HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 307/56
EN
Official Journal of the European Union
7.11.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 1018/2012
of 5 November 2012
amending Regulations (EC) No 232/2009, (EC) No 188/2007, (EC) No 186/2007, (EC) No 209/2008,
(EC) No 1447/2006, (EC) No 316/2003, (EC) No 1811/2005, (EC) No 1288/2004, (EC) No 2148/2004,
(EC) No 1137/2007, (EC) No 1293/2008, (EC) No 226/2007, (EC) No 1444/2006, (EC) No 1876/2006,
(EC) No 1847/2003, (EC) No 2036/2005, (EC) No 492/2006, (EC) No 1200/2005, and (EC) No
1520/2007 as regards the maximum content of certain micro-organisms in complete feedingstuffs
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
functional group ‘gut flora stabilisers’ was authorised for
10 years by Commission Regulation (EC) No
1137/2007 ( 11 ) for chickens for fattening.
Having regard to the Treaty on the Functioning of the European
Union,
(4) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No
1831/2003, the holder of the authorisation has proposed
changing the terms of the authorisation of Bacillus subtilis
Having regard to Regulation (EC) No 1831/2003 of the
DSM 17299 as set out in the Regulation referred to in
European Parliament and of the Council of 22 September
recital 3.
2003 on additives for use in animal nutrition ( 1 ) and in
particular Article 13(1), (2) and (3) thereof,
(5) The
opinions
adopted
by
the
European
Food
Safety
Authority (‘the Authority’) on the use of certain micro-
Whereas:
organisms in feed were based on the Qualified
Presumption of Safety (QPS) status of the micro-
organisms concerned (‘Scientific Opinion on the main
tenance of the list of QPS biological agents intentionally
(1) The
use
of Saccharomyces cerevisiae NCYC Sc 47 belonging
added to food and feed (2011 update)’ (
to the additive category ‘zootechnical additives’ and to

12 )). The holders
of the authorisations have proposed to delete the limi
the functional group ‘gut flora stabilisers’ was authorised
tation concerning the maximum content of the micro-
for 10 years by Commission Regulation (EC) No
organisms Saccharomyces cerevisiae NCYC Sc 47 and
232/2009 ( 2 ) for dairy buffaloes, by Commission Regu
Bacillus subtilis DSM 17299 in complete feedingstuffs,
lation (EC) No 1447/2006 ( 3 ) for lambs for fattening, by
on the basis that the maximum doses were not
Commission Regulation (EC) No 188/2007 ( 4 ) for dairy
consistent with the QPS approach.
goats and dairy sheep, by Commission Regulation (EC)

