HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 100/22
EN
Official Journal of the European Union
14.4.2011
COMMISSION IMPLEMENTING REGULATION (EU) No 361/2011
of 13 April 2011
concerning the authorisation of Enterococcus faecium NCIMB 10415 as a feed additive for chickens
for fattening (holder of authorisation DSM Nutritional products Ltd represented by DSM
Nutritional Products Sp. z o.o) and amending Regulation (EC) No 943/2005
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
feed additive for chickens for fattening, requesting that
additive be classified in the additive category
‘zootechnical additives’. That application was accom
panied by the particulars and documents required
Having regard to the Treaty on the Functioning of the European
pursuant to Article 7(3) of Regulation (EC)
Union,
No 1831/2003.
Having regard to Regulation (EC) No 1831/2003 of the
European Parliament and of the Council of 22 September
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
2003 on additives for use in animal nutrition ( 1 ), and in
concluded in its opinion of 22 June 2010 ( 8 ) that,
particular Article 9(2) thereof,
under the proposed conditions of use, Enterococcus
faecium NCIMB 10415 does not have an adverse effect
on animal health, human health or on the environment,
and that that additive has the potential to increase the
Whereas:
final body weight of chickens for fattening. The
Authority does not consider that there is a need for
specific requirements of post-market monitoring. It also
verified the report on the method of analysis of the feed
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
additive in feed submitted by the European Union
orisation of additives for use in animal nutrition and
Reference Laboratory for Feed Additives set up by Regu
for the grounds and procedures for granting such auth
lation (EC) No 1831/2003.
orisation. Article 10 of that Regulation provides for the
re-evaluation of additives authorised pursuant to Council
Directive 70/524/EEC ( 2 ).
(5) The
assessment
of Enterococcus faecium NCIMB 10415
shows that the conditions for authorisation, as
(2) The
preparation
of Enterococcus faecium NCIMB 10415
provided for in Article 5 of Regulation (EC)
was authorised in accordance with Directive 70/524/EEC
No 1831/2003, are satisfied. Accordingly, the use of
as a feed additive without a time limit for use on calves
that preparation should be authorised as specified in
up to 6 months by Commission Regulation (EC) No
Annex I to this Regulation.
1288/2004 ( 3 ), for use on chickens for fattening and
pigs for fattening by Commission Regulation (EC)
No 943/2005 ( 4 ), for use on sows by Commission Regu
lation (EC) No 1200/2005 ( 5 ), for use on piglets by
Commission Regulation (EC) No 252/2006 (
(6)
As a consequence of a new authorisation being granted

6 ) and for
use on cats and dogs by Commission Regulation (EC)
by this Regulation, the entry concerning Enterococcus
No 102/2009
(
faecium NCIMB 10415 for chickens for fattening in Regu

7 ). That additive was subsequently
entered in the Community Register of feed additives as
lation (EC) No 943/2005 should be deleted.
an existing product, in accordance with Article 10(1)(b)
of Regulation (EC) No 1831/2003.
(7)
Since the modifications to the conditions of the auth
orisation are not related to safety reasons, it is appro
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
priate to allow a transitional period for the disposal of
No 1831/2003 in conjunction with Article 7 of that
existing stocks of premixtures and compound feed.
Regulation, an application was submitted for the re-
evaluation of Enterococcus faecium NCIMB 10415 as a
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
(8) The
measures
provided
for
in
this
Regulation
are
in
( 3 ) OJ L 243, 15.7.2004, p. 10.
accordance with the opinion of the Standing
( 4 ) OJ L 159, 22.6.2005, p. 6.
Committee on the Food Chain and Animal Health,
( 5 ) OJ L 195, 27.7.2005, p. 6.
( 6 ) OJ L 44, 15.2.2006, p. 3.
( 7 ) OJ L 34, 4.2.2009, p. 8.
( 8 ) EFSA Journal 2010; 8(7):1661.

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EN
14.4.2011 Official
Journal
of
the
European
Union L
100/23
HAS ADOPTED THIS REGULATION:
Article 3
Premixtures and compound feed containing Enterococcus faecium
Article 1
NCIMB 10415 labelled in accordance with Directive
70/524/EEC may continue to be placed on the market and
The preparation specified in Annex I, belonging to the additive
used until stocks are exhausted.
category ‘zootechnical additives’ and to the functional group
‘gut flora stabilisers’, is authorised as an additive in animal
nutrition subject to the conditions laid down in that Annex.
Article 2
Article 4
Annex I to Regulation (EC) No 943/2005 is replaced by the text
This Regulation shall enter into force on the 20th day following
in Annex II to this Regulation.
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, 13 April 2011.
For the Commission
The President
José Manuel BARROSO

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L 100/24
ANNEX I
Minimum
Maximum
Identification Name of the
Species or
content
content
number of
holder of
Additive
Composition, chemical formula, description, analytical
category of
Maximum age
Other provisions
End of period of
the additive
authorisation
method
animal
authorisation
CFU/kg of complete feedingstuff
with a moisture content of 12 %
EN

Category of zootechnical additives. Functional group: gut flora stabilisers
4b1705 DSM
Nutri Enterococcus
Additive composition
Chickens for
3 × 108
— 1.
In
the
directions
for
use
4 May 2021
tional
faecium
fattening
of the additive and
Products Ltd
Preparation of Enterococcus faecium
premixture, indicate the
represented
NCIMB 10415
storage temperature,
by DSM
NCIMB 10415 containing a minimum of:
storage life and stability
Nutritional
to pelleting.
products Sp.
coated form (with shellac):
Z o.o
2. The use is permitted in
Off
2 × 1010 CFU/g of additive;
feed containing the auth
icial
orised coccidiostats: deco
Jour
Other microencapsulated forms:
quinate, monensin
sodium, robenidine
nal
hydrochloride, diclazuril,
1 × 1010 CFU/g additive
or semduramycin.
of
the
Characterisation of the active substance
European
Enterococcus faecium
NCIMB 10415
Union
Analytical method (1 )
Enumeration: spread plate method using bile
esculin azide agar
Identification: Pulsed- Field Gel Electrophoresis
(PFGE)
(1 ) Details of the analytical methods are available at the following address of the European Union Reference Laboratory for Feed Additives: www.irmm.jrc.be/eurl-feed-additives
14.4.2011

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14.4.2011 Off
ANNEX II
Annex I to Regulation (EC) No 943/2005 is replaced by the following:
‘ANNEX I
EN
Species or
Minimum
Maximum

content
content
EC No Additive Chemical
formula,
description
category of
Maximum age
Other provisions
End of period of
animal
authorisation
CFU/kg of complete feedingstuff
Micro-organisms
E 1705 Enterococcus
Preparation of Enterococcus faecium containing a
Pigs for
— 0,35
×
109
1,0 × 109 In the directions for use of Without a time
faecium
minimum of:
fattening
the additive and premixture,
limit’
indicate the storage
NCIMB 10415 Microencapsulated form:
temperature, storage life
and stability to pelleting.
icial
1,0 × 1010 CFU/g of additive;
Jour
Granulated form:
nal
3,5 × 1010 CFU/g additive
of
the
European
Union
L
100/25

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