Veterinary Medicinal Products

L.N.162 of 1998

FOOD, DRUGS AND DRINKING WATER ACT

(CAP. 231)

Veterinary Medicinal Products

(Maximum Residue Limits) Regulations, 1998

IN exercise of the powers conferred by sections 12 and 28 of the

Food, Drugs and Drinking Water Act, the Minister of Health, Care of

the Elderly and Family Affairs, on the advice of the Council of Health

and of the Malta Standardisation Authority, has made the following

regulations: -

These regulations may be cited as the V eterinary Medici nat Cilaliun and

Products (Maximum Residue Limits) Regulations, 1998, and shall come commencemMI.

into force on the 1st October, 1998.

(Regulation 3)

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

1. Anti-infectious agents

Chemotherapeutics

1.1.

Sulfonamides

1.1.1.

MRLs

Phannacological Iy

Marker residue

Animal species

Target tissues

active substance(s)

,

100 ~glk:g

All substances belonging

Parent drug

Muscle, liver,

All food producing

to the sulfonamide group

species

kidney, fat

100 ~g/kg

Bovine, Ovine, Caprine

Milk

Other provisions: The combined total residues of all substances within the sulfonamide group should not exceed 100 ~glkg

Antibiotics

1.2.

].2.1.

Penicillins

MRLs

Pharmacologically active

Marker residue

Animal species

Target tissues

substance(s)

SO ~g/kg

I .2.1 .1. Benzylpenicillin

Benzylpenicillin

All food producing

Muscle, liver

specles

kidney, fat

4 ~glkg

Milk

Marker residue

Animal species

MRLs

Phannacologicallyactive

Target tissues

substance(s)

1.2.1.2. Ampicillin

All food producing

Muscle, liver

Ampicillin

50llglkg

species

kidney, fat

4 ~gfkg

Milk

1.2.1.3. Amoxicillin

Amoxicillin

AIl food producing

Muscle, liver

50llglkg

specIes

kidney, fat

Milk

4 j.J.glkg

1.2.1.4. Oxacillin

All food producing

Muscle, liver

Oxacillin

300 Jlglkg

specIes

kidney, fat

Milk

30 Ilg!kg

1.2.L5. Cloxacillin

Cloxacillin

All food producing

Muscle, liver

300 I!g!kg

specIes

kidney, fat

t:Jj

Milk

30llglkg

w

tIl

Animal species

Phannacologically active

Marker residue

MRLs

Target tissues

w

substance(s)

N

1.2.1.6. Dicloxacillin

Dic10xacillin

All food producing

Muscle, liver,

300 Jlglkg

kidney, fat

species

30 Jlglkg

Milk

1.2.1.7. Penethamate

Muscle, liver,

Benzylpenicillin

Bovine

SO Jlg/kg

kidney, fat

Milk

4 Jlg/kg

1.2.2

Cephalosporins

MRLs

Animal species

Target tissues

Marker residue

Phannacologicallyactive

substance(s)

1.2.2.1. Cefquinome

Bovine

200 Jlglkg

Kidney

Cefquinome

Liver

100 Jlglkg

Muscle

5OIlg/kg

Fat

50 Jlg/kg

20 Jlglkg

Milk

1.2.3.

Quinolones

Animal species

Marker residue

MRLs

Target tissues

Phannacologicallyactive

substance(s)

Muscle, liver

Sum of enrofloxacin and

Bovine. porcine, poultry

1.2.3.1 . Enrofl oxacin

30llglkg

kidney

ciprofloxacin

Chicken

Liver

Sarafloxacin

1.2.3.2. Sarafloxacin

100 Ilglkg

Skin and fat

IOllglkg

Liver

Chicken. turkey

1.2.3.3. Difloxacin

Difloxacin

200 Ilglkg

Kidney

150 Ilglkg

Muscle

50llglkg

Skin and fat

200 Ilglkg

I .2.4.

Macrolides

MRLs

Target tissues

Animal species

PhannacologicaJlyactive

Marker residue

substance(s)

Liver, kidney

1OOOIlg!kg

Bovine, ovine. porcine

1.2.4.1. Tilmicosin

Tilmicosin

Muscle, fat

50 llglkg

Ovine

Milk

50 11gil

Li ver, kidney, fat

Bovine

300 j..lg/kg

1.2.4.2 Spiramycin

Sum of spiramycin and

to

.

.

Muscle

neosplramycm

200 Ilglkg

>-

w

Milk

200 Ilglkg

w

t:I:l

Animal species

Pharmacologically active

Marker residue

Target tissues

MRLs

w

substance(s)

~

400 ~g/kg

Chicken

1.2.4.2. Spiramycin

Liver

300 ~glkg

(cont.)