No 186/2007 ( 5 ) for horses, and by Commission Regu
lation (EC) No 209/2008 ( 6 ) for pigs for fattening. It was
(6)
In order to avoid market distortions it is appropriate to
authorised without a time limit by Commission Regu
delete the limitation concerning the maximum content
lation (EC) No 316/2003 ( 7 ) for cattle for fattening, by
also as regards authorisations of other micro-organisms
Commission Regulation (EC) No 1811/2005 ( 8 ) for dairy
having the same QPS status.
cows, by Commission Regulation (EC) No 1288/2004 ( 9 )
for sows, and by Commission Regulation (EC) No
2148/2004 ( 10 ) for weaned piglets.
(7) In
accordance
with
Article
13(1)
the
Authority
was
requested to provide an opinion on the possibility to
delete the maximum content for other micro-organisms
(2) In
accordance
with
Article
13(3)
of
Regulation
(EC)
No
having the same QPS status: Saccharomyces cerevisiae
1831/2003, the holder of the authorisations has
CNCM I-1077 authorised for 10 years by Commission
proposed changing the terms of the authorisations of
Regulation (EC) No 1293/2008 ( 13 ) for lambs, by
Saccharomyces cerevisiae NCYC Sc 47 as set out in the
Commission Regulation (EC) No 226/2007 ( 14 ) for
Regulations referred to in recital 1.
dairy goats and dairy sheep and without a time limit
by Commission Regulation (EC) No 1200/2005 ( 15 ) for
dairy cows and cattle for fattening; Saccharomyces cerevisiae
CNCM I-1079 authorised without a time limit by
(3) The
use
of Bacillus subtilis DSM 17299 belonging to the
additive category ‘zootechnical additives’ and to the
Commission Regulation (EC) No 1847/2003 ( 16 ) for
piglets and by Commission Regulation (EC) No
2036/2005 ( 17 ) for sows; Saccharomyces cerevisiae CBS
( 1 ) OJ L 268, 18.10.2003, p. 29.
493.94 authorised without a time limit by Commission
( 2 ) OJ L 74, 20.3.2009, p. 14.
( 3 ) OJ L 271, 30.9.2006, p. 28.
( 4 ) OJ L 57, 24.2.2007, p. 3.
( 11 ) OJ L 256, 2.10.2007, p. 5.
( 5 ) OJ L 63, 1.3.2007, p. 6.
( 12 ) EFSA Journal 2011;9(12):2497.
( 6 ) OJ L 63, 7.3.2008, p. 3.
( 13 ) OJ L 340, 19.12.2008, p. 38.
( 7 ) OJ L 46, 20.2.2003, p. 15.
( 14 ) OJ L 64, 2.3.2007, p. 26.
( 8 ) OJ L 291, 5.11.2005, p. 12.
( 15 ) OJ L 195, 27.7.2005, p. 6.
( 9 ) OJ L 243, 15.7.2004, p. 10.
( 16 ) OJ L 269, 21.10.2003, p. 3.
( 10 ) OJ L 370, 17.12.2004, p. 24.
( 17 ) OJ L 328, 15.12.2005, p. 13.

