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

Authorisation

Article 1

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.

Repeal

Article 2

Implementing Regulation (EU) 2015/723 is repealed.

Transitional measures

Article 3

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. 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.

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 3a880 Biotin Additive composition Biotin Characterisation of the active substance D-(+)-biotin C 10 H 16 N 2 O 3 S CAS number: 58-85-5 Biotin, solid form, produced by chemical synthesis Purity criteria: min. 97 % Analytical method  ( 1 ) For the determination of D-(+)-biotin in feed additive: potentiometric titration assay and optical rotation identification (European Pharmacopeia monograph 1073). For the determination of biotin in the feed additive, premixtures and compound feed: Reversed Phase High Performance Liquid Chromatography coupled to mass spectrometry (RP-HPLC-MS/MS). For the determination of biotin in water: microbiological assay (US Pharmacopoeia – Biotin assay/biological test). 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. 7 August 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/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 3a880i Biotin Additive composition Preparation containing 2 % of biotin Solid form Characterisation of the active substance D-(+)-biotin C 10 H 16 N 2 O 3 S CAS number: 58-85-5 Biotin, solid form, produced by chemical synthesis Purity criteria: min. 97 % Analytical method  ( 2 ) For the determination of D-(+)-biotin in feed additive: potentiometric titration assay and optical rotation identification (European Pharmacopeia monograph 1073). For the determination of biotin in the feed additive, premixtures and compound feed: Reversed Phase High Performance Liquid Chromatography coupled to mass spectrometry (RP-HPLC-MS/MS). For the determination of biotin in water: microbiological assay (US Pharmacopoeia – Biotin assay/biological test). 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. 7 August 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/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 3a880ii Biotin Additive composition Preparation containing 10 % of biotin Solid form Characterisation of the active substance D-(+)-biotin C 10 H 16 N 2 O 3 S CAS number: 58-85-5 Biotin, solid form, produced by chemical synthesis Purity criteria: min. 97 % Analytical method  ( 3 ) For the determination of D-(+)-biotin in feed additive: potentiometric titration assay and optical rotation identification (European Pharmacopeia monograph 1073). For the determination of biotin in the feed additive, premixtures and compound feed: Reversed Phase High Performance Liquid Chromatography coupled to mass spectrometry (RP-HPLC-MS/MS). For the determination of Biotin in water: microbiological assay (US Pharmacopoeia – Biotin assay/biological test). 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. 7 August 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 . ( 3 )   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 .