Date: 2025-09-10Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
Commission Implementing Regulation (EU) 2025/1795 authorises riboflavin (vitamin B2) produced with *Bacillus subtilis* CGMCC 7.449, as a feed additive for all animal species. It classifies the additive under nutritional additives, functional group vitamins, and sets conditions for its use. The authorisation is valid until 29 September 2035.
Key Points / Main Content:
* **Authorisation:**
* Riboflavin produced with *Bacillus subtilis* CGMCC 7.449 and its preparation are authorised as feed additives for all animal species.
* The additive falls under the category of nutritional additives and the functional group of vitamins, provitamins, and chemically well-defined substances having similar effect.
* **Conditions of Use:**
* The additive can be used via water for drinking.
* Directions for use of the additive and premixtures must include storage conditions, stability to heat treatment, and stability in water.
* Users must establish operational procedures and organizational measures to address potential risks.
* Where risks cannot be eliminated, the additive and premixtures shall be used with personal breathing and skin protective equipment.
* **Specifications:**
* Riboflavin (3a825iii): Minimum 98% purity.
* Preparation: Minimum 80% riboflavin, maximum 3% water.
* **Analytical Methods:**
* Specific analytical methods for determining riboflavin content in feed additives, premixtures, compound feed, and water are referenced, with details available at the European Union Reference Laboratory.
* **Expiration:**
* The authorisation is valid until 29 September 2035.
Impact Analysis:
* **Animal Feed Industry (Manufacturers and Distributors):**
* Impact: Can legally incorporate riboflavin produced with *Bacillus subtilis* CGMCC 7.449 into animal feed, provided they adhere to the specified conditions.
* Action Required: Update product formulations, adjust manufacturing processes to comply with the regulation, ensure proper labeling, and implement risk management procedures and protective measures.
* **Animal Feed Businesses:**
* Impact: Must adhere to operational and organisational measures.
* Action Required: Establish procedures and measures to address potential risks resulting from the use of the additive.
* **End Users (Farmers, Animal Owners):**
* Impact: Access to animal feed containing the authorised riboflavin additive.
* Action Required: Follow the updated product instructions.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's budget.
Bacillus subtilis CGMCC 7.449: A specific strain of Bacillus subtilis used in the production of riboflavin (vitamin B2) as a feed additive.
Riboflavin: Also known as Vitamin B2, a nutritional additive for animal feed.
Regulation (EC) No 1831/2003: A regulation of the European Parliament and of the Council on additives for use in animal nutrition.
European Food Safety Authority: An agency of the European Union that provides independent scientific advice and risk assessment on food and feed safety.
Ursula VON DER LEYEN: The President of the European Commission.
Brussels: The de facto capital city of the European Union, located in Belgium. The location where the regulation was adopted.
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