Commission Implementing Regulation (EU) 2025/1424 of 17 July 2025 concerning the renewal of the authorisation of biotin and two preparations of biotin as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/723

Official Journal EN of the European Union L series 2025/1424 18.7.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1424 of 17 July 2025 concerning the renewal of the authorisation of biotin and two preparations of biotin as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/723 (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 and renewing such authorisation. (2) Biotin was authorised as a feed additive for all animal species as both a substance and as preparations for 10 years by Commission Implementing Regulation (EU) 2015/723(2). (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted for the renewal of the authorisation of biotin and two preparations of biotin at concentrations of 2 % or 10 % for all animal species, requesting the additives 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’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2025(3)that under the conditions of use currently authorised biotin and the preparations of biotin at concentrations of 2 % or 10 % remain safe for all animal species, the consumers and the environment. The Authority further stated that biotin is not irritant to skin, eyes and is not a dermal sensitiser, and that exposure by inhalation is likely. The Authority stated that the application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additives. Therefore, it concluded that there is no need for assessing the efficacy of the additives in the context of this renewal of the authorisation. The Authority considered that there is no 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 the assessment carried out regarding the method of analysis of biotin as a feed additive in the context of the previous authorisation are valid and applicable for the current application. In accordance with Article 5(4), point (c), of Commission Regulation (EC) No 378/2005(4), an evaluation report of the Reference Laboratory is therefore not required. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) 2015/723 of 5 May 2015 concerning the authorisation of biotin as a feed additive for all animal species (OJ L 115, 6.5.2015, p. 22, ELI: http://data.europa.eu/eli/reg_impl/2015/723/oj). (3) EFSA Journal. 2025;23:e9250. https://doi.org/10.2903/j.efsa.2025.9250. (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 additive (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/2025/1424/oj 1/6EN OJ L, 18.7.2025 (6) Implementing Regulation (EU) 2015/723 provides that biotin is allowed to be placed on the market and used as an additive consisting of a preparation, but the composition of such preparation has erroneously not been specified in the terms of the authorisation. A more accurate description of biotin authorised as preparations at concentrations of 2 % or 10 % should be provided for, by specifying the composition of the additives authorised as preparations. A different identification number should also be assigned to distinguish between the three additives. (7) In view of the above, the Commission considers that biotin and the preparations of biotin at concentrations of 2 % or 10 % satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation of those additives should be renewed. 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. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. (8) As a consequence of the renewal of the authorisation of biotin and the preparations of biotin at concentrations of 2 % or 10 %, Implementing Regulation (EU) 2015/723 should be repealed. (9) Since the names of the additives have been modified, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation. (10) 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 Authorisation The authorisation of the substance and the preparations 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 renewed subject to the conditions laid down in that Annex. Article 2 Repeal Implementing Regulation (EU) 2015/723 is repealed. Article 3 Transitional measures 1. The feed additives biotin and its preparations as authorised by Implementing Regulation (EU) 2015/723 and premixtures containing those substances, which are produced and labelled before 7 February 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted. 2. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 7 August 2026 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals. 2/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1424/ojEN OJ L, 18.7.2025 3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 7 August 2027 in accordance with the rules applicable before 7 August 2025 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for non-food producing animals. 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, 17 July 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/1424/oj 3/6ANNEX Minimum Maximum Species content content Identifica­ or Maxi­ End of period tion Composition, chemical formula, description, analytical Additive category mum mg of active substance/kg Other provisions of number of method of age of complete feedingstuff authorisation the additive animal with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a880 Biotin Additive composition All - - - 1. The additive may be used via 7 August animal water for drinking. 2035 Biotin species 2. The directions for use of the Characterisation of the active substance additive and premixtures D-(+)-biotin shall indicate the storage C H N O S conditions, the stability to 10 16 2 3 CAS number: 58-85-5 heat treatment and the Biotin, solid form, produced by chemical synthesis stability in water for Purity criteria: min. 97 % drinking. Analytical method(1) 3. For users of the additive and premixtures, feed business For the determination of D-(+)-biotin in feed additive: potentiometric titration assay and optical rotation operators shall establish identification (European Pharmacopeia monograph operational procedures and 1073). organisational measures to address potential risks For the determination of biotin in the feed additive, resulting from their use. premixtures and compound feed: Reversed Phase High Where those risks cannot be Performance Liquid Chromatography coupled to mass eliminated by such spectrometry (RP-HPLC-MS/MS). procedures and measures, the additive and premixtures For the determination of biotin in water: shall be used with personal microbiological assay (US Pharmacopoeia – Biotin breathing protective assay/biological test). 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. 4/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1424/oj EN OJ L, 18.7.2025Minimum Maximum Species content content Identifica­ or Maxi­ End of period tion Composition, chemical formula, description, analytical Additive category mum mg of active substance/kg Other provisions of number of method of age of complete feedingstuff authorisation the additive animal with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a880i Biotin Additive composition All - - - 1. The additive may be used via 7 August animal water for drinking. 2035 Preparation containing 2 % of biotin species Solid form 2. The directions for use of the additive and premixtures Characterisation of the active substance shall indicate the storage D-(+)-biotin conditions, the stability to C H N O S heat treatment and the 10 16 2 3 CAS number: 58-85-5 stability in water for Biotin, solid form, produced by chemical synthesis drinking. Purity criteria: min. 97 % 3. For users of the additive and Analytical method(1) premixtures, feed business operators shall establish For the determination of D-(+)-biotin in feed additive: operational procedures and potentiometric titration assay and optical rotation organisational measures to identification (European Pharmacopeia monograph address potential risks 1073). resulting from their use. Where those risks cannot be For the determination of biotin in the feed additive, eliminated by such premixtures and compound feed: Reversed Phase High procedures and measures, Performance Liquid Chromatography coupled to mass the additive and premixtures spectrometry (RP-HPLC-MS/MS). shall be used with personal breathing protective For the determination of biotin in water: equipment. microbiological assay (US Pharmacopoeia – Biotin assay/biological test). (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/2025/1424/oj 5/6 OJ L, 18.7.2025 ENMinimum Maximum Species content content Identifica­ or Maxi­ End of period tion Composition, chemical formula, description, analytical Additive category mum mg of active substance/kg Other provisions of number of method of age of complete feedingstuff authorisation the additive animal with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a880ii Biotin Additive composition All - - - 1. The additive may be used via 7 August animal water for drinking. 2035 Preparation containing 10 % of biotin species Solid form 2. The directions for use of the additive and premixtures Characterisation of the active substance shall indicate the storage D-(+)-biotin conditions, the stability to C H N O S heat treatment and the 10 16 2 3 CAS number: 58-85-5 stability in water for Biotin, solid form, produced by chemical synthesis drinking. Purity criteria: min. 97 % 3. For users of the additive and Analytical method(1) premixtures, feed business operators shall establish For the determination of D-(+)-biotin in feed additive: operational procedures and potentiometric titration assay and optical rotation organisational measures to identification (European Pharmacopeia monograph address potential risks 1073). resulting from their use. Where those risks cannot be For the determination of biotin in the feed additive, eliminated by such premixtures and compound feed: Reversed Phase High procedures and measures, Performance Liquid Chromatography coupled to mass the additive and premixtures spectrometry (RP-HPLC-MS/MS). shall be used with personal breathing protective For the determination of Biotin in water: equipment. microbiological assay (US Pharmacopoeia – Biotin assay/biological test). (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. 6/6 ELI: http://data.europa.eu/eli/reg_impl/2025/1424/oj EN OJ L, 18.7.2025