Commission Implementing Regulation (EU) 2023/1705 of 7 September 2023 concerning the authorisation of a preparation of riboflavin (vitamin B2) produced by Bacillus subtilis CGMCC 13326 as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1705
• Articles: 3

Article 1 Authorisation

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’, is authorised as a feed 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 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

3a825V

‘Riboflavin’ or ‘Vitamin B 2 ’

Additive composition

Preparation with ≥ 80 % of Riboflavin.

Maximum 3 % 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 13326

Analytical method

( 1 )

For the determination of riboflavin in the feed additive preparation 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:

—

High Performance Liquid Chromatography with Fluorescence detection, HPLC-FLD (EN 14152)

All animal species

—

—

—

1.

In the directions for use of the additive and premixtures, the storage conditions, the 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 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, eye and skin protective equipment.

28 September 2033

( 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.