Skin and fat

200 ~gIkg

Muscle

t.2.5.

Florfenicol and related compounds

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

200 ~gIkg

Bovine

1.2.5.1. FIorfenicol

Sum of Florfenicol and its

Muscle

300 ~glkg

metabolites measured as

Kidney

3000 ~g/k.g

Florfenicol-amine

Liver

1.2.6.

Tetracyclines

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

600 ~g/kg

All food producing

Kidney

1.2.6.1. Tetracycline

Sum of parent drug and

300 ~g/kg

Liver

its 4-epimer

species

Muscle

100 Ilg/kg

Milk

100 I±glkg

200 ~g/kg

Eggs

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

600 ~g/kg

1.2.6.2. Oxytetracycline

Sum of parent drug and

All food producing

Kidney

300 ~g/kg

its 4-epimer

specIes

Liver

100 ~g/kg

Muscle

Milk

lOOllglkg

200 Ilglkg

Eggs

600 ~g/kg

1.2.6.3. Chlortetracycline

Sum of parent drug and

All food producing

Kidney

its 4-epimer

species

Liver

300llglkg

Muscle

lOOllglkg

Milk

lOOIlg/kg

200 Jlglkg

Eggs

2. Antiparasitic agents

2.1.

Agents acting against endoparasites

2.1.1.

Avennectins

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.1 .1.1 I vennectin

22,23-Dihydro-

Bovine

Liver

100 Ilglkg

avermectin B I a

Fat

40 Ilglkg

Porcine, ovine, equidae

Liver

151lglkg

Fat

20llglkg

Bovine

2.1.1.2. A bamecti n

Avennectin B 1a

Liver

20llglkg

Fat

IOllglkg

tl:l

2.1.1.3. Doramectin

Liver

Doramectin

Bovine

151lglkg

w

Fat

25 lJ.g!kg

UI

t1j

2.1.2.

Salicylanilides

W

QO

0\

Animal species

Target tissues

Marker residue

Pharmacologically active

MRLs

substance(s)

1000 ~gfkg

Muscle, liver

Bovine

2.1.2.1 Closantel

Closantel

3000 ~gfkg

Kidney, fat

Muscle. 1iver

Ovine

)500 Ilg/kg

5000 ~g1kg

Kidney

Fat

2000 Ilgfkg

2.1.3.

Tetra-hydro-imidazoles (imidazolthiazoles)

Animal species

MRLs

Target tissues

Pharm aco1ogi cally acti ve

Marker residue

substance(s)

10 ~gIkg

Muscle, kidney, fat

Bovine, ovine, porcine,

Levamiso1e

2.1 .3.1 Levamisole

poultry

Liver

100 Ilglkg

2.2. Agents acting against ectoparasites

2.2.1 Organophosphates

MRLs

Pharmacologically active

Marker residue

Animal species

Target tissues

substance(s)

700 ~g/kg

2.2.1.]. Diazinon

Diazinon

Bovine,ovine

Fat

20 ~glkg

Kidney, liver,

muscle

Bovine, ovine, caprine

Mille

20 Jlg/kg

2.2.2.

Fonnamidines

Target tissues

Marker residue

Phannacologically active

Animal species

MRLs

substance(s)

2.2.2.] Amitraz

Porcine

Fat and skin

Sum of arnitTaz and all

400 Ilglkg

Kidney, liver

metabolites containing

200 Ilglkg

OJ

the 2,4-DMA moeity,

w

expressed as amitraz

-...l

tv

3. Agents acting on the nervous system

....

Agents acting on the autonomic nervous system

3.1.

Vol

3.1.1.

Anti -adrenergi cs

Phannacologically active

Marker residue

Animal species

Target tissues

MRLs

substance(s)

Carazo] 01

25 ~gIkg

3.1.1.1. Carazolol

Porcine

Liver, kidney

5 ~gIkg

Muscle, fat and skin

In these regulations, unless the context otherwise Inlerprelalion,

(1)

requlres-

"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 mgtKg or IJ..IKg

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.

(Regulation 4)

List of substances not subject to maximum residue limits

1. Inorganic chemicals

Pharmacologically active substance(s)

Animal species

All food producing species

1.1 Hydrogen peroxide

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 Polyvin-

ylpyrrolidone-iodine

1.4. Sodioum chlorite

Bovine (for topical use only)

All food producing species

1.5. Calcium acetate

Calci urn 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

All food producing species (for use as

1.6. Hydrochloric acid

excipient)

Bovine, ovine, caprine (for topical use

1.7. Sodioum dichloroisocyanurate

only)

