MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 1
SUBSIDIARY LEGISLATION 231.34
MAXIMUM RESIDUE LIMITS IN VETERINARY 
MEDICINAL PRODUCTS REGULATIONS
1st October, 1998
Legal Notice 162 of 1998.
Title.
in Veterinary Medicinal Products Regulations.
Interpretation.
"Director" means the Director for Veterinary Services;
"maximum residue limit" or "MRL" means the maximum
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
environment. Furthermore, the MRL may be reduced to be
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.
Substances subject 
to MRL.
3. 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.
Substances not 
subject to MRL.
4. 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.
Substances subject 
to a provisional 
MRL.
5. 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.
2 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
Substances where 
MRL cannot be 
fixed.
6. (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.
How to establish 
MRL.
7. (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.
Listing of 
products.
8. (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.
Food-producing 
animals.
9. 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.
Saving.
S.L.231.32
10. 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
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 3
hormonal action.
4 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
FIRST SCHEDULE
(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
1.2.  Antibiotics
1.2.1. Penicillins
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
All substances 
belonging to the 
sulfonamide group
Parent drug All food produc-
ing species
100 µg/kg Muscle, liver, 
kidney, fat
Bovine, Ovine, 
Caprine
100 µg/kg Milk
Other provisions: The combined total residues of all substances within the sulfonamide group 
should not exceed 100 µg/kg
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.1.1.
Benzylpenicillin
Benzylpenicillin All food produc-
ing species
50 µg/kg Muscle, liver, 
kidney, fat
4 µg/kg Milk
1.2.1.2.
Ampicillin
Ampicillin All food produc-
ing species
50 µg/kg Muscle, liver, 
kidney, fat
4 µg/kg Milk
1.2.1.3.
Amoxicillin
Amoxicillin All food produc-
ing species
50 µg/kg Muscle, liver, 
kidney, fat
4 µg/kg Milk
1.2.1.4.
Oxacillin
Oxacillin All food produc-
ing species
300 µg/kg Muscle, liver, 
kidney, fat
30 µg/kg Milk
1.2.1.5.
Cloxacillin
Cloxacillin All food produc-
ing species
300 µg/kg Muscle, liver, 
kidney, fat
30 µg/kg Milk
1.2.1.6.
Dicloxacillin
Dicloxacillin All food produc-
ing species
300 µg/kg Muscle, liver, 
kidney, fat
30 µg/kg Milk
1.2.1.7.
Penethamate
Benzylpenicillin Bovine 50 µg/kg Muscle, liver, 
kidney, fat
4 µg/kg Milk
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 5
1.2.2.  Cephalosporins
1.2.3. Quinolones
1.2.4. Macrolides
1.2.5. Florfenicol and related compounds
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.2.1.
Cefquinome
Cefquinome Bovine 200 µg/kg
100 µg/kg
50 µg/kg
50 µg/kg
20 µg/kg
Kidney
Liver
Muscle
Fat
Milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.3.1.
Enrofloxacin
Sum of 
enrofloxacin and 
ciprofloxacin
Bovine, porcine, 
poultry
30 µg/kg Muscle, liver 
kidney
1.2.3.2.
Sarafloxacin
Sarafloxacin Chicken 100 µg/kg
10 µg/kg
Liver
Skin and fat
1.2.3.3.
Difloxacin
Difloxacin Chicken, turkey 200 µg/kg
150 µg/kg
50 µg/kg
200 µg/kg
Liver
Kidney
Muscle
Skin and fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.4.1.
Tilmicosin
Tilmicosin Bovine, ovine, 
porcine
1000 µg/kg
50 µg/kg
Liver, kidney 
Muscle, fat
Ovine 50 µg/kg Milk
1.2.4.2.
Spiramycin
Sum of 
spiramycin and 
neospiramycin
Bovine 300 µg/kg
200 µg/kg
200 µg/kg
Liver, kidney, fat 
Muscle
Milk
Chicken 400 µg/kg
300 µg/kg
200 µg/kg
Liver
Skin and fat
Muscle
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.5.1.
