COMMI SSION IMPLEMENTING REGUL ATION (EU) 2017/455 
of 15 March 2017 
concer ning the author isation of a preparation of Lactobacillus fermentum (NCIMB 41636), 
Lactobacillus plantar um (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed 
additiv e for dogs 
(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 provides 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 the preparation of Lactobacillus ferm entum (NCIMB 41636), Lactobacillus plantar um (NCIMB 41638) and 
Lactobacillus rhamnosus (NCIMB 41640). That application was accompan ied 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 the preparation of Lactobacillus fermentum (NCIMB 41636), Lactoba ­
cillus plantar um (NCIMB 41638) and Lactobacillus rhamnosus (NCIMB 41640) as a feed additive for dogs to be 
classified in the additive categor y ‘technological additives ’. 
(4)  The European Food Safet y Author ity (‘the Author ity’) concluded in its opinion of 1 December 2015 (2) that the 
preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantar um (NCIMB 41638) and Lactobacillus 
rhamnosus (NCIMB 41640) does not have an adverse effect on animal health, human health or the environment. 
The Author ity has also concluded that the addition of the additive to pasteur ised milk or to an oat-based product 
results in an acidification contr ibuting to the preser vation of the resulting food intended for dogs. The Author ity 
does not consider that there is a need for specifi c requirements of post-market monitoring. It also verified the 
repor t on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by 
Regulation (EC) No 1831/2003. 
(5)  The assessment of the preparation of Lactobacillus fermentum (NCIMB 41636), Lactobacillus plantar um (NCIMB 
41638) and Lactobacillus rhamnosus (NCIMB 41640) shows that the conditions for author isation, as provided for 
in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of this preparation should be 
author ised as specified in the Annex to this Regulation. 
(6)  The measures provided 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 preparation specifi ed in the Annex, belonging to the additive catego ry ‘technological additives ’ and to the functional 
group ‘preser vatives’, is author ised as an additive in animal nutr ition, subject to the conditions laid down in that Annex. 16.3.2017 L 71/15 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)EFSA Journal 2016;14(1):4340. 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 State s. 
Done at Brussels, 15 Marc h 2017. 
For the Commission 
The Presid ent 
Jean-Claude JUNCKER  16.3.2017 L 71/16 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the additive Name of 
the holder 
of author is­
ation Additive Composi tion, chemical formula, 
descr iption, analytical method Species or 
categor y of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of 
period of 
author is­
ation CFU of additive/kg of feed 
mat erial 
Categor y of technological additiv es. Functional group: preser vativ es 
1a001 — Lactobacillus 
fermentum 
(NCIMB 
41636), 
Lactobacillus 
plantar um 
(NCIMB 
41638) and 
Lactobacillus 
rhamnosus 
(NCIMB 
41640) Additiv e composition 
Preparation of Lactobacillus fer­
mentum (NCIMB 41636), Lacto ­
bacillus plantar um (NCIMB 
41638) and Lactobacillus rhamno ­
sus (NCIMB 41640) containing 
a minimum of total Lactobacilli 
of 1,0 × 108 CFU/g additive 
(hav ing a minimum of each Lac­
tobacillus of 1,0 × 107 CFU/g ad­
ditive) 
Char acter isation of the active sub­
stance 
Viable cells of Lactobacillus fer­
mentum (NCIMB 41636), Lacto ­
bacillus plantar um (NCIMB 
41638) and Lactobacillus rhamno ­
sus (NCIMB 41640) 
Analytical method (1) 
Enumeration in the feed addi ­
tive: spread plate method on 
MRS agar (EN 15787) 
Identif ication: Pulsed Field Gel 
Electrophoresis (PFGE). Dogs — — — 1.In the directions for use of the addi ­
tive and premixture, indicate the 
storag e conditions. 
2.  This additive shall be used only in 
oat derived products and pas­
teuri sed milk. 
3.Recommended use levels of addi ­
tive: 
—  6 × 108 CFU/kg of oat derived 
products (90 % moisture con­
tent); 
—2,7 × 1010 CFU/kg of pas­
teurised milk. 
4.For users of the additive and pre­
mixtures, feed business operators 
shall establish operational proce ­
dures and appropr iate organisation ­
al measures to address the pote ntial 
risks by inhalation, dermal contact 
or eyes contact. Where risks cannot 
be reduced to an accepta ble level by 
these procedures and measures, the 
additive and premixtures shall be 
used with appropr iate personal pro­
tective equipment, including skin 
protection. 5 Apr il 
2027 
(1)  Details of the analytical methods are available at the following address of the Reference Laboratory : http://ir mm.jrc.ec.europa.eu/EURLs/EURL_feed _additives/Pag es/index.aspx   16.3.2017 L 71/17 Official Jour nal of the European Union EN