All food producing species

1.8 Boric acid and borates

1.9. Magnesium

All food producing species

AU food producing species

1.10. Magnesium sulphate

All food producing species

1.11. Magnesium hydroxide

All food producing species

1.12. Magnesiurn stearate

All food producing species

1.13. Magnesi urn glutamate

1.14. Magnesium orotate

All food producing species

All food producing species

1.15. Magnesium aluminium silicate

All food producing species

1.16. Magnesium oxide

1. t 7 . Magnesium carbonate

All food producing species

All food producing species

1.18. Magnesi urn phosphate

Pharmacologically active substance(s)

Animal species

1.19. Magnesium glycerophosphate

All food producing species

1.20. Magnesium aspartate

All food producing species

All food producing species

1.21. Magnesium citrate

1.22. Magnesium acetate

All food producing species

1.23. Magnesium trisilicate

All food producing species

Organic Compounds

2. Pharmacologically active substance(s)

Animal species

2.1.

Etiproston tromethamine

Bovine, porcine

2.2.

Ketanserin tartrate

Equidae

Bovine

2.3.

Fertireline acetate

2.4.

Human menopausal urinary

Bovine

gonadotrophin

2.5. Lactic acid

All food producing species

Ovine, caprine

2.6. Melatonin

2.7. Iodine organic compounds

All food producing species

-Iodoform

2.8. Acetyl cysteine

All food producing species

All food producing species

2.9. Gonadotrophin releasing hormone

2.10 Pregnant Mare Serum

Gonadotrophine

All food producing species

2.11 17B-Oestradiol

All food producing mammals (for

therapeutic 'and zootechnical uses only)

2.12 Romifidine

Equidae (for therapeutic uses only)

Bovine. Equidae (for therapeutic uses

2.13 Detomidine

i only)

I Bovine. (for therapeutic uses only)

2.14. Brorizolam

2.15. Human chorion gonadotrophin

(HCG)

All food producing species

All food producing mammals

2.16 Oxytocin

2.17 Lecirelin

Bovine, equidae, rabbit

2.18 Dinoprost tromethamine

All mammalian species

All food producing species (for use as

2.19 Malic acid

excipient)

2.20 L-tartaric acid and its mono-and di- All food producing species (for use as

excipient)

basic salt of sodium,

potassium and calcium

All food producing species (for use as

2.21. Benzylalcohol

excipient)

2.22. Ethanol

All food producing species (for use as

excipient)

All food producing species (for use as

2.23. N-butanol

excipient)

Animal species

Pharmacologically active substance(s)

All food producing species (excludes

2.24. Mineral hydrocarbons, low to high

viscosity including micro-

aromatic and unsaturated compounds)

cristalline waxes, approximately

C1 O-C60;aliphatic, branched

aliphatic and alicyclic compounds

2.25 Buserelin

All food producing species

Bovine, equidae

2.26 Ketoprofen

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 n-butane

All food producing species

2.33 Isobutane

All food producing species

Equidae

2.34. Polysulphated glycosaminoglycan

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

Bovine (newborn calves)

2.38. Papaverine

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

All food producing species

2.43. Ethyl lactate

2.44. Heptam..inol

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

All food producing species

2.48. Peracetic acid

2,49. Carbetocin

All mammalian food producing species

All food producing species

2.50. Quillaia sapocin

All food producing species

2.51. Butyl 4-hydroxybenzoate

2.52. Sodium butyl4-hydroxybenzoate

All food producing species

All food producing species

2.53. Sodium benzyl4-hydroxybenzoate

2.54. Cetrimide

All food producing species

All food producing species

2.55. Lobeline

All mammalian food producing species

2.56. Pancreatin

(for topical use only)

All food producing species

2.57. Chlorocresol

2.58. Thymol

All food producing species

2.59. Dembrexine

Equidae

Pharmacologically active substance(s)

Animal species

2.60. Dic1azuril

. 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. Aeetylmethionine

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. Ethylenediarninetetraacetic 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 . Fannie acid

All food producing species

3.22. Follicle stimulating honnone

(natural FSH from all species and

their synthetic analogues)

All food producing species

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

All food producing species

3.30. Isopropanol

3.31 . Lanolin

All food producing species

All food producing species

3.32, Luteinizing honnone

(natural LH from all species and

their synthetic analogues)

Pharmacologically active substance(s)

