Commission Implementing Regulation (EU) 2020/994 of 9 July 2020 concerning the authorisation of monensin and nicarbazin (Monimax) as a feed additive for turkeys for fattening, chickens for fattening and chickens reared for laying (holder of authorisation Huvepharma NV) (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/994
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of 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

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

51776

Huvepharma NV.

Monensin

80 g/kg

Nicarbazin 80 g/kg (Monimax)

Additive composition:

Preparation of:

Monensin (as monensin sodium) 80 g/kg

(monensin A ≥ 90%, monensin A+B≥ 95%, monensin C 0.2-0.3%)

Nicarbazin 80 g/kg

(Ratio 1:1)

Starch: 15 g/kg.

Wheat meal: 580 g/kg.

Calcium carbonate: q.s. 1000 g

Granular form

Chickens for fattening

40 mg monensin sodium

40 mg nicarbazin

50 mg monensin sodium

50 mg nicarbazin

1.

The additive shall be incorporated in compound feed in the form of a premixture.

2.

The additive shall not be mixed with other coccidiostats.

3.

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’.

4.

Post-market monitoring programmes shall be carried out by the holder of authorisation for:

—

resistance to bacteria and Eimeria spp.;

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including eye, dermal and breathing protection.

30.7.2030

25 μg monensin sodium/kg of wet skin + fat;

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

15 000 μg of DNC/kg of wet liver;

6 000 μg of DNC/kg of wet kidney;

4 000 μg of DNC/kg for wet muscle and wet skin/fat.

Turkeys for fattening

16 weeks

Chickens reared for laying

16 weeks

Characterisation of the active substance:

Monensin as monensin sodium technical substance (activity ≥ 27%)

CAS number 22373-78-0 produced by Streptomyces cinnamonensis 28682 BCCM/LMG S-19095) consisting of:

—

monensin A sodium:

sodium (2-[5-ethyltetrahydro-5-[tetrahydro-3-methyl-5-[tetrahydro-6-hydroxy-6-(hydroxymethyl)-3,5-dimethyl-

2H-pyran-2-yl]-2-furyl]-2-furyl]-9-hydroxy-β-methoxy-α,γ,2,8-tetramethyl-1,6-dioxaspiro-[4.5]decane-7-butyric acid; C 36 H 61 NaO 11 ,

—

monensin B sodium: sodium 4-(9-hydroxy-2-(5’-(6-hydroxy-

6-(hydroxymethyl)-3,5-dimethyltetrahydro-2H-pyran-2-yl)-2,3’-dimethyloctahydro-[2,2’-bifuran]-5-yl)-

2,8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxy-2-methylpentanoate;

C 35 H 59 NaO 11 ,

—

monensin C sodium: sodium 2-ethyl-4-(2-(2-ethyl-5’-(6-hydroxy-6-(hydroxymethyl)-

3,5-dimethyltetrahydro-2H-pyran-2-yl)-3’-methyloctahydro-[2,2’-bifuran]-5-yl)-9-hydroxy-2,8-dimethyl-

1,6-dioxaspiro[4.5]decan-7-yl)-3-methoxypentanoate,; C 37 H 63 NaO 11

Nicarbazin

C 19 H 18 N 6 O 6.

CAS number: 330-95-0 equimolecular complex of:

—

4,4-dinitrocarbanilide (DNC) (67.4-73%)

C 13 H 10 N 4 O 5 ,

—

2-hydroxy-4,6-dimethylpyrimidine

(HDP) (27-30%)

—

free HDP ≤ 2.5%.

C 6 H 8 N 2 O

Related impurities:

—

p-nitro- aniline (PNA): ≤ 0,1 %

—

methyl(4-nitrophenyl) carbamate (M4NPC): ≤ 0.4 %.

Analytical method

( 1 )

Quantification of monensin in the feed additive:

High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS)

Quantification of monensin in premixtures and feedingstuffs:

High Performance Liquid Chromatography using post-column derivatisation coupled to Visible detection (HPLC-VIS) - EN ISO 14183

Quantification of nicarbazin in the feed additive:

High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV)

Quantification of nicarbazin in premixtures and feedingstuffs:

High Performance Liquid Chromatography using post-column derivatisation coupled to UltraViolet detection (HPLC-UV) - EN ISO 15782

For the quantification of monensin sodium and nicarbazin in tissues:

Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods complying with the requirements set by Commission Decision 2002/657/EC

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports