2024/1325 of 8 May 2024 concerning the authorisation of a preparation of cyanocobalamin (vitamin B12) produced with Ensifer adhaerens CGMCC 21299 as a feed additive for all animal species

Official Journal EN of the European Union L series 2024/1325 13.5.2024 COMMISSION IMPLEMENTING REGULATION (EU) 2024/1325 of 8 May 2024 concerning the authorisation of a preparation of cyanocobalamin (vitamin B ) produced with 12 Ensifer adhaerens CGMCC 21299 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 2003on 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 a preparation of cyanocobalamin (vitamin B ) produced with Ensifer adhaerens CGMCC 21299. The application 12 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 a preparation of cyanocobalamin (vitamin B ) produced with Ensifer 12 adhaerens CGMCC 21299 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 22 March 2024(2)that, under the proposed conditions of use, the preparation of cyanocobalamin (vitamin B ) produced with Ensifer adhaerens 12 CGMCC 21299 is safe for all animal species, consumers and the environment. The Authority further concluded that the preparation of cyanocobalamin (vitamin B ) produced with Ensifer adhaerens CGMCC 21299, due to the 12 presence of nickel, is considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. Due to the lack of data, the Authority could not conclude on the potential of the preparation to be an eye irritant. The Authority concluded that the preparation is efficacious in meeting animals’ nutritional requirements when administered via feed. The Authority does not consider that there is a need for specific requirements of post- market monitoring. It 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 the preparation cyanocobalamin (vitamin B ) produced with 12 Ensifer adhaerens CGMCC 21299 satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance 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. (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: http://data.europa.eu/eli/reg/2003/1831/oj. (2) EFSA Journal. 2024;22(4),e8752. ELI: http://data.europa.eu/eli/reg_impl/2024/1325/oj 1/3EN OJ L, 13.5.2024 HAS ADOPTED THIS REGULATION: Article 1 Authorisation The preparation specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, 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, 8 May 2024. For the Commission The President Ursula VON DER LEYEN 2/3 ELI: http://data.europa.eu/eli/reg_impl/2024/1325/ojANNEX Minimum Maximum Identifica- content content tion Species or Maxi- Composition, chemical formula, description, End of period of number of Additive category mum Other provisions analytical method mg of active substance/kg of authorisation the feed of animal age complete feedingstuff with a additive moisture content of 12 % Category: nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a837 ‘Cyanocobala­ Additive composition All ani­ - - - 1. In the directions for use of 2 June 2034 balamin’ or ‘Vita­ Preparation with ≤ 1 % of cyanocobalamin mal spe­ the additive and premix­ Vitamin B ’ Nickel: maximum 0,5 mg/kg cies tures, the storage conditions 12 Solid form and the stability to heat Characterisation of active substance treatment shall be indicated. Cyanocobalamin 2. For users of the additive and Chemical formula: C H CoN O P premixtures, feed business 63 88 14 14 CAS number: 68-19-9 operators shall establish op­ Purity: minimum 96 % erational procedures and or­ Produced by fermentation with Ensifer adhae­ ganisational measures to ad­ rens CGMCC 21299 dress potential risks resulting from their use. Where those Analytical method(1) risks cannot be eliminated by For the quantification of cyanocobalamin such procedures and mea­ (vitamin B 12) in the feed additive preparation sures, the additive and pre­ and in compound feed: reversed phase high mixtures shall be used with performance liquid chromatography coupled personal breathing, eye and to spectrophotometric detection (HPLC-UV). skin protective equipment. (1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports. ELI: http://data.europa.eu/eli/reg_impl/2024/1325/oj 3/3 OJ L, 13.5.2024 EN