Animal species

3.33. Magnesium chloride

All food producing species

3.34. Magnesium gluconate

All food producing species

AU food producing species

3.35. Magnesium hypophosphite

All food producing species

3.36. Mannitol

All food producing species

3.37. Montanide

3.38. Methylbenzoate

All food producing species

All food producing species

3.39. Monothioglycerol

3.40. Myglyol

All food producing species

3.41.0rgotein

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

All food producing species

3.45. Polyethylene glycol 400

3.46. Polyethylene glycol 600

All food producing species

3.47. Polyethylene glycol 3500

All food producing species

All food producing species

3.48. Polysorbate 80

All food producing species

3.49. Serotonin

All food producing species

3.50. Sodium chloride

3.5 L. Sodium cromoglycate

All food producing species

3.52. Sodium dioctyJsulphosuccinate

All food producing species

All food producing species

3.53. Sodium forrnaldehydesulphoxylate

3.54. Sodium laury] sulphate

All food producing species

3.55. Sodium pyrosulphite

All food producing species

3.56. Sodium stearate

All food produGing species

All food producing species

3.57. Sodium thiosulphate

3.58. Tragacanth

All food producing species

AU food producing species

3.59. Urea

3.60. Zinc sulphate

All food producing species

All food producing species

3.61 . Zinc oxide

3.62. Polyethylene glycols

All food producing species

(molecular 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 homeopathic All food producing species

veterinary medicinal products

provided that their concentration

in the product does not exceed one

part per ten thousand

S. 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

(Regulation 5)

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

residue limits have been fixed

Anti-infectious agents

1. Chemotherapeutics

1.1.

Diamino pyrimidine derivates

1.1.\ .

Animal species

Target tissues

Pharmacologically active

Marker residue

MRLs

substance(s)

Muscle, liver

Trimcthoprim

Tri methopri m

All food producing species

50 Ilg/kg

J . J .1.1.

kidney. fat, milk

Benzenesu 1 phonamides

1.1.2.

MRLs

Target tissues

Pharmacologically acrive

Marker residue

Animal species

substance(s)

Bovine

Clorsulon

Clorsulon

Muscle

50 IJ.glkg

J .1 .2.1.

Liver

150 Ilglkg

400 lJ.g/kg.

Kidney

Liver

1.1.2.2. Baquiloprim

Baquiloprim

Bovine

300 Ilglkg

Kidney

150 j.l.gIkg

Fat

10 Ilg/kg

Milk

30 Ug/kg

OJ

Porcine

Liver. kidney

50 IJ.g/kg

W

Fat and skin

40 Ilglkg

\D

Vl

1.2.

Antibiotics

'"

1.2.2.

Macrolides

UJ

\0

0\

MRLs

Phannacologicallyactive

Marker residue

Animal species

Target tissues

substance(s)

600 ~glkg

1.2.2.1. Spiramycin

Spiramycin

Porcine

Liver

300 ~glkg

Kidney. muscle

200 Ilg!k~

Fat

100 ~gIkg

1.2.2.2. Tylosin

Tylosin

Bovine, porcine. poultry

Muscle. lever

kidney

50-ul!!kg

Bovine

Milk

1.2.2.3. Erythromycin

Erythromycin

Li ver, kidney,

Bovine, ovine. porcine.

400llglkg

poultry

muscle, fat

BovlOe. ovme

Mille

40Jlglkg

Eggs

Poultry

200 ul!!kg

1.2.2.4. Josamycin

Josamycin

Chicken

Kidney

400 Ilglkg

200 ~glkg

Liver, muscle, fat

Eggs

200 Ilglkg

1.2.3.

Thiamphenicol and related compounds

MRLs

Pharmacologically active

Marker residue

Animal species

Target tissues

substance(s)

1.2.3.1. Thiarnphenicol

4O~glkg

Thiamphenicol

Bovine, poultry

Muscle, liver

kidney, fat

1.2.4.

Cephalosporins

MRLs

Target tissues

Animal species

Marker residue

Pharmacologically active

substancc(s)

2000 ~gfkg

Kidney, liver

Bovine

1.2.4.1. Ceftiofur

Sum of all residues

Muscle

retaining the betalactam

200 Ilglkg

Fat

structure expressed as

600 Ilglkg

100 Ilg/kg

Milk

desfuroylceftiofur

Kidney

Porcine

4000Jlglkg

Liver

3000 Ilglkg

Muscle

500 Ilglkg

600 Ilglkg

Fat

1.2.5.

Aminoglycosides

MRLs

Target tissues

Animal species

Pharmacologically active

Marker residue

substance(s)

Kidney

Bovine, procine, poultry

1.2.5.1. Spectinomycin

Spectinomycin

5000 Ilg/kg

2000 ~g/kg

Liver

Muscle

300 Ilglkg

500 Ilg/kg

Fat

Bovine

Milk

200 Ilgfkg'

J .2.5.2. Streptomycin

Bovine. ovine, porcine,

Kidney

Streptomycin

1000 Ilglkg

Muscle, liver, fat

poultry

500 Ilglkg

Milk

Bovine ovine

200 Ilg/kg

Bovine, ovine, porcine,

Kidney

1.2.5.3. Dihydrostreptomycin

Dihydrostreptomyci n

1000 Ilglkg

to

poultry

Muscle, liver, fat

500 Ilg/kg

W

200 ~gIkg

Milk

Bovine.ovine

\0

-....l

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

tl:l

substancc(s)

