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Official Journal of the European Union
24.2.2011
COMMISSION REGULATION (EU) No 169/2011
of 23 February 2011
concerning the authorisation of diclazuril as a feed additive for guinea fowls (holder of
authorisation Janssen Pharmaceutica N.V.)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
(5)
New data were submitted in support of the application
for the authorisation of diclazuril for guinea fowls. The
Having regard to the Treaty on the Functioning of the European
European Food Safety Authority (the Authority)
Union,
concluded in its opinion of 5 October 2010 ( 5 ) that,
under the proposed conditions of use, diclazuril does
Having regard to Regulation (EC) No 1831/2003 of the
not have an adverse effect on animal health, human
European Parliament and of the Council of 22 September
health or the environment and that its use controls cocci
2003 on additives for use in animal nutrition (
diosis in guinea fowls. It considers that there is a need for

1 ), and in
particular Article 9(2) thereof,
specific requirements of post-market monitoring to
control the possible development of bacterial and/or
Eimeria spp resistances. The Authority also verified the
Whereas:
report on the method of analysis of the feed additive
in feed submitted by the Community Reference
(1) Regulation
(EC)
No
1831/2003
provides
for
the
auth
Laboratory set up by Regulation (EC) No 1831/2003.
orisation of additives for use in animal nutrition and
for the grounds and procedures for granting such auth
(6) The
assessment
of
diclazuril
shows
that
the
conditions
orisation.
for authorisation, as provided for in Article 5 of Regu
lation (EC) No 1831/2003, are satisfied. Accordingly, the
(2) In
accordance
with
Article
7
of
Regulation
(EC)
use of this preparation should be authorised as specified
No 1831/2003 an application was submitted for the
in the Annex to this Regulation.
authorisation of diclazuril. That application was accom
panied by the particulars and documents required under
(7) The
measures
provided
for
in
this
Regulation
are
in
Article 7(3) of Regulation (EC) No 1831/2003.
accordance with the opinion of the Standing
Committee on the Food Chain and Animal Health,
(3) The
application
concerns
the
authorisation
of
a
new
use HAS ADOPTED THIS REGULATION:
of diclazuril as a feed additive for guinea fowls, to be
classified in the additive category ‘coccidiostats and histo
Article 1
monostats’.
The preparation specified in the Annex, belonging to the
additive category ‘coccidiostats and histomonostats’, is auth
(4) The
use
of
diclazuril
was
authorised
for
10
years
in
accordance with Council Directive 70/524/EEC (
orised as an additive in animal nutrition subject to the

2 ) as a
feed additive for use in chickens reared for laying up
conditions laid down in that Annex.
to 16 weeks and turkeys up to 12 weeks by Commission
Article 2
Regulation (EC) No 2430/1999 ( 3 ). The use for chickens
for fattening was authorised for 10 years by Commission
This Regulation shall enter into force on the 20th day following
Regulation (EU) No 1118/2010 ( 4 ).
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, 23 February 2011.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 268, 18.10.2003, p. 29.
( 2 ) OJ L 270, 14.12.1970, p. 1.
( 3 ) OJ L 296, 17.11.1999, p. 3.
( 4 ) OJ L 317, 3.12.2010, p. 5.
( 5 ) EFSA Journal 2010; 8(10):1866.

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24.2.2011 Off
ANNEX
Minimum
Maximum
content
content
Maximum
Identification
Name of the
Residue Limits
Additive
Species or
number of
holder of
Composition, chemical formula, description, analytical
category of
Maximum
mg of active
Other provisions
End of period of
(MRLs) in the
the additive
authorisation
(Trade name)
method
animal
age
authorisation
relevant
substance/kg of complete
foodstuffs of
EN
feedingstuff with a moisture
animal origin

content of 12 %
Coccidiostats and histomonostats
5 1 771 Janssen
Diclazuril
Additive composition
Guinea fowls
—
1
1 1.
The
additive
16 March 2021 1
500
μg
Pharmaceutica 0,5 g/100 g
Diclazuril: 0,50 g/100 g.
shall be incor
diclazuril/kg
N.V.
(Clinacox
Protein-poor soybean meal:
porated in
of wet liver
0,5 %)
compound feed
99,25 g/100 g
1 000 μg
in form of a
diclazuril/kg
Polyvidone K 30: 0,20 g/100 g
premixture.
of wet kidney
Sodium hydroxide: 0,05 g/100 g
2. Diclazuril shall
500 μg
not be mixed
diclazuril/kg
icial
Characterisation of the active substance
with other
of wet muscle
Jour
Diclazuril, C
coccidiostats.

17H 9Cl 3N 4O 2,
500 μg
(±)-4-chlorophenyl[2,6-dichloro4-
3. For
safety:
diclazuril/kg
nal
breathing
(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-triazin-2-
of wet skin/fat
protection,
of
yl)phenyl]acetonitrile,
glasses and
the
CAS number: 101831-37-2
gloves shall be
European
Related impurities:
used during
Degradation compound (R064318): ≤ 0,1 %
handling.
Other related impurities (T001434, R066891,
4. The holder of
R068610, R070156, R070016):
the authori
Union
sation shall
≤ 0,5 % individually
carry out a
Total impurities: ≤ 1,5 %
post-market
monitoring
Analytical method (1 )
programme on
For determination of diclazuril in feed:
the resistance
reversed-phase high performance liquid chro
to bacteria and
matography (HPLC) using Ultraviolet detection
Eimeria spp.
at 280 nm (Regulation (EC) No 152/2009)
For determination of diclazuril in poultry
tissues: HPLC coupled to triple quadrupole
mass spectrometer (MS/MS) using one
precursor ion and two product ions
(1 ) Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives
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