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26.3.2013 Official
Journal
of
the
European
Union L
86/15
COMMISSION IMPLEMENTING REGULATION (EU) No 288/2013
of 25 March 2013
concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi
(NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No
1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(4) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
application was submitted for the authorisation of the
preparation of Bacillus cereus var. toyoi (NCIMB
Having regard to the Treaty on the Functioning of the European
40112/CNCM I-1012) as a feed additive for cattle for
Union,
fattening, rabbits for fattening, chickens for fattening,
piglets (weaned), pigs for fattening and sows for repro
duction and, in accordance with Article 7 of that Regu
Having regard to Regulation (EC) No 1831/2003 of the
lation, an application was submitted for a new use of
European Parliament and of the Council of 22 September
that preparation for calves for rearing, both applications
2003 on additives for use in animal nutrition (
requesting the additive to be classified in the additive

1 ), and in
particular Article 13(2) thereof,
category ‘zootechnical additives’. Those applications
were accompanied by the particulars and documents
required under Article 7(3) of Regulation (EC) No
1831/2003.
Whereas:
(5) The
European
Food
Safety
Authority
(‘the
Authority’)
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
concluded in its opinion of 16 October 2012 ( 9 ) that
orisation of additives for use in animal nutrition and
the strain of Bacillus cereus harbours resistance deter
for the grounds and procedures for granting, denying
minants to two antibiotics used in human and veterinary
or suspending such authorisation. Article 10 of that
medicine, one of which at least can now be ascribed to
Regulation provides for the re-evaluation of additives
an acquired resistance. It was also determined that,
authorised pursuant to Council Directive 70/524/EEC ( 2 ).
because of the presence of genes having the same organi
sation as pathogenic Bacillus cereus strains, it has to be
assumed that the Bacillus cereus strain contained in the
preparation subject to the application has the capacity to
(2) The
preparation
of Bacillus cereus var. toyoi (NCIMB
elaborate functional toxins involved in foodborne
40112/CNCM I-1012) was authorised without a time
diseases.
limit in accordance with Directive 70/524/EEC as a
feed additive for use for piglets under two months and
sows by Commission Regulation (EC) No 256/2002 ( 3 ),
for piglets from two to four months and pigs for
(6) The
information
available
does
not
allow
one
to
exclude
fattening by Commission Regulation (EC) No
the risk that the preparation of Bacillus cereus var. toyoi
1453/2004 (
(NCIMB 40112/CNCM I-1012) may spread resistance to

4 ), for cattle for fattening by Commission
Regulation (EC) No 255/2005 (
those antibiotics to other micro-organisms and may

5 ) and for rabbits for
fattening and chickens for fattening by Commission
expose to the risk of the toxins those handling the
Regulation (EC) No 1200/2005 (
additive or consumers. Consequently, it has not been

6 ). The preparation was
subsequently entered in the European Union Register of
established that that preparation does not have an
feed additives as an existing product, in accordance with
adverse effect on animal health or on human health,
Article 10(1) of Regulation (EC) No 1831/2003.
when used under the proposed conditions.
(3) That
preparation
was
also
authorised
in
accordance
with (7) The
conclusions
from
the
Authority
concerning
the
Regulation (EC) No 1831/2003 for 10 years for turkeys
safety of the preparation apply to its use for all the
for fattening by Commission Regulation (EC) No
animal species for which an authorisation has been
166/2008 (
granted, including for turkeys for fattening and for

7 ) and for rabbit breeding does by
Commission Regulation (EC) No 378/2009 (
rabbit breeding does, as authorised by Regulations (EC)

8 ).
No 166/2008 and (EC) No 378/2009.
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 41, 13.2.2002, p. 6.
(8) Those
authorisations
therefore
no
longer
meet
the
( 4 ) OJ L 269, 17.8.2004, p. 3.
conditions set out by Article 5 of Regulation (EC) No
( 5 ) OJ L 45, 16.2.2005, p. 3.
1831/2003.
( 6 ) OJ L 195, 27.7.2005, p. 6.
( 7 ) OJ L 50, 23.2.2008, p. 11.
( 8 ) OJ L 116, 9.5.2009, p. 3.
( 9 ) EFSA Journal 2012; 10(10):2924.

