COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/1705 
of 7 September 2023
concer ning the author isation of a preparation of ribof lavin (vitamin B2) produced by Bacillus subtilis 
CGMCC 13326 as a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION,
Havi ng regar d to the Treaty on the Functioning of the European Union,
Havi ng rega rd to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 Sept ember 2003 on 
additives for use in animal nutr ition (1), and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provid es for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of a preparation of ribof lavin (vitamin B2) produced by Bacillus subtilis CGMCC 13326. The application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) That application concer ns the author isation of a preparation of ribof lavin produced by Bacillus subtilis CGMCC 
13326 as a feed additive for all animal species, to be classified in the additive cate gory ‘nutr itional additives’ and in 
the functional group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar effect’.
(4) The European Food Safety Authority (‘the Author ity’) concluded in its opinion of 1 Febr uary 2023 (2)that, under the 
proposed conditions of use, the preparation of ribof lavin produced by Bacillus subtilis CGMCC 13326 is safe for all 
animal species consumers and the environment. The Author ity further concluded that ribof lavin is a known 
photosensi tiser whic h may elicit skin and eye photoaller gic reactions and that the preparation of ribof lavin 
produced by Bacillus subtilis CGMCC 13326 has a risk for users of exposure by inhalation and that in the absence of 
data, it cannot conclude on the potential of skin and eye irritation or dermal sensitisation of the additive. The 
Authority concluded that the additive is efficacious in cover ing the animal’s nutr itional requirements. The Author ity 
does not consider that there is a need for specifi c requirements of post-market monitori ng. It also verified the repor t 
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 preparation of ribof lavin produced by Bacillus subtilis 
CGMCC 13326 satisfies the conditions provi ded for in Article 5 of Regulation (EC) No 1831/2003. According ly, 
the use of that substance should be author ised In addition, the Commission considers that appropr iate prot ective 
measures should be taken to prevent adverse effects on the health of the users of the additive.
(6) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed,
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2023;21(2):7874.EN Offi cial Jour nal of the European Union 8.9.2023 L 221/11  HAS ADOPTED THIS REGUL ATION:
Article 1
Author isation
The preparation specified in the Annex, belonging to the additive catego ry ‘nutr itional additives ’ and to the functional 
group ‘vitamins, pro-vitamins and chemically well-def ined substances having similar effect’, is author ised as a feed additive 
in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
Entr y into force
This Regulation shall enter into force on the twentieth day followi ng 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, 7 Sept ember 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union L 221/12 8.9.2023  ANNEX 
Identifica -
tion 
number of 
the additiveAdditiveComposition, chemical formula, descr iption, analytical 
methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationmg of active 
substance/kg of 
complet e feedingstuff 
with a moisture conten t 
of 12 %
Categor y of nutr itional additiv es. Functional group: vita mins, pro-vitami ns and chemically well-def ined subst ances hav ing similar effect
3a825V ‘Ribof lavin’ 
or ‘Vitamin 
B2’Additive composition
Preparation with ≥ 80 % of Ribof lavin.
Maximum 3 % water
Solid form
Char acter isation of active substance
Ribof lavin
Chemical formula: C17H20N4O6
CAS number: 83-88-5
Purity: minimum 98 %
Produced by fermentation with Bacillus subtilis 
CGMCC 13326
Analytical method (1)
For the deter mination of ribof lavin in the feed additive 
preparation and premixtures:
— High Performan ce Liquid Chromat ography with 
UV detec tion, HPLC -UV (VDLUF A Bd. III, 13.9.1)
For the determination of ribof lavin (as total vitamin 
B2) in compo und feed:
— High Performan ce Liquid Chromat ography with 
Fluorescence detec tion, HPLC -FLD (EN 14152)All animal 
species— — — 1.In the directions for use of the addi ­
tive and premixtures, the stora ge con­
ditions, the stability to heat treatment 
shall be indicate d.
2.For users of the additive and premix ­
tures, feed business operators shall 
establish operational procedures and 
organisational measures to address 
poten tial risks resulting from their 
use. Where those risks cannot be 
eliminated by such procedures and 
measures, the additive and premix ­
tures shall be used with personal 
breathing, eye and skin prot ective 
equipment.28 September 
2033
(1)Details of the analytical methods are avail able at the follo wing address of the Reference Laboratory : https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-repor ts.EN Offi cial Jour nal of the European Union 8.9.2023 L 221/13