Florfenicol
Sum of 
Florfenicol and 
its metabolites 
measured as 
Florfenicol-
amine
Bovine 200 µg/kg
300 µg/kg
3000 µg/kg
Muscle
Kidney
Liver
6 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
1.2.6. Tetracyclines
2. Antiparasitic agents
2.1. Agents acting against endoparasites
2.1.1. Avermectins
2.1.2. Salicylanilides
2.1.3. Tetra-hydro-imidazoles (imidazolthiazoles)
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.6.1.
Tetracycline
Sum of parent 
drug and its 
4-epimer
All food produc-
ing species
600 µg/kg
300 µg/kg
100 µg/kg
100 µg/kg
200 µg/kg
Kidney
Liver
Muscle
Milk
Eggs
1.2.6.2.
Oxytetracycline
Sum of parent 
drug and its 
4-epimer
All food produc-
ing species
600 µg/kg
300 µg/kg
100 µg/kg
100 µg/kg
200 µg/kg
Kidney
Liver
Muscle
Milk
Eggs
1.2.6.3.
Chlortetracycline
Sum of parent 
drug and its 
4-epimer
All food produc-
ing species
600 µg/kg
300 µg/kg
100 µg/kg
100 µg/kg
200 µg/kg
Kidney
Liver
Muscle
Milk
Eggs
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.1.1.1.
Ivermectin
22, 23-Dihydro- 
avermectin B 1a
Bovine 100 µg/kg
40 µg/kg
Liver
Fat
Porcine, ovine, 
equidae
15 µg/kg
20 µg/kg
Liver
Fat
2.1.1.2.
Abamectin
Avermectin B 1a Bovine 20 µg/kg
10 µg/kg
Liver
Fat
2.1.1.3.
Doramectin
Doramectin Bovine 15 µg/kg
25 µg/kg
Liver
Fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.1.2.1.
Closantel
Closantel Bovine 1000 µg/kg
3000 µg/kg
Muscle, liver
Kidney, fat
Ovine 1500 µg/kg
5000 µg/kg
2000 µg/kg
Muscle, liver
Kidney
Fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.1.2.1.
Levamisole
Levamisole Bovine, ovine, 
porcine, poultry
10 µg/kg
100 µg/kg
Muscle, kidney, 
fat
Liver
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 7
2.2. Agents acting against ectoparasites
2.2.1. Organophosphates
2.2.2. Formamidines
3. Agents acting on the nervous system
3.1. Agents acting on the autonomic nervous system
3.1.1. Anti-adrenergics
SECOND SCHEDULE
(Regulation 4)
List of substances not subject to maximum residue limits
1. Inorganic chemicals
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.2.1.1.
Diazinon
Diazinon Bovine, ovine 700 µg/kg
20 µg/kg
Fat
Kidney, liver, 
muscle
Bovine, ovine, 
caprine
20 µg/kg Milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.2.2.1.
Amitraz
Sum of amitraz 
and all metabo-
lites containing 
the 2,4-DMA 
moeity, 
expressed as
amitraz
Porcine 400 µg/kg
200 µg/kg
Fat and skin
Kidney, liver
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
3.1.1.1.
