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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)

EU Regulation No 2430/1999 · Adopted 16 November 1999 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 feedingstuffsf1, as last amended by Commission Regulation (EC) No 1636/1999f2, 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/ECf3, 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:

Annotations to the whole text

Footnotes

f1

OJ L 270, 14.12.1970, p. 1.

f2

OJ L 194, 27.7.1999, p. 17.

f3

OJ L 235, 17.9.1996, p. 39.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. Signature
  5. Annex IAnnex I
  6. Annex IIAnnex II

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.

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.

3

This Regulation shall enter into force on the seventh day of its publication in the Official Journal of the European Communities.

Signature

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Annex I

F1

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 F2Maximum Residue Limits (MRLs)
mg of active substance/kg of complete feedingstuff
F3
F4. . . . .
E 764 F5Huvepharma 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 laying16 weeks23—30.9.2009
F6
F7
F8

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 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