Commission Regulation (EC) No 2430/1999 of 16 November 1999 linking the authorisation of certain additives belonging to the group of coccidiostats and other medicinal substances in feedingstuffs to persons responsible for putting them into circulation (Text with EEA relevance)
Modified by
  • Council Regulation (EC) No 1756/2002of 23 September 2002amending Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of an additive and amending Commission Regulation (EC) No 2430/1999(Text with EEA relevance), 302R1756, October 3, 2002
  • Commission Regulation (EC) No 2037/2005of 14 December 2005amending the conditions for authorisation of a feed additive belonging to the group of coccidiostats(Text with EEA relevance), 305R2037, December 15, 2005
  • Commission Regulation (EC) No 249/2006of 13 February 2006amending Regulations (EC) No 2430/1999, (EC) No 937/2001, (EC) No 1852/2003 and (EC) No 1463/2004 as regards the terms of the authorisation of certain additives in feedingstuffs belonging to the group of coccidiostats and other medicinal substances(Text with EEA relevance), 306R0249, February 14, 2006
Commission Regulation (EC) No 2430/1999of 16 November 1999linking the authorisation of certain additives belonging to the group of coccidiostats and other medicinal substances in feedingstuffs to persons responsible for putting them into circulation(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 feedingstuffsOJ L 270, 14.12.1970, p. 1., as last amended by Commission Regulation (EC) No 1636/1999OJ L 194, 27.7.1999, p. 17., and in particular Article 9h(3)(b) and Article 9i(3)(b) thereof,Whereas:(1)because of the risk for human and animal health posed by the circulation in the Community of poor copies of zootechnical additives, Directive 70/524/EEC, as amended by Council Directive 96/51/ECOJ L 235, 17.9.1996, p. 39., provides for the linking of the authorisation of certain classes of additives to the person responsible for putting them into circulation;(2)in particular Article 9h of Directive 70/524/EEC provides for the replacement of the provisional authorisations of additives included in Annex I after 31 December 1987 and belonging to the group of coccidiostats and other medicinal substances and transferred to Chapter II of Annex B by authorisations linked to the person responsible for putting them into circulation for a period of 10 years;(3)in particular Article 9i of Directive 70/524/EEC provides for the replacement of the provisional authorisations of additives included in Annex II before 1 April 1998 and belonging to the group of coccidiostats and other medicinal substances and transferred to Chapter III of Annex B by provisional authorisations linked to the person responsible for putting them into circulation;(4)the additives listed in the Annexes to this Regulation were the subject of new applications for authorisation by the person responsible for the dossier on the basis of which the former authorisations were given or by their successors. The applications relating to those additives were accompanied by the required monographs and identification notes;(5)the linking of the authorisation to a person responsible for putting the additive into circulation is based on a purely administrative procedure and did not entail a fresh assessment of the additives. Although the authorisations are given for a specified period they may be withdrawn at any time in accordance with Article 9m and Article 11 of Directive 70/524/EEC. In particular, authorisations of additives may be withdrawn as a result of the re-evaluation carried out under Article 9g of Directive 70/524/EEC;(6)the measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for Feedingstuffs,HAS ADOPTED THIS REGULATION:
Article 1The provisional authorisations of the additives listed in Annex I to this Regulation are replaced by authorisations granted to the person responsible for putting the additive in circulation, inserted in the second column of Annex I.
Article 2The provisional authorisations of the additives listed in Annex II to this Regulation are replaced by provisional authorisations granted to the person responsible for putting the additive into circulation, inserted in the second column of Annex II.
