Commission Implementing Regulation (EU) 2023/651 of 20 March 2023 concerning the authorisation of riboflavin (vitamin B2) produced by Bacillus subtilis KCCM 10445 and a preparation of riboflavin produced by Bacillus subtilis KCCM 10445 as feed additives for all animal species (Text with EEA relevance)

Article 1

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.

Article 2

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

ANNEX

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
3a825 iii
‘Riboflavin’ or ‘Vitamin B 2 ’
Additive composition
Riboflavin with a maximum of 1,5 % of water
Solid form
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 for drinking 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 or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin and breathing protection.
11.4.2033
Characterisation of active substance
Chemical formula: C 17 H 20 N 4 O 6
CAS number: 83-88-5
Purity: minimum 98 %
Produced by fermentation with Bacillus subtilis KCCM 10445
Analytical method
( 1 )
For the determination of riboflavin in the feed additive: — European Pharmacopoeia Ph. Eur 01/2008:0292
For the determination of riboflavin in premixtures: — High Performance Liquid Chromatography with UV detection (HPLC-UV) — VDLUFA Bd. III, 13.9.1
For the determination of riboflavin (as total vitamin B2) in compound feed and water: — High Performance Liquid Chromatography with Fluorescence detection (HPLCFLD) — EN 14152
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
3a825 IV
‘Riboflavin’ or ‘Vitamin B 2 ’
Additive composition
Preparation containing a minimum of 80 % of riboflavin and a maximum of 3 % of water
Solid form
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 for drinking shall be indicated.
3.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organizational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin protection.
11.4.2033
Characterisation of active substance
Chemical formula: C 17 H 20 N 4 O 6
CAS number: 83-88-5
Purity: minimum 98 %
Produced by fermentation with Bacillus subtilis KCCM 10445
Analytical method
( 2 )
For the determination of riboflavin in the feed additive: European Pharmacopoeia Ph. Eur. monograph:0292
For the determination of riboflavin in premixtures: — High Performance Liquid Chromatography with UV detection (HPLC-UV) — VDLUFA Bd. III, 13.9.1
For the determination of riboflavin (as total vitamin B2) in compound feed and water: — High Performance Liquid Chromatography with Fluorescence detection (HPLCFLD) — EN 14152.
( 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
( 2 )   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

Schedules & Appendices

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