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23.10.2013 Official
Journal
of
the
European
Union
L
281/1
II
(Non-legislative acts)
REGULATIONS
COMMISSION IMPLEMENTING REGULATION (EU) No 1014/2013
of 22 October 2013
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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(EC) No 600/2005
( 6 ), (EU) No 874/2010
( 7 ),
Commission Implementing Regulations (EU) No
388/2011 ( 8 ), (EU) No 532/2011 ( 9 ) and (EU) No
900/2011 ( 10 ).
Having regard to the Treaty on the Functioning of the European
Union,
(2) The
applicant
claims
that,
as
a
result
of
Pfizer
Ltd’s
decision to make its Animal Health Division a stand-
alone company under the name of Zoetis Belgium SA
and transfer all the marketing authorisations for cocci
diostats from Pfizer Ltd to Zoetis Belgium SA, the latter
Having regard to Regulation (EC) No 1831/2003 of the
owns the marketing rights for the additives decoquinate,
European Parliament and of the Council of 22 September
lasalocid A sodium, maduramicin ammonium alpha,
2003 on additives for use in animal nutrition ( 1 ) and in
robenidine hydrochloride and salinomycin.
particular Article 13(3) thereof,
(3)
The proposed change of the terms of the authorisations
is purely administrative in nature and does not entail a
new assessment of the additives concerned. The
Whereas:
European Food Safety Authority was informed of the

application.
( 6 ) Commission Regulation (EC) No 600/2005 of 18 April 2005
concerning a new authorisation for 10 years of a coccidiostat as
(1) Pfizer
Ltd
has
submitted
an
application
in
accordance
an additive in feedingstuffs, the provisional authorisation of an
additive and the permanent authorisation of certain additives in
with Article 13(3) of Regulation (EC) No 1831/2003
feedingstuffs (OJ L 99, 19.4.2005, p. 5).
proposing to change the name of the holder of the
( 7 ) Commission Regulation (EU) No 874/2010 of 5 October 2010
authorisations as regards Commission Regulations
concerning the authorisation of lasalocid A sodium as a feed
(EC) No 2380/2001
( 2 ), (EC) No 1289/2004
( 3 ),
additive for turkeys up to 16 weeks (holder of authorisation
(EC) No 1455/2004
(
Alpharma (Belgium) BVBA) and amending Regulation (EC) No

4 ), (EC) No 1800/2004
( 5 ),
2430/1999 (OJ L 263, 6.10.2010, p. 1).
( 8 ) Commission Implementing Regulation (EU) No 388/2011 of
( 1 ) OJ L 268, 18.10.2003, p. 29.
19 April 2011 concerning the authorisation of maduramicin
( 2 ) Commission Regulation (EC) No 2380/2001 of 5 December 2001
ammonium alpha as a feed additive for chickens for fattening
concerning the 10 year authorisation of an additive in feedingstuffs
(holder of authorisation Alpharma (Belgium) BVBA) and
(OJ L 321, 6.12.2001, p. 18).
amending Regulation (EC) No 2430/1999 (OJ L 104, 20.4.2011,
( 3 ) Commission Regulation (EC) No 1289/2004 of 14 July 2004
p. 3).
concerning the authorisation for 10 years of the additive Deccox
( 9 ) Commission Implementing Regulation (EU) No 532/2011 of
in feedingstuffs, belonging to the group of coccidiostats and other
31 May 2011 concerning the authorisation of robenidine hydro
medicinal substances (OJ L 243, 15.7.2004, p. 15).
chloride as a feed additive for rabbits for breeding and rabbits for
( 4 ) Commission Regulation (EC) No 1455/2004 of 16 August 2004
fattening (holder of authorisation Alpharma Belgium BVBA) and
concerning the authorisation for 10 years of the additive ‘Avatec
amending Regulations (EC) No 2430/1999 and (EC) No
15 %’ in feedingstuffs, belonging to the group of coccidiostats and
1800/2004 (OJ L 146, 1.6.2011, p. 7).
other medicinal substances (OJ L 269, 17.8.2004, p. 14).
( 10 ) Commission Implementing Regulation (EU) No 900/2011 of
( 5 ) Commission Regulation (EC) No 1800/2004 of 15 October 2004
7 September 2011 concerning the authorisation of lasalocid A
concerning the authorisation for 10 years of the additive Cycostat
sodium as a feed additive for pheasants, guinea fowl, quails and
66G in feedingstuffs, belonging to the group of coccidiostats and
partridges other than laying birds (holder of authorisation
other medicinal substances (OJ L 317, 16.10.2004, p. 37).
Alpharma (Belgium) BVBA) (OJ L 231, 8.9.2011, p. 15).

