Commission Implementing Regulation (EU) 2025/2171 of 29 October 2025 concerning the renewal of the authorisation of calcium D-pantothenate (vitamin B5) and D-panthenol (vitamin B5) as feed additives for all animal species and repealing Implementing Regulation (EU) No 669/2014

Official Journal EN of the European Union L series 2025/2171 30.10.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/2171 of 29 October 2025 concerning the renewal of the authorisation of calcium D-pantothenate (vitamin B ) and 5 D-panthenol (vitamin B ) as feed additives for all animal species and repealing Implementing 5 Regulation (EU) No 669/2014 (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) Calcium D-pantothenate and D-panthenol were authorised for 10 years as feed additives for all animal species by Commission Implementing Regulation (EU) No 669/2014(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 calcium D-pantothenate (vitamin B ) and D-panthenol (vitamin B ) for all animal species, 5 5 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. (4) The European Food Safety Authority (‘the Authority’) concluded in its opinions of 26 June 2024(3)and 28 January 2025(4)that, under the conditions of use currently authorised calcium D-pantothenate and D-panthenol remain safe for all animal species, the consumers and the environment. The Authority further stated that calcium D-pantothenate was considered of low toxicity by inhalation and that the exposure through inhalation is likely. In addition, it concluded that it is not irritant to the eyes and the skin and is not a skin sensitiser. For D-panthenol, the Authority concluded that it is considered to be a skin and eye irritant, and a dermal and respiratory sensitiser. 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. (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 calcium D-pantothenate and D-panthenol 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), evaluation reports of the Reference Laboratory are 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) No 669/2014 of 18 June 2014 concerning the authorisation of calcium D-pantothenate and D-panthenol as feed additives for all animal species (OJ L 179, 19.6.2014, p. 62,ELI: http://data.europa.eu/eli/reg_impl/2014/ 669/oj). (3) EFSA Journal. 2024;22:e8901. https://doi.org/10.2903/j.efsa.2024.8901. (4) EFSA Journal. 2025;23:e9252. https://doi.org/10.2903/j.efsa.2025.9252. (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). ELI: http://data.europa.eu/eli/reg_impl/2025/2171/oj 1/5EN OJ L, 30.10.2025 (6) In view of the above, the Commission considers that calcium D-pantothenate (vitamin B ) and D-panthenol (vitamin 5 B ) satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the authorisation 5 of these additives should be renewed. Currently, the name of these feed additives only refers to calcium D-pantothenate or D-panthenol. The Commission considers that it is appropriate to add the reference to the common name of the vitamin ‘vitamin B and to grant the possibility for operators to indicate the additive on the 5’ label of feed materials and compound feed with the common name of the vitamin or with the specific chemical substance (calcium D-pantothenate or panthenol). In both cases the reference on the label should be accompanied with the identification number that is different for each additive and allows to identify the exact chemical substance that is used in the feed. Such a modification should allow farmers and pet owners, to easily identify vitamin B on 5 the label of the compound feed. 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. (7) As a consequence of the renewal of the authorisation of calcium D-pantothenate (vitamin B ) and D-panthenol 5 (vitamin B ), Implementing Regulation (EU) No 669/2014 should be repealed. 5 (8) Since the name 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. 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 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 Implementing Regulation (EU) No 669/2014 is repealed. Article 3 Transitional measures 1. The feed additives calcium D-pantothenate and D-panthenol as authorised by Implementing Regulation (EU) No 669/2014 and premixtures containing those substances, which are produced and labelled before 19 May 2026 in accordance with the rules applicable before 19 November 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 19 November 2026 in accordance with the rules applicable before 19 November 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. 3. Compound feed and feed materials containing the feed additives referred to in paragraph 1, which are produced and labelled before 19 November 2027 in accordance with the rules applicable before 19 November 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. 2/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2171/ojEN OJ L, 30.10.2025 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, 29 October 2025. For the Commission The President Ursula VON DER LEYEN ELI: http://data.europa.eu/eli/reg_impl/2025/2171/oj 3/5ANNEX Minimum Maximum content content Identification Species or End of period Composition, chemical formula, description, analytical Maximum number of the Additive category mg of active substance/kg Other provisions of method age additive of animal of complete feedingstuff authorisation with a moisture content of 12 % Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a841 ‘Calcium Additive composition All - - - 1. The additive may be used via 19 November D-pantothe­ animal water for drinking. 2035 Calcium D-pantothenate. nate’ or species Solid form 2. The directions for use of the ‘vitamin B 5’ additive and premixtures Characterisation of the active substance shall indicate the storage conditions, the stability to Calcium D-pantothenate heat treatment and the Chemical formula: Ca[C H NO ] 9 16 52 stability in water for CAS number: 137-08-6 drinking. Produced by chemical synthesis. Purity criteria: 3. For users of the additive and 1. Min. 98 % (on dry matter basis); premixtures, feed business 2. Max. 0,5 % 3-aminopropionic acid. operators shall establish operational procedures and Analytical method(1) organisational measures to address potential risks — For the determination of Calcium resulting from their use. D-pantothenate in the feed additive: Where those risks cannot be potentiometric titration with perchloric acid eliminated by such and identification by specific optical rotation procedures and measures, (European Pharmacopoeia Monograph the additive and premixtures 0470); shall be used with personal — For the determination of Calcium breathing protective D-pantothenate in water, premixtures and equipment. compound feed: High Performance Liquid Chromatography coupled to mass spectrometry (HPLC-MS). (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. 4/5 ELI: http://data.europa.eu/eli/reg_impl/2025/2171/oj EN OJ L, 30.10.2025Minimum Maximum Identification Species or content content End of period Composition, chemical formula, description, analytical Maximum number of the Additive category Other provisions of method age additive of animal mg of active substance/l of authorisation water Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a842 ‘D-Panthe­ Additive composition All - - - 1. The additive shall only be 19 November nol’ or animal used via water for drinking. 2035 D-Panthenol ‘vitamin B species 5’ Liquid form 2. The directions for use of the additive and premixtures Characterisation of the active substance shall indicate the storage conditions, the stability to D-Panthenol heat treatment and the Chemical formula: C H NO 9 19 4 stability in water for CAS number: 81-13-0 drinking. Produced by chemical synthesis. Purity criteria: 3. For users of the additive and 1. Min. 98 % on anhydrous matter basis premixtures, feed business (water < 1 %); operators shall establish 2. Max. 0,5 % 3-aminopropionic acid. operational procedures and organisational measures to Analytical method(1) address potential risks resulting from their use. — For the determination of D- panthenol in the Where those risks cannot be feed additive: titration with perchloric acid eliminated by such and potassium hydrogen phthalate and procedures and measures, identification by specific optical rotation and the additive and premixtures infrared spectroscopy (European shall be used with personal Pharmacopoeia monograph 0761). skin, eye and breathing — For the determination of D- panthenol in protective equipment. water: Reverse Phase High-Performance Liquid Chromatography, coupled to UV detector (RP-HPLC-UV). (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/2025/2171/oj 5/5 OJ L, 30.10.2025 EN