COMMISSION IMPLEMENTING REGUL ATION (EU) 2020/1092 
of 24 July 2020 
amending Implementing Regulation (EU) No 1263/2011 as regards the author isation of Lactococcus 
lactis (NCIMB 30160) 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 13(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 or modifying such author isation. 
(2) The use of Lactococcus lactis NCIMB 30160 as a feed additive was author ised for all animal species by Commission 
Implementing Regulation (EU) No 1263/2011 (2). 
(3) In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission request ed the European Food 
Safety Author ity (‘the Author ity’) to issue an opinion on whether the author isation of Lactococcus lactis (NCIMB 
30160) as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, 
consider ing a modifi cation of the term s of that author isation. The modification relat es to the formulation of the 
additive, consisting of the inclusion of polye thylene glycol (PEG 4000) in the list of cryoprotect ants that can be used 
for the manufacture of the additive. The request was accompanied by the relevant suppor ting data. 
(4) The Author ity concluded in its opinions of 6 Marc h 2018 (3) and 7 October 2019 (4) that, under the proposed 
conditions of use, preparations of PEG 4000 as an excipient in formulations with Lactococcus lactis (NCIMB 30160) 
do not modify the previous conclusions that the additive does not have an adverse effect on animal health, human 
health or the envi ronment and that it is efficacious as silage additive. Theref ore, no safety concer ns are expecte d 
when PEG 4000 is used as a cryoprotectant in the additive Lactococcus lactis NCIMB 30160 up to a maximum 
concentration of 0,025 mg PEG 4000/kg silage. The Author ity does not consider that there is a need for specific 
requirements of post-market monitori ng. 
(5) The assessment of the proposed modifi cation to the author isation shows that the conditions for author isation, as 
provid ed for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. 
(6) Implementing Regulation (EU) No 1263/2011 should theref ore be amended according ly. 
(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 Annex to Implementing Regulation (EU) No 1263/2011 is amended in accordance with the Annex to this Regulation. 
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Implementing Regulation (EU) No 1263/2011 of 5 December 2011 concer ning the author isation of Lactobacillus buchner i 
(DSM 16774), Lactobacillus buchner i (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus 
plantar um (DSM 12836), Lactobacillus plantar um (DSM 12837), Lactobacillus brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB 
30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus 
pentosaceus (DSM 12834) as feed additives for all animal species (OJ L 322, 6.12.2011, p. 3). 
(3)EFSA Journal 2018; 16(3):5218. 
(4)EFSA Journal 2019; 17(11):5890. EN Offi cial Jour nal of the European Union L 241/10                                                                                                                                         27.7.2020   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, 24 July 2020.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union 27.7.2020                                                                                                                                         L 241/11   ANNEX 
In the Annex to Implementing Regulation (EU) No 1263/2011, the entr y concer ning the additive with the identification number 1k2082 is replaced by the following:                                                                
Identification 
number of the 
additive Additive Composi tion, chemical formula, 
descr iption, analytical method Species or 
categor y of 
animal Maximum age Minimum 
conten t Maximum 
conten t 
Other provisions End of period of 
author isation CFU of additive/kg of fresh 
material 
Categor y of technological additiv es. Functional group: silage additiv es 
‘1k2082 Lactococcus lactis 
(NCIMB 30160) Additive composition: 
Preparation of Lactococcus lactis 
(NCIMB 30160) containing a mini­
mum of 4 × 1011 CFU/g additive 
One of the following cryoprot ec­
tants: ascorbic acid, lacto se, manni­
tol, monosodium glutamate, so­
dium citrate, whey powder or 
polyet hylene glycol (PEG 4000) 
Char acter isation of the activ e substance: 
Lactococcus lactis (NCIMB 30160) 
Analytical method (1): 
Enumeration: pour plate method 
using MSR agar (ISO 15214) 
Identif ication: Pulsed-Field Gel Elec­
trophoresis (PFGE) All animal 
species - - - 1. In the directions for use of the 
additive and premixtures, the 
stora ge conditions shall be indi­
cated . 
2. Minimum conte nt of the additive 
when used without combination 
with other micro-orga nisms as si­
lage additives: 1 × 108 CFU/kg 
fresh material. 
3.If used as a cryoprotectant, poly­
ethylen e glycol (PEG 4000) shall 
be used up to a maximum con­
centration of 0,025 mg/kg si­
lage . 
4.For users of the additive and pre­
mixtures, feed business opera­
tors shall establish operational 
procedures and organisational 
measures to address poten tial 
risks resulting from its use. 
Where those risks cannot be 
eliminated or reduced to a mini­
mum by such procedures and 
measures, the additive and pre­
mixtures shall be used with per­
sonal prote ctive equipment, in­
cluding breathing prot ection. 16.8.2030 
(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 L 241/12                                                                                                                                         27.7.2020