Carazolol
Carazolol Porcine 25 µg/kg
5 µg/kg
Liver, kidney
Muscle, fat and 
skin
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
compounds including:
All food producing species
- Sodium and potassium-iodide
- Sodium and potassium-iodate
- Iodophors including Polyvinyl-
pyrrolidone-iodine
1.4. Sodium chlorite Bovine (for topical use only)
8 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
2. Organic Compounds
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
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
gonadotrophin
Bovine
2.5. Lactic acid All food producing species
2.6. Melatonin Ovine, caprine
2.7. Iodine organic compounds
- Iodoform
All food producing species
2.8. Acetyl cysteine All food producing species
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 9
2.9. Gonadotrophin releasing hormone All food producing species
2.10. Pregnant Mare Serum
Gonadotrophine
All food producing species
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
(HCG)
All food producing species
2.16. Oxytocin All food producing mammals
2.17. Lecirelin Bovine, equidae, rabbit
2.18. Dinoprost tromethamine All mammalian species
2.19. Malic acid All food producing species (for use as
excipient)
2.20. L-tartaric acid and its mono-and
dibasic salt of sodium, potassium
and calcium
All food producing species (for use as
excipient)
2.21. Benzylalcohol All food producing species (for use as
excipient)
2.22. Ethanol All food producing species (for use as
excipient)
2.23. N-butanol All food producing species (for use as
excipient)
2.24. Mineral hydrocarbons, low to high
viscosity including microcristalline
waxes, approximately C10-C60;
aliphatic, branched aliphatic and
alicyclic compounds
All food producing species (excludes
aromatic and unsaturated 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 udder may be used as food for human
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
10 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
3. Substances generally recognized as safe
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
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
and salts
All food producing species
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
(natural FSH from all species and
their synthetic analogues)
All food producing species
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 11
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
(natural HCG and its synthetic
analogues)
All food producing species
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
from all species and their synthetic
analogues)
All food producing species
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
weight ranging from 200 to 10000)
All food producing species
12 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
4. Substances used in homeopathic veterinary medicinal products
5.1. Substances used as food additives in foodstuffs for human consumption
THIRD 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
1.1.2. Benzenesulphonamides
1.2. Antibiotics
1.2.2. Macrolides
Pharmacologically active substance(s) Animal species
4.1. All substances used in
homeopathic veterinary medicinal products
provided that their concentration in the
product does not exceed one part per ten
thousand
All food producing species
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).
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.1.1.1.
Trimethoprim
Trimethoprim All food produc-
ing species
50 µg/kg Muscle, liver 
kidney, fat, milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.1.2.1.
Clorsulon
Clorsulon Bovine 50 µg/kg
150 µg/kg
400 µg/kg
Muscle
Liver
Kidney
1.1.2.2.
Baquiloprim
Baquiloprim Bovine 300 µg/kg
150 µg/kg
10 µg/kg
30 µg/kg
Liver
Kidney
Fat
Milk
Porcine 50 µg/kg
40 µg/kg
Liver, kidney
Fat and skin
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.2.1.
Spiramycin
Spiramycin Porcine 600 µg/kg
300 µg/kg
200 µg/kg
Liver
Kidney, muscle
Fat
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 13
1.2.3. Thiamphenicol and related compounds
1.2.4. Cephalosporins
1.2.5. Aminoglycosides
1.2.2.2.
Tylosin
Tylosin Bovine, porcine, 
poultry
100 µg/kg Muscle, liver 
kidney
Bovine 50 µg/kg Milk
1.2.2.3.
Erythromycin
Erythromycin Bovine, ovine, 
porcine, poultry
400 µg/kg Liver, kidney, 
muscle, fat
Bovine, ovine 40 µg/kg Milk
Poultry 200 µg/kg Eggs
1.2.2.4.
Josamycin
Josamycin Chicken 400 µg/kg
200 µg/kg
200 µg/kg
Kidney
Liver, muscle, fat
Eggs
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.3.1.
Thiamphenicol
Thiamphenicol Bovine, poultry 40 µg/kg Muscle, liver 
kidney, fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.4.1.
Ceftiofur
Sum of all resi-
dues retaining 
the betalactam 
structure 
expressed as des-
furoylceftiofur
Bovine 2000 µg/kg
200 µg/kg
600 µg/kg
100 µg/kg
Kidney, liver
Muscle
Fat
Milk
Porcine 4000 µg/kg
3000 µg/kg
500 µg/kg
600 µg/kg
Kidney
Liver
Muscle
Fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.5.1.
Spectinomycin
Spectinomycin Bovine, porcine, 
poultry
5000 µg/kg
2000 µg/kg
300 µg/kg
500 µg/kg
Kidney
Liver
Muscle
Fat
Bovine 200 µg/kg Milk
1.2.5.2.
Streptomycin
Spectinomycin Bovine, ovine, 
porcine, poultry
1000 µg/kg
500 µg/kg
Kidney
Muscle, liver, fat
Bovine, ovine 200 µg/kg Milk
1.2.5.3.
Dihydrostreptomy-
cin
Dihydrostrepto-
mycin
Bovine, ovine, 
porcine, poultry
1000 µg/kg
500 µg/kg
Kidney
Muscle, liver, fat
Bovine, ovine 200 µg/kg Milk
14 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
1.2.6. Quinolones
1.2.7. Naphtalene-ringed ansamycin
1.2.8. Polymyxins
1.2.5.4.
