OpenLegislation

Annex II

United Kingdom

Original text. Later amendments are not shown.

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 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—2025

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’

30.9.2000f1
Chickens reared for laying12 weeks3050

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’

30.9.2000f2
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 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 %

F1Turkeys 12 weeks 1 1 Use prohibited at least five days before slaughter 30.9.2000
Chickens reared for laying16 weeks11—30.9.2000f3
28Roche 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 %

Turkeys16 weeks55

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

Annotations

Textual amendments

F1

Deleted by Commission Implementing Regulation (EU) No 888/2011 of 5 September 2011 concerning the authorisation of diclazuril as a feed additive for turkeys for fattening (holder of authorisation Janssen Pharmaceutica N.V.) and amending Regulation (EC) No 2430/1999 (Text with EEA relevance).

Footnotes

f1

First authorisation: Commission Directive 96/7/EC (OJ L 51, 1.3.1996, p. 45).

f2

First authorisation: Commission Directive 96/66/EC (OJ L 272, 25.10.1996, p. 32).

f3

First authorisation: Commission Directive 97/72/EC (OJ L 351, 23.12.1997, p. 55).