W

1.2.5.4. Gentamicin

Bovine, porcine,

Gentamicin

\0

1000 llg/kg

Kidney

Liver

200 llg/kg

lOO ug!k.2,

Muscle fat

100 ~glkg

Bovine

Milk

I .2.5.5. Neomycin

Neomycin

Bovine, ovine, caprine, por-

5000 Ilglkg

Kidney

(including f ramycetin)

cine, chicken. turkey, duck

500 llg/kg

Muscle. liver, fat

Milk

Bovine, ovine. caprine

500 llglkg

Eggs

Chicken

500 Jlglkg

1.2.5.6. Aminosidine

Aminosidine

Bovine, porcine, rabbits,

Liver. kidney

1500 llglkg

chicken

500 llglkg

Muscle

t .2.6. Quinolones

Pharmacological! y acti ve

Marker residue

Animal species

MRLs

Target tissues

substance(s)

] .2.6.1. Danotloxacin

Danofloxacin

Bovine

Liver

900 llglkg

Kidney

5OOI1g/kg

Muscle

300 Ilglkg

20011glkg

Fat

1200 Jlg/kg

Chicken

Liver, kidney

Skin and fat

600 llglkg

300 uglkg

Muscle

] .2.6.2. Decoquinate

Decoquinate

Bovine,ovine

Muscle, liver,

500 Jlg/kg

kidney, fat

1.2.6.3. Marbotloxacin

Marbofloxacin

Muscle, liver, kidney

150 Jlglkg

Bovine

Milk

75 llglkg

50 UQIkQ

Fat

150 Ilglkg

Porcine

Muscle, lever, kidney

Fat and skin

50 lJ.g/kg

Naphtalene-ringed ansamycin

1.2.7.

MRLs

Animal species

Target tissues

Marker residue

Pharmacologically active

substance(s)

1.2.7.1. Rifaximin

Rifaximin

Bovine

Milk

600 Ilglkg

1.2.8.

PoJymyx.ins

MRLs

Target tissues

Animal species

Marker residue

PhannacologicalJ y acti ve

substance(s)

200 ~glkg

Bovine, ovme, porcin~,

Kidney

1.2.8.1. Colistin

Colistin

150 ~glkg

Liver, muscle, fat

chicken, rabbits

SO Ilg/kg

Milk

Bovine.ovine

300 ~glkg

Eggs

Chicken

I .2.9.

Penicillins

MRLs

Animal species

Target tissues

Phannacologicallyactive

Marker residue

substance(s)

SO ~glkg

Liver, kidney,

1.2.9.1. Penethamate

Ovine

Benzylpenicillin

muscle, fat

4 ~g/kg

Milk

to

Liver, kidney

Porcine

50 Jlglkg

w

muscle, fat

ID

ID

ttl

2. Antiparasitic agents

.-

2.1.

Agents acting against endo-parasites

2.1.1.

Benzimidazoles and pro-benzimidazoles

Pharmacologically active

Animal species

Target tissues

MRLs

Marker residue

substance(s)

1000 ~glkg

All food producing species

2.1 .1.1. Febantel

Liver

Combined residues of

10 ~glkg

Muscle, kidney, fat

oxfendazole,oxfendazole

sulfone and fenbendazole

Milk

10 J!g/kg

Other provisions

The MRLs cover all residues of febantel, fenbendazole and oxfendazole

1000 ~glkg

AU food producing species

2.1.1.2. Fenbendazole

Liver

Combined residues of

Muscle, kidney, fat

oxfendazole,oxfendazole

10 J.1g1kg

Milk

sulfone and fenbendazole

10 Jlglkg

Other provisions

The MRLs cover all residues of febantel. fenbendazole and oxfendazole

1000 ~gIkg

All f<XXi producing species

Liver

2.1.13. Oxfendazole

Combined. residues of

Muscle, kidney, fat

oxfendazole, oxfendazo1e

10 J!gIkg

Milk

sulfone and fenbendazole

10 J!glkg

Other provisions

The MRLs cover all residues of febantel. fenbendazole and oxfendazole

Bovine,Ovine

Muscle, fat, milk.

