1999R2430 — EN — 27.10.2008 — 006.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B 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) (OJ L 296, 17.11.1999, p.3)

Amended by:









▼B

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)







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 1636/1999 ( 2 ), 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/EC ( 3 ), 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, Whereas: HAS ADOPTED THIS REGULATION:







Article 1

The 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 2

The 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 3

This 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







Registration 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 Other provisions Period of authorisation ►M2 Maximum Residue Limits (MRLs) ◄ mg of active substance/kg of complete feedingstuff E 758 ►M5 Alpharma (Belgium) BVBA ◄ Robenidine 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 — 50 66 Use prohibited at least five days before slaughter 30.9.2009 ▼M2 Coccidiostats and histomonostats E 763 Alpharma (Belgium) BVBA Lasalocid A sodium 15 g/100 g (Avatec 15 % cc) Additive composition: Lasalocid A sodium: 15 g/100 g Corn cob meal: 80,95 g/100 g Lecithin: 2 g/100 g Soya oil: 2 g/100 g Ferric oxide: 0,05 g/100 g Active 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 % Turkeys 12 weeks 90 125 Use 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’. 30.9.2009 Regulation (EEC) No 2377/90 Lasalocid A sodium 15 g/100 g (Avatec 150 G) Additive composition: Lasalocid A sodium: 15 g/100 g Calcium sulphate dihydrate: 80,9 g/100 g Calcium lignosulphonate 4 g/100 g Ferric oxide: 0,1 g/100 g Active 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 % Turkeys 12 weeks 90 125 Use 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’. 30.9.2009 Regulation (EEC) No 2377/90 ▼B E 764 ►M3 Huvepharma nv ◄ Halofuginone 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 laying 16 weeks 2 3 — 30.9.2009 ▼M1 ————— ▼B E 770 ►M5 Alpharma (Belgium) BVBA ◄ Maduramicin 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 g Chickens for fattening — 5 5 Use prohibited at least five days before slaughter 30.9.2009 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’ ▼M6 E 771 Janssen Pharmaceutica nv 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 hydroxide: 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 middling: 60 g/100 gActive substance:DiclazurilC17H9Cl3N4O2,(±)-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 % individually Total impurities: ≤ 1,5 % Chickens for fattening — 1 1 — 30.9.2009 1 500 μg diclazuril/kg of wet liver 1 000 μg diclazuril/kg of wet kidney 500 μg diclazuril/kg of wet muscle 500 μg diclazuril/kg of wet skin/fat ▼B E 772 Eli Lilly and Company Ltd Narasin 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 kg Chickens for fattening — 80 100 Use prohibited at least five days before slaughter 30.9.2009 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: 330-95-0 Equimolecular complex of 1,3-bis(4-nitrophenyl) urea and 4,6-dimethylpyrimidin-2-ol, in granular form Related 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’ (1) Reference: Fresenius Z. Anal Chem (1984) 318: 522-524, Springer-Verlag 1984.









ANNEX II







Registration 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 Other provisions Period of authorisation mg of active substance/kg of complete feedingstuff 26 Hoechst Roussel Vet GmbH Salinomycin 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 sodium Rabbits for fattening — 20 25 Use prohibited at least five days before slaughter 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’ 30.9.2000 (1) Chickens reared for laying 12 weeks 30 50 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’ 30.9.2000 (2) 27 Janssen 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 % individually Total impurities: ≤ 1,5 % Turkeys 12 weeks 1 1 Use prohibited at least five days before slaughter 30.9.2000 (1) Chickens reared for laying 16 weeks 1 1 — 30.9.2000 (3) 28 Roche Vitamins Europe Ltd Maduramicin 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 % Turkeys 16 weeks 5 5 Use prohibited at least five days before slaughter 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’ 30.9.2000 (2) (1) First authorisation: Commission Directive 96/7/EC (OJ L 51, 1.3.1996, p. 45). (2) First authorisation: Commission Directive 96/66/EC (OJ L 272, 25.10.1996, p. 32). (3) First authorisation: Commission Directive 97/72/EC (OJ L 351, 23.12.1997, p. 55).