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

Authorisation

Article 1

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.

Repeal

Article 2

Implementing Regulation (EU) No 669/2014 is repealed.

Transitional measures

Article 3

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.

Entry into force

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

ANNEX Identification number of the additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/kg of complete feedingstuff 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 D-pantothenate’ or ‘vitamin B 5’ Additive composition Calcium D-pantothenate. Solid form Characterisation of the active substance Calcium D-pantothenate Chemical formula: Ca[C 9 H 16 NO 5 ] 2 CAS number: 137-08-6 Produced by chemical synthesis. Purity criteria: 1. Min. 98 % (on dry matter basis); 2. Max. 0,5 % 3-aminopropionic acid. Analytical method  ( 1 ) — For the determination of Calcium D-pantothenate in the feed additive: potentiometric titration with perchloric acid and identification by specific optical rotation (European Pharmacopoeia Monograph 0470); — For the determination of Calcium D-pantothenate in water, premixtures and compound feed: High Performance Liquid Chromatography coupled to mass spectrometry (HPLC-MS). All animal species - - - 1. The additive may be used via water for drinking. 2. The directions for use of the additive and premixtures shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing protective equipment. 19 November 2035 Identification number of the additive Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation mg of active substance/l of water Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a842 ‘D-Panthenol’ or ‘vitamin B 5’ Additive composition D-Panthenol Liquid form Characterisation of the active substance D-Panthenol Chemical formula: C 9 H 19 NO 4 CAS number: 81-13-0 Produced by chemical synthesis. Purity criteria: 1. Min. 98 % on anhydrous matter basis (water < 1 %); 2. Max. 0,5 % 3-aminopropionic acid. Analytical method  ( 2 ) — For the determination of D- panthenol in the feed additive: titration with perchloric acid and potassium hydrogen phthalate and identification by specific optical rotation and infrared spectroscopy (European Pharmacopoeia monograph 0761). — For the determination of D- panthenol in water: Reverse Phase High-Performance Liquid Chromatography, coupled to UV detector (RP-HPLC-UV). All animal species - - - 1. The additive shall only be used via water for drinking. 2. The directions for use of the additive and premixtures shall indicate the storage conditions, the stability to heat treatment and the stability in water for drinking. 3. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal skin, eye and breathing protective equipment. 19 November 2035 ( 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 )   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 .