Article 3This Regulation shall enter into force on the seventh day of its publication in the Official Journal of the European Communities.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Reference: Fresenius Z. Anal Chem (1984) 318: 522-524, Springer-Verlag 1984.Coccidiostats and histomonostats
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsPeriod of authorisationMaximum Residue Limits(MRLs)
mg of active substance/kg of complete feedingstuff
E 758Roche Vitamins Europe LtdRobenidine hydrochloride 66 g/kg(Cycostat 66 G)Additive composition:Robenidine hydrochloride: 66 g/kgLignosulfonate: 40 g/kgCalcium sulfate dihydrate: 894 g/kgActive substance:Robenidine hydrochloride, C15H13Cl2N5.HCl, 1,3-bis[(p-chlorobenzylidene)amino]guanidine hydrochloride,CAS number: 25875-50-7Related impurities:N.N′.N″-Tris[(p-Cl-benzylidene)amino]guanidine: ≤ 1 %Bis-[4-Cl-benzylidene]hydrazine: ≤ 1 %Rabbits for breeding purposes—5066Use prohibited at least five days before slaughter30.9.2009
E 763Alpharma (Belgium) BVBALasalocid A sodium 15 g/100 g(Avatec 15 % cc)Additive composition:Lasalocid A sodium: 15 g/100 gCorn cob meal: 80,95 g/100 gLecithin: 2 g/100 gSoya oil: 2 g/100 gFerric oxide: 0,05 g/100 gActive substance:Lasalocid A sodium, C34H53O8Na,CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)Related impurities:Lasalocid sodium B-E: ≤ 10 %Turkeys12 weeks90125Use prohibited at least five days before slaughter. Indicate in the instructions for use:"Dangerous for equine species""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated".30.9.2009Regulation (EEC) No 2377/90
Lasalocid A sodium 15 g/100 g(Avatec 150 G)Additive composition:Lasalocid A sodium: 15 g/100 gCalcium sulphate dihydrate: 80,9 g/100 gCalcium lignosulphonate 4 g/100 gFerric oxide: 0,1 g/100 gActive substance:Lasalocid A sodium, C34H53O8Na,CAS number: 25999-20-6, sodium salt of 6-[(3R, 4S, 5S, 7R)-7-[(2S, 3S, 5S)-5-ethyl-5-[(2R, 5R, 6S)-5-ethyl-5-hydroxy-6-methyltetrahydro-2H-pyran2-yl]-tetrahydro-3-methyl-2-furyl]-4-hydroxy-3,5-dimethyl-6-oxononyl]-2,3-cresotic acid, produced by Streptomyces lasaliensis subsp. lasaliensis (ATCC 31180)Related impurities:Lasalocid sodium B-E: ≤ 10 %Turkeys12 weeks90125Use prohibited at least five days before slaughter. Indicate in the instructions for use:"Dangerous for equine species""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated".30.9.2009Regulation (EEC) No 2377/90
E 764Huvepharma nvHalofuginone hydrobromide 6 g/kg(Stenorol)Additive composition:Halofuginone gydrobromide: 6 g/kgGelatine: 13,2 g/kgStarch: 19,2 g/kgSugar: 21,6 g/kgCalcium carbonate: 940 g/kgActive substance:Halofuginone hydrobromide,C16H17BrClN3O3, HBrDL-trans-7-bromo-6-chloro-3-(3-(3-hydroxy-2-piperidy)acetonyl)quinazolin-4(3H)-one hydrobromide,CAS number: 64924-67-0Related impurities:Cis-isomer of halofuginone: < 1,5 %Chickens for laying16 weeks23—30.9.2009
E 769Solvay Pharmaceuticals BVNifursol 50 g/100 g(Salfuride 50DF)Additive composition:Nifursol: 50 g/100 gSoyabean oil: 34 g/100 gCorn starch qs 100 gTurkeys—5075Use prohibited at least five days before slaughter30.9.2009
Active substance:Nifursol,C12H7N5O9.3,5-dinitro-N′-(5-nitrofurfurylidene)salicylohydrazide,CAS number: 16915-70-1Purity: ≥ 98,5 % on an anhydrous basisRelated impurities:3,5 dinitrosalicylic acid hydrazide: ≤ 0,5 %5-nitro-2-furfuralazine: ≤ 0,5 %Maximum amount of dust emitted during handling, as determined by the Stauber Heubach method: 0,1 μg nifursol
E 770Roche Vitamins Europe LtdMaduramicin ammonium alpha 1 g/100 g(Cygro 1 %)Additive composition:Maduramicin ammonium alpha: 1 g/100 gBenzyl alcohol: 5 g/100 gCorn cob grits qs 100 gChickens for fattening—55Use prohibited at least five days before slaughter30.9.2009
Active substance:Maduramicin ammonium alpha, C47H83O17N,CAS number: 84878-61-5,ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis (ATCC 31585) (NRRL 12515)Related impurities:Maduramicin ammonium beta: < 10 %Indicate in the instructions for use:"Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicate"
