EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/5864438/2023 CIS Rev.1 
(POOL/G5/2023/5864438/5864438R1 -
EN CIS.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
correcting Implementing Regulation (EU) 2022/415 concerning the authorisation 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 sorbate, 
acetic acid, sodium diace tate and calcium acetate, propionic acid, sodium propionate, 
calcium propionate and ammonium propionate, formic acid, sodium formate, calcium 
formate and ammonium formate, and lactic acid produced by  Bacillus coagulans  (LMG 
S-26145 or DSM 23965), or  Bacill us smithii  (LMG S -27890) or  Bacillus subtilis  (LMG S -
27889) and calcium lactate as feed additives for all animal species  
(Text with EEA relevance)    
EN 1  EN This draft has not been adopted or endorsed by the European Commission. Any views 
expressed are the preliminary views of the Commission services and may not in any 
circumstances be regarded as stating an official position of the Commission. The 
information  transmitted is intended only for the Member State or entity to which it is 
addressed for discussions and may contain confidential and/or privileged material  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
correcting Implementing Regulation (EU) 2022/ 415 concerning the authorisation 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 sorbate, 
acetic acid, sodium diacetate and calcium acetate, propionic acid, sod ium propionate, 
calcium propionate and ammonium propionate, formic acid, sodium formate, 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  
(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 nutrition1, and in p articular 
Article 9(2) thereof,  
Whereas:  
(1) The use of acetic acid, of sodium diacetate, of calcium acetate  and of ammonium 
formate as feed additiv es was authorised for a 10 -year period by Commission 
Implementing Regulation (EU) 2022/4152 only for certain animal species , while the 
title of that Implementing Regulation erroneously refers to an authorisation for all 
animal species.  
(2) The use of lactic a cid and of calcium lactate as feed additive s was authorised for a 10 -
year period also by Implementing Regulation (EU) 2022/415.   
(3) In the Annex to Implementing Regulation (EU) 2022/415 regarding  the additive s 
lactic acid (identified as “1a270” ) and calcium l actate  (identified as “1a327”) , in the 
 
1 OJ L 268, 18.10.2003, p . 29. 
2 Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 concerning the authorisation 
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 sorbate, acetic acid, sodium diacetate and 
calcium acetat e, propionic  acid, sodium propionate, calcium propionate and ammonium propionate, 
formic acid, sodium formate, 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).    
EN 2  EN column “Species or category of animal”, the category ‘ ruminants with a non-
functional rumen ’ is covered by the scope of  “All animal species other than pigs and 
ruminants with a functional rumen” , while,  according to the opinion of t he European 
Food Safety Authority of 12 November 20193, a safe dose for pre -ruminants could not 
be established.  The additive s lactic acid and calcium lactate should therefore not have 
been authorised for  use for  ruminants wit h a non -functional rumen.  
(4) In the Annex to Implementing Regulation (EU) 2022/415 regarding the additive 
calcium acetate  (identified as “1a263” ), an entry related to iron was wrongly added  in 
the column “Composition, chemical formula, description, analytical  method”  under 
the heading “Characterisation of the active substance”.  
(5) Implementing Regulation (EU) 2022/415 should therefore  be corrected  accordingly .  
(6) The measures provided fo r in this Regulation are in accordance with the opinion of the 
Standing Committ ee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Implementing Regulation (EU)  2022/ 415 is corrected as follows:  
(1) the title is replaced by the following:  
“Commission Implementing Regulation (EU) 2022/415 of 11 March 2022 
concerning the authorisation 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 sorbate, acetic acid, sodium diacetate and calcium acetate, 
propionic  acid, sodium propionate, calcium propionate and ammonium propionate, 
formic acid, sodium formate, 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  certain animal species”;  
(2) in the fo urth column of the Annex entitled “Species or category of animal”, 
concerning the entr ies 1a270 on lactic acid  and 1a327 on calcium lactate , the categor y 
“All animal spe cies other than pigs and ruminants with a functional rumen” is replaced 
by “All animal species other than pigs and ruminants”;  
(3) in the third column of the A nnex  entitled “Composition, chemical formula, 
description, analytical method”, concerning the entry 1 a263 on  calcium acetate , the 
heading  “Characterisation of the active substance”  is replaced by  the following:  
“Calcium acetate ≥  98,7 % 
C4H6CaO 4 
CAS No  62-54-4 
Water ≤  6 % 
Non volatile matter ≤  30 mg/kg  
Formic acid and its salts and other oxidisable material ≤  1g/kg  
Produced by chemical synthesis ”. 
 
3 EFSA Journal 20 19;17(12):5914 .  
EN 3  EN Article 2 
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,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN