MAXIMUM RESIDUE LIMITS IN VETERINARY MEDICINAL PRODUCTS REGULATIONS

MAXIMUM RESIDUE LIMITS IN

VETERINARY MEDICINAL PRODUCTS

SUBSIDIARY LEGISLATION 449.19

MAXIMUM RESIDUE LIMITS IN VETERINARY

MEDICINAL PRODUCTS REGULATIONS

1st October, 1998

LEGAL NOTICE 162 of 1998.

The title of these regulations is Maximum Residue Limits

in Veterinary Medicinal Products Regulations.

(Regulation 3)

List of pharmacologically active substances for which maximum residue limits have been

fixed

1. Anti-infectious agents

1.1.

Chemotherapeutics

1.1.1. Sulfonamides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

All substances

Parent drug

All food produc- 100 µ g/kg

Muscle, liver,

belonging to the

ing species

kidney, fat

sulfonamide group

Bovine, Ovine,

100 µ g/kg

Milk

Caprine

Other provisions: The combined total residues of all substances within the sulfonamide group

should not exceed 100 µ g/kg

1.2.

Antibiotics

1.2.1.

Penicillins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.1.1.

Benzylpenicillin All food produc- 50 µ g/kg

Muscle, liver,

Benzylpenicillin

ing species

kidney, fat

4 µ g/kg

Milk

1.2.1.2.

Ampicillin

All food produc- 50 µ g/kg

Muscle, liver,

Ampicillin

ing species

kidney, fat

4 µ g/kg

Milk

1.2.1.3.

Amoxicillin

All food produc- 50 µ g/kg

Muscle, liver,

Amoxicillin

ing species

kidney, fat

4 µ g/kg

Milk

1.2.1.4.

Oxacillin

All food produc- 300 µ g/kg

Muscle, liver,

Oxacillin

ing species

kidney, fat

30 µ g/kg

Milk

1.2.1.5.

Cloxacillin

All food produc- 300 µ g/kg

Muscle, liver,

Cloxacillin

ing species

kidney, fat

30 µ g/kg

Milk

1.2.1.6.

Dicloxacillin

All food produc- 300 µ g/kg

Muscle, liver,

Dicloxacillin

ing species

kidney, fat

30 µ g/kg

Milk

1.2.1.7.

Benzylpenicillin Bovine

50 µ g/kg

Muscle, liver,

Penethamate

kidney, fat

4 µ g/kg

Milk

1.2.2.

Cephalosporins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.2.1.

Cefquinome

Bovine

200 µ g/kg

Kidney

Cefquinome

100 µ g/kg

Liver

50 µ g/kg

Muscle

50 µ g/kg

Fat

20 µ g/kg

Milk

1.2.3.

Quinolones

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.3.1.

Sum of

Bovine, porcine, 30 µ g/kg

Muscle, liver

Enrofloxacin

enrofloxacin and

poultry

kidney

ciprofloxacin

1.2.3.2.

Sarafloxacin

Chicken

100 µ g/kg

Liver

Sarafloxacin

10 µ g/kg

Skin and fat

1.2.3.3.

Difloxacin

Chicken, turkey

200 µ g/kg

Liver

Difloxacin

150 µ g/kg

Kidney

50 µ g/kg

Muscle

200 µ g/kg

Skin and fat

1.2.4.

Macrolides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.4.1.

Tilmicosin

Bovine, ovine,

1000 µ g/kg

Liver, kidney

Tilmicosin

porcine

50 µ g/kg

Muscle, fat

Ovine

50 µ g/kg

Milk

1.2.4.2.

Sum of

Bovine

300 µ g/kg

Liver, kidney, fat

Spiramycin

spiramycin and

200 µ g/kg

Muscle

neospiramycin

200 µ g/kg

Milk

Chicken

400 µ g/kg

Liver

300 µ g/kg

Skin and fat

200 µ g/kg

Muscle

1.2.5.

Florfenicol and related compounds

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.5.1.

Sum of

Bovine

200 µ g/kg

Muscle

Florfenicol

Florfenicol and

300 µ g/kg

Kidney

its metabolites

3000 µ g/kg

Liver

measured as

Florfenicol-

amine

1.2.6.

Tetracyclines

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.6.1.

Sum of parent

All food produc- 600 µ g/kg

Kidney

Tetracycline

drug and its

ing species

300 µ g/kg

Liver

4-epimer

100 µ g/kg

Muscle

100 µ g/kg

Milk

200 µ g/kg

Eggs

1.2.6.2.

Sum of parent

All food produc- 600 µ g/kg

Kidney

Oxytetracycline

drug and its

ing species

300 µ g/kg

Liver

4-epimer

100 µ g/kg

Muscle

100 µ g/kg

Milk

200 µ g/kg

Eggs

1.2.6.3.

Sum of parent

All food produc- 600 µ g/kg

Kidney

Chlortetracycline drug and its

ing species

300 µ g/kg

Liver

4-epimer

100 µ g/kg

Muscle

100 µ g/kg

Milk

200 µ g/kg

Eggs

2. Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.1.

Avermectins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.1.1.1.

22, 23-Dihydro- Bovine

100 µ g/kg

Liver

Ivermectin

avermectin B 1a

40 µ g/kg

Fat

Porcine, ovine,

15 µ g/kg

Liver

equidae

20 µ g/kg

Fat

2.1.1.2.

Avermectin B 1a Bovine

20 µ g/kg

Liver

Abamectin

10 µ g/kg

Fat

2.1.1.3.

Doramectin

Bovine

15 µ g/kg

Liver

Doramectin

25 µ g/kg

Fat

2.1.2.

Salicylanilides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.1.2.1.

Closantel

Bovine

1000 µ g/kg

Muscle, liver

Closantel

3000 µ g/kg

Kidney, fat

Ovine

1500 µ g/kg

Muscle, liver

5000 µ g/kg

Kidney

2000 µ g/kg

Fat

2.1.3.

Tetra-hydro-imidazoles (imidazolthiazoles)

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.1.2.1.

Levamisole

Bovine, ovine,

10 µ g/kg

Muscle, kidney,

Levamisole

porcine, poultry

fat

100 µ g/kg

Liver

2.2.

Agents acting against ectoparasites

2.2.1.

Organophosphates

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.1.1.

Diazinon

Bovine, ovine

700 µ g/kg

Fat

Diazinon

20 µ g/kg

Kidney, liver,

muscle

Bovine, ovine,

20 µ g/kg

Milk

caprine

2.2.2.

Formamidines

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.2.1.

Sum of amitraz

Porcine

400 µ g/kg

Fat and skin

Amitraz

and all metabo-

200 µ g/kg

Kidney, liver

lites containing

the 2,4-DMA

moeity,

expressed as

amitraz

3. Agents acting on the nervous system

3.1.

Agents acting on the autonomic nervous system

3.1.1.

Anti-adrenergics

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

3.1.1.1.

Carazolol

Porcine

25 µ g/kg

Liver, kidney

Carazolol

5 µ g/kg

Muscle, fat and

skin

(1)

In these regulations, unless the context otherwise -

"Director" means the Director for Veterinary Services;

"m axim um r esid ue lim it" or "MRL " m eans t he m axim um

concentration of residue resulting from the use of a veterinary

medicinal product (expressed in mg/Kg or u/Kg on a fresh weight

basis) which may be legally permitted or recognised as acceptable

in food. This limit is either based on the type and amount of residue

considered to be without any toxicological hazard for human health

as expressed by the acceptable daily intake (ADI), or on the basis

of a temporary ADI that utilises an additional safety factor. In order

to assess this limit one also takes into account other relevant public

health risks as well as food technology aspects. When establishing

a maximum residue limit consideration is also given to residues

that are found in food of plant origin and/or come from the

en v ir o n m ent . Fu r th er m o r e, th e MR L m ay b e r ed u ced to b e

consistent with good practices in the use of veterinary drugs and to

the extent that practical analytical methods are available;

"residues of veterinary medicinal products" means all

pharmacologically active substances, whether active principals,

excipients or degradation products, and their metabolites which

remain in foodstuffs made from animals to which the veterinary

medicinal product in question has been administered.

(2) These regulations shall not apply to active principles of

biological origin intended to produce active or passive immunity or

to diagnose a state of immunity used in immunological veterinary

medicinal products.

(Regulation 4)

List of substances not subject to maximum residue limits

1. Inorganic chemicals

Pharmacologically active substance(s)

Animal species

1.1. Hydrogen peroxide

All food producing species

1.2. Sulphur

Bovine, porcine, ovine, caprine, equidae

1.3. Iodine and iodine inorganic

All food producing species

compounds including

- Sodium and potassium-iodide

- Sodium and potassium-iodate

- Iodophors including Polyvinyl-

pyrrolidone-iodine

1.4. Sodium chlorite

Bovine (for topical use only)

1.5.

