LegalizeCommission 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)
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 | Maximum Residue Limits (MRLs) |
|---|---|---|---|---|---|---|---|---|---|---|
| mg of active substance/kg of complete feedingstuff | ||||||||||
| ————— | ||||||||||
| ————— | ||||||||||
| E 764 | Huvepharma nv | Halofuginone hydrobromide 6 g/kg (Stenorol) | Additive composition: Halofuginone gydrobromide: 6 g/kg Gelatine: 13,2 g/kg Starch: 19,2 g/kg Sugar: 21,6 g/kg Calcium carbonate: 940 g/kg Active substance: Halofuginone hydrobromide, C16H17BrClN3O3, HBr DL-trans-7-bromo-6-chloro-3-(3-(3-hydroxy-2-piperidy)acetonyl)quinazolin-4(3H)-one hydrobromide, CAS number: 64924-67-0 Related impurities: Cis-isomer of halofuginone: < 1,5 % | Chickens for laying | 16 weeks | 2 | 3 | — | 30.9.2009 | |
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| (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/kg Silicium dioxide 10-100 g/kg Calcium carbonate: 350-700 g/kg Active 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 g Soybean meal: 99,25 g/100 g Polyvidone K 30: 0,2 g/100 g Sodium hydroxyde: 0,0538 g/100 g Diclazuril: 0,2 g/100 g Soybean meal: 39,7 g/100 g Polyvidone K 30: 0,08 g/100 g Sodium hydroxide: 0,0215 g/100 g Wheat middlings: 60 g/100 g Active 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: 101831-37-2 Related impurities: Degradation compound (R064318): ≤ 0,2 % Other related impurities (R066891, R066896, R068610, R070156, R068584, R070016): ≤ 0,5 % individually Total impurities: ≤ 1,5 % | — | — | — | — | — | |
| 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 g Benzyl alcohol: 5 g/100 g Corn cob grits qs 100 g 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 % | 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). |
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