Commission Regulation (EU) No 885/2010 of 7 October 2010 concerning the authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd) and amending Regulation (EC) No 2430/1999 Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2018/1957of 11 December 2018amending Regulation (EC) No 885/2010 as regards the terms of authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd)(Text with EEA relevance), 32018R1957, December 12, 2018
Commission Regulation (EU) No 885/2010of 7 October 2010concerning the authorisation of the preparation of narasin and nicarbazin as a feed additive for chickens for fattening (holder of authorisation Eli Lilly and Company Ltd) and amending Regulation (EC) No 2430/1999(Text with EEA relevance)
Article 1The 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 2In Annex I to Regulation (EC) No 2430/1999, the entry under the registration number of additive E 772, concerning Narasin 80 g/kg — Nicarbazin 80 g/kg (Maxiban G160), is deleted.Premixture and compound feed containing the feed additive labelled in accordance with Regulation (EC) No 2430/1999 may continue to be placed on the market and remain on the market and used until stocks are exhausted.
Article 3This Regulation shall enter into force on the 20th day following 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.ANNEX
Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/crl-feed-additivesCoccidiostats and histomonostats
Identification number of the additiveName of the holder of authorisationAdditiveComposition, chemical formula, description, analytical methodSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsEnd of period of authorisationMaximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
5 1 772Elanco GmbHNarasin 80 g activity/kgNicarbazin 80 g/kg(Maxiban G160)Additive compositionNarasin: 80 g activity/kgNicarbazin: 80 g/kg(Ratio 1:1)Vegetal or mineral oil: 10-30 g/kgVermiculite: 0-20 g/kgMicro tracer red: 4-11 g/kgCorn cob grits or rice hulls qs 1 kgActive substance1.Narasin, C43H72O11CAS number: 55134-13-9polyether monocarboxylic acid produced by Streptomyces aureofaciens (NRRL 8092), in granular formNarasin A activity: ≥ 85 %2.Nicarbazin, C19H18N6O6.CAS number: 330-95-0equimolecular complex of 1,3-bis(4-nitrophenyl) urea and 4,6 dimethylpyrimidin-2-ol, in granular formRelated impurities: p-nitroaniline: ≤ 0,3 %Analytical methodsFor the determination of narasin: reversed-phase high performance liquid chromatography (HPLC) using post-column derivatisation with vanillin and detection at 520 nm - ISO 14183:2005.For determination of nicarbazin: high performance liquid chromatography method and ultraviolet detection (HPLC-UV) spectrometry (LC-MS/MS)Chickens for fattening—40 mg Narasin40 mg Nicarbazin50 mg Narasin50 mg Nicarbazin1.Indicate in the instructions for use: "Dangerous for equine species, turkeys and rabbits""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated".2.The additive shall be incorporated in compound feed in form of a premixture.3.The preparation of narasin and nicarbazin shall not be mixed with other coccidiostats.4.A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation.5.From 28 October 2013 the p-nitroaniline content shall be ≤ 0,1 %.6.For safety: breathing protection shall be used during handling.28 October 202050 μg of narasin/kg for fresh liver, muscle, kidney and skin/fat.15000 μg of dinitrocarbanilide (DNC)/kg of fresh liver;6000 μg of DNC/kg of fresh kidney;4000 μg of DNC/kg for fresh muscle and fresh skin/fat.
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