Calcium acetate

All food producing species

Calcium benzoate

Calcium carbonate

Calcium chloride

Calcium gluconate

Calcium hydroxide

Calcium hypophosphite

Calcium malate

Calcium oxide

Calcium phosphate

Calcium polyphosphates

Calcium propionate

Calcium silicate

Calcium stearate

Calcium sulphate

1.6.

Hydrochloric acid

All food producing species (for use as

excipient)

1.7. Sodium dichloroisocyanurate

Bovine, ovine, caprine (for topical use only)

1.8. Boric acid and borates

All food producing species

1.9. Magnesium

All food producing species

1.10. Magnesium sulphate

All food producing species

1.11. Magnesium hydroxide

All food producing species

1.12. Magnesium stearate

All food producing species

1.13. Magnesium glutamate

All food producing species

1.14. Magnesium orotate

All food producing species

1.15. Magnesium aluminium silicate

All food producing species

1.16. Magnesium oxide

All food producing species

1.17. Magnesium carbonate

All food producing species

1.18. Magnesium phosphate

All food producing species

1.19. Magnesium glycerophosphate

All food producing species

1.20. Magnesium aspartate

All food producing species

1.21. Magnesium citrate

All food producing species

1.22. Magnesium acetate

All food producing species

1.23. Magnesium trisilicate

All food producing species

2. Organic Compounds

Pharmacologically active substance(s)

Animal species

2.1. Etiproston tromethamine

Bovine, porcine

2.2. Ketanserin tartrate

Equidae

2.3. Fertireline acetate

Bovine

2.4. Human

menopausal

urinary

Bovine

gonadotrophin

2.5. Lactic acid

All food producing species

2.6. Melatonin

Ovine, caprine

2.7. Iodine organic compounds

All food producing species

- Iodoform

2.8. Acetyl cysteine

All food producing species

2.9. Gonadotrophin releasing hormone

All food producing species

2.10. Pregnant

Mare

Serum

All food producing species

Gonadotrophine

2.11. 17ß-Oestradiol

All food producing mammals (for

therapeutic and zootechnical uses only)

2.12. Romifidine

Equidae (for therapeutic uses only)

2.13. Detomidine

Bovine, Equidae (for therapeutic uses only)

2.14. Brotizolam

Bovine, (for therapeutic uses only)

2.15. Human chorion

gonadotrophin

All food producing species

(HCG)

2.16. Oxytocin

All food producing mammals

2.17. Lecirelin

Bovine, equidae, rabbit

2.18. Dinoprost tromethamine

All mammalian species

2.19. Malic acid

A l l fo o d p ro d u c i n g s p e c ie s ( fo r u s e a s

excipient)

2.20. L-tartaric acid and its mono-and

A l l fo o d p ro d u c i n g s p e c ie s ( fo r u s e a s

dibasic salt of sodium, potassium excipient)

and calcium

2.21. Benzylalcohol

A l l fo o d p ro d u c i n g s p e c ie s ( fo r u s e a s

excipient)

2.22. Ethanol

A l l fo o d p ro d u c i n g s p e c ie s ( fo r u s e a s

excipient)

2.23. N-butanol

A l l fo o d p ro d u c i n g s p e c ie s ( fo r u s e a s

excipient)

2.24. Mineral hydrocarbons, low to high

All food producing species (excludes

viscosity including microcristalline aromatic and unsaturated compounds)

w ax es, a pp ro xim ately C1 0-C6 0 ;

aliphatic, branched aliphatic and

alicyclic compounds

2.25. Buserelin

All food producing species

2.26. Ketoprofen

Bovine, equidae

2.27. Caffeine

All food producing species

2.28. Theophylline

All food producing species

2.29. Theobromine

All food producing species

2.30. Ketoprofen

Porcine

2.31. Propane

All food producing species

2.32. e-butane

All food producing species

2.33. Isobutane

All food producing species

2.34. Polysulphated glycosaminoglycan

Equidae

2.35. Rifaximin

Bovine (for intramammary use - except if

the ud der ma y be use d as fo od fo r hu man

consumption - and intrauterine use only)

2.36. Tau fluvalinate

Honey bees

2.37. Phenol

All food producing species

2.38. Papaverine

Bovine (newborn calves)

2.39. Policresuline

All food producing species (for topical use

only)

