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

• CELEX: Implementing Regulation (EU) 2025/1795
• Articles: 3

Article 1 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.

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 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 .