Commission Implementing Regulation (EU) 2025/1795 of 9 September 2025 concerning the authorisation of riboflavin (vitamin B2) produced with Bacillus subtilis CGMCC 7.449 and a preparation of riboflavin produced with Bacillus subtilis CGMCC 7.449, as feed additives for all animal species
Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗
Authorisation
The substance and the preparation 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’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
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 .
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 3a825iii ‘Riboflavin’ or ‘Vitamin B 2 ’ Additive composition Riboflavin with a maximum of 1,5 % of water Solid form Characterisation of active substance Riboflavin Chemical formula: C 17 H 20 N 4 O 6 CAS number: 83-88-5 Purity: minimum 98 % Produced by fermentation with Bacillus subtilis CGMCC 7.449 Analytical method ( 1 ) — For the determination of riboflavin in the feed additive: European Pharmacopoeia monograph 0292 or High Performance Liquid Chromatography with UV detection, HPLC-UV (VDLUFA Bd. III, 13.9.1) — For the determination of riboflavin in the premixtures: High Performance Liquid Chromatography with UV detection, HPLC-UV (VDLUFA Bd. III, 13.9.1) — For the determination of riboflavin (as total vitamin B 2 ) in compound feed and water: High Performance Liquid Chromatography with Fluorescence detection, HPLC-FLD (EN 14152) All animal species — — — 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water shall be indicated. 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 and skin protective equipment. 29 September 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 3a825vi ‘Riboflavin’ or ‘Vitamin B 2 ’ Additive composition Preparation containing a minimum of 80 % of riboflavin and a maximum of 3 % of water Solid form Characterisation of active substance Riboflavin Chemical formula: C 17 H 20 N 4 O 6 CAS number: 83-88-5 Purity: minimum 98 % Produced by fermentation with Bacillus subtilis CGMCC 7.449 Analytical method ( 2 ) — For the determination of riboflavin in the feed additive and premixtures: High Performance Liquid Chromatography with UV detection, HPLC-UV (VDLUFA Bd. III, 13.9.1) — For the determination of riboflavin (as total vitamin B 2 ) in compound feed and water: High Performance Liquid Chromatography with Fluorescence detection, HPLC-FLD (EN 14152) All animal species — — — 1. The additive may be used via water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water shall be indicated. 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 and skin protective equipment. 29 September 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 .
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.