COUNCIL DIRECTIVE (70/524/EEC)

of 23 November 1970

concerning additives in feeding-stuffs

(70/524/EEC)

 

Coccidiostats and other medical substances

Reg. numb. 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 mg of active substance/kg of complete feedingstuff
Maximum content mg of active substance/kg of complete feedingstuff
Other previsions
Period of authorization

[29

Phibro Animal Health, sprl

Semduramicin sodium (Aviax 5%)

Additive composition:

Semduramicin sodium: 51,3 g/kg
Sodium carbonate: 40 g/kg
Mineral oil: 50 g/kg
Sodium aluminosilicate: 20g/kg
Soybean mill run: 838,7 g/kg

Active substance:

Semduramicin sodium,
C45H76O16Na5.HCl,

sodium salt of a monocarboxylic acid polyether ionophore produced by Actinomadura roseorufa (ATCC 53664)

Related impurities:
Descarboxylsemduramicin: maximum 2%
Desmethoxylsemduramicin: maximum 2%
Hydroxysemduramicin: maximum 2%
Total: maximum 5%

Chickens for fattening

-

20

25

Use prohibited at least five days before slaughter

30.9.2009 ](5)

[E 758

Roche Vitamins Europe Ltd

Robenidine hydrochloride 66 g/kg (Cycostat 66 G)

Additive composition:

Robenidine hydrochloride: 66 g/kg
Lignosulfonate: 40 g/kg
Calcium sulfate dihydrate: 894 g/kg

Active substance:

Robenidine hydrochloride,
C15H13Cl2N5.HCl,
1,3-bis[(p-chloro
benzylidene)amino] guanidine hydrochloride,
CAS number: 25875-50-7

Related impurities:
N.N'.N'''-Tris
[(p-Cl-benzylidene) amino] guanidine: 1% maximum
Bis-[4-Cl-
benzylidene] hydrazine: 1% maximum

Rabbits for breeding purposes

-

50

66

Use prohibited at least five days before slaughter

30.9.2009 ](1)

[E 763

Produits Roche SA

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
-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% maximum

Turkeys

12 weeks

90

125

Use prohibited at least five days before slaughter

Indicate in the instructions for use:
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances can be contraindicated"

30.9.2009 ](1)

[E 764

Hoechst Roussel Vet GmbH

Halofuginone hydrobromide 6 g/kg (Stenorol)

Additive composition:

Halofuginone hydrobromide: 6 g/kg
Gelatine: 13,2 g/kg
Strach: 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: less than 1,5%

Chickens for laying

16 weeks

2

3

-

30.9.2009 ](1)

[E 766

Intervet International bv

Salinomycin sodium 120 g/kg (Sacox 120)

Additive composition:

Salinomycin sodium: 120 g/kg minimum
Silicium dioxide: 10 to 100 g/kg
Calcium carbonate: 350 to 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 maximum
40 g 17-epi-20-desoxy
-salinomycin/kg salinomycin sodium maximum

Rabbits for fattening

-

20

25

Use prohibited at least 5 days before slaughter

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contra-indicated"

31.5.2011 ](3)

[E 769

Solvay Pharma. BV

Nifursol 50 g/100 g (Salfuride 50 DF)

Additive composition:

Nifursol: 50 g/100 g
Soyabean oil: 34 g/100 g
Corn starch qs 100 g

Active substance:

Nifursol
C12H7N5O9,
3,5-dinitro-N'-(5
-nitrofurfurylidene) salicylohydrazide
CAS number: 16915-70-1
Purity: 98,5% minimum on an anhydrous basis

Related impurities:
3,5 dinitrosalicylic acid hydrazide: 0,5% maximum
5-nitro-2
-furfuralazine: 0,5% maximum

Turkeys

-

50

75

Use prohibited at least five days before slaughter

Maximum amount of dust emitted during handling, as determined by the Strauber Heubach method (Reference: Fresenius Z. Anal. Chem. (1984) 318: 522-524, Springer-Verlag 1984): 0,1 mg nifursol

30.9.2009 ](1)

[[E 770

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,
C47H83N17O17,
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: less than 10%

Chickens for fattening

-

5

5

Use prohibited at least five days before slaughter

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contraindicated"

30.9.2009 ](1)

Alpharma AS

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,
C47H83N17O17,
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: less than 10%

Turkeys

16 weeks

5

5

Use prohibited at least five days before slaughter

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contraindicated"

15.12.2011 ](4)

[[E 771

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: 0,2g/100 g
Soybean meal: 39,7 g/100 g
Polyvidone K 30: 0,08 g/100 g
Sodium hydroxyde: 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% maximum
Other related impurities (R066891, R066896, R068610, R070153, R068584, R070016): 0,5% individually maximum
Total impurities: 1,5% maximum

Chickens for fattening

-

1

1

Use prohibited at least five days before slaughter

30.9.2009 ](1)

Turkeys for fattening

12 weeks

1

1

Use prohibited at least five days before slaughter

28.2.2011 ](2)

[E 772

Eli Lilly and Company Ltd

Narasin 80 g/kg
Nicarbazin 80 g/kg
(Maxiban G160)

Additive composition:

Narasin: 80 g activity/kg
Nicarbazin: 80 g/kg
Soyabean oil or mineral oil: 10-30 g/kg
Vermiculite: 0-20 g/kg
Microtracer F-Red: 11 g/kg
Corn cob grits or rice hulls qs 1 kg

Active substance:

Narasin:
C43H72O11,
CAS number: 55134-13-9,
polyether monocarboxylic acid produced by Streptomyxes aureofaciens (NRRL 8092),
in granular form, narasin A activity: 85% minimum