Gentamicin
Gentamicin Bovine, porcine 1000 µg/kg
200 µg/kg
100 µg/kg
Kidney
Liver
Muscle, fat
Bovine 100 µg/kg Milk
1.2.5.5.
Neomycin
(including framyc-
etin)
Neomycin Bovine, ovine, 
caprine, porcine, 
chicken, turkey, 
duck
5000 µg/kg
500 µg/kg
Kidney
Muscle, liver, fat
Bovine, ovine, 
caprine
500 µg/kg Milk
Chicken 500 µg/kg Eggs
1.2.5.6.
Aminosidine
Aminosidine Bovine, porcine, 
rabbits, chicken
1500 µg/kg
500 µg/kg
Liver, kidney
Muscle
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.6.1.
Danofloxacin
Danofloxacin Bovine 900 µg/kg
500 µg/kg
300 µg/kg
200 µg/kg
Liver
Kidney
Muscle
Fat
Chicken 1200 µg/kg
600 µg/kg
300 µg/kg
Liver, kidney
Skin and fat
Muscle
1.2.6.2.
Decoquinate
Decoquinate Bovine, ovine 500 µg/kg Muscle, liver
Kidney, fat
1.2.6.3.
Marbofloxacin
Marbofloxacin Bovine 150 µg/kg
75 µg/kg
50 µg/kg
Muscle, liver, 
kidney
Milk
Fat
Porcine 150 µg/kg
50 µg/kg
Muscle, liver, 
kidney
Fat and skin
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.7.1.
Rifaximin
Rifaximin Bovine 600 µg/kg Milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.8.1.
Colistin
Colistin Bovine, ovine, 
porcine, chicken, 
rabbits
200 µg/kg
150 µg/kg
Kidney
Liver, muscle, fat
Bovine, ovine 50 µg/kg Milk
Chicken 300 µg/kg Eggs
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 15
1.2.9. Penicillins
2. Antiparasitic agents
2.1. Agents acting against endo-parasites
2.1.1. Benzimidazoles and pro-benzimidazoles
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
1.2.9.1.
Penethamate
Benzylpenicillin Ovine 50 µg/kg
4 µg/kg
Liver, kidney, 
muscle, fat
Milk
Porcine 50 µg/kg Liver, kidney, 
muscle, fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.1.1.1.
Febantel
Combined resi-
dues of oxfenda-
zole, oxfendazole 
sulfone and fen-
bendazole
All food produc-
ing species
1000 µg/kg
10 µg/kg
10 µg/kg
Liver
Muscle, kidney, 
fat
Milk
Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole
2.1.1.2.
Fenbendazole
Combined resi-
dues of oxfenda-
zole, oxfendazole 
sulfone and fen-
bendazole
All food produc-
ing species
1000 µg/kg
10 µg/kg
10 µg/kg
Liver
Muscle, kidney, 
fat
Milk
Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole
2.1.1.3.
Oxfendazole
Combined resi-
dues of oxfenda-
zole, oxfendazole 
sulfone and fen-
bendazole
All food produc-
ing species
1000 µg/kg
10 µg/kg
10 µg/kg
Liver
Muscle, kidney, 
fat
Milk
Other provisions: The MRLs cover all residues of febantel, fenbendazole and oxfendazole
2.1.1.4.
Albendazole
Sum of albenda-
zole and metabo-
lites which are 
measured as 
2-amino-benzim-
idazole sulphone
Bovine, Ovine 100 µg/kg
500 µg/kg
1000 µg/kg
Muscle, fat, milk
Kidney
Liver
2.1.1.5.
Thiabendazole
Sum of thiaben-
dazole and 
5-hydroxythia-
bendazole
Bovine, ovine, 
caprine
100 µg/kg Muscle, liver 
kidney, fat, milk
2.1.1.6.