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EN
7.11.2012 Official
Journal
of
the
European
Union L
307/57
Regulation (EC) No 1288/2004 for cattle for fattening
HAS ADOPTED THIS REGULATION:
and calves and by Commission Regulation (EC) No
1811/2005 ( 1 ) for dairy cows; Saccharomyces cerevisiae
Article 1
MUCL 39885 authorised without a time limit by
Commission Regulation (EC) No 492/2006 ( 2 ) for cattle
Amendment to Regulation (EC) No 232/2009
for fattening; Bacillus amyloliquefaciens CECT 5940 auth
In column 8, maximum content, of the entry for 4b1702,
orised for 10 years by Commission Regulation (EC) No
Saccharomyces cerevisiae NCYC Sc47 in the Annex to Regulation
1292/2008 ( 3 ) for chickens for fattening; Lactobacillus
(EC) No 232/2009, the words ‘1,4 × 10 9 ’ are deleted.
farciminis CNCM MA 67/4R authorised for four years
by Commission Regulation (EC) No 1876/2006 ( 4 ) for
chickens and turkeys for fattening and laying hens and
Article 2
without a time limit by Commission Regulation (EC) No
Amendment to Regulation (EC) No 188/2007
492/2006 for weaned piglets; Pediococcus acidilactici
CNCM MA18/5M authorised without a time limit by
In column 8, maximum content of the entry for 4b1702,
Commission Regulation (EC) No 1200/2005 for
Saccharomyces cerevisiae NCYC Sc47 in the Annex to Regulation
chickens for fattening and by Commission Regulation
(EC) No 188/2007, the words ‘7,5 × 10 9 ’ are deleted.
(EC) No 2036/2005 for pigs for fattening; Lactobacillus
acidophilus D2/CSL CECT4529 authorised without a time
Article 3
limit by Commission Regulation (EC) No 1520/2007 ( 5 )
for laying hens; Bacillus subtilis C-3102 (DSM 15544)
Amendment to Regulation (EC) No 186/2007
authorised for 10 years by Commission Regulation (EC)
In column 8, maximum content of the entry for 4b1702,
No 1444/2006 ( 6 ) for chickens for fattening.
Saccharomyces cerevisiae NCYC Sc47 in the Annex to Regulation
(EC) No 186/2007, the words ‘7 × 10 9 ’ are deleted.
(8) The
Authority
concluded
in
its
opinion
of
24
April
Article 4
2012 ( 7 ) that the setting of a maximum content of
Saccharomyces cerevisiae NCYC Sc 47, Bacillus subtilis
Amendment to Regulation (EC) No 209/2008
DSM 17299, Saccharomyces cerevisiae CNCM I-1077,
In column 8, maximum content of the entry for 4b1702,
Saccharomyces cerevisiae CNCM I-1079, Saccharomyces
Saccharomyces cerevisiae NCYC Sc47 in the Annex to Regulation
cerevisiae CBS 493.94, Saccharomyces cerevisiae MUCL
(EC) No 209/2008, the words ‘1,00 × 10 10 ’ are deleted.
39885, Bacillus amyloliquefaciens CECT 5940, Lactobacillus
farciminis CNCM MA 67/4R, Pediococcus acidilactici CNCM
Article 5
MA18/5M, Lactobacillus acidophilus D2/CSL CECT4529,
and Bacillus subtilis C-3102 (DSM 15544) in complete
Amendment to Regulation (EC) No 1447/2006
feedingstuff does not offer any additional degree of
safety for the target animals and consumers. Therefore,
In column 8, maximum content of the entry for E 1702,
there are no reasons to maintain the maximum content
Saccharomyces cerevisiae NCYC Sc47 in the Annex to Regulation
for them.
(EC) No 1447/2006, the words ‘1,4 × 10 10 ’ are deleted.
Article 6
(9) The
conditions
provided
for
in
Article
5
of
Regulation
Amendment to Regulation (EC) No 316/2003
(EC) No 1831/2003 are satisfied.
In column 7, maximum content of the entry for E 1702,
Saccharomyces cerevisiae NCYC Sc47 in Annex I to Regulation
(EC) No 316/2003, the words ‘8 × 10 9 ’ are deleted.
(10) Regulations (EC) No 232/2009, (EC) No 188/2007, (EC)
No 186/2007, (EC) No 209/2008, (EC) No 1447/2006,
(EC) No 316/2003, (EC) No 1811/2005, (EC) No
Article 7
1288/2004, (EC) No 2148/2004, (EC) No 1137/2007,
Amendment to Regulation (EC) No 1811/2005
(EC) No 1293/2008, (EC) No 226/2007, (EC) No
1444/2006, (EC) No 1876/2006, (EC) No 1847/2003,
Annex III to Regulation (EC) No 1811/2005 is amended as
(EC) No 2036/2005, (EC) No 492/2006, (EC) No
follows:
1200/2005, and (EC) No 1520/2007 should therefore
be amended accordingly.
(1) in column 7, maximum content, of the entry for E 1702,
Saccharomyces cerevisiae NCYC Sc 47, the words ‘2 × 10 9 ’ are
deleted;
(11) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
(2) in column 7, maximum content, of the entry for E 1704,
Committee on the Food Chain and Animal Health,
Saccharomyces cerevisiae CBS 493.94, the words ‘3,5 × 10 8 ’
are deleted.
( 1 ) OJ L 291, 5.11.2005, p. 12.
( 2 ) OJ L 89, 28.3.2006, p. 6.
Article 8
( 3 ) OJ L 340, 19.12.2008, p. 36.
( 4 ) OJ L 360, 19.12.2006, p. 126.
Amendment to Regulation (EC) No 1288/2004
( 5 ) OJ L 335, 20.12.2007, p. 17.
( 6 ) OJ L 271, 30.9.2006, p. 19.
Annex I to Regulation (EC) No 1288/2004 is amended as
( 7 ) EFSA Journal 2012;10(5):2680.
follows:

