II 
(Non-legislative acts) 
REGUL ATIONS 
COMMI SSION IMPLEMENTING REGUL ATION (EU) 2019/764 
of 14 May 2019 
concer ning the author isation of a preparation of Lactobacillus hilg ardii CNCM I-4785 and 
Lactobacillus buchner i CNCM I-4323/NCIMB 40788 as a feed additiv e for all animal species 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Having regar d to the Treaty on the Functioning of the European Union, 
Having regar d to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 
on additives for use in animal nutr ition (1), and in particular Article 9(2) thereof, 
Whereas: 
(1)  Regulation (EC) No 1831/2003 provi des for the author isation of additives for use in animal nutr ition and for the 
grounds and procedures for granting such author isation. 
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitte d for the author is­
ation of a preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchner i CNCM I-4323/NCIMB 
40788. That application was accompan ied by the particulars and documents required under Article 7(3) of 
Regulation (EC) No 1831/2003. 
(3) That application concer ns the author isation of a preparation of Lactobacillus hilgardii CNCM I-4785 and Lactoba ­
cillus buchner i CNCM I-4323/NCIMB 40788 as a feed additive for all animal species to be classifie d in the additive 
catego ry ‘technological additives ’. 
(4)  The European Food Safety Author ity (‘the Auth ority’) concluded in its opinion of 2 Octobe r 2018 (2) that, under 
the proposed conditions of use, the preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchner i 
CNCM I-4323/NCIMB 40788 does not have an adverse effect on animal health, consumer safety or the 
environment. It also concluded that the additive is considered a potential respirato ry sensitiser and that no 
conclusion could be drawn on skin or eyes sensitisation or irritation by the additive. 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 the users of the additive. The Authority also concluded that the preparation concer ned has 
the potential to improve the production of silage from easy and moderate ly difficult to ensile forage mat erials. The 
Author ity does not consider that there is a need for specifi c requirements of post-market monitori ng. It also 
verified the repor t on the method of analysis of the feed additive in feed submitted by the Reference Laborat ory 
set up by Regulation (EC) No 1831/2003. 
(5)  The assessment of the preparation of Lactobacillus hilgardii CNCM I-4785 and Lactobacillus buchner i CNCM 
I-4323/NCIMB 40788 shows that the conditions for author isation, as provid ed for in Article 5 of Regulation (EC) 
No 1831/2003, are satisfied. According ly, the use of that preparation should be author ised as specifi ed in the 
Annex to this Regulation. 
(6)  The measures provi ded for in this Regulation are in accordance with the opinion of the Standing Committee on 
Plants, Animals, Food and Feed, 15.5.2019 L 126/1 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Jour nal 2018; 16(10):5455. HAS ADOPTED THIS REGUL ATION: 
Article 1 
The preparation specifi ed in the Annex, belonging to the additive catego ry ‘technological additives ’ and to the functional 
group ‘silag e additives’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that 
Annex. 
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 State s. 
Done at Brussels, 14 May 2019. 
For the Commission 
The President 
Jean-Claude JUNCK ER  15.5.2019 L 126/2 Official Jour nal of the European Union EN     ANNEX 
Identification 
number of 
the additive Additive Composition, chemical formula, descr iption, 
analytical method Species or 
category of 
animal Maximum 
age Minimum 
conten t Maximum 
conten t 
Other provisi ons End of period 
of  
author isation CFU of additive/kg of 
fresh material 
Technological additiv es: silage additiv es 
1k20757 Lactobacillus hilgardii 
CNCM I-4785 and 
Lactobacillus buchner i 
CNCM I-4323/NCIMB 
40788 Additive composition: 
Preparation of Lactobacillus hilgardii 
CNCM I-4785 and Lactobacillus buchner i 
CNCM I-4323/NCIMB 40788 contain ­
ing a minimum of 1.5 × 1011 CFU/g 
additive (ratio of 1:1). 
Char acter isation of the activ e substance: 
Viable cells of Lactobacillus hilgardii 
CNCM I-4785 and Lactobacillus buchner i 
CNCM I-4323/NCIMB 40788. 
Analytical method (1) 
Enumeration in the feed additive and 
premixtures: spread plate method on 
MRS agar: EN 15787. 
Identif ication of the feed additive: 
Pulsed Field Gel Electrophoresis (PFGE). All animal 
species — — — 1.In the directions for use of the addi ­
tive and premixtures, the storage 
conditions shall be indicate d. 
2.  Minimum content of the additive 
when used without combination 
with other micro-organis ms as si­
lage additives: 3 × 108 CFU/kg 
(L. hilgardii CNCM I-4785 and 
L. buchner i CNCM I-4323/NCIMB 
40788 in ratio of 1:1) of easy and 
moderately difficult to ensile fresh 
mater ial(2). 
3.For users of the additive and pre­
mixtures, feed business operat ors 
shall establish operational proce ­
dures 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 per­
sonal protective equipment, includ ­
ing breathing protection. 4 June 2029 
(1)  Details of the analytical methods are available at the following address of the Reference Laborato ry: https://ec.europa.eu/jrc/en/eurl/feed-addi tives/evaluation-repor ts 
(2)  Easy to ensile forage: > 3 % soluble carbohydrat es in fresh mat erial. Moderately difficult to ensile forage: 1,5-3,0 % soluble carbohydrat es in the fresh material. Commission Regulation (EC) No 429/2008 of 
25 Apr il 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regar ds the preparation and the presentation of applications and 
the assessment and the author isation of feed additives (OJ L 133, 22.5.2008, p. 1).   15.5.2019 L 126/3 Official Jour nal of the European Union EN     