COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/2118 
of 16 December 2020 
concer ning the renewal of the author isation of Pediococcus pentosaceus DSM 16244 as a feed additiv e 
for all animal species and repealing Regulation (EU) No 514/2010 
(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 and renewing such author isation. 
(2) Pediococcus pentosaceus DSM 16244 was author ised for 10 years as a feed additive for all animal species by 
Commission Regulation (EU) No 514/2010 (2). 
(3) In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitte d for the renewal of 
the author isation of Pediococcus pentosaceus DSM 16244 as a feed additive for all animal species, requesting the 
additive to be classif ied in the additive catego ry ‘technological additives ’. That application was accompanied by the 
particulars and documents required under Article 14(2) of that Regulation. 
(4) The European Food Safet y Auth ority (‘the Auth ority’) concluded in its opinion of 25 May 2020 (3) that the applicant 
has provid ed evidence that the additive compl ies with the existing conditions of author isation. The Author ity 
concluded that Pediococcus pentosaceus DSM 16244 does not have an adverse effect on animal health, consumer 
safety or the envi ronment. It also concluded that is not irritant to skin and eyes but considered a skin and 
respirato ry sensitiser . Theref ore, the Commission considers that appropr iate prot ective measures should be taken to 
prevent adverse effects on human health, in particular as regards to users of the additive. 
(5) The assessment of Pediococcus pentosaceus DSM 16244 shows that the conditions for author isation, as provided for in 
Article 5 of Regulation (EC) No 1831/2003, are satisfied. According ly, the author isation of that additive should be 
renewed as specified in the Annex to this Regulation. 
(6) As a consequence of the renewal of the author isation of Pediococcus pentosaceus DSM 16244 as a feed additive under 
the conditions laid down in the Annex to this Regulation, Regulation (EU) No 514/2010 should be repealed. 
(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 author isation of the additive specifi ed in the Annex, belonging to the additive cate gory ‘technological additives’ and to 
the functional group ‘silag e additives ’, is renewed subject to the conditions laid down in that Annex. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EU) No 514/2010 of 15 June 2010 concer ning the author isation of Pediococcus pentosaceus (DSM 16244) as a 
feed additive for all animal species (OJ L 150, 16.6.2010, p. 42). 
(3)EFSA Journal 2020;18(6):6166. EN Offi cial Jour nal of the European Union 17.12.2020                                                                                                                                       L 426/15   Article 2 
Regulation (EU) No 514/2010 is repealed. 
Article 3 
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, 16 December 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 426/16                                                                                                                                       17.12.2020   ANNEX 
Identification 
number of the 
additive Additive Composition, chem ical formula, 
descr iption, analytical method Species or categor y of 
animal Maximum 
age Minimum 
content Maximum 
content Other provisions End of period 
of 
author isation CFU/kg of fresh mat erial 
Categor y of technological additiv es. Functional group: silage additiv es 
1k2101 Pediococcus 
pentosaceus DSM 
16244 Additive composition 
Preparation of Pediococcus pentosaceus 
DSM 16244 containing a minimum 
of 4 × 1011 CFU/g additive. All animal species - - - 1. In the directions for use of the 
additive and premixtures, the 
stora ge conditions shall be 
indicated . 
2. Minimum content of the additive 
when used without combination 
with other micro-org anisms as 
silage additives: 1×108 CFU/kg 
fresh mate rial. 
3. For users of the additive and 
premixtures, feed business 
operat ors shall establish 
operational procedures and 
organisational measures to 
address poten tial risks resulting 
from its use. Where those risks 
cannot be eliminate d or reduced 
to a minimum by such 
procedures and measures, the 
additive and premixtures shall be 
used with personal prote ctive 
equipment, including gloves and 
breathing prot ection. 6.1.2031 
Char acter isation of the active substance 
Pediococcus pentosaceus DSM 16244. 
Analytical method (1) 
— Enumeration: spread plate  
method on MSR agar  
(EN 15786). 
— Identif ication: pulsed-f ield gel  
electrophoresis (PFGE) method. 
(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 17.12.2020                                                                                                                                       L 426/17   