COMMISSION IMPLEMENTING REGUL ATION (EU) No 1083/2014 
of 15 Oct ober 2014 
concer ning the author isation of a preparation of Enterococcus faecium DSM 7134 (Bonvital) as a 
feed additiv e for sows 
(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 submitted for the author isa­
tion of the preparation of Entero coccus faecium DSM 7134 (Bonvital). That application was accompanied 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 the preparation of Entero coccus faecium DSM 7134 (Bonvit al) as a 
feed additive for sows to be used for the duration of the entire reproductive cycle, to be classified in the additive 
catego ry ‘zootec hnical additives’. 
(4)  The use of the preparation of Enterococcus faecium DSM 7134 was author ised provisionally for piglets and pigs for 
fattening by Commission Regulation (EC) No 666/2003 (2), provisionally for sows by Commission Regulation 
(EC) No 2154/2003 (3), provisionally for chick ens for fattening by Commission Regulation (EC) No 521/2005 (4), 
for 10 years for weaned piglets and pigs for fattening by Commission Regulation (EC) No 538/2007 (5) and for 
10 years for sows from day 90 of pregnancy to the end of lactation by Commission Regulation (EC) 
No 1521/2007 (6). 
(5)  The European Food Safety Author ity (the Auth ority) concluded in its opinion of 18 Febr uary 2014 (7) that, under 
the proposed conditions of use, the preparation of Enterococcus faecium DSM 7134 (Bonvit al) does not have an 
adverse effect on animal health, human health or the environment. It also concluded that the additive has the 
poten tial to increase litter weight gain or maintain sow condition. The Authority 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 methods of analysis 
of the feed additives in feed submitte d by the Reference Laborat ory set up by Regulation (EC) No 1831/2003. 
(6)  The assessment of the preparation of Entero coccus faecium DSM 7134 (Bonvital) 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 
that preparation should be author ised as specified in the Annex to this Regulation. 
(7)  As a consequence of the author isation being grant ed by this Implementing Regulation, Regulation (EC) 
No 1521/2007 should be repealed. 16.10.2014 L 298/5 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 666/2003 of 11 Apr il 2003 provisionally author ising the use of certain micro-organisms in feeding ­
stuffs (OJ L 96, 12.4.2003, p. 11). 
(3)Commission Regulation (EC) No 2154/2003 of 10 December 2003 provisionally author ising certain micro-organisms in feedingstuffs 
(Enter ococcus faecium and Lactobacillus acidophilus) (OJ L 324, 11.12.2003, p. 11). 
(4)Commission Regulation (EC) No 521/2005 of 1 Apr il 2005 concer ning the permanent author isation of an additive and the provisional 
author isation of new uses of certain additives already author ised in feedingstuffs (OJ L 84, 2.4.2005, p. 3). 
(5)Commission Regulation (EC) No 538/2007 of 15 May 2007 concer ning the author isation of a new use of Enterococcus faecium DSM 7134 
(Bon vital) as a feed additive (OJ L 128, 16.5.2007, p. 16). 
(6)Commission Regulation (EC) No 1521/2007 of 19 December 2007 concer ning the author isation of a new use of Enterococcus faecium 
DSM 7134 (Bon vital) as a feed additive (OJ L 335, 20.12.2007, p. 24). 
(7)EFSA Jour nal 2014; 12(2):3565 (8)  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 categor y ‘zootec hnical additives’ and the functional group ‘gut 
flora stabilisers ’ is author ised as an additive in animal nutr ition subject to the conditions laid down in this Annex. 
Article 2 
Regulation (EC) No 1521/2007 is repealed. 
Article 3 
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 October 2014. 
For the Commission 
The Presid ent 
José Manuel BARR OSO  16.10.2014 L 298/6 Official Jour nal of the European Union EN     ANNEX 
Identification 
number of 
the additive Name of the 
holder of 
author isation Additive Compo sition, chemical formula, descr iption, 
analytical method Species or 
categ ory of 
animal Maximum 
age Minimum 
content Maximum 
content 
Other provisions End of period 
of author isation CFU/kg of com plete 
feed ingstuff with a 
moisture conten t of 12 % 
Categor y of zootechnical additiv es. Functional group: gut flora stabilisers 
4b1841 Lactos an GmbH 
& Co KG Enterococcus 
faecium  
DSM 7134 Additive composition 
Preparation of Enterococcus faecium  
DSM 7134 containing a minimum of: 
Powder: 1 × 1010 CFU/g of additive 
Granulat ed (microencapsulated):  
1 × 1010 CFU/g of additive 
Char acter isation of the active substance 
Viable cells of Entero coccus faecium  
DSM 7134 
Analytical method (1) 
Enumeration: spread plate method 
using bile esculin azide agar  
(EN 15788) 
Identification: Pulsed Field Gel Electro ­
phoresis (PFGE). Sows — 5 × 108 — 1.  In the directions for 
use of the additive 
and premixture, indi ­
cate the storage 
conditions and stabi ­
lity to pelleting. 
2.  For safety: it is 
recommended to use 
breathing protection 
and gloves during 
handling. 5 November 
2024 
(1)  Details of the analytical methods are avail able at the following address of the European Union Reference Laboratory for Feed Additives: http://ir mm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/P ages/ index. 
aspx   16.10.2014 L 298/7 Official Jour nal of the European Union EN