Commission Implementing Regulation (EU) 2019/901 of 29 May 2019 concerning the authorisation of riboflavin produced by Ashbya gossypii (DSM 23096), riboflavin produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) and riboflavin 5′-phosphate sodium salt produced by Bacillus subtilis (DSM 17339 and/or DSM 23984) (sources of vitamin B2) as feed additives for all animal species. (Text with EEA relevance.)
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 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’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.
Transitional Measures
1. The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 23 June 2019 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until 23 December 2019. 2. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2020 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals. 3. Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 23 June 2021 in accordance with the rules applicable before 23 June 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
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 Name of the holder of authorisation 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 additive/kg of complete feedingstuff with a moisture content of 12 % Category of nutritional additives. Functional group: Vitamins, provitamins and chemically well-defined substances having similar effect. 3a825i — ‘Riboflavin’ or ‘Vitamin B 2 ’ Additive composition Riboflavin produced by Ashbya gossypii DSM 23096 Characterisation of the active substance Riboflavin C 17 H 20 N 4 O 6 CAS number: 83-88-5 Riboflavin solid form produced by Ashbya gossypii DSM 23096 Purity criteria: min. 80 % of riboflavin Method of analysis ( 1 ) For the determination of Riboflavin in the feed additive: spectrophotometry at 444 nm For the determination of Riboflavin in premixtures: high-Performance Liquid Chromatography coupled to UV detector, HPLC-UV (VDLUFA Bd.III, 13.9.1) For the determination of Riboflavin in feedingstuffs: high Performance Liquid Chromatography with Fluorescence detection, HPLC-FL (EN 14152) All animal species — — — 1. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 2. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 23 June 2029 3a825ii — ‘Riboflavin’ or ‘Vitamin B 2 ’ Additive composition Riboflavin Characterisation of the active substance Riboflavin C 17 H 20 N 4 O 6 CAS number: 83-88-5 Riboflavin solid form produced by Bacillus subtilis DSM 17339 and/or DSM 23984 Purity criteria: min. 96 %, Method of analysis ( 1 ) For the determination of Riboflavin in the feed additive: spectrophotometry at 444 nm (Ph.Eur.6.0, method 01/2008:0292) For the determination of Riboflavin in premixtures: high-Performance Liquid Chromatography coupled to UV detector, HPLC-UV (VDLUFA Bd.III, 13.9.1) For the determination of Riboflavin in feedingstuffs and water: high Performance Liquid Chromatography with Fluorescence detection, HPLC-FL (EN 14152) All animal species — — — 1. Riboflavin may be placed on the market and used as an additive consisting of a preparation. 2. May be used in water for drinking. 3. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. 4. For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 23 June 2029 3a 826 ‘Riboflavin 5′-phosphate monosodium salt’ or ‘Vitamin B 2 ’ Additive composition Riboflavin 5′-phosphate ester monosodium salt Characterisation of the active substance Riboflavin 5′-phosphate monosodium salt C 17 H 22 N 4 O 9 PNa CAS number: 130-40-5 Riboflavin 5′-phosphate ester monosodium salt solid form produced after phosphorylation of riboflavin 98 % produced by Bacillus subtilis DSM 17339 and/or DSM 23984. Purity criteria: min. 65 %, Method of analysis ( 1 ) For the determination of Riboflavin 5′-phosphate monosodium salt in feed additive: spectrophotometry method at 444 nm (Ph.Eur.6.0, method 01/2008:0786) For the determination of Riboflavin in premixtures: high-Performance Liquid Chromatography coupled to UV detector, HPLC-UV (VDLUFA Bd.III, 13.9.1) For the determination of Riboflavin 5′-phosphate monosodium salt (as total Vitamin B 2 ) in feedingstuffs and water: high Performance Liquid Chromatography with Fluorescence detection, HPLC-FL (EN 14152) All animal species — — — 1. May be used in water for drinking. 2. In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment 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 by inhalation,dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection, safety glasses and gloves. 23 June 2029 ( 1 ) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.