Commission Regulation (EC) No 1852/2003 of 21 October 2003 authorising the use for 10 years of a coccidiostat in feedingstuffs (Text with EEA relevance)
Date: 2003-10-21
Institutions: European Commission
Subjects: animal feedingstuffs, food additive, market approval, veterinary drug

22.10.2003

EN

Official Journal of the European Union

L 271/13

COMMISSION REGULATION (EC) No 1852/2003

of 21 October 2003

authorising the use for 10 years of a coccidiostat 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 Commission Regulation (EC) No 1847/2003 (2),
and in particular Articles 3 and 9 thereof,

Whereas:

(1)

(2)

(3)

Directive 70/524/EEC provides that Member States are
to require that no additive may be put into circulation
unless a Community authorisation has been granted.

In the case of additives listed in Part I of Annex C to
Directive 70/524/EEC, which includes coccidiostats and
other medicinal substances, an authorisation linked to
the person responsible for putting them into circulation
may be given. Such authorisation may be given for a
period of 10 years if all the relevant conditions laid
down in that Directive are satisfied.

The assessment of the application for an authorisation
for a period of 10 years submitted in respect of the
coccidiostat preparation,
‘Sacox 120 microGranulate’,
shows that the relevant conditions laid down in Direc-
tive 70/524/EEC are satisfied.

The Scientific Committee for Animal Nutrition has deliv-
ered a favourable opinion with regard to the safety and
the coccidiostat preparation
the favourable effects of
which belongs to the group ‘Coccidiostats and other
medicinal substances’, for chickens reared for laying.

(4)

(5)

(6)

Accordingly,
the coccidiostat preparation ‘Sacox 120
microGranulate’ should be authorised for a period of 10
years and included in the list of authorised additives
linked to the person responsible for putting them into
circulation and authorised for a period of 10 years as
provided for in Directive 70/524/EEC.

to the

additive

The assessment of the application shows that certain
procedures are required to protect workers from expo-
sure
‘Sacox 120 microGranulate’.
However, such protection is assured by the application
of Council Directive 89/391/EEC of 12 June 1989 on
the introduction of measures to encourage improve-
ments in the safety and health of workers at work (3).

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

HAS ADOPTED THIS REGULATION:

Article 1

The additive ‘Sacox 120 microGranulate’ belonging to the
group ‘Coccidiostats and other medicinal substances’ as set out
in the Annex is authorised for use as an additive in animal
nutrition under the conditions laid down in the Annex.

Article 2

into force on the 20th day
This Regulation shall enter
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 October 2003.

For the Commission

David BYRNE

Member of the Commission

(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 269, 21.10.2003, p. 3.

(3) OJ L 183, 29.6.1989, p. 1.

Registra-
tion
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

Minimum
content

Maximum
content

mg of active substance/kg
of complete feedingstuff

Other provisions

Period of
authorisation

ANNEX

‘Coccidiostats and other medicinal substances

E766

Intervet Interna-
tional bv

Salinomycin sodium 120 g/kg
(Sacox 120 microGranulate)

350-

carbonate:

Additive composition:
Salinomycin sodium: ≥ 120 g/
kg
Silicon dioxide: 10-100 g/kg
Calcium
700 g/kg
Active substance:
Salinomycin sodium,
C42H69O11Na,
CAS number: 53003-10-4,
sodium salt of a polyether
monocarboxylic acid produced
by fermentation of Streptomyces
albus (DSM 12217)
Related impurities:
< 42 mg elaiophylin/kg salino-
mycin sodium.
< 40 g
nomycin/kg
sodium

17-epi-20-desoxy-sali-
salinomycin

Chickens reared
for laying

12 weeks

50

50

11.11.2013’

for equines and

Indicate in the instructions for
use:
“Dangerous
turkeys”
“This feedingstuff contains an
simultaneous use
ionophore:
with
medicinal
certain
tiamulin) can
substances (e.g.
be contra-indicated”.

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