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L 281/2
EN
Official Journal of the European Union
23.10.2013
(4) To
allow
the
applicant
to
exploit
its
marketing
rights (b) in the second column of the Annex, the words ‘Pfizer Ltd’
under the name of Zoetis Belgium SA it is necessary to
are replaced by ‘Zoetis Belgium SA’.
change the terms of the respective authorisations.
Article 7
(5)
Regulations (EC) No 2380/2001, (EC) No 1289/2004,
(EC) No 1455/2004, (EC) No 1800/2004, (EC) No
Amendment to Implementing Regulation (EU) No
600/2005, (EU) No 874/2010, and Implementing Regu
388/2011
lations (EU) No 388/2011, (EU) No 532/2011 and (EU)
Implementing Regulation (EU) No 388/2011 is amended as
No 900/2011 should therefore be amended accordingly.
follows:
(6)
Since the modifications to the terms of the authorisations
(a) in the title, the words ‘Alpharma (Belgium) BVBA’ are
are not related to safety reasons, it is appropriate to
replaced by ‘Zoetis Belgium SA’;
provide for a transitional period during which existing
stocks may be used up.
(b) in the second column of the Annex, the words ‘Pfizer Ltd’
are replaced by ‘Zoetis Belgium SA’.
(7) 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
HAS ADOPTED THIS REGULATION:
532/2011
Implementing Regulation (EU) No 532/2011 is amended as
Article 1
follows:
Amendment to Regulation (EC) No 2380/2001
In the second column of the Annex, the words ‘Pfizer Ltd’ are
(a) in the title, the words ‘Alpharma Belgium BVBA’ are
replaced by ‘Zoetis Belgium SA’.
replaced by ‘Zoetis Belgium SA’;
Article 2
(b) in the second column of Annex I, the words ‘Pfizer Ltd’ are
replaced by ‘Zoetis Belgium SA’;
Amendment to Regulation (EC) No 1289/2004
In the second column of the Annex, the words ‘Pfizer Ltd’ are
Article 9
replaced by ‘Zoetis Belgium SA’.
Amendment to Implementing Regulation (EU) No
900/2011
Article 3
Implementing Regulation (EU) No 900/2011 is amended as
Amendment to Regulation (EC) No 1455/2004
follows:
In the second column of the Annex, the words ‘Pfizer Ltd’ are
replaced by ‘Zoetis Belgium SA’.
(a) in the title, the words ‘Alpharma (Belgium) BVBA’ are
replaced by ‘Zoetis Belgium SA’;
Article 4
Amendment to Regulation (EC) No 1800/2004
(b) in the second column of the Annex to Regulation (EU) No
900/2011, the words ‘Pfizer Ltd’ are replaced by ‘Zoetis
In the second column of the Annex, the words ‘Pfizer Ltd’ are
Belgium SA’.
replaced by ‘Zoetis Belgium SA’.
Article 5
Article 10
Amendment to Regulation (EC) No 600/2005
Transitional measures
In the second column of Annex I, the words ‘Pfizer Ltd’ are
The existing stocks which have been produced and labelled
replaced by ‘Zoetis Belgium SA’.
before 12 November 2013 in accordance with the rules
applicable before 12 November 2013 may continue to be
placed on the market and used until they are exhausted.
Article 6
Amendment to Regulation (EU) No 874/2010
Article 11
Regulation (EU) No 874/2010 is amended as follows:
Entry into force
This Regulation shall enter into force on the twentieth day
(a) in the title, the words ‘Alpharma (Belgium) BVBA’ are
following that of its publication in the Official Journal of the
replaced by ‘Zoetis Belgium SA’;
European Union.

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EN
23.10.2013 Official
Journal
of
the
European
Union
L
281/3
This Regulation is binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 October 2013.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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