Official Gazette Notification Text
Official TranscriptOfficial Journal EN of the European Union L series 2025/1795 10.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1795 of 9 September 2025 concerning the authorisation of riboflavin (vitamin B ) produced with Bacillus subtilisCGMCC 7.449 2 and a preparation of riboflavin produced with Bacillus subtilisCGMCC 7.449, as feed additives for all animal species (Text with EEA relevance) THE EUROPEAN...
Official Journal EN of the European Union L series 2025/1795 10.9.2025 COMMISSION IMPLEMENTING REGULATION(EU) 2025/1795 of 9 September 2025 concerning the authorisation of riboflavin (vitamin B ) produced with Bacillus subtilisCGMCC 7.449 2 and a preparation of riboflavin produced with Bacillus subtilisCGMCC 7.449, as feed additives 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 (vitamin B ) produced with Bacillus subtilisCGMCC 7.449 and a preparation of riboflavin produced with 2 Bacillus subtilisCGMCC 7.449. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concerns the authorisation of the substance riboflavin (vitamin B ) produced with Bacillus subtilis 2 CGMCC 7.449 and the preparation of riboflavin produced with Bacillus subtilisCGMCC 7.449, as feed additives for all animal species, to be classified in the additive category ‘nutritional additives’ and in the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’.
(4) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 January 2025(2)that, under the proposed conditions of use, riboflavin produced with Bacillus subtilis CGMCC 7.449 and the preparation of riboflavin, produced with Bacillus subtilis CGMCC 7.449, are safe for all animal species, consumers and the environment. The Authority further concluded that the additives are not dermal nor eye irritants but are dermal and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. The Authority also concluded that the additives are efficacious in covering the animal’s nutritional requirements. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives 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 the substance riboflavin produced with Bacillus subtilisCGMCC
7.449 and the preparation of riboflavin produced with Bacillus subtilis CGMCC 7.449, satisfy the conditions as
provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of the substance and the preparation should be authorised. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on 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,
(1) OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj.
(2) EFSA Journal2025;23:e9249, https://doi.org/10.2903/j.efsa.2025.9249.
ELI: http://data.europa.eu/eli/reg_impl/2025/1795/oj 1/4EN OJ L, 10.9.2025
HAS ADOPTED THIS REGULATION:
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 September 2025.
For the Commission The President Ursula VON DER LEYEN 2/4 ELI: http://data.europa.eu/eli/reg_impl/2025/1795/ojANNEX Minimum Maximum Identifica content content tion Species or End of period Composition, chemical formula, description, analytical Maximum number of Additive category Other provisions of method age mg of active substance/kg of the of animal authorisation complete feedingstuff with a additive moisture content of 12% Category of nutritional additives. Functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effect 3a825iii ‘Riboflavin’ Additive composition All — — — 1. The additive may be used via 29 September or ‘Vitamin animal water for drinking. 2035 Riboflavin with a maximum of 1,5 % of water B ’ species 2 Solid form 2. In the directions for use of the additive and premixtures, Characterisation of active substance the storage conditions, the stability to heat treatment Riboflavin and the stability in water shall
Chemical formula: C H N O 17 20 4 6 be indicated.
CAS number: 83-88-5
Purity: minimum 98 % 3. For users of the additive and Produced by fermentation with Bacillus subtilis premixtures, feed business CGMCC 7.449 operators shall establish operational procedures and Analytical method(1) organisational measures to address potential risks — For the determination of riboflavin in the feed resulting from their use.
additive: European Pharmacopoeia monograph Where those risks cannot be 0292 or High Performance Liquid eliminated by such Chromatography with UV detection, HPLC-UV procedures and measures, (VDLUFA Bd. III, 13.9.1) the additive and premixtures — For the determination of riboflavin in the shall be used with personal
premixtures: High Performance Liquid breathing and skin protective Chromatography with UV detection, HPLC-UV equipment. (VDLUFA Bd. III, 13.9.1) — For the determination of riboflavin (as total vitamin B ) in compound feed and water: High 2 Performance Liquid Chromatography with Fluorescence detection, HPLC-FLD (EN 14152)
(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.
ELI:
http://data.europa.eu/eli/reg_impl/2025/1795/oj 3/4 OJ L,
10.9.2025 ENMinimum Maximum Identifica content content Species or End of period tion Composition, chemical formula, description, analytical Maximum Additive category Other provisions of number of method age mg of active substance/kg of of animal authorisation the additive 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’ Additive composition All — — — 1. The additive may be used via 29 September or ‘Vitamin animal water for drinking. 2035 Preparation containing a minimum of 80 % of B ’ species 2 riboflavin and a maximum of 3 % of water 2. In the directions for use of Solid form the additive and premixtures, the storage conditions, the Characterisation of active substance stability to heat treatment and the stability in water shall Riboflavin be indicated.
Chemical formula: C H N O 17 20 4 6
CAS number: 83-88-5 3. For users of the additive and
Purity: minimum 98 % premixtures, feed business Produced by fermentation with Bacillus subtilis operators shall establish CGMCC 7.449 operational procedures and organisational measures to Analytical method(1) address potential risks resulting from their use.
— For the determination of riboflavin in the feed Where those risks cannot be
additive and premixtures: High Performance eliminated by such Liquid Chromatography with UV detection, procedures and measures, HPLC-UV (VDLUFA Bd. III, 13.9.1) the additive and premixtures — For the determination of riboflavin (as total shall be used with personal vitamin B ) in compound feed and water: breathing and skin protective 2 High Performance Liquid Chromatography equipment.
with Fluorescence detection, HPLC-FLD (EN
14152)
(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.
4/4
ELI:
http://data.europa.eu/eli/reg_impl/2025/1795/oj EN OJ L,
10.9.2025