1999R2430 — EN — 31.03.2003 — 001.001 — 1
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►B COMMISSIONREGULATION(EC)No2430/1999
of16November1999
linking the authorisation of certain additives belonging to the group of coccidiostats and other
medicinal substancesinfeedingstuffstopersonsresponsibleforputtingthemintocirculation
(TextwithEEArelevance)
(OJ L 296, 17.11.1999, p. 3)
Amended by:
Official Journal
No page date
►M1Council Regulation (EC) No 1756/2002 of 23 September 2002 L 265 1 3.10.2002
▼B
COMMISSIONREGULATION(EC)No2430/1999
of16November1999
linkingtheauthorisationofcertainadditivesbelongingtothegroup
of coccidiostats and other medicinal substances in feedingstuffs to
personsresponsibleforputtingthemintocirculation
(TextwithEEArelevance)
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 Commis-
sion 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 zootechnicaladditives, Directive 70/524/EEC, as amended by Council Direc-tive 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 9hof Directive 70/524/EEC provides for th e
replacement of the provisional authorisations of additivesincluded in Annex I after 31 December 1987 and belonging tothe 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 aperiod of 10 years;
(3)in particular Article 9i of Directive 70/524/EEC provides for thereplacement 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 trans-ferred to Chapter III of Annex B by provisional authorisationslinked 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 formerauthorisations were given or by their successors. The applica-tions relating to those additives were accompanied by therequired monographs and identification notes;
(5)the linking of the authorisation to a person responsible forputting the additive into circulation is based on a purely admin-istrative procedure and did not entail a freshassessment of th eadditives. Although the authorisations are given for a specifiedperiod they may be withdrawn at any time in accordance withArticle 9m and Article 11 of Directive 70/524/EEC. In parti-
cular, authorisations of additives may be withdrawn as a result
of the re-evaluation carried out under Article 9g of Directive70/524/EEC;
(6)the measures provided for in this Regulation are in accordancewith the opinion of the Standing Committee for Feedingstuffs,1999R2430 — EN — 31.03.2003 — 001.001 — 2
(1) OJ L 270, 14.12.1970, p. 1.
(2) OJ L 194, 27.7.1999, p. 17.
(3) OJ L 235, 17.9.1996, p. 39.
▼B
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 respon-sible 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 inthe second column of Annex II.
Article 3
This Regulation shall enter into force on the seventh day of its publica-
tion in the Official Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable
in all Member States.1999R2430 — EN — 31.03.2003 — 001.001 — 3
ANNEX I
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 758 Roche Vitamins
Europe LtdRobenidine
hydrochloride
66 g/kg
(Cycostat 66 G)Additivecomposition:
Robenidine hydrochloride: 66 g/kg
Lignosulfonate: 40 g/kg
Calcium sulfate dihydrate: 894 g/kgActivesubstance:
Robenidine hydrochloride, C
15H13Cl2N5.HCl,
1,3-bis[(p-chlorobenzylidene)amino]guani-
dine hydrochloride,
CAS number: 25875-50-7Related impurities:
N.N′.N″-Tris[(p-Cl-benzylidene)amino]gua-
nidine: ≤1%
Bis-[4-Cl-benzylidene]hydrazine: ≤1%Rabbits for
breeding
purposes— 50 66 Use prohibited at least
five days before slaughter30.9.2009▼B1999R2430 — EN — 31.03.2003 — 001.001 — 4
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 763 Produits Roche
SALasalocid A
sodium 15 g/
100 g
(Avatec 15 % cc)Additivecomposition:
Lasalocid A sodium: 15 g/100 g
Corn cob meal: 80,95 g/100 g
Lecithin: 2 g/100 gSoya oil: 2 g/100 g
Ferric oxide: 0,05 g/100 g
Activesubstance:Lasalocid A sodium,
C
34H53O8Na,
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-méthyl-
tetrahydro-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 instruc-
tions for use:
‘This feddingstuff
contains an ionophore:
simultaneous use with
certain medicinal
substances can be contra-
indicated’30.9.2009▼B1999R2430 — EN — 31.03.2003 — 001.001 — 5
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 764 Hoechst
Roussel Vet
GmbHHalofuginone
hydrobromide
6 g/kg
(Stenorol)Additivecomposition:
Halofuginone gydrobromide: 6 g/kg
Gelatine: 13,2 g/kg
Starch: 19,2 g/kgSugar: 21,6 g/kg
Calcium carbonate: 940 g/kg
Activesubstance:Halofuginone hydrobromide,
C
16H17BrClN3O3, 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 weeks 2 3 — 30.9.2009▼B1999R2430 — EN — 31.03.2003 — 001.001 — 6
▼M1
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 770
Roche Vitamins
Europe LtdMaduramicin
ammonium alpha
1 g/100 g
(Cygro 1 %)Additivecomposition:
Maduramicin ammonium alpha: 1 g/100 g
Benzyl alcohol: 5 g/100 gCorn cob grits qs 100 gChickens for
fattening— 5 5 Use prohibited at least
five days before slaughter30.9.2009
Activesubstance:
Maduramicin ammonium alpha, C
47H83O17N,
CAS number: 84878-61-5,
ammonium salt of a polyether monocar-
boxylic acid produced by Actinomadura
yumaensis (ATCC 31585) (NRRL 12515)
Related impurities:
Maduramicin ammonium beta: < 10 %Indicate in the instruc-
tions for use:
‘Dangerous for equines’
‘This feedingstuff
contains an ionophore:simultaneous use with
certain medicinal
substances (e.g. tiamulin)
can be contraindicate’▼B1999R2430 — EN — 31.03.2003 — 001.001 — 7
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 771 Janssen Animal
HealthB.V.B.ADiclazuril 0,5 g/
100 g
(Clinacox 0,5 %
Premix)
Diclazuril 0,2 g/
100 g
(Clinacox 0,2 %
Premix)Additivecomposition:
Diclazuril: 0,5 g/100 g.