2.40. Papain

All food producing species

2.41. Dimethyl phtalate

All food producing species

2.42. Diethyl phtalate

All food producing species

2.43. Ethyl lactate

All food producing species

2.44. Heptaminol

All food producing species

2.45. Menthol

All food producing species

2.46. Phloroglucinol

All food producing species

2.47. Trimethylphloroglucinol

All food producing species

2.48. Peracetic acid

All food producing species

2.49. Carbetocin

All mammalian food producing species

2.50. Quillaia sapocin

All food producing species

2.51. Butyl 4-hydroxybenzoate

All food producing species

2.52. Sodium butyl 4-hydroxybenzoate

All food producing species

2.53. Sodium benzyl 4-hydroxybenzoate

All food producing species

2.54. Cetrimide

All food producing species

2.55. Lobeline

All food producing species

2.56. Pancreatin

All mammalian food producing species (for

topical use only)

2.57. Chlorocresol

All food producing species

2.58. Thymol

All food producing species

2.59. Dembrexine

Equidae

2.60. Diclazuril

Ovine (for oral use in lambs only)

2.61. Etamiphylline camsylate

All food producing species

3. Substances generally recognized as safe

Pharmacologically active substance(s)

Animal species

3.1. Absinthium extract

All food producing species

3.2. Acetylmethionine

All food producing species

3.3. Aluminium hydroxide

All food producing species

3.4. Aluminium monostearate

All food producing species

3.5. Ammonium sulfate

All food producing species

3.6. Benzoyl benzoate

All food producing species

3.7. Benzyl p-hydroxybenzoate

All food producing species

3.8. Calcium borogluconate

All food producing species

3.9. Calcium citrate

All food producing species

3.10. Camphor

All food producing species (external use

only)

3.11. Cardamon extract

All food producing species

3.12. Diethyl sebacate

All food producing species

3.13. Dimethicone

All food producing species

3.14. Dimethyl acetamide

All food producing species

3.15. Dimethyl sulphoxide

All food producing species

3.16. Ethylenediaminetetraacetic

acid

All food producing species

and salts

3.17. Eucalyptol

All food producing species

3.18. Epinephrine

All food producing species

3.19. Ethyl oleate

All food producing species

3.20. Formaldehyde

All food producing species

3.21. Formic acid

All food producing species

3.22. Follicle

stimulating

hormone

All food producing species

(natural FSH from all species and

their synthetic analogues)

3.23. Glutaraldehyde

All food producing species

3.24. Guaiacol

All food producing species

3.25. Heparin and its salts

All food producing species

3.26. Human chorionic gonadotropin

All food producing species

(natural HCG and its synthetic

analogues)

3.27. Iron ammonium citrate

All food producing species

3.28. Iron dextran

All food producing species

3.29. Iron glucoheptonate

All food producing species

3.30. Isopropanol

All food producing species

3.31. Lanolin

All food producing species

3.32. Luteinizing hormone (natural LH

All food producing species

from all species and their synthetic

analogues)

3.33. Magnesium chloride

All food producing species

3.34. Magnesium gluconate

All food producing species

3.35. Magnesium hypophosphite

All food producing species

3.36. Mannitol

All food producing species

3.37. Montanide

All food producing species

3.38. Methylbenzoate

All food producing species

3.39. Monothioglycerol

All food producing species

3.40. Myglyol

All food producing species

3.41. Orgotein

All food producing species

3.42. Poloxalene

All food producing species

3.43. Poloxamer

All food producing species

3.44. Polyethylene glycol 200

All food producing species

3.45. Polyethylene glycol 400

All food producing species

3.46. Polyethylene glycol 600

All food producing species

3.47. Polyethylene glycol 3500

All food producing species

3.48. Polysorbate 80

All food producing species

3.49. Serotonin

All food producing species

3.50. Sodium chloride

All food producing species

3.51. Sodium cromoglycate

All food producing species

3.52. Sodium dioctylsulphosuccinate

All food producing species

3.53. Sodium formaldehydesulphoxylate

All food producing species

3.54. Sodium lauryl sulphate

All food producing species

3.55. Sodium pyrosulphite

All food producing species

3.56. Sodium stearate

All food producing species

3.57. Sodium thiosulphate

All food producing species

3.58. Tragacanth

All food producing species

3.59. Urea

All food producing species

3.60. Zinc sulphate

All food producing species

3.61. Zinc oxide

All food producing species

3.62. Polyethylene glycols (molecular

All food producing species

weight ranging from 200 to 10000)

4. Substances used in homeopathic veterinary medicinal products

Pharmacologically active substance(s)

Animal species

4.1. All

substances

used

in

All food producing species

homeopathic veterinary medicinal products

provided that their concentration in the

product does not exceed one part per ten

thousand

5.1.

