HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 49/50
EN
Official Journal of the European Union
22.2.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 160/2013
of 21 February 2013
amending Regulations (EC) No 162/2003, (EC) No 971/2008, (EU) No 1118/2010 and (EU) No
169/2011 and Implementing Regulation (EU) No 888/2011 as regards the name of the holder of
the authorisation of diclazuril in animal feed
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
Regulations (EC) No 162/2003, (EC) No 971/2008, (EU)
No 1118/2010 and (EU) No 169/2011 and Imple
Having regard to the Treaty on the Functioning of the European
menting Regulation (EU) No 888/2011 should
Union,
therefore be amended accordingly.
Having regard to Regulation (EC) No 1831/2003 of the
(6)
Since safety reasons do not require the immediate appli
European Parliament and of the Council of 22 September
cation of the amendments made by this Regulation to
2003 on additives for use in animal nutrition ( 1 ), and in
Regulations (EC) No 162/2003, (EC) No 971/2008, (EU)
particular Article 13(3) thereof,
No 1118/2010 and (EU) No 169/2011 and Imple
menting Regulation (EU) No 888/2011, it is appropriate
Whereas:
to provide for a transitional period during which existing
stocks may be used up.
(1) Janssen
Pharmaceutica
NV
has
submitted
an
application
under Article 13(3) of Regulation (EC) No 1831/2003
(7) The
measures
provided
for
in
this
Regulation
are
in
proposing to change the name of the holder of the auth
accordance with the opinion of the Standing
orisation as regards Commission Regulations (EC) No
Committee on the Food Chain and Animal Health,
162/2003 of 30 January 2003 concerning the authori
sation of an additive in feedingstuffs
( 2 ), (EC) No
971/2008 of 3 October 2008 concerning a new use of
HAS ADOPTED THIS REGULATION:
a coccidiostat as additive in feedingstuffs ( 3 ), (EU) No
1118/2010 of 2 December 2010 concerning the auth
Article 1
orisation of diclazuril as a feed additive for chickens for
Amendment to Regulation (EC) No 162/2003
fattening (holder of authorisation Janssen Pharmaceutica
NV) and amending Regulation (EC) No 2430/1999 ( 4 )
In column 2 of the Annex to Regulation (EC) No 162/2003 the
and (EU) No 169/2011 of 23 February 2011 concerning
words ‘Janssen Pharmaceutica NV’ are replaced by ‘Eli Lilly and
the authorisation of diclazuril as a feed additive for
Company Ltd’.
guinea fowls (holder of authorisation Janssen Phar
maceutica N.V.) ( 5 ) and Commission Implementing Regu
Article 2
lation (EU) No 888/2011 of 5 September 2011
concerning the authorisation of diclazuril as a feed
Amendment to Regulation (EC) No 971/2008
additive for turkeys for fattening (holder of authorisation
In column 2 of the Annex to Regulation (EC) No 971/2008 the
Janssen Pharmaceutica N.V.) and amending Regulation
words ‘Janssen Pharmaceutica nv’ are replaced by ‘Eli Lilly and
(EC) No 2430/1999 ( 6 ).
Company Ltd’.
(2)
The applicant claims that, with effect from 7 July 2011,
Janssen Animal Health, a division of Janssen Phar
Article 3
maceutica NV, was acquired by Eli Lilly and Company
Amendment to Regulation (EU) No 1118/2010
Ltd, which now owns the marketing rights for the
additive diclazuril. The applicant has submitted relevant
In column 2 of the Annex to Regulation (EU) No 1118/2010
data supporting its request.
the words ‘Janssen Pharmaceutica NV’ are replaced by ‘Eli Lilly
and Company Ltd’.
(3)
The proposed change of the terms of the authorisation is
purely administrative in nature and does not entail a
Article 4
fresh assessment of the additive concerned. The
Amendment to Regulation (EU) No 169/2011
European Food Safety Authority was informed of the
application.
In column 2 of the Annex to Regulation (EU) No 169/2011 the
words ‘Janssen Pharmaceutica N.V.’ are replaced by ‘Eli Lilly and
(4) To allow Eli Lilly and Company Ltd to exploit its
Company Ltd’.
marketing rights it is necessary to change the terms of
the authorisations.
Article 5
Amendment to Implementing Regulation (EU) No
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 26, 31.1.2003, p. 3.
888/2011
( 3 ) OJ L 265, 4.10.2008, p. 3.
In column 2 of the Annex to Implementing Regulation (EU) No
( 4 ) OJ L 317, 3.12.2010, p. 5.
( 5 ) OJ L 49, 24.2.2011, p. 6.
888/2011 the words ‘Janssen Pharmaceutica N.V.’ are replaced
( 6 ) OJ L 229, 6.9.2011, p. 9.
by ‘Eli Lilly and Company Ltd’.

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EN
22.2.2013 Official
Journal
of
the
European
Union L
49/51
Article 6
Transitional measure
Existing stocks of this additive which are in conformity with the provisions applying before the date of
entry into force of this Regulation may continue to be placed on the market and used until they are
exhausted.
Article 7
Entry into force
This Regulation shall enter into force on the twentieth day following that of 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, 21 February 2013.
For the Commission
The President
José Manuel BARROSO

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Document Outline

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