2.1.1.4. Albendazole

Sum of albendazole and

100 J.1g1kg

Kidney

metabolites which are

500 J.1g1kg

measured as 2-amino-

Liver

1000 J.1g1kg

benzimidazole suIphone

Pharmacologically active

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2. I .1.5. Thiabendazole

Bovine, ovine, caprine

Sum of thiabendazole and

Muscle, liver

100 J.!glkg

5- hydroxythiabendazole

kidney, fat, milk

2.1.1.6. Triclabenclazole

Bovine,ovine

Sum of extractable residues

Muscle, liver,

150 Ilg/kg

that may be oxidized to

kidney

50 Ilglkg

ketatric1abendazole

Fat

2.1.1.7. Flubendazole

Flubendazo1e

Poultry, game birds

Liver

500 Ilglkg

Muscle

200 Ilglkg

Eggs

400 Ilglkg

Porcine

Muscle, liver

10 Ilglkg

kidney. fat

Bovine, ovine, porcine,

2.1.1.8. Oxibendazole

Oxibendazole

Muscle, liver

100 Ilglkg

eauidae

kidnev. fat

50 )J.g/k.g

Bovine,ovine

Milk

2.1.1.9. Netobimin

Bovine, ovine, caprine

Sum of netobimin and

Liver

1000 Ilglkg

albendazole and metabolite .

Kidney

500 Ilglkg

of albendazo1e measured

Muscle, fat

I00 Ilglkg

as 2-amino-benzimidazole

Milk

100 Ilglkg

sulphone

ttl

- -

i)

t::D

2.2.

Agents acting against ectoparasites

....

2.2.1.

Formamidines

~

tv

Pharmacologically active

MRLs

Marker residue

Animal species

Target tissues

substance(s)

2.2.1.]. Amitraz

Sum of amitraz and

Bovine

Kidney, liver fat

200 Ilg/kg

10 ~glkg

Mille

metabolites which are

Ovme

measured as

Fat

400 Ilglkg

2.4-dimethylaniline

Kidney, liver

200 Ilglkg

2.2.2.

Organophosphates

Pharmacologically active

Marker residue

Target tissues

Animal species

MRLs

substance(s)

100 ~glkg

2.2.2.1. Azamethiphos

Azamethiphos

Muscle and skin in

Salmonidae

natural proportions

2.2.3.

Iminophenyl thiazolidine derivative

Pharmaco I ogically acti ve

Marker residue

Animal species

MRLs

Target tissues

substance(s)

2.2.3.1. Cymiazole

Cymiazole

Bees

Honey

1000 Ilglkg

2.3.

Agents acting against endo- and ectoparasites

Avermectins

2.3.1.

MRLs

Animal species

PharmacoIogically acti ve

Marker residue

Target tissues

substance(s)

200 ~g/kg

2.3.1.1. Moxidectin

Moxidectin

Bovine,ovine

Fat

20 ~glkg

Kidney. liver

3. Agents acting on the nervous system

Agents acting on the central nervous system

3.1.

Butyrophenone tranquillizers

3.1.1.

MRLs

PharmacoJogicali y acti ve

Marker residue

Animal species

Target tissues

substance(s)

100 ~g!kg

All food producing species

Kidney

3.1.1.1. Azaperone

Azaperol

50 ~g/kg

Liver, muscle, fat

3.2.

Agents acting on the automatic nervous system

3.2.1.

3 2 sympathomimetic agents

MRLs

Pharmacologically active

Animal species

Target tissues

Marker residue

s ubstance(s)

0,5 ~g/kg

Liver, kidney

3.2.1 .1. Clenbuterol

CJenbuterol

Bovine

0,1 ~glkg

(Indication: solely for tocolysis

Muscle

hydrochloride

0,05 Ilglkg

in parturient cows)

Milk

0,5 ~gIkg

Liver, kidney

Equidae

Muscle

(lndicalions: locolysis and the

0,1 Ilglkg

tl:1

treatment of respiratory ailments

~

w

4. Corticoids

tIl

GIucocorticoids

4.1.

~

MRLs

Target tissues

Pharmacologically active

Marker residue

Animal species

substance(s)

Bovine, porcine, equidae

Liver

4.1.1. Dexamethasone

Dexamethasone

2.5 Ilglkg

Muscle, kidney

0,5 Ilglkg

Milk

Bovine

0,3 Ilglkg

5. Anti-inflammatory agents

5.1.

Nonsteroidal anti-inflarrunatory agents

5.1.1.

Arylpropionic acid derivative

MRLs

Animal species

Target tissues

Pharmacologically active

Marker residue

substance(s)

5.1.1.\. Vedaprofen

Liver

Vedaprofen

Equidae

100 Jlg/kg

Kidney

1000 Ilg/kg

50 Jlg/kg

Muscle

Liver, kidney

5.1.1.2. Carprofen

Bovine

Carprofen

1000 Jlg/kg

Muscle, fat

500 Jlg/kg

Liver, kidney

Equidae

1000 Ilglkg

Muscle

50 Ilg/kg

100 Ilg!kg

Fat

Meta, wara li ssir evalwazzjoni ta' xi sustanza

farrnakologikament attiva Ii tkun uzata fi prodotti mediCinali veterinarji.

ikun jidher Ii din rna tkunx rnehtiega ghall-harsien tas-sahha pubblika

sabiex jigi stabbilit limitu ta' fdal massimu, dik is-sustanza ghandha

tigi inklui:a flista Ii hemm fit-Tieni Skeda Ii tinsab rna' dawn ir-

regolarnenti.

