COMMISSION IMPLEMENTING REGUL ATION (EU) No 1108/2014 
of 20 Oct ober 2014 
concer ning the author isation of a preparation of Clostr idium butyr icum (FERM BP-2789) as a feed 
additiv e for turke ys for fattening and turk eys reared for breeding (holder of author isation 
Miyar isan Phar maceutical Co. Ltd represented by Miyar isan Phar maceutical Europe S.L.U.) 
(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 a new use of a 
preparation of Clostr idium butyr icum (FERM BP-2789). That application was accompanied by the particulars and 
documents required under Article 7(3) of Regulation (EC) No 1831/2003, and by the relevant data to suppor t its 
requests. 
(3)  The application concer ns the author isation of the preparation of Clostr idium butyr icum (FERM BP-2789) as a feed 
additive for turke ys for fattening and turke ys reared for breeding, to be classified in the additive categor y ‘zoot ech­
nical additives’. 
(4)  The use of the preparation of Clostr idium butyr icum (FERM BP-2789), belonging to the additive catego ry of 
‘zoot echnical additives ’, was author ised for 10 years as a feed additive for use on chic kens for fattening by 
Commission Regulation (EC) No 903/2009 (2) and for minor avian species (excluding laying birds) and for 
weaned piglets and minor porcine species (weaned) by Commission Implementing Regulation (EU) 
No 373/2011 (3). 
(5)  The European Food Safety Auth ority (‘the Author ity’) concluded in its opinion of 4 Marc h 2014 (4) that, under 
the proposed conditions of use, the preparation of Clostr idium butyr icum (FERM BP-2789) does not have an 
adverse effect on animal health, human health and the environment. It also concluded that the additive has the 
poten tial to improve performa nce in turk eys for fattening and that this conclusion can be extended to turke ys 
reared for breeding. The Author ity does not consider that there is a need for specific 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. 21.10.2014 L 301/16 Official Jour nal of the European Union EN     
(1)OJ L 268, 18.10.2003, p. 29. 
(2)Commission Regulation (EC) No 903/2009 of 28 September 2009 concer ning the author isation of the preparation of Clostr idium butyr ­
icum FERM-BP 2789 as a feed additive for chic kens for fattening (holder of author isation Miyar isan Phar maceutical Co. Ltd, represented 
by Miyar isan Phar maceutical Europe S.L.U) (OJ L 256, 29.9.2009, p. 26). 
(3)Commission Implementing Regulation (EU) No 373/2011 of 15 Apr il 2011 concer ning the author isation of the preparation of Clostr i­
dium butyr icum FERM-BP 2789 as a feed additive for minor avian species excep t laying birds, weaned piglets and minor porcine species 
(weaned) and amending Regulation (EC) No 903/2009 (holder of author isation Miyar isan Phar maceutical Co. Ltd, represented by Miyar ­
isan Phar maceutical Europe S.L.U.) (OJ L 102, 16.4.2011, p. 10). 
(4)EFSA Journal 2013; 11(1):3040. (6) The assessment of the preparation of Clostr idium butyr icum (FERM BP-2789) shows that the conditions for author i­
sation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfi ed. According ly, the use of that 
preparation should be author ised as specif ied in the Annex to this Regulation. 
(7)  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 specif ied in the Annex, belonging to the additive categor y ‘zootec hnical additives’ and to the functional 
group ‘gut flora stabilisers ’, 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 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, 20 October 2014. 
For the Commission 
The Presid ent 
José Manuel BARR OSO  21.10.2014 L 301/17 Official Jour nal of the European Union EN     ANNEX 
Identifica ­
tion 
number of 
the 
additive Name of the 
holder of 
author isation Additive Composition, chem ical 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 complet e 
feedingstuff with a 
moisture content of 12 % 
Categor y of zootechnical additiv es. Functional group: gut flora stabilisers 
4b1830 Miyar isan 
Phar maceutical 
Co.Ltd repre ­
sented by 
Miyar isan 
Phar maceutical 
Europe S.L.U. Clostr idium 
butyr icum 
FERM BP-2789  Additive composition 
Preparation of Clostr idium butyr icum 
FERM BP-2789 containing in solid 
form a minimum of 5 × 108 CFU/g 
of additive. 
Char acter isation of the activ e substance 
Viable spores of Clostr idium butyr icum 
FERM BP-2789. 
Analytical method (1) 
Enumeration: pour plate method 
based on ISO 15213 standard. 
Identification: pulsed-fie ld gel electro ­
phoresis (PFGE) method.  Turke ys 
for 
fattening 
Turke ys 
reared for 
breeding  — 1,25 × 108 — 1.  In the directions for use 
of the additive and 
premixture, indicate the 
storag e conditions and 
stability to pelleting. 
2.  Use is allowed in feed 
containing (for the 
animal categor y) the 
author ised coccidiostats: 
monensin sodium, robe ­
nidine, maduramicin 
ammonium, lasalocid 
sodium or diclazur il. 
3.  For safety: breathing 
protection and safet y 
glasses shall be used 
during handling. 10 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   21.10.2014 L 301/18 Official Jour nal of the European Union EN