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
Date: 2024-04-10
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, drinking water, food additive, market approval, vitamin








L_202401056EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/1056


11.4.2024







            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
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:







(1)


Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.












(2)


In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(3)


The application concerns the authorisation of riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445, as a feed additive for all animal species, requesting that additive to be classified in the category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. The applicant also requested the additive to be authorised for use in water for drinking.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 27 September 2022 (2) that, under the proposed conditions of use, riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 is safe for all animal species, consumers and the environment. It also concluded that is not a skin/eye irritant, and it is not considered a respiratory sensitiser and that riboflavin is a known photosensitiser which may elicit skin and eye photoallergic reactions. The Authority further concluded that riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 is effective in covering the animals’ requirements for vitamin B2, when administered via feed and/or water for drinking. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(5)


In view of the above, the Commission considers that riboflavin 5’-phosphate monosodium salt (vitamin B2) produced by Bacillus subtilis KCCM 10445 satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of that substance should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects the health of the users of the additive.












(6)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



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.





This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 April 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29. ELI: http://data.europa.eu/eli/reg/2003/1831/oj


(2)  
            EFSA Journal 2022;20(11):7608.




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 B2’



Additive composition

Riboflavin 5’-phosphate ester monosodium salt
Solid form

Characterisation of active substance

Riboflavin 5’-phosphate ester monosodium salt
Chemical formula: C17H20N4O9PNa
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 B2) in premixtures: High Performance Liquid Chromatography with Fluorescence detection (HPLC-FLD).
For the determination of riboflavin 5’-phosphate ester monosodium salt (as total vitamin B2) 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




ELI: http://data.europa.eu/eli/reg_impl/2024/1056/oj
ISSN 1977-0677 (electronic edition)