HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 38/36
EN
Official Journal of the European Union
11.2.2012
COMMISSION IMPLEMENTING REGULATION (EU) No 118/2012
of 10 February 2012
amending Regulations (EC) No 2380/2001, (EC) No 1289/2004, (EC) No 1455/2004, (EC) No
1800/2004, (EC) No 600/2005, (EU) No 874/2010, Implementing Regulations (EU) No 388/2011,
(EU) No 532/2011 and (EU) No 900/2011 as regards the name of the holder of the authorisation of
certain additives in animal feed and correcting Implementing Regulation (EU) No 532/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
ammonium alpha as a feed additive for chickens for
fattening (holder of authorisation Alpharma (Belgium)
BVBA) and amending Regulation (EC) No 2430/1999 ( 8 ),
(EU) No 532/2011 of 31 May 2011 concerning the
Having regard to the Treaty on the Functioning of the European
authorisation of robenidine hydrochloride as a feed
Union,
additive for rabbits for breeding and rabbits for
fattening (holder of authorisation Alpharma Belgium
BVBA) and amending Regulations (EC) No 2430/1999
and (EC) No 1800/2004 ( 9 ) and as regards (EU) No
Having regard to Regulation (EC) No 1831/2003 of the
900/2011 of 7 September 2011 concerning the auth
European Parliament and of the Council of 22 September
orisation of lasalocid A sodium as a feed additive for
2003 on additives for use in animal nutrition ( 1 ) and in
pheasants, guinea fowl, quails and partridges other than
particular Article 13(3) thereof,
laying birds (holder of authorisation Alpharma (Belgium)
BVBA) ( 10 ).
Whereas:
(2) The
applicants
claim
that,
with
effect
from
1
March
2011 as a result of the acquisition of Alpharma BVBA
by Pfizer Ltd, the latter owns the marketing rights for the
(1) Alpharma
BVBA
and
Pfizer
Ltd
have
submitted
an
appli
additives decoquinate, lasalocid A sodium, maduramicin
cation under Article 13(3) of Regulation (EC) No
ammonium alpha, robenidine hydrochloride and sali
1831/2003 proposing to change the name of the
nomycin.
holder of the authorisations as regards Commission
Regulations (EC) No 2380/2001 of 5 December 2001
concerning the 10-year authorisation of an additive in
feedingstuffs ( 2 ), (EC) No 1289/2004 of 14 July 2004
(3)
The proposed change of the terms of the authorisations
concerning the authorisation for 10 years of the
is purely administrative in nature and does not entail a
additive Deccox in feedingstuffs, belonging to the
fresh assessment of the additives concerned. The
group of coccidiostats and other medicinal substances ( 3 ),
European Food Safety Authority was informed of the
(EC) No 1455/2004 of 16 August 2004 concerning the
application.
authorisation for 10 years of the additive ‘Avatec 15 %’
in feedingstuffs, belonging to the group of coccidiostats
and other medicinal substances ( 4 ), (EC) No 1800/2004
of 15 October 2004 concerning the authorisation for 10
(4) To
allow
the
applicant
to
exploit
its
marketing
rights
years of the additive Cycostat 66G in feedingstuffs,
under the name of Pfizer Ltd it is necessary to change
belonging to the group of coccidiostats and other
the terms of the authorisations.
medicinal substances ( 5 ), (EC) No 600/2005 of 18 April
2005 concerning a new authorisation for 10 years of a
coccidiostat as an additive in feedingstuffs, the
provisional authorisation of an additive and the
(5) Regulations
(EC)
No
2380/2001,
(EC)
No
1289/2004,
permanent authorisation of certain additives in feeding
(EC) No 1455/2004, (EC) No 1800/2004, (EC) No
stuffs (
600/2005, (EU) No 874/2010, Implementing Regu

6 ), (EU) No 874/2010 of 5 October 2010
concerning the authorisation of lasalocid A sodium as
lations (EU) No 388/2011, (EU) No 532/2011 and
a feed additive for turkeys up to 16 weeks (holder of
(EU) No 900/2011 should therefore be amended accord
authorisation Alpharma (Belgium) BVBA) and amending
ingly.
Regulation (EC) No 2430/1999 ( 7 ), Commission Imple
menting Regulations (EU) No 388/2011 of 19 April
2011 concerning the authorisation of maduramicin
(6)
Since the modifications to the conditions of the auth
orisations are not related to safety reasons, it is appro
( 1 ) OJ L 268, 18.10.2003, p. 29.
priate to provide for a transitional period during which
( 2 ) OJ L 321, 6.12.2001, p. 18.
existing stocks may be used up.
( 3 ) OJ L 243, 15.7.2004, p. 15.
( 4 ) OJ L 269, 17.8.2004, p. 14.
( 5 ) OJ L 317, 16.10.2004, p. 37.
( 8 ) OJ L 104, 20.4.2011, p. 3.
( 6 ) OJ L 99, 19.4.2005, p. 5.
( 9 ) OJ L 146, 1.6.2011, p. 7.
( 7 ) OJ L 263, 6.10.2010, p. 1.
( 10 ) OJ L 231, 8.9.2011, p. 15.

