COMMISSION IMPLEMENTING REGUL ATION (EU) 2023/53 
of 4 Januar y 2023
concer ning the author isation of a preparation of Pediococcus acidilactici CNCM I-4622 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 an author isation.
(2) In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitte d for the 
author isation of a preparation of Pediococcus acidilactici CNCM I-4622. That application was accompanied 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 a preparation of Pediococcus acidilactici CNCM I-4622 as a feed additive 
for all animal species, to be classif ied in the additive categor y ‘technological additives’ and in the functional groups 
‘acidity regulator s’ and ‘hygiene condition enhancers’.
(4) The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 29 June 2022 (2)that, under the 
proposed conditions of use, the preparation of Pediococcus acidilactici CNCM I-4622 does not have adverse effects on 
animal health, consumer safety or the environment. It also concluded that it is considered a respirato ry sensitiser , but 
not irritant to eyes/skin or a skin sensitiser . The Auth ority further concluded that the preparation showed a potential 
to reduce the pH and the growth of colif orms in liquid feeds. It also verified the repor t on the methods of analysis of 
the feed additive in feed submitte d by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of the preparation of Pediococcus acidilactici CNCM I-4622 shows that the conditions for 
author isation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the use of 
this preparation should be author ised. The Commission considers that appropr iate protective measures should be 
taken to prevent adverse effects on human health, in particular as regards 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,
HAS ADOPTED THIS REGUL ATION:
Article 1
1. The preparation specif ied in the Annex, belonging to the additive catego ry ‘techn ological additives ’ and to the 
functional group ‘acidity regulator s’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in 
that Annex.
2. The preparation specif ied in the Annex, belonging to the additive catego ry ‘techn ological additives ’ and to the 
functional group ‘hygiene condition enhancers’, is author ised as an additive in animal nutr ition, subject to the conditions 
laid down in that Annex.
(1)OJ L 268, 18.10.2003, p. 29.
(2)EFSA Jour nal 2022;20(8):7424.EN Offi cial Jour nal of the European Union L 3/8 5.1.2023  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, 4 Januar y 2023 .
For the Commission
The President
Ursula VON DER LEYENEN Offi cial Jour nal of the European Union 5.1.2023 L 3/9  ANNEX 
Identification 
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 isation CFU of additive/kg of 
complet e feed with a 
moisture content of 12 %
Categor y: technological additiv es. Functional group: acidity regulators.
4d1712 Pediococcus 
acidilactici CNCM 
I-4622Additive composition
Preparation of Pediococcus 
acidilactici CNCM I-4622 
containing a minimum of 1 × 
1010 CFU/g
Solid formAll animal 
species- 1 x 109- 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2.The additive shall be used only in mash com ­
pound feed intended for the preparation of liquid 
feed on the farm and/or in solid feed mater ials 
intended for the preparation of liquid feed on 
the farm.
3.May be used in feed containing the followi ng per­
mitted coccidiostats: halofuginone, diclazur il, 
decoquinate and nicarbazin.
4.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial risks resulting from its use. Where 
those risks cannot be eliminated or reduced to a 
minimum by such procedures and measures, the 
additive and premixtures shall be used with per­
sonal prot ective equipment, including breathing 
prote ction.24.1.2033
Char acter isation of the active 
substance
Viable cells of Pediococcus 
acidilactici CNCM I-4622
Analytical method (1)
Enumeration: Spread plate 
method using MRS agar (EN 
15786)
Identif ication: Pulsed Field Gel 
Electrophoresis (PFGE) or DNA 
sequencing methods
(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_enEN Offi cial Jour nal of the European Union L 3/10 5.1.2023  Identification 
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 isationCFU of additive/kg of 
fresh material
Categor y: technological additiv es. Functional group: hygiene condition enhancers (reduction of the growth of colifor ms).
4d1712 Pediococcus 
acidilactici CNCM 
I-4622Additive composition
Preparation of Pediococcus 
acidilactici CNCM I-4622 
containing a minimum of 1 × 
1010 CFU/g
Solid formAll animal 
species- 1 x 109- 1.In the directions for use of the additive and pre­
mixtures, the storage conditions shall be indi ­
cated .
2The additive shall be used only in mash com ­
pound feeds intended for the preparation of li­
quid feed on the farm and/or in solid feed mater i­
als intended for the preparation of liquid feed on 
the farm.
3.May be used in feed containing the followi ng per­
mitted coccidiostats: halofuginone, diclazur il, 
decoquinate and nicarbazin.
4.For users of the additive and premixtures, feed 
business operat ors shall establish operational 
procedures and organisational measures to ad­
dress poten tial risks resulting from its use. Where 
those risks cannot be eliminated or reduced to a 
minimum by such procedures and measures, the 
additive and premixtures shall be used with per­
sonal prot ective equipment, including breathing 
prote ction.24.1.2033
Char acter isation of the active 
substance
Viable cells of Pediococcus 
acidilactici CNCM I-4622
Analytical method (1)
Enumeration: Spread plate 
method using MRS agar (EN 
15786)
Identif ication: Pulsed Field Gel 
Electrophoresis (PFGE) or DNA 
sequencing methods
(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_enEN Offi cial Jour nal of the European Union 5.1.2023 L 3/11  