Nicarbazin:
C19H18N6O6,
CAS number: 330-95-0
Equimolecular complex of 1,3-bis(4
-nitrophenyl) urea and 4,6-dimethyl
pyrimidin-2-ol, in granular form

Related impurities:
p-nitroaniline: 1% maximum

Chickens for fattening

-

80

100

Use prohibited at least five days before slaughter

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contraindicated"

30.9.2009 ](1)


(1) Commission Regulation (EC) N° 2430/1999 (OJ L 296, 17.11.1999)
(2) Commission Regulation (EC) N° 418/2001 (OJ L 62, 2.3.2001)
(3) Commission Regulation (EC) N° 937/2001 (OJ L 130, 12.5.2001)
(4) Commission Regulation (EC) N° 2380/2001 (OJ L 321, 6.12.2001)
(4) Commission Regulation (EC) N° 1041/2002 (OJ L 157, 14.6.2002)

 

 

 

List of additives linked to a person responsible for putting them into circulation

and authorised on a provisional basis for no longer than five years

in the case of additives which have been the subject of provisional authorisation before 1 April 1998

 

Coccidiostats and other medical substances

Reg. numb. 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 mg of active substance/kg of complete feedingstuff
Maximum content mg of active substance/kg of complete feedingstuff
Other previsions
Period of authorization

[26

Intervet International bv

Salinomycin sodium 120 g/kg (Sacox 120)

Additive composition:

Salinomycin sodium: 120 g/kg minimum
Silicium dioxide: 10 to 100 g/kg
Calcium carbonate: 350 to 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 maximum/kg salinomycin sodium
40 g 17-epi-20-desoxy
-salinomycin maximum/kg salinomycin sodium

Chickens reared for laying

12 weeks

30

50

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contraindicated"

13.10.2001 (a)](1)

[27

Janssen Animal Health BVBA

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: 0,2g/100 g
Soybean meal: 39,7 g/100 g
Polyvidone K 30: 0,08 g/100 g
Sodium hydroxyde: 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% maximum
Other related impurities (R066891, R066896, R068610, R070153, R068584, R070016): 0,5% individually maximum
Total impurities: 1,5% maximum

Chickens reared for laying

16 weeks

1

1

-

14.12.2002 (b)](1)

[28

Alpharma AS

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,
C47H83N17O17,
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: less than 10%

Turkeys

16 weeks

5

5

Use prohibited at least five days before slaughter

Indicate in the instructions for use:
"Dangerous for equines"
"This feddingstuff contains an ionophore: simultaneous use with certain medical substances (e.g. tiamulin) can be contraindicated"

13.10.2001 (a)](1)


(a) First authorisation: Commision Directive 96/66/EC (OJ L 272, 25.10.1996)
(b) First authorisation: Commision Directive 97/72/EC (OJ L 351, 23.12.1997)

(1) Commission Regulation (EC) N° 2200/2001 of 17 October 2001 (OJ L 299, 15.11.2001)

 

 

 

Additives linked to a person responsible for putting them into circulation,

inserted in Annex I before 1 January 1998

 

Coccidiosats and other medical sustances

Reg. number
Name and registration number of person responsible for marketing (*)
Additive
Chemical name, description
Species or category of animal
Maximum age
Minimum content mg/kg complete feedingstuff
Maximum content mg/kg complete feedingstuff
Other provisions

E 756

Decoquinate1

3-ethoxycarbonyl
-4-hydroxy-6-decyloxy
-7-ethoxyquinoline

Chickens for fattening

-

20

40

Use prohibited at least 3 days before slaughter

E 757

Monensin sodium1

C36H61O11Na (sodium salt of polyether monocarboxylic acid produced by Streptomyces cinnamonensis)

Chickens for fattening

-

100

125

Use prohibited at least 3 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"

Chickens reared for laying

16 weeks

100

120

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"

Turkeys

16 weeks

90

100

Use prohibited at least 3 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"

E 758

Robenidine1

1,3-bis[(4
-chlorobenzylidene)
-amino]-guanidine hydrochloride

Chickens for fattening, turkeys

-

30

36

Use prohibited at least 5 days before slaughter

Rabbits for fattening

-

50

66

Use prohibited at least 5 days before slaughter

E 759

Ronidazole1

(1-methyl-5
-nitroimidazol-2-yl)
methylcarbamate

Turkeys

-

60

60

Use prohibited from laying age onwards and at least 6 days before slaughter respectively

E 763

Lasalocid sodium1

C34H53O8Na (sodium salt of polyether monocarboxylic acid produced by Streptomyces lasaliensis)

Chickens for fattening

-

75

125

Use prohibited at least 5 days before slaughter Indicate in the instructions for use: "This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances can be contraindicated"

Chickens reared for laying

16 weeks

75

125

-

E 764

Halofuginone1

dl-trans-7-bromo
-6-chloro-3-[3
-(3-hydroxy-2
-piperidyl)acetonyl]
-quinazolin-4-(2H)-one hydrobromide

Chickens for fattening

-

2

3

Use prohibited at least 5 days before slaughter

Turkeys

12 weeks

2

3

Use prohibited at least 5 days before slaughter

E 765

Narasin1

C43H72O11 (polyether of monocarboxylic acid produced by Streptomyces aureofaciens)

Chickens for fattening

-

60

70

Use prohibited at least 5 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"

E 766

Salinomycin sodium1

C42H69O11Na (sodium salt of a polyether monocarboxylic acid produced by Streptomyces albus). Elaiophylin content: less than 42 mg per kg of salinomycin sodium. 17-epi-20-desoxy
-salinomycin content: less than 40 g per kg of salinomycin sodium

Chickens for fattening

-

60

70

Use prohibited at least 5 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"


1. First authorisation 12 April 1991, Commission Directive 91/248/EEC (OJ L 124, 18.5.1991)


[back to Directive text]