Triclabendazole
Sum of extracta-
ble residues that 
may be oxidized 
to ketatriclaben-
dazole
Bovine, ovine 150 µg/kg
50 µg/kg
Muscle, liver, 
kidney,
Fat
16 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
2.2. Agents acting against ectoparasites
2.2.1. Formamidines
2.2.2. Organophosphates
2.2.3. Iminophenyl thiazolidine derivative
2.3. Agents acting against endo- and ectoparasites
2 3.1. Avermectins
2.1.1.7.
Flubendazole
Flubendazole Poultry, game 
birds
500 µg/kg
200 µg/kg
400 µg/kg
Liver
Muscle
Eggs
Porcine 10 µg/kg Muscle, liver 
kidney, fat
2.1.1.8.
Oxibendazole
Oxibendazole Bovine, ovine, 
porcine, equidae
100 µg/kg Muscle, liver 
kidney, fat
Bovine, ovine 50 µg/kg Milk
2.1.1.9.
Netobimin
Sum of neto-
bimin and alben-
dazole and 
metabolites of 
albendazole 
measured as 
2-amino-benzim-
idazole sulphone
Bovine, ovine, 
caprine
1000 µg/kg
500 µg/kg
100 µg/kg
100 µg/kg
Liver
Kidney
Muscle, fat
Milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.2.1.1.
Amitraz
Sum of amitraz 
and metabolites 
which are meas-
ured as 2,4-
dimethylaniline
Bovine 200 µg/kg
10 µg/kg
Kidney, liver, fat
Milk
Ovine 400 µg/kg
200 µg/kg
Fat
Kidney, liver
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.2.2.1.
Azamethiphos
Azamethiphos Salmonidae 100 µg/kg Muscle and skin 
in natural propor-
tions
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.2.3.1.
Cymiazole
Cymiazole Bees 1000 µg/kg Honey
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
2.3.1.1.
Moxidectin
Moxidectin Bovine, ovine 200 µg/kg
20 µg/kg
Fat
Kidney, liver
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 17
3. Agents acting on the nervous system
3.1. Agents acting on the central nervous system
3.1.1. Butyrophenone tranquillizers
3.2. Agents acting on the automatic nervous system
3.2.1. ß 2 sympathomimetic agents
4. Corticoids
4.1. Glucocorticoids
5. Anti-inflammatory agents
5.1. Nonsteroidal anti-inflammatory agents
5.1.1. Arylpropionic acid derivative
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
3.1.1.1.
Azaperone
Azaperol All food produc-
ing species
100 µg/kg
50 µg/kg
Kidney
Liver, muscle, fat
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
3.2.1.1.
Clenbuterol
hydrochloride
Clenbuterol Bovine
(Indication: 
solely for tocoly-
sis in parturient 
cows)
0,5 µg/kg
0,1 µg/kg
0,05 µg/kg
Liver, kidney
Muscle
Milk
Equidae
(Indications:
tocolysis and the 
treatment of res-
piratory ail-
ments)
0,5 µg/kg
0,1 µg/kg
Liver, kidney
Muscle
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
4.1.1.
Dexamethasone
Dexamethasone Bovine, porcine, 
equidae
2.5 µg/kg
0,5 µg/kg
Liver
Muscle, kidney
Bovine 0,3 µg/kg Milk
Pharmacologically 
active
substance(s)
Marker residue Animal species MRLs Target tissues
5.1.1.1.
Vedaprofen
Vedaprofen Equidae 100 µg/kg
1000 µg/kg
50 µg/kg
Liver
Kidney
Muscle
5.1.1.2.
Carprofen
Carprofen Bovine 1000 µg/kg
500 µg/kg
Liver, kidney
Muscle, fat
Equidae 1000 µg/kg
50 µg/kg
100 µg/kg
Liver, kidney
Muscle
Fat
18 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
FOURTH 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
FIFTH SCHEDULE
(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
1) Name or corporate name and permanent address of the applicant.
2) Name of the veterinary medicinal product.
3) 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.
4) Manufacturing authorization, if any.
5) Marketing authorizations, if any.
6) Summary of the characteristics of the veterinary medicinal product(s).
A) 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
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS  g S.L.231.34 19
- pharmacological.
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.
20 g S.L.231.34
MAXIMUM RESIDUE LIMITS IN 
VETERINARY MEDICINAL PRODUCTS 
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.