Substances used as food additives in foodstuffs for human consumption

Pharmacologically active substance(s)

Animal species

5.1. Substances with an E number

All food producing species (only substances

approved as additives in foodstuffs for human

consumption).

The list of pharmacologically active substances used in

veterinary medicinal products in respect of which maximum

residue limits have been established shall be contained in the First

Schedule.

(Regulation 5)

List of pharmacologically active substances used in veterinary medicinal products for which

provisional maximum residue limits have been fixed

1. Anti-infectious agents

1.1. Chemotherapeutics

1.1.1. Diamino pyrimidine derivates

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.1.1.1.

Trimethoprim

All food produc- 50 µ g/kg

Muscle, liver

Trimethoprim

ing species

kidney, fat, milk

1.1.2. Benzenesulphonamides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.1.2.1.

Clorsulon

Bovine

50 µ g/kg

Muscle

Clorsulon

150 µ g/kg

Liver

400 µ g/kg

Kidney

1.1.2.2.

Baquiloprim

Bovine

300 µ g/kg

Liver

Baquiloprim

150 µ g/kg

Kidney

10 µ g/kg

Fat

30 µ g/kg

Milk

Porcine

50 µ g/kg

Liver, kidney

40 µ g/kg

Fat and skin

1.2. Antibiotics

1.2.2. Macrolides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.2.1.

Spiramycin

Porcine

600 µ g/kg

Liver

Spiramycin

300 µ g/kg

Kidney, muscle

200 µ g/kg

Fat

1.2.2.2.

Tylosin

Bovine, porcine, 100 µ g/kg

Muscle, liver

Tylosin

poultry

kidney

Bovine

50 µ g/kg

Milk

1.2.2.3.

Erythromycin

Bovine, ovine,

400 µ g/kg

Liver, kidney,

Erythromycin

porcine, poultry

muscle, fat

Bovine, ovine

40 µ g/kg

Milk

Poultry

200 µ g/kg

Eggs

1.2.2.4.

Josamycin

Chicken

400 µ g/kg

Kidney

Josamycin

200 µ g/kg

Liver, muscle, fat

200 µ g/kg

Eggs

1.2.3. Thiamphenicol and related compounds

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.3.1.

Thiamphenicol

Bovine, poultry

40 µ g/kg

Muscle, liver

Thiamphenicol

kidney, fat

1.2.4. Cephalosporins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.4.1.

Sum of all resi- Bovine

2000 µ g/kg

Kidney, liver

Ceftiofur

dues retaining

200 µ g/kg

Muscle

the betalactam

600 µ g/kg

Fat

structure

100 µ g/kg

Milk

expressed as des-

furoylceftiofur

Porcine

4000 µ g/kg

Kidney

3000 µ g/kg

Liver

500 µ g/kg

Muscle

600 µ g/kg

Fat

1.2.5. Aminoglycosides

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.5.1.

Spectinomycin

Bovine, porcine, 5000 µ g/kg

Kidney

Spectinomycin

poultry

2000 µ g/kg

Liver

300 µ g/kg

Muscle

500 µ g/kg

Fat

Bovine

200 µ g/kg

Milk

1.2.5.2.

Spectinomycin

Bovine, ovine,

1000 µ g/kg

Kidney

Streptomycin

porcine, poultry 500 µ g/kg

Muscle, liver, fat

Bovine, ovine

200 µ g/kg

Milk

1.2.5.3.

Dihydrostrepto-

Bovine, ovine,

1000 µ g/kg

Kidney

Dihydrostreptomy- mycin

porcine, poultry 500 µ g/kg

Muscle, liver, fat

cin

Bovine, ovine

200 µ g/kg

Milk

1.2.5.4.

Gentamicin

Bovine, porcine

1000 µ g/kg

Kidney

Gentamicin

200 µ g/kg

Liver

100 µ g/kg

Muscle, fat

Bovine

100 µ g/kg

Milk

1.2.5.5.

Neomycin

Bovine, ovine,

5000 µ g/kg

Kidney

Neomycin

caprine, porcine, 500 µ g/kg

Muscle, liver, fat

(including framyc-

chicken, turkey,

etin)

duck

Bovine, ovine,

500 µ g/kg

Milk

caprine

Chicken

500 µ g/kg

Eggs

1.2.5.6.