Il-tista ta' sustanzi farmakologikament attivi li jintuZaw fi

(Regulation 6)

List of pharmacologically active substances for which no maximum levels can

be fixed

1. Nitro furan s, except furazolidone

2. Ronidazole

3. Dapsone

Chloramphenicol

4.

5. Furazolidone

6. Dimetridazole

7. Colchicine

8. Avoparcin

prodotti medicinali veterinaIji Ii dwarhom ikunu gew stabbiliti I-limiti

ta' fdal massimu provizOlji huma dawk li hemm fit-Tielet Skeda 1 i Ii nsab

rna' dawn ir-regolamenti.

(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 authorisation, if any.

Marketing authorisations, jf any.

5)

6)

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

Safety documentation

Expert report

Precise identification oj the substance concerned by the application

I .1)

International non-proprietary name.

1.2)

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

1.3)

Chemical Abstract Service (CAS) name.

1.4)

Classification

- therapeutic

- pharmacological.

1.5)

Synonyms and abbreviations.

1.6)

Structural fonnuta.

t .7)

Molecular formula.

1.8)

Molecular weight.

I .9)

Degree of impurity.

I .10)

Qualitative and quantitative composition of impurities.

1.1 L)

Description of physical properties

- fusion point

- boiling point

- vapour pressure

- solubiJ ity in water and organic sol vents expressed in gil, with indication

of temperature

- density

- refractive index, rotation. etc.

Relevant pharmacological studies

A.2)

Pharmacodynamics.

2.1)

2.2)

Pharmacokinetics.

Toxicological studies

A.3)

Single dose toxicity.

3.1)

Repeated dose toxicity.

3.2)

Tolerance in the target species of animal.

3.3)

Reproductive toxicity including teratogenicity.

3.4)

I

Study of the effects on reproduction.

3.4.1)

Embryotoxicity/fetotoxicity, including teratogenicity.

3.4.2)

3.5)

Mutagenicity.

3.6)

Caricinogenicity.

Studies of other effects

A.4)

Imrnunotoxicity.

4.1)

Microbiological properties of residues.

4.2)

on the human gut flora;

4.2.1)

4.2.2) on the organisms and micro-organisms used for industrial food

processing.

4.3)

Observations in humans.

Residue documentation

B .0)

Expert report

Precise identification of the substance concerned by the application

B.l)

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

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

Pharmacokinetics

2.1 )

(absorption, distribution, biotransfonnation, excretion).

Depletion of residues.

2.2)

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.J)

accuracy, including sensiti vity;

3.2.3)

preClSton;

3.2.4)

limit of detection;

3.2.5)

limit of quantitation;

3.2.6)

practicability and applicability under norrnallaboratory conditions;

3.2.7)

susceptibility to interference.

(1) Meta jkun jidher Ii rna jistax jigi stabbilit limitu ta' fdal

rnassimu dwar xi sustanza farmakologikament attiva Ii tintui.a fi prodotti

medicinali veteriruuji minhabba til-fatt li I-fdalijiet ras-sustanzi involuti,

fliema livell ikun, foggetti tat-ikd Ii joriginaw miUeannimali jkunu

jikkostitwixxu periklu ghas-sahha tal-konsurnatur, dik is-sustanza

ghandha tkun inkluia flista Ii herrun fIT-Raba' Skeda Ii tinsab rna' dawn

ir-regolamenti.

(2) Ghandu jkun projbit l-ghoti tas-sustanzi fil-Iista Ii hemrn

fir-Raba' Skeda Ii tinsab rna' dawn ir-regolamenti iiI annimali Ii

jipproducu I-ikel.

0) Sabiexjigu stabbiIiti l-limiti ta' fdal massimu ta' prodotti

rnediCinali veterinarji uiati f' oggetti tal-ikel ta' origini mill-annimali,

ikun mehtieg Ii jigi speCifikat I-isped tal-annimal fejn dawk il-fdalijiet

jistghu jkunu preienti, iI-livelli Ii jistghu jkunu prezenti fkull wiehed

mit-tessuti tal-laham relevanti miksubin miJl-annimal ikkurat (target

tissue) u x~xorta tal-fdal Ii jkun relevanti ghas-sorveljar ta' fdalijiet

(marker residue).