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EN
11.2.2012 Official
Journal
of
the
European
Union L
38/37
(7) The
maximum
residue
limits
(MRLs)
for
turkeys
and
Article 6
chickens for fattening introduced into the Annex to
Regulation (EC) No 1800/2004 by Commission Regu
Amendment to Regulation (EU) No 874/2010
lation (EC) No 101/2009 ( 1 ) and the trade name
In column 2 of the Annex to Regulation (EU) No 874/2010,
‘Robenz 66 G’ for turkeys and chickens for fattening
the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Pfizer
introduced into the Annex to Regulation (EC) No
Ltd’.
1800/2004 by Commission Regulation (EC) No
214/2009 ( 2 ) were, by error, omitted in the Annex to
Regulation (EC) No 1800/2004 as amended by Imple
menting Regulation (EU) No 532/2011. It is therefore
Article 7
necessary to reintroduce these MRLs and the trade name.
Amendment to Implementing Regulation (EU) No
388/2011
(8) Therefore,
the
Annex
to
Implementing
Regulation
(EU) In column 2 of the Annex to Implementing Regulation (EU) No
No 532/2011 should be corrected accordingly.
388/2011, the words ‘Alpharma (Belgium) BVBA’ are replaced
by ‘Pfizer Ltd’.
(9) The
measures
provided
for
in
this
Regulation
are
in
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
Article 8

Amendment to Implementing Regulation (EU) No
532/2011
HAS ADOPTED THIS REGULATION:
In column 2 of Annex I to Implementing Regulation (EU) No
532/2011 the words ‘Alpharma Belgium BVBA’ are replaced by
‘Pfizer Ltd’.
Article 1
Amendment to Regulation (EC) No 2380/2001
In column 2 of the Annex to Regulation (EC) No 2380/2001,
Article 9
the words ‘Alpharma Belgium BVBA’ are replaced by ‘Pfizer Ltd’.
Amendment to Implementing Regulation (EU) No
900/2011
Article 2
In column 2 of the Annex to Implementing Regulation (EU) No
900/2011, the words ‘Alpharma (Belgium) BVBA’ are replaced
Amendment to Regulation (EC) No 1289/2004
by ‘Pfizer Ltd’.
In column 2 of the Annex to Regulation (EC) No 1289/2004,
the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Pfizer
Ltd’.
Article 10
Correction to Implementing Regulation (EU) No 532/2011
Article 3
Annex II to Implementing Regulation (EU) No 532/2011 is
Amendment to Regulation (EC) No 1455/2004
corrected in accordance with the Annex to this Regulation.
In column 2 of the Annex to Regulation (EC) No 1455/2004,
the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Pfizer
Ltd’.
Article 11
Transitional measures
Article 4
Existing stocks which are in conformity with the provisions
applying before the date of entry into force of this Regulation
Amendment to Regulation (EC) No 1800/2004
may continue to be placed on the market and used until
In column 2 of the Annex to Regulation (EC) No 1800/2004,
2 September 2012.
the words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Pfizer
Ltd’.
Article 12
Article 5
Entry into force
Amendment to Regulation (EC) No 600/2005
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union.
In column 2 of Annex I to Regulation (EC) No 600/2005, the
words ‘Alpharma (Belgium) BVBA’ are replaced by ‘Pfizer Ltd’.
( 1 ) OJ L 34, 4.2.2009, p. 5.
Article 10 and the Annex shall, however, apply from 21 June
( 2 ) OJ L 73, 19.3.2009, p. 12.
2011.

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L 38/38
EN
Official Journal of the European Union
11.2.2012
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2012.
For the Commission
The President
José Manuel BARROSO

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EN
11.2.2012 Official
Journal
of
the
European
Union L
38/39
ANNEX
In Annex II to Implementing Regulation (EU) No 532/2011, the Annex to Regulation (EC) No 1800/2004 as amended by
Implementing Regulation (EU) No 532/2011 is corrected as follows:
(1) in column 3 the words ‘(Cycostat 66G)’ are replaced by ‘(Robenz 66 G)’;
(2) A new column is added:
‘Maximum residue limits (MRLs) in the relevant
foodstuffs of animal origin
800 μg robenidine hydrochloride/kg of wet
liver.
350 μg robenidine hydrochloride/kg of wet
kidney.
200 μg robenidine hydrochloride/kg of wet
muscle.
1 300 μg robenidine hydrochloride/kg of wet
skin/fat.
400 μg robenidine hydrochloride/kg of
skin/fat.
400 μg robenidine hydrochloride/kg of wet
liver.
200 μg robenidine hydrochloride/kg of wet
kidney.
200 μg robenidine hydrochloride/kg of wet
muscle.’

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Document Outline

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