Commission Implementing Regulation (EU) 2024/762 of 1 March 2024 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, 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
Date: 2024-03-01
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, chemical compound, food additive, market approval








L_202400762EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2024/762


4.3.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/762
of 1 March 2024
         
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, 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
(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)


The use of acetic acid, of sodium diacetate, of calcium acetate and of ammonium formate as feed additives was authorised for a 10-year period by Commission Implementing Regulation (EU) 2022/415 (2) 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 acid and of calcium lactate as feed additives 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 additives lactic acid (identified as ‘1a270’) and calcium lactate (identified as ‘1a327’), in the 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 the European Food Safety Authority of 12 November 2019 (3), a safe dose for pre-ruminants could not be established. The additives lactic acid and calcium lactate should therefore not have been authorised for use for ruminants with 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 for in this Regulation are in accordance with the opinion of the Standing Committee 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 fourth column of the Annex entitled ‘Species or category of animal’, concerning the entries 1a270 on lactic acid and 1a327 on calcium lactate, the category ‘All animal species 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 Annex entitled ‘Composition, chemical formula, description, analytical method’, concerning the entry 1a263 on calcium acetate, the text under the heading ‘Characterisation of the active substance’ is replaced by the following:






 



                                    ‘Calcium acetate ≥ 98,7 %










 


C4H6CaO4











 


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’.










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, 1 March 2024.


For the Commission


The President

Ursula VON DER LEYEN
            





(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 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 all animal species (OJ L 85, 14.3.2022, p. 6).

(3)  
            EFSA Journal 2019;17(12):5914.


ELI: http://data.europa.eu/eli/reg_impl/2024/762/oj
ISSN 1977-0677 (electronic edition)