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L 307/58
EN
Official Journal of the European Union
7.11.2012
(1) in column 7, maximum content, of the entry for E 1702,
Article 16
Saccharomyces cerevisiae NCYC Sc 47, the words ‘1 × 10 10 ’ are
deleted;
Amendment to Regulation (EC) No 2036/2005
Annex I to Regulation (EC) No 2036/2005 is amended as
follows:
(2) in column 7, maximum content, of the entry for E 1704,
Saccharomyces cerevisiae CBS 493.94, the words ‘2 × 10 9 ’ and
‘1,7 × 10 8 ’ are deleted.
(1) in column 7, maximum content, of the entry for E 1703,
Saccharomyces cerevisiae CNCM I-1079, the words ‘6 × 10 9 ’
are deleted;
Article 9
Amendment to Regulation (EC) No 2148/2004
(2) in column 7, maximum content, of the entry for E 1712,
Pediococcus acidilactici CNCM MA18/5M, the words ‘1 × 10 9 ’
In column 7, maximum content of the entry for E 1702,
are deleted.
Saccharomyces cerevisiae NCYC Sc47 of Annex II to Regulation
(EC) No 2148/2004, the words ‘1 × 10 10 ’ are deleted.
Article 17
Article 10
Amendment to Regulation (EC) No 492/2006
Amendment to Regulation (EC) No 1137/2007
Annex II to Regulation (EC) No 492/2006 is amended as
follows
In column 8, maximum content of the entry for 4b1821
Bacillus subtilis DSM 17299 of the Annex to Regulation (EC)
No 1137/2007, the words ‘1,6 × 10 9 ’ are deleted.
(1) in column 7, maximum content, of the entry for E 1710,
Saccharomyces cerevisiae MUCL 39885, the words ‘9 × 10 9 ’
are deleted;
Article 11
Amendment to Regulation (EC) No 1293/2008
(2) in column 7, maximum content, of the entry for E 1714,
Lactobacillus farciminis CNCM MA 67/4R, the words
In column 8, maximum content of the entry for 4b1711
‘1 × 10 10 ’ are deleted.
Saccharomyces cerevisiae CNCM I-1077 of the Annex to Regu
lation (EC) No 1293/2008, the words ‘7,3 × 10 9 ’ are deleted.
Article 18
Amendment to Regulation (EC) No 1200/2005
Article 12
Annex II to Regulation (EC) No 1200/2005 is amended as
Amendment to Regulation (EC) No 226/2007
follows:
In column 8, maximum content of the entry for 4b1711
Saccharomyces cerevisiae CNCM I-1077 of the Annex to Regu
lation (EC) No 226/2007, the words ‘3 × 10
(1) in column 7, maximum content, of the entry for E 1711,

9 ’ and ‘1,2 × 10 9 ’
are deleted.
Saccharomyces cerevisiae CNCM I-1077, the words ‘2 × 10 9 ’
and ‘1,6 × 10 9 ’ are deleted;
Article 13
(2) in column 7, maximum content, of the entry for E 1712,
Amendment to Regulation (EC) No 1444/2006
Pediococcus acidilactici CNCM MA18/5M, the words ‘1 × 10 10 ’
are deleted.
In column 8, maximum content of the entry for 4b1820
Bacillus subtilis DSM 17299 of the Annex to Regulation (EC)
No 1444/2006, the words ‘1 × 10
Article 19

9 ’ are deleted.
Amendment to Regulation (EC) No 1520/2007
Article 14
Annex IV to Regulation (EC) No 1520/2007 is amended as
follows:
Amendment to Regulation (EC) No 1876/2006
In column 7, maximum content of the entry for 12 Lactobacillus
In column 7, maximum content of the entry for E 1715 Lacto
farciminis CNCM MA 67/4R of Annex I to Regulation (EC) No
bacillus acidophilus D2/CSL CECT4529, the words ‘1 × 10 9 ’ are
1876/2006, the words ‘1 × 10 9 ’ are deleted.
deleted.
Article 15
Article 20
Amendment to Regulation (EC) No 1847/2003
Entry into force
In column 7, maximum content of the entry for E 1703
This Regulation shall enter into force on the twentieth day
Saccharomyces cerevisiae CNCM I-1079 of Annex II to Regulation
following that of its publication in the Official Journal of the
(EC) No 1847/2003, the words ‘6 × 10 9 ’ are deleted.
European Union.

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EN
7.11.2012 Official
Journal
of
the
European
Union L
307/59
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 November 2012.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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