(2) Sabiex isir kontroll dwar il-fdaJijiet, il-limid ta' fdal

massimu ghandhorn jigu stabbiliti ghat-target tissue tal-fwied jew tal-

kilwa; iida, billi l-fwied u I-kilwa ta' spiss jitnehhew mill-karkassi Ii

jinbieghu f'kummerc internazzjonali, iI-limiti ta' fdal massimi

ghandhom ghaldaqstant dejjernjigu stabbiliti ghal tess uti muskolari jew

xahmin.

(3) Fil-kaZ ta' prodotti medicinali veterinarji mahsuba ghall-

uiu fuq tajr Ii jbid, annimali tal-halib jew nahal tal-ghasel, iI-limiti ta'

fda! massimi ghandhom ukoll jigu stabbiliti ghall-bajd, halib,jew ghasel.

(I) Sustanza fannakologikament attiva gdida. mahsuba biex Tqeghid la' prodOlli

tintuia fi prodotti mediCinali veterinarji Ii jinghataw Iii annimali Ii fug il-Iisti,

jipproduCll l-halib, jistghu biss jigu inkluzi fl-Ewwel, fit-Tieni u fit-

Tielet Skedi Ii jinsabu rna' dawn ir-regolamenti jekk min ikun

responsabbli ghat-tqeghid taghhom fis-suqjaghmel applikazzjoni dwar

dan lid-Direttur. Dik l-appIikazzjoni ghandu jkun fiha t-taghlif u 1-

partikolaritajiet imsemmija fil-Hames Skeda,

Id-Direttur jista', wara Ii jifli t-taghrif gdid jew wara Ii

(2)

jerga' jifli t-taghrif Ii jkollu, jemenda kull dispozizzjoni Ii hemm fl-

Ewwel, fit-Tieni, fit-Tielet u fir-Raba' Skedi Ii jinsabu rna' dawn ir-

regolamenti jekk dan ikun rnehtieg Ii jsir ghall-harsien tas-sahha tal-

'bniedem jew tal-annimali.

Id-Direttur majistaxjipprojbixxi jew iioJllITi il-kummerc

(3)

ta' oggetti tal-ikellijoriginaw mill-annimali u Ii jkunu gejjin minn pajjizi

ohm minhabba fli jkun fihom fdalijiet ta' prodotti mediCinali veterinarji

jell il-kwantita ta' fdal rna tkunx teccedi l-limitu ta' fdal massimu Ii

hemm fl-EwweI Skeda jew fit-Tielet Skeda, jew inkella jekk dik is-

sustanza tkun qeghda fil-lista Ii hemm fit- Tieni Skeda,

L-ghoti IiI annimali Ii jipproducu I-ikel ta' prodtti mediCinali Annirnali Ii

veterinarji Ii jkun fihom sustanzi attivi farrnakologki Ii rna jkunux jipproduCu !-ike!'

imsemmija fl-Ewwel, fit-Tieni jew fit-Tielet Skedi li jinsabu rna' dawn

ir-regolamenti ghandhu jkun projbit, Wief fil-kaZ ta' provi kliniCi Ii jkunu

accettati rnill-awtoritajiet kompetenti u sakenuri I-ogg-etti tal-ikel Ii

jinkisbu minn bhejjem Ii jintuzaw f'dawk il-provi rna jkunx fihom

fdalijiet Ii jkunu ta' periklu ghas-sahha tal-bniedem.

Ebda haga f dawn ir-regolamenti m' ghandha tmur kontra d- RiseN•.

dispozizzjonijiet tar-Regolamenti ta' 1-1998 dwar Fdalijiet fil-Laham. AL 1421.8.')-1998

Ii jipprojbixxu I-uiu, fit-trobbija tal-bhejjem, ta' terti sustanzi Ii

ghandhom azzjoni ormonika.

veterinary medicinal products in respect of which maximwn residue

limits have been established shall be contained in the First Schedule to

these regulations.

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 sU.bstance shall be included in a list in the Second

Schedule to these regulations.

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 to these regulations.

6. (l) 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 to these regulations.

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

Schedule to these regulations to food-producing animals shall be

prohibited.

7. (l) 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 Ii ver 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.

8. (1) A new pharmacological! y acti ve substance, intended to Lisling of p~odUCls.

be used in veterinary medicinal products administered to food producing

animals, may only be included in the First, Second and Third Schedules

to these regulations 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 to these regulations 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.

9. The administration to food-producing animals of veterinary food-producing

animals.

medicinal products containing pharmacologically active substances

which are not mentioned in the First, Second or Third Schedules to

these regulations 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.

10. Nothing in these regulations shall operate against the Saving.

provisions of the Residues in Meat Regulations, 1998, prohibiting the L.N, 142 of 199R.

use, in livestock fanning, of certain substances which have a honnonal

action.