ELI: http://data.europa.eu/eli/reg_impl/2023/2644/oj 1/3COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/2644 
of 28 November 2023
concer ning the author isation of lactic acid produced by Weizmannia coagulans DSM 32789 as a feed 
additiv e for all animal species except all aquatic animals and ruminants without a functional rumen 
(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 an author isation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the author isation 
of lactic acid produced by Weizmannia coagulans (synonym Bacillus coagulans) DSM 32789. That application was 
accompan ied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
(3) The application concer ns the author isation of lactic acid produced by Weizmannia coagulans DSM 32789 as a feed 
additive for all animal species excep t for fish, requesting that additive to be classified in the catego ry ‘techn ological 
additives ’ and in the functional group ‘preser vatives’.
(4) The applicant requested the additive to be author ised for use also in wate r for drinking. However , Regulation (EC) 
No 1831/2003 does not allow the author isation of technological additives for use in wate r for drinking. Theref ore, 
the use of the additive in water for drinking should not be allowed.
(5) The European Food Safety Author ity (‘the Author ity’) concluded in its opinions of 24 March 2022 (2)and of 
22 March 2023 (3)that, under the proposed conditions of use, lactic acid produced by Weizmannia coagulans DSM 
32789 is safe for the target species excep t for pre-r uminants and is safe for the consumers and the environment. It 
also concluded that lactic acid produced by Weizmannia coagulans DSM 32789 is corrosive to the skin, eyes and 
mucous membranes. The Author ity further concluded that since lactic acid is used in food as a preser vative it is 
reasonable to expect that the effect seen in food will be obser ved in feed when it is used at comparable 
concentrations and conditions. The Author ity also verified the repor t on the method of analysis of the feed additive 
in feed submitted by the European Union Reference Laboratory set up by Regulation (EC) No 1831/2003, which 
considered that the evaluation repor t issued on 21 Febr uary 2012 relat ed to lactic acid author ised by Commission 
Implementing Regulation (EU) 2022/415 (4)including an addendum issued on 1 June 2021 , is valid and applicable 
for the current application.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Journal 2022;20(4):7268.
(3)EFSA Journal 2023;21(4):7965.
(4)Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 concer ning the author isation of malic acid, citric acid 
produced by Aspergillus niger DSM 25794 or CGMCC 4513/CGMCC 5751 or CICC 40347/CGMCC 5343, sorbic acid and potassium 
sorbat e, acetic acid, sodium diacetate and calcium acetate, propionic acid, sodium propionate, calcium propionate and ammonium 
propionat e, formic acid, sodium format e, calcium formate and ammonium formate, and lactic acid produced by Bacillus coagulans 
(LMG S-26145 or DSM 23965), or Bacillus smithii (LMG S-27890) or Bacillus subtilis (LMG S-27889) and calcium lactate as feed 
additives for all animal species (OJ L 85, 14.3.2022, p. 6).
Offi cial Jour nal  
of the European Union EN 
L series    
2023/2644  29.11.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2644/oj 2/3(6) In view of the above, the Commission considers that lactic acid produced by Weizmannia coagulans DSM 32789 
satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. According ly, the use of that 
additive should be author ised. In addition, the Commission considers that appropr iate prote ctive measures should 
be taken to prevent adverse effects on the health of the users of the additive.
(7) 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,
HAS ADOPTED THIS REGUL ATION:
Article 1
The substance specifi ed in the Annex, belonging to the additive cate gory ‘technological additives ’ and to the functional 
group ‘preser vatives’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex.
Article 2
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, 28 November 2023 .
For the Commission
The President
Ursula VON DER LEYENOJ L, 29.11.2023 EN  ELI: http://data.europa.eu/eli/reg_impl/2023/2644/oj 3/3ANNEX 
Identi- 
fication 
number of 
the additiveAdditiveCompo sition, chem ical formula, 
descr iption, analytical methodSpecies or 
categor y of 
animalMaximum 
ageMinimum 
contentMaximum 
content
Other provisionsEnd of period of 
author isationmg/kg of complet e 
feedi ngstuff with a 
moisture content of 
12 %
Categor y: technological additiv es. Functional group: preser vativ es
1a270i Lactic acid Additiv e composition
Lactic acid ≥ 74 % (w/w)
Liquid form
Char acter isation of the activ e 
substance
Lactic acid:
D-lactic acid ≤ 3 %
L-lactic acid ≥ 97 %
C3H6O3
CAS no 79-33-4
Produced by fermentation of:
Weizmannia coagulans DSM 32789
Method of Analys is(1)
For the determination of lactic acid in 
the feed additive, premixtures and 
compo und feed:
Ion Chromat ography with 
Conductivity Detection, IC-CD (EN 
17294)All animal 
species other 
than
pigs, rumi ­
nants and all 
aquatic ani­
mals— — 20 000 1.The mixture of differ ent sources of lactic 
acid shall not exceed the permitted max ­
imum levels in compl ete feedingstuffs for 
relat ed species.
2.In the directions for use of the additive, 
premixture and related feed for food-pro ­
ducing animals, the followi ng shall be in­
dicated: ‘The simultaneous use of differ ­
ent organic acids or their salts is contra- 
indicated where one or more of them is 
used at or near the maximum permitted 
conte nt.’
3.For users of the additive and premixtures, 
feed business operators shall establish op­
erational procedures and appropr iate or­
gani sational measures to address the po­
tential risks resulting from their use. 
Where those risks cannot be eliminated 
by such procedures and measures, the ad­
ditive and premixtures shall be used with 
personal skin, eye and breathing prote c­
tive equipment.19 December 2033
Pigs and 
ruminants 
with a 
functional 
rumen50 000
(1)Details of the analytical methods are available at the following address of the Reference Laborato ry: https://joint-research-c entre.ec.europa.eu/eurl-fa-eurl-f eed-additives/eurl-fa-author isation/eurl-f a-evaluation- 
repor ts_enOJ L, 29.11.2023 EN