Commission Implementing Regulation (EU) 2024/1056 of 10 April 2024 concerning the authorisation of riboflavin 5’-phosphate monosodium salt (vitamin B2), produced by Bacillus subtilis KCCM 10445, as a feed additive for all animal species

• CELEX: Implementing Regulation (EU) 2024/1056
• Articles: 3

Article 1 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.

Article 2 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.

Schedules & Appendices

ANNEX

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

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‘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