Aminosidine

Bovine, porcine, 1500 µ g/kg

Liver, kidney

Aminosidine

rabbits, chicken 500 µ g/kg

Muscle

1.2.6. Quinolones

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.6.1.

Danofloxacin

Bovine

900 µ g/kg

Liver

Danofloxacin

500 µ g/kg

Kidney

300 µ g/kg

Muscle

200 µ g/kg

Fat

Chicken

1200 µ g/kg

Liver, kidney

600 µ g/kg

Skin and fat

300 µ g/kg

Muscle

1.2.6.2.

Decoquinate

Bovine, ovine

500 µ g/kg

Muscle, liver

Decoquinate

Kidney, fat

1.2.6.3.

Marbofloxacin

Bovine

150 µ g/kg

Muscle, liver,

Marbofloxacin

kidney

75 µ g/kg

Milk

50 µ g/kg

Fat

Porcine

150 µ g/kg

Muscle, liver,

kidney

50 µ g/kg

Fat and skin

1.2.7. Naphtalene-ringed ansamycin

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.7.1.

Rifaximin

Bovine

600 µ g/kg

Milk

Rifaximin

1.2.8. Polymyxins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.8.1.

Colistin

Bovine, ovine,

200 µ g/kg

Kidney

Colistin

porcine, chicken,

150 µ g/kg

Liver, muscle, fat

rabbits

Bovine, ovine

50 µ g/kg

Milk

Chicken

300 µ g/kg

Eggs

1.2.9. Penicillins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

1.2.9.1.

Benzylpenicillin Ovine

50 µ g/kg

Liver, kidney,

Penethamate

muscle, fat

4 µ g/kg

Milk

Porcine

50 µ g/kg

Liver, kidney,

muscle, fat

2. Antiparasitic agents

2.1. Agents acting against endo-parasites

2.1.1. Benzimidazoles and pro-benzimidazoles

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.1.1.1.

Combined resi- All food produc- 1000 µ g/kg

Liver

Febantel

dues of oxfenda- ing species

10 µ g/kg

Muscle, kidney,

zole, oxfendazole

fat

sulfone and fen-

10 µ g/kg

Milk

bendazole

Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole

2.1.1.2.

Combined resi- All food produc- 1000 µ g/kg

Liver

Fenbendazole

dues of oxfenda- ing species

10 µ g/kg

Muscle, kidney,

zole, oxfendazole

fat

sulfone and fen-

10 µ g/kg

Milk

bendazole

Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole

2.1.1.3.

Combined resi- All food produc- 1000 µ g/kg

Liver

Oxfendazole

dues of oxfenda- ing species

10 µ g/kg

Muscle, kidney,

zole, oxfendazole

fat

sulfone and fen-

10 µ g/kg

Milk

bendazole

Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole

2.1.1.4.

Sum of albenda- Bovine, Ovine

100 µ g/kg

Muscle, fat, milk

Albendazole

zole and metabo-

500 µ g/kg

Kidney

lites which are

1000 µ g/kg

Liver

measured as

2-amino-benzim-

idazole sulphone

2.1.1.5.

Sum of thiaben- Bovine, ovine,

100 µ g/kg

Muscle, liver

Thiabendazole

dazole and

caprine

kidney, fat, milk

5-hydroxythia-

bendazole

2.1.1.6.

Sum of extracta- Bovine, ovine

150 µ g/kg

Muscle, liver,

Triclabendazole

ble residues that

kidney,

may be oxidized

50 µ g/kg

Fat

to ketatriclaben-

dazole

2.1.1.7.

Flubendazole

Poultry, game

500 µ g/kg

Liver

Flubendazole

birds

200 µ g/kg

Muscle

400 µ g/kg

Eggs

Porcine

10 µ g/kg

Muscle, liver

kidney, fat

2.1.1.8.

Oxibendazole

Bovine, ovine,

100 µ g/kg

Muscle, liver

Oxibendazole

porcine, equidae

kidney, fat

Bovine, ovine

50 µ g/kg

Milk

2.1.1.9.

Sum of neto-

Bovine, ovine,

1000 µ g/kg

Liver

Netobimin

bimin and alben- caprine

500 µ g/kg

Kidney

dazole and

100 µ g/kg

Muscle, fat

metabolites of

100 µ g/kg

Milk

albendazole

measured as

2-amino-benzimi-

dazole sulphone

2.2. Agents acting against ectoparasites

2.2.1. Formamidines

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.1.1.

