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13.7.2013 Official
Journal
of
the
European
Union L
192/35
COMMISSION IMPLEMENTING REGULATION (EU) No 667/2013
of 12 July 2013
concerning the authorisation of diclazuril as a feed additive for chickens reared for laying (holder of
authorisation Eli Lilly and Company Ltd) and repealing Regulation (EC) No 162/2003
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
coccidiosis in chickens reared for laying. It also verified
the report on the method of analysis of the feed additive
in feed submitted by the Reference Laboratory set up by
Regulation (EC) No 1831/2003.
Having regard to the Treaty on the Functioning of the European
Union,
(5) The
assessment
of
diclazuril,
CAS
number
101831-37-2,
shows that the conditions for authorisation, as provided
Having regard to Regulation (EC) No 1831/2003 of the
for in Article 5 of Regulation (EC) No 1831/2003, are
European Parliament and of the Council of 22 September
satisfied. Accordingly, the use of that preparation should
2003 on additives for use in animal nutrition ( 1 ), and in
be authorised as specified in the Annex to this Regu
particular Article 9(2) thereof,
lation.
Whereas:
(6)
As a consequence of the granting of a new authorisation
under Regulation (EC) No 1831/2003, Regulation (EC)
No 162/2003 should be repealed.
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
orisation. Article 10 of that Regulation provides for the
(7)
Since safety reasons do not require the immediate appli
re-evaluation of additives authorised pursuant to Council
cation of the modifications to the conditions of auth
Directive 70/524/EEC (
orisation, it is appropriate to allow a transitional period

2 ).
for interested parties to prepare themselves to meet the
new requirements resulting from the authorisation.
(2) Diclazuril,
CAS
number
101831-37-2,
was
authorised
for 10 years in accordance with Directive 70/524/EEC
as a feed additive for use on chickens reared for laying
(8) The
measures
provided
for
in
this
Regulation
are
in
by Commission Regulation (EC) No 162/2003 (
accordance with the opinion of the Standing

3 ). That
preparation was subsequently entered in the Register of
Committee on the Food Chain and Animal Health,
feed additives as an existing product, in accordance with
Article 10(1) of Regulation (EC) No 1831/2003.
HAS ADOPTED THIS REGULATION:
(3) In
accordance
with
Article
10(2)
of
Regulation
(EC)
No
1831/2003 in conjunction with Article 7 thereof, an
Article 1
application was submitted for the re-evaluation of dicla
zuril, as a feed additive for chickens reared for laying,
The preparation specified in the Annex, belonging to the
requesting that additive to be classified in the additive
additive category ‘coccidiostats and histomonostats’ is auth
category ‘coccidiostats and histomonostats’. That appli
orised as an additive in animal nutrition subject to the
cation was accompanied by the particulars and
conditions laid down in that Annex.
documents required under Article 7(3) of Regulation
(EC) No 1831/2003.
Article 2
Regulation (EC) No 162/2003 is repealed.
(4) The
European
Food
Safety
Authority
(‘the
Authority’)
concluded in its opinion of 31 January 2013 ( 4 ) that,
under the proposed conditions of use in feed, diclazuril
does not have an adverse effect on animal, human health
Article 3
or the environment and it is effective in controlling
The preparation specified in the Annex and feed containing that
preparation, which are produced and labelled before 2 February
( 1 ) OJ L 268, 18.10.2003, p. 29.
2014 in accordance with the rules applicable before 2 August
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 26, 31.1.2003, p. 3.
2013 may continue to be placed on the market and used until
( 4 ) EFSA Journal 2013; 11(3):3106.
the existing stocks are exhausted.

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L 192/36
EN
Official Journal of the European Union
13.7.2013
Article 4
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, 12 July 2013.
For the Commission
The President
José Manuel BARROSO

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13.7.2013 Off
ANNEX
Minimum
Maximum
content
content
Maximum Residue
Identification Name of the
Species or
Limits (MRLs) in
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the relevant
the additive
authori
(Trade name)
analytical method
age
authorisation
mg of active substance/kg of
sation
animal
foodstuffs of
EN
complete feedingstuff with a
animal origin
moisture content of 12 %

Coccidiostats and histomonostats
51771 Eli
Lilly Diclazuril
Additive composition
Chickens
16
1
1 1.
The
additive
shall
be
incor 2 August 2023 Commission
and
0,5 g/100 g
reared for
weeks
porated in compound feed in
Regulation (EU)
Company
Diclazuril: 0,50 g/100 g
laying
the form of a premixture.
No 37/2010 (3 )
Ltd
(Clinacox
0,5 %)
Protein-poor soybean meal:
2. Diclazuril shall not be mixed
99,25 g/100 g
with other coccidiostats.
Polyvidone K 30: 0,20 g/100 g
3. For safety: breathing protection,
icial
glasses and gloves shall be used
Jour
Sodium hydroxide: 0,05 g/100 g
during handling.
nal
Characterisation of the active substance
4. A post-market monitoring
programme concerning the
of
Diclazuril, C
the

17H 9Cl 3N 4O 2, (±)-4-chloro
resistance to bacteria and
phenyl[2,6-dichloro-4- (2,3,4,5-
Eimeria spp. shall be carried
European
tetrahydro-3,5-dioxo-1,2,4-triazin-2-
out by the holder of authori
yl)phenyl]acetonitrile,
sation.
CAS number: 101831-37-2
Union
Related impurities:
Degradation compound (R064318):
≤ 0,1 %
Other related impurities (T001434,
R066891, R068610, R070156,
R070016): ≤ 0,5 % individually
Total impurities: ≤ 1,5 %
Analytical method (1 )
For determination of diclazuril in feed:
reversed-phase high performance liquid
L
chromatography (HPLC) using Ultraviolet
192/37
detection at 280 nm (Commission Regu
lation (EC) No 152/2009 (2 )).

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L 192/38
Minimum
Maximum
content
content
Maximum Residue
Identification Name of the
Species or
Limits (MRLs) in
number of
holder of
Additive
Composition, chemical formula, description,
category of Maximum
Other provisions
End of period of
the relevant
the additive
authori
(Trade name)
analytical method
age
authorisation
mg of active substance/kg of
sation
animal
foodstuffs of
complete feedingstuff with a
animal origin
moisture content of 12 %
For determination of diclazuril in poultry
EN
tissues: HPLC coupled to triple quad

rupole mass spectrometer (MS/MS) using
one precursor ion and two diagnostic
product ions.
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx
(2 ) OJ L 54, 26.2.2009, p. 1.
(3 ) OJ L 15, 20.1.2010, p. 1.
Off
icial
Jour
nal
of
the
European
Union
13.7.2013

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Document Outline

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