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L 86/16
EN
Official Journal of the European Union
26.3.2013
(9) It
is
possible
that
supplementary
data
concerning
the
Article 3
safety of use of the preparation of Bacillus cereus var.
toyoi (NCIMB 40112/CNCM I-1012) bring new
Suspension of the authorisation provided for by
elements that would allow a re-consideration of the
Regulation (EC) No 255/2005
assessment carried out for that additive. In this respect,
The authorisation provided for by Regulation (EC) No
the applicant for the authorisation of that preparation
255/2005 concerning the preparation specified in entry E
argues that new evidence may be provided in order to
1701 of Annex I to that Regulation is suspended.
demonstrate the safety of the additive. To this end, the
applicant committed itself to produce supplementary
data which, it states, should be available by April
2013. Those data would consist of new studies
Article 4
supporting a new taxonomical classification of the
micro-organism as a new Bacillus species, the non-trans
Suspension of the authorisation provided for by
ferability of the antibiotic resistance and the non-func
Regulation (EC) No 1200/2005
tionality of the enterotoxin genes present in the genome
The authorisation provided for by Regulation (EC) No
of Bacillus var. toyoi.
1200/2005 concerning the preparation specified in entry E
1701 of Annex II to that Regulation is suspended.
(10) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1831/2003, the authorisations of the preparation of
Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012)
Article 5
provided for by Regulations (EC) No 256/2002, (EC)
Suspension of the authorisation provided for by
No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005,
Regulation (EC) No 166/2008
(EC) No 166/2008 and (EC) No 378/2009 should
therefore be suspended, pending the submission and
The authorisation provided for in Article 1 of Regulation (EC)
assessment of the supplementary data. The suspension
No 166/2008 is suspended.
measure should be reviewed after due assessment of
those data by the Authority.
Article 6
(11) Since
further
use
of
the
preparation
as
a
feed
additive
Suspension of the authorisation provided for by
may cause a risk to human and animal health, respective
Regulation (EC) No 378/2009
products should be withdrawn from the market as soon
as possible. For practical reasons however, a limited tran
The authorisation provided for in Article 1 of Regulation (EC)
sitional period should be allowed for the withdrawal
No 378/2009 is suspended.
from the market of the products concerned in order to
enable operators to comply properly with the withdrawal
obligation.
Article 7
Transitional measures
(12) The
measures
provided
for
in
this
Regulation
are
in
Existing stocks of the preparation of Bacillus cereus var. toyoi
accordance with the opinion of the Standing
(NCIMB 40112/CNCM I-1012) for use for cattle for fattening,
Committee on the Food Chain and Animal Health,
rabbits for fattening, chickens for fattening, piglets, pigs for
fattening, sows, turkeys for fattening and rabbit breeding
does, and of premixtures containing that preparation, shall be
HAS ADOPTED THIS REGULATION:
withdrawn from the market by 14 June 2013. Feed materials
and compound feed produced with that preparation or with
premixtures containing that preparation before 14 June 2013
Article 1
shall be withdrawn from the market by 15 October 2013.
Suspension of the authorisation provided for by
Regulation (EC) No 256/2002
Article 8
The authorisation provided for by Regulation (EC) No
256/2002 concerning the preparation specified in entry E
Review of the measure
1701 of Annex III to that Regulation is suspended.
This Regulation shall be reviewed by 15 April 2015.
Article 2
Article 9
Suspension of the authorisation provided for by
Regulation (EC) No 1453/2004
Entry into force
The authorisation provided for by Regulation (EC) No
This Regulation shall enter into force on the twentieth day
1453/2004 concerning the preparation specified in entry E
following that of its publication in the Official Journal of the
1701 of Annex I to that Regulation is suspended.
European Union.

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EN
26.3.2013 Official
Journal
of
the
European
Union L
86/17
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 March 2013.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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