Sum of amitraz Bovine

200 µ g/kg

Kidney, liver, fat

Amitraz

and metabolites

10 µ g/kg

Milk

which are meas-

ured as 2,4-

dimethylaniline

Ovine

400 µ g/kg

Fat

200 µ g/kg

Kidney, liver

2.2.2. Organophosphates

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.2.1.

Azamethiphos

Salmonidae

100 µ g/kg

Muscle and skin

Azamethiphos

in natural propor-

tions

2.2.3. Iminophenyl thiazolidine derivative

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.3.1.

Cymiazole

Bees

1000 µ g/kg

Honey

Cymiazole

2.3. Agents acting against endo- and ectoparasites

2 3.1. Avermectins

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.3.1.1.

Moxidectin

Bovine, ovine

200 µ g/kg

Fat

Moxidectin

20 µ g/kg

Kidney, liver

3. Agents acting on the nervous system

3.1. Agents acting on the central nervous system

3.1.1. Butyrophenone tranquillizers

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

3.1.1.1.

Azaperol

All food produc- 100 µ g/kg

Kidney

Azaperone

ing species

50 µ g/kg

Liver, muscle, fat

3.2. Agents acting on the automatic nervous system

3.2.1. ß 2 sympathomimetic agents

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

3.2.1.1.

Clenbuterol

Bovine

0,5 µ g/kg

Liver, kidney

Clenbuterol

(Indication

0,1 µ g/kg

Muscle

hydrochloride

solely for tocoly- 0,05 µ g/kg

Milk

sis in parturient

cows)

Equidae

0,5 µ g/kg

Liver, kidney

(Indications

0,1 µ g/kg

Muscle

tocolysis and the

treatment of res-

piratory ail-

ments)

4. Corticoids

4.1.

Glucocorticoids

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

4.1.1.

Dexamethasone

Bovine, porcine, 2.5 µ g/kg

Liver

Dexamethasone

equidae

0,5 µ g/kg

Muscle, kidney

Bovine

0,3 µ g/kg

Milk

5. Anti-inflammatory agents

5.1. Nonsteroidal anti-inflammatory agents

5.1.1. Arylpropionic acid derivative

Pharmacologically

active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

5.1.1.1.

Vedaprofen

Equidae

100 µ g/kg

Liver

Vedaprofen

1000 µ g/kg

Kidney

50 µ g/kg

Muscle

5.1.1.2.

Carprofen

Bovine

1000 µ g/kg

Liver, kidney

Carprofen

500 µ g/kg

Muscle, fat

Equidae

1000 µ g/kg

Liver, kidney

50 µ g/kg

Muscle

100 µ g/kg

Fat

Where, following an evaluation of a pharmacologically

active substance used in veterinary medicinal products, it appears

that it is not necessary for the protection of public health to

establish a maximum residue limit, that substance shall be included

in a list in the Second Schedule.

(Regulation 6)

List of pharmacologically active substances for which no maximum levels can be

fixed

1. Nitrofurans, except furazolidone

2. Ronidazole

3. Dapsone

4. Chloramphenicol

5. Furazolidone

6. Dimetridazole

7. Colchicine

8. Avoparcin

The list of pharmacologically active substances used in

veterinary medicinal products in respect of which provisional

maximum residue limits have been established shall be contained in

the Third Schedule.

MAXIMUM RESIDUE LIMITS IN

VETERINARY MEDICINAL PRODUCTS

(Regulation 8)

Information and particulars to be included in an application for the establishment of

a maximum residue limit for a pharmacologically active substance used in veterinary

medicinal products

Administrative particulars

Name or corporate name and permanent address of the applicant.

Name of the veterinary medicinal product.

Qualitative and quantitative composition in terms of active principles, with

mention of the international non-proprietary name recommended by the World

Health Organisation (WHO), where such name exits.

Manufacturing authorization, if any.

Marketing authorizations, if any.

Summary of the characteristics of the veterinary medicinal product(s).

Safety documentation

A.0 Expert report

A.1) Precise identification of the substance concerned by the application

1.1)

International non-proprietary name.

1.2)

International Union of Pure and Applied Chemistry (IUPAC) name.

1.3)

Chemical Abstract Service (CAS) name.

1.4)

Classification

-

therapeutic

-

pharmacological.

MAXIMUM RESIDUE LIMITS IN

VETERINARY MEDICINAL PRODUCTS

1.5)

Synonyms and abbreviations.

1.6)

Structural formula.

1.7)

Molecular formula.

1.8)

Molecular weight.

1.9)

Degree of impurity.