Soybean meal: 99,25 g/100 g
Polyvidone K 30: 0,2 g/100 gSodium hydroxyde: 0,0538 g/100 g
Diclazuril: 0,2 g/100 g
Soybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 g
Sodium hydroxide: 0,0215 g/100 g
Wheat middlings: 60 g/100 gActivesubstance:
Diclazuril,
C
17H9Cl3N4O2,
(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-
tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phe-
nyl]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 for
fattening— 1 1 Use prohibited as least
five days before slaughter30.9.2009▼B1999R2430 — EN — 31.03.2003 — 001.001 — 8
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisa-
tionmg of active substance/
kg of complete feeding-
stuff
E 772 Eli Lilly and
Company LtdNarasin 80 g/kg
— Nicarbazin
80 g/kg
(Maxiban G160)Additivecomposition:
Narasin: 80 g activity/kg
Nicarbazin: 80 g/kg
Soyabean oil or mineral oil: 10-30 g/kgVermiculite: 0-20 g/kg
Microtracer F-Red: 11 g/kg
Corn cob grits or rice hulls qs 1 kgChickens for
fattening— 80 100 Use prohibited at least
five days before slaughter30.9.2009
Activesubstance:
(a) Narasin, C
43H72O11, CAS number:
55134-13-9, polyether monocarboxylic
acid produced by Streptomyxes aureofa-
ciens(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-dimethylpyri-
midin-2-ol, in granular form
Related impurities:
p-nitroaniline: ≤1%Indicate in the instruc-
tions for use:
‘Dangerous for equines’
‘This feedingstuff
contains an ionophore:
simultaneous use with
certain medicinal
substances (e.g. tiamulin)
can be contraindicated’▼B1999R2430 — EN — 31.03.2003 — 001.001 — 9
▼M1
ANNEX II
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisation mg of active substance/
kg of complete
feedingstuff
26 Hoechst
Roussel Vet
GmbHSalinomycin
sodium 120 g/kg
(Sacox 120)Additivecomposition:
Salinomycin sodium ≥120 g/kg
Silicium dioxide 10-100 g/kgCalcium carbonate: 350-700 g/kg
Activesubstance:
Salinomycin sodium, C
42H69O11Na,
CAS number: 53003-10-4,
sodium salt of a polyether monocarboxylic
acid produced by fermentation of Strepto-
myces albus (DSM 12217)
Related impurities:< 42 mg elaiophylin/kg salinomycin sodium
< 40 g 17-epi-20-desoxy-salinomycin/kg
salinomycin sodiumRabbits for
fattening— 20 25 Use prohibited at least
five days before
slaughter
Indicate in the instruc-
tions 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 laying12 weeks 30 50 Indicate in the instruc-
tions 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)▼B1999R2430 — EN — 31.03.2003 — 001.001 — 10
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisation mg of active substance/
kg of complete
feedingstuff
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)Additivecomposition:
Diclazuril: 0,5 g/100 g
Soybean meal: 99,25 g/100 g
Polyvidone K 30: 0,2 g/100 gSodium hydroxyde: 0,0538 g/100 g
Diclazuril: 0,2 g/100 g
Soybean meal: 39,7 g/100 gPolyvidone K 30: 0,08 g/100 g
Sodium hydroxide: 0,0215 g/100 g
Wheat middlings: 60 g/100 gActivesubstance:
Diclazuril, C
17H9Cl3N4O2,
(±)-4-chlorophenyl[2,6-dichloro-4-(2,3,4,5-
tetrahydro-3,5-dioxo-1,2,4-triazin-2-yl)phe-
nyl]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 %Turkeys 12 weeks 1 1 Use prohibited at least
five days before
slaughter30.9.2000(1)
Chickens reared
for laying16 weeks 1 1 — 30.9.2000(3)▼B1999R2430 — EN — 31.03.2003 — 001.001 — 11
Registration
number of
additiveName and registra-
tion number of
person responsible
for putting additive
into circulationAdditive (trade
name)Composition, chemical formula, descriptionSpecies or category
of animalMaximum
ageMinimum
contentMaximum
content
Other provisionsPeriod of
authorisation mg of active substance/
kg of complete
feedingstuff
28 Roche Vitamins
Europe LtdMaduramicin
ammonium
alpha 1 g/100 g
(Cygro 1 %)Additivecomposition:
Maduramicin ammonium alpha: 1 g/100 g
Benzyl alcohol: 5 g/100 g
Corn cob grits qs 100 gActivesubstance:
Maduramicin ammonium alpha, C
47H83O17N,
CAS number: 84878-61-5,ammonium salt of a polyether monocar-
boxylic 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 instruc-
tions 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).▼B1999R2430 — EN — 31.03.2003 — 001.001 — 12