Authorisation
The substance 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 authorised as an additive 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.
ANNEXSupplementary provisions
ANNEX
Identification number of the feed 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: nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect
3a826i
‘Riboflavin 5’-phosphate monosodium salt’ or ‘Vitamin B 2 ’
Additive composition
Riboflavin 5’-phosphate ester monosodium salt
Solid form
Characterisation of active substance
Riboflavin 5’-phosphate ester monosodium salt
Chemical formula: C 17 H 20 N 4 O 9 PNa
CAS number: 130–40-5
Content: 73-79 % of riboflavin on dry mater
Riboflavin 5’-phosphate ester monosodium salt produced after phosphorylation of riboflavin 98 %, produced by Bacillus subtilis KCCM 10445
Analytical method
( 1 )
For the determination of riboflavin 5’-phosphate ester monosodium salt in the feed additive: Spectrophotometry at 444 nm European Pharmacopoeia Monograph 0786.
For the determination of riboflavin 5’-phosphate ester monosodium salt (as total vitamin B 2 ) in premixtures: High Performance Liquid Chromatography with Fluorescence detection (HPLC-FLD).
For the determination of riboflavin 5’-phosphate ester monosodium salt (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.
The directions for use of the additive and premixture 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. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including skin and eye protection.
1 May 2034
( 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