Commission Implementing Regulation (EU) 2026/460 of 26 February 2026 concerning the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/897

Official Journal EN of the European Union L series 2026/460 27.2.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/460 of 26 February 2026 concerning the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species and repealing Implementing Regulation (EU) 2015/897 (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 an authorisation. (2) Thiamine hydrochloride and thiamine mononitrate were authorised for a period of 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) 2015/897(2). (3) In accordance with Article 14(1) of Regulation (EC) No 1831/2003, two applications were submitted for the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate and for one preparation of thiamine mononitrate as feed additives 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’. Those applications were accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003. One of the applicants, requesting the authorisation of the preparation of thiamine mononitrate as a feed additive for all animal species, withdrew its application for the preparation. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 March 2025(3) and 4 April 2025(4)that the applicants have provided evidence that thiamine hydrochloride and thiamine mononitrate remain safe for all animal species, as well as for the consumers, the users and the environment under the conditions of use currently authorised. The Authority further concluded that thiamine hydrochloride and thiamine mononitrate are skin and eye irritants and are considered skin and respiratory sensitisers. Any dermal and respiratory exposure is considered a risk. The Authority stated that the applications for renewal of the authorisation do 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 the renewal of the authorisation. The Authority considered that there is no need for specific requirements of post-market monitoring. (1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. (2) Commission Implementing Regulation (EU) 2015/897 of 11 June 2015 concerning the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives for all animal species (OJ L 147, 12.6.2015, p. 8, ELI: http://data.europa.eu/eli/reg_impl/2015/ 897/oj). (3) EFSA Journal. 2025;23:e9347. https://doi.org/10.2903/j.efsa.2025.9347. (4) EFSA Journal. 2025;23:e9405. https://doi.org/10.2903/j.efsa.2025.9405. ELI: http://data.europa.eu/eli/reg_impl/2026/460/oj 1/6EN OJ L, 27.2.2026 (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 methods of analysis of thiamine hydrochloride and thiamine mononitrate as feed additives 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(5), the evaluation reports of the Reference Laboratory are therefore not required. (6) In view of the above, the Commission considers that thiamine hydrochloride and thiamine mononitrate 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 additives. Those protective measures should be without prejudice to other workers’ safety requirements under Union law. (7) As a consequence of the renewal of the authorisation of thiamine hydrochloride and thiamine mononitrate as feed additives, Implementing Regulation (EU) 2015/897 should be repealed. (8) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation resulting from the fact that the preparations of thiamine mononitrate as feed additives for all animal species are not renewed, 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. (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 Renewal of the authorisation The authorisation of the substances 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 of Implementing Regulation (EU) 2015/897 Implementing Regulation (EU) 2015/897 is repealed. Article 3 Transitional measures 1. The preparations of thiamine mononitrate, as authorised by Implementing Regulation (EU) 2015/897 and premixtures containing those additives which are intended for all animal species, and which are produced and labelled before 19 September 2026 in accordance with the rules applicable before 19 March 2026 may continue to be placed on the market and used until the stocks concerned are exhausted. (5) 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). 2/6 ELI: http://data.europa.eu/eli/reg_impl/2026/460/ojEN OJ L, 27.2.2026 2. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 March 2027 in accordance with the rules applicable before 19 March 2026 may continue to be placed on the market and used until the stocks concerned are exhausted if they are intended for food-producing animals. 3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 March 2028 in accordance with the rules applicable before 19 March 2026 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, 26 February 2026. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2026/460/oj 3/6ANNEX Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period number of the category of Other provisions additive analytical method age mg of active substance/kg of of authorisation additive animal complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a820 ‘Thiamine Additive composition All animal - - - 1. The additive may be used via 19.3.2036 hydroclor­ species water for drinking. Thiamine hydrochloride ide’ or 2. In the directions for use of the Solid form ‘Vitamin additive and premixtures, the B ’ Characterisation of active substance storage conditions, the 1 stability to heat treatment Thiamine hydrochloride and the stability in water for Chemical formula: C H ClN OS•HCl 12 17 4 drinking shall be indicated. CAS number: 67-03-8 3. For users of the additive and Purity: minimum 98,5 % on anhydrous premixtures, feed business basis operators shall establish Produced by chemical synthesis operational procedures and Analytical method(1) organisational measures to address potential risks For the characterisation of thiamine resulting from their use. hydrochloride in the feed additive: Where those risks cannot be — high performance liquid eliminated by such chromatography with UV detection procedures and measures, (HPLC-UV) – US Pharmacopeia the additive and premixtures (‘thiamine hydrochloride’ monograph). shall be used with personal For the quantification of thiamine breathing, eye and skin hydrochloride in premixtures: protective equipment. — ion-exchange high performance liquid chromatography coupled to UV detector (HPLC-UV) – VDLUFABd. III, 13.9.1, or — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006. 4/6 ELI: http://data.europa.eu/eli/reg_impl/2026/460/oj EN OJ L, 27.2.2026Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period number of the category of Other provisions additive analytical method age mg of active substance/kg of of authorisation additive animal complete feed with a moisture content of 12 % For the quantification of thiamine hydrochloride in compound feed: — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006. For the quantification of thiamine hydrochloride in water for drinking: — reversed phase high performance liquid chromatography with post-column derivatisation and fluorescence detection (HPLC-FLD). (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. Minimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period number of the category of Other provisions additive analytical method age mg of active substance/kg of of authorisation additive animal complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a821 ‘Thiamine Additive composition All animal - - - 1. The additive may be used via 19.3.2036 mononi­ species water for drinking. Thiamine mononitrate trate’ or 2. In the directions for use of the Solid form ‘Vitamin additive and premixtures, the B ’ Characterisation of active substance storage conditions, the 1 stability to heat treatment Thiamine mononitrate and the stability in water for Chemical formula: C H N OS•NO 12 17 4 3 drinking shall be indicated. CAS number: 532-43-4 ELI: http://data.europa.eu/eli/reg_impl/2026/460/oj 5/6 OJ L, 27.2.2026 ENMinimum Maximum content content Identification Species or Name of the Composition, chemical formula, description, Maximum End of period number of the category of Other provisions additive analytical method age mg of active substance/kg of of authorisation additive animal complete feed with a moisture content of 12 % Purity: minimum 98 % on anhydrous basis 3. For users of the additive and Produced by chemical synthesis premixtures, feed business operators shall establish Analytical method(1) operational procedures and For the characterisation of thiamine organisational measures to mononitrate in the feed additive: address potential risks — high performance liquid resulting from their use. chromatography with UV detection Where those risks cannot be (HPLC-UV) – US Pharmacopeia eliminated by such (‘thiamine mononitrate’ monograph). procedures and measures, the additive and premixtures For the quantification of thiamine shall be used with personal mononitrate in premixtures: breathing, eye and skin — ion-exchange high performance liquid protective equipment. chromatography coupled to UV detector (HPLC-UV) – VDLUFABd. III, 13.9.1, or — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006. For the quantification of thiamine mononitrate in compound feed: — reversed phase high performance liquid chromatography coupled to fluorescence detection (HPLC-FLD) – decree 20.2.2006, Official Italian Journal No 50, 1.3.2006. For the quantification of thiamine mononitrate in water for drinking: — reversed phase high performance liquid chromatography with post-column derivatisation and fluorescence detection (HPLC-FLD). (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. 6/6 ELI: http://data.europa.eu/eli/reg_impl/2026/460/oj EN OJ L, 27.2.2026