Commission Regulation (EC) No 162/2003 of 30 January 2003 concerning the authorisation of an additive in feedingstuffs (Text with EEA relevance)
Date: 2003-01-30
Institutions: European Commission
Subjects: animal nutrition, food additive, foodstuffs legislation, market approval

31.1.2003

EN

Official Journal of the European Communities

L 26/3

COMMISSION REGULATION (EC) No 162/2003

of 30 January 2003

concerning the authorisation of an additive in feedingstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 70/524/EEC of 23
November 1970 concerning additives in feedingstuffs (1), as last
amended by Council Regulation No 1756/2002 (2), and in
particular Article 9 thereof,

Whereas:

(3)

(4)

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the safety and
the favourable effects on animal productions of
the
coccidiostat preparation under the conditions set out in
the Annex to this Regulation.

The measures provided for in this Regulation are in
accordance with the opinion of the Standing Committee
on Food Chain and Animal Health,

(1)

(2)

Under Article 2(aaa) of Directive 70/524/EEC authorisa-
tions for putting coccidiostats into circulation are to be
linked to the person responsible for putting them into
circulation. Such authorisations may be given for a
period of 10 years provided all the conditions laid down
in Article 3a of that Directive are met.

for

request

authorisation
The
the
assessment of
submitted in respect of
the coccidiostat preparation
specified in the Annex to this Regulation, shows that the
conditions referred to in Article 3a of Directive 70/524/
EEC are satisfied. The coccidiostat preparation may
therefore be authorised and included in Chapter I of the
list of authorised additives in feedingstuffs referred to in
Article 9t(b) of that Directive.

HAS ADOPTED THIS REGULATION:

Article 1

The additive belonging to the group ‘Coccidiostats and other
medicinal substances’ listed in the Annex to this Regulation is
authorised for use as additive in animal nutrition under the
conditions laid down in the Annex.

Article 2

This Regulation shall enter into force on the day following that
of its publication in the Official Journal of the European Commu-
nities.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 January 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 265, 3.10.2002, p. 1.

Registration
number of
additive

Name and registration
number of person
responsible for putting
additive into circulation

Additive
(trade name)

Composition, chemical formula, description

Species or category of
animal

Maximum
age

mg of active substance/kg of
complete feedingstuff

Minimum
content

Maximum
content

Other
provisions

End of
period of
authorisation

ANNEX

reared

for

16 weeks

1

1

—

20.1.2013

Coccidiostats and other medicinal substances

E 771

Janssen Animal Health
BVBA

Diclazuril 0,5 g/100 g
(Clinacox 0,5 % Premix)

Diclazuril 0,2 g/100 g
(Clinacox 0,2 % Premix)

Additive composition:
Diclazuril: 0,5 g/100 g
Soybean meal: 99,25 g/100 g
Polyvidone K 30: 0,2 g/100 g
Sodium hydroxide: 0,0538 g/100 g

Chickens
laying

Diclazuril: 0,2 g/100 g
Soybean meal: 39,7 g/100 g
Polyvidone K 30: 0,08 g/100 g
Sodium hydroxide: 0,0215 g/100 g
Wheat middlings: 60 g/100 g

Active substance:
Diclazuril, C17H9Cl3N4O2
(±)4-chlorophenyl[2,6-dichloro-4-
(2,3,4,5-tetrahydro-3,5-dioxo-1,2,4-
triazin-2-yl)phenyl]acetonitrile
CAS number: 101831-37-2

Related impurities:
degradation compound (RO64318):
≤ 0,2 %
(RO66891,
related impurities
other
RO66896,
RO70156,
(RO68610,
RO68584, RO70016): ≤ 0,5 % indivi-
dually
Total impurities: ≤ 1,5 %

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