E 771Janssen Animal Health B.V.B.ADiclazuril 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 gPolyvidone K 30: 0,2 g/100 gSodium hydroxyde: 0,0538 g/100 gDiclazuril: 0,2 g/100 gSoybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 gSodium hydroxide: 0,0215 g/100 gWheat middlings: 60 g/100 gActive 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: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,2 %Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Chickens for fattening—11Use prohibited as least five days before slaughter30.9.2009
E 772Eli Lilly and Company LtdNarasin 80 g/kg — Nicarbazin 80 g/kg(Maxiban G160)Additive composition:Narasin: 80 g activity/kgNicarbazin: 80 g/kgSoyabean oil or mineral oil: 10-30 g/kgVermiculite: 0-20 g/kgMicrotracer F-Red: 11 g/kgCorn cob grits or rice hulls qs 1 kgChickens for fattening—80100Use prohibited at least five days before slaughter30.9.2009
Active substance:(a)Narasin, C43H72O11,CAS number: 55134-13-9,polyether monocarboxylic acid produced by Streptomyxes aureofaciens (NRRL 8092), in granular form, narasin A activity: ≥ 85 %(b)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: ≤ 1 %Indicate in the instructions for use:"Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"
ANNEX II
First authorisation: Commission Directive 96/7/EC (OJ L 51, 1.3.1996, p. 45).First authorisation: Commission Directive 96/66/EC (OJ L 272, 25.10.1996, p. 32).First authorisation: Commission Directive 97/72/EC (OJ L 351, 23.12.1997, p. 55).
Registration number of additiveName and registration number of person responsible for putting additive into circulationAdditive(trade name)Composition, chemical formula, descriptionSpecies or category of animalMaximum ageMinimum contentMaximum contentOther provisionsPeriod of authorisation
mg of active substance/kg of complete feedingstuff
26Hoechst Roussel Vet GmbHSalinomycin sodium 120 g/kg(Sacox 120)Additive composition:Salinomycin sodium ≥ 120 g/kgSilicium dioxide 10-100 g/kgCalcium carbonate: 350-700 g/kgActive 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 salinomycin sodium< 40 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodiumRabbits for fattening—2025Use prohibited at least five days before slaughterIndicate in the instructions for use:"Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"30.9.2000
Chickens reared for laying12 weeks3050Indicate in the instructions for use:"Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"30.9.2000
27Janssen Animal Health B.V.B.A.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 gSoybean meal: 99,25 g/100 gPolyvidone K 30: 0,2 g/100 gSodium hydroxyde: 0,0538 g/100 gDiclazuril: 0,2 g/100 gSoybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 gSodium hydroxide: 0,0215 g/100 gWheat middlings: 60 g/100 gActive 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: 101831-37-2Related impurities:Degradation compound (R064318): ≤ 0,2 %Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individuallyTotal impurities: ≤ 1,5 %Turkeys12 weeks11Use prohibited at least five days before slaughter30.9.2000
Chickens reared for laying16 weeks11—30.9.2000
28Roche Vitamins Europe LtdMaduramicin ammonium alpha 1 g/100 g(Cygro 1 %)Additive composition:Maduramicin ammonium alpha: 1 g/100 gBenzyl alcohol: 5 g/100 gCorn cob grits qs 100 gActive substance:Maduramicin ammonium alpha, C47H83O17N,CAS number: 84878-61-5,ammonium salt of a polyether monocarboxylic acid produced by Actinomadura yumaensis (ATCC 31585) (NRRL 12515)Related impurities:Maduramicin ammonium beta: < 10 %Turkeys16 weeks55Use prohibited at least five days before slaughterIndicate in the instructions for use:"Dangerous for equines""This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g. tiamulin) can be contraindicated"30.9.2000