1.10) Qualitative and quantitative composition of impurities.

1.11) Description of physical properties

-

fusion point

-

boiling point

-

vapour pressure

-

solubility in water and organic solvents expressed in g/l, with

indication of temperature

-

density

-

refractive index, rotation, etc.

A.2) Relevant pharmacological studies

2.1) Pharmacodynamics.

2.2) Pharmacokinetics.

A.3) Toxicological studies

3.1) Single dose toxicity.

3.2) Repeated dose toxicity.

3.3) Tolerance in the target species of animal.

3.4) Reproductive toxicity, including teratogenicity.

3.4.1) Study of the effects on reproduction.

3.4.2) Embryotoxicity/fetotoxicity, including teratogenicity.

3.5) Mutagenicity.

3.6) Caricinogenicity.

A.4) Studies of other effects

4.1) Immunotoxicity.

4.2) Microbiological properties of residues.

4.2.1)

on the human gut flora;

4.2.2)

on the organisms and micro-organisms used for industrial food

processing.

4.3) Observations in humans.

B)

Residue documentation

B.0) Expert report

B.1) Precise identification of the substance concerned by the application

The substance concerned should be identified in accordance with item A.1.

However, where the application relates to one or more veterinary medicinal

products, the product itself should be identified in detail, including

-

qualitative and quantitative composition;

-

purity;

-

identification of the manufacturer’s batch used in the studies;

-

relationship of the final product;

-

specific activity and radio-purity of labelled substances;

-

position of labelled atoms on the molecule.

B.2) Residue studies

2.1) Pharmacokinetics

(absorption, distribution, biotransformation, excretion).

2.2) Depletion of residues.

2.3) Elaboration of maximum residue limits (MRLs).

B.3) Routine analytical method for the detection of residues

3.1) Description of the method.

3.2) Validation of the method.

3.2.1)

specificity;

3.2.2)

accuracy, including sensitivity;

3.2.3)

precision;

3.2.4)

limit of detection;

3.2.5)

limit of quantitation;

3.2.6)

practicability and applicability under normal laboratory conditions;

3.2.7)

susceptibility to interference.

(1) Where it appears that a maximum residue limit cannot

be established in respect of a pharmacologically active substance

used in veterinary medicinal products because residues of the

substances concerned, at whatever limit, in foodstuffs of animal

origin constitute a hazard to the health of the consumer, that

substance shall be included in a list in the Fourth Schedule.

(2) The administration of the substances listed in the Fourth

Schedule to food-producing animals shall be prohibited.

(1) In establishing maximum residue limits for residues of

veterinary medicinal products used in foodstuffs of animal origin, it

is necessary to specify the animal species in which such residues

may be present, the levels which may be present in each of the

relevant meat tissues obtained from the treated animal (target

tissue), and the nature of the residue which is relevant for the

monitoring of residues (marker residue).

(2) In order to control for residues, maximum residue limits

shall be established for the target tissue of liver or kidney; however,

since liver and kidney are frequently removed from the carcasses

marketed in the international trade, maximum residue limits should

therefore also always be established for muscle or fat tissues.

(3) In the case of veterinary medicinal products intended to be

used for laying birds, lactating animals or honey bees, maximum

residue limits shall also be established for eggs, milk, or honey.

(1) A new pharmacologically active substance, intended to

be used in veterinary medicinal products administered to food

producing animals, may only be included in the First, Second and

Third Schedules if the person responsible for marketing submits a

relative application to the Director. Such application shall contain

the information and particulars referred to in the Fifth Schedule.

(2) The Director may, after assessing new information or after

reassessing existing information, amend any provision contained in

the First, Second, Third and Fourth Schedules if it is necessary for

the protection of human or animal health.

(3) The Director may not prohibit or impede the trade of

foodstuffs of animal origin and originating in other countries on the

ground that they contain residues of veterinary medicinal products

if the quantity of residue does not exceed the maximum residue

limit found in the First Schedule or in the Third Schedule, or if the

substance concerned is listed in the Second Schedule.

The administration to food-producing animals of

veterinary medicinal products containing pharmacologically active

substances which are not mentioned in the First, Second or Third

Schedules shall be prohibited, except in the case of clinical trials

accepted by the competent authorities and provided that foodstuffs

obtained from livestock used in such trials do not contain residues

which constitute a hazard to human health.

Nothing in these regulations shall operate against the

provisions of the Residues in Meat Regulations, prohibiting the

use, in livestock farming, of certain substances which have a

hormonal action.