Commission Regulation (EC) No 1095/2008 of 6 November 2008 amending Regulation (EC) No 109/2007 as regards the terms of the authorisation of the feed additive monensin sodium (Coxidin) (Text with EEA relevance)

• CELEX: Regulation (EC) No 1095/2008
• Articles: 3

Article 1

The Annex to Regulation (EC) No 109/2007 is replaced by the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union .

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

(Trade name)

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Provisional maximum residue limits (MRLs) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff with a moisture content of 12 %

Coccidiostats and histomonostats

5 1 701

Huvepharma

NV Belgium

Monensin sodium

(Coxidin)

Active substance

C 36 H 61 O 11 Na

Sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis , 28682 LMG S-19095 in powder form.

Factor composition:

Monensin A: not less than 90 %

Monensin A + B: not less than 95 %

Monensin C: 0,2-0,3 %

Additive composition

Monensin sodium technical substance equivalent to monensin activity: 25 %

Perlite: 15-20 %

Wheat bran: 55-60 %

Analytical method

( 1 )

Method for determination of the active substance: high performance liquid chromatography (HPLC) with post-column derivatisation and UV detection (λ = 520 nm)

Chickens for fattening

—

100

125

1.

Use prohibited at least one day before slaughter

2.

The additive shall be incorporated in compound feedingstuffs in form of a premixture

3.

Maximum permitted dose of monensin sodium in complementary feedingstuffs:

—

625 mg/kg for chickens for fattening;

—

500 mg/kg for turkeys

4.

Monensin sodium shall not be mixed with other coccidiostats

5.

Indicate in the instructions for use:

‘Dangerous for equines. This feedingstuff contains an ionophore: avoid simultaneous administration with tiamulin and monitor for possible adverse reactions when used concurrently with other medicinal substances’

6.

Wear suitable protective clothing, gloves and eye/face protection. In case of insufficient ventilation in the premise, wear suitable respiratory equipments

6.2.2017

25 μg monensin sodium/kg of wet skin + fat

8 μg monensin sodium/kg of wet liver, wet kidney and wet muscle

Turkeys

16 weeks

60

100

( 1 )   Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additives