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APPENDIX V. PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS

(Retained at Step 4 of the Codex Procedure)

NOTE: Section 5 - Reference to JECFA Reports - contains references to the reports of meetings of the Joint FAO/WHO Expert Committee on Food Additives, as published in the WHO Technical Report Series (TRS). Relevant toxicological monographs are published in the WHO Food Additives Series (FAS) and residue monographs of the substances concerned are published in the FAO Food and Nutrition Paper (FNP) Series.

1. Substance: Azaperone


2 Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle and fat (pigs)

(b) MRL:

(b) 60 µg/kg (Temporary)(MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Sum of azaperone and azaperol

3.2 (a) Commodity:

(a) Liver and kidney (pigs)

(b) MRL:

(b) 100 µg/kg (Temporary) (MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Sum of azaperone and azaperol

4. Reference to recommended method(s) of analysis

Keukens, H.J., Aerts, M. M. L., J. Chromatography., 484, 144 (1989) (kidney/pigs)(provisional; 1995)
Rose, M. D., Shearer, G., J. Chromatography., 624, 471 (1992) (kidney, liver/pigs)(provisional; 1995)
Haagsma, N., Bathelt, E. R., Engelsma, J. W., J. Chromatography., 436, 73 (1988)(muscle, kidney, liver/pigs)(provisional; 1995)
van Ginkel, L. A., Schuillens, P. L. W. J., Gilling, N., Anal. Chim. Acta,, 225, 137 (1989)(muscle, kidney, liver/pigs)(provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 815 (1991)
WHO FAS 29 (1991)
FAO FNP 41/4 (1991)
WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

None


1. Substance: Chlortetracycline and tetracycline


2 Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Group ADI for chlortetracycline, oxytetracycline and tetracycline)

3.1 (a) Commodity:

(a) Muscle (cattle, pigs & poultry)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Chlortetracycline & tetracycline

3.2 (a) Commodity:

(a) Liver (cattle, pigs, sheep & poultry)

(b) MRL:

(b) 300 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Chlortetracycline & tetracycline

3.3 (a) Commodity:

(a) Kidney (cattle, pigs, sheep & poultry)

(b) MRL:

(b) 600 µg/kg (Temporary

(c) Definition of residue on which MRL was set:

(c) Chlortetracycline & tetracycline

3.4 (a) Commodity:

(a) Eggs (poultry)

(b) MRL:

(b) 200 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Chlortetracycline & tetracycline

4. Reference to recommended method(s) of analysis

AOAC 995.04 (milk/cattle)(provisional; 1995)
AOAC 995.09 (muscle, kidney/cattle, pigs, poultry)(provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS in preparation
WHO FAS 35 in preparation
FAO FNP 41/8 in preparation

6. Reference to previous Codex Reports:

None


1. Substance: Dexamethasone


2 Acceptable Daily Intake (ADI) as established by JECFA

0-0.015 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle and kidney (cattle, horses and pigs)

(b) MRL:

(b) 0.5 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

3.2 (a) Commodity:

(a) Liver (cattle, horses and pigs)

(b) MRL:

(b) 2.5 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 0.3 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Dexamethasone

4. Reference to recommended method(s) of analysis


5. Reference to JECFA Reports:

WHO TRS 851 (1995)
WHO FAS 33 (1994)
FAO FNP 41/6 (1994)
WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 95/31


1. Substance: Diclazuril


2 Acceptable Daily Intake (ADI) as established by JECFA

0-20 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle (sheep, rabbits & poultry)

(b) MRL:

(b) 500 µg/kg (Temporary)(MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.2 (a) Commodity:

(a) Liver (sheep, rabbits & poultry)

(b) MRL:

(b) 3000 µg/kg (Temporary) (MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.3 (a) Commodity:

(a) Kidney (sheep, rabbits & poultry)

(b) MRL:

(b) 2000 µg/kg (Temporary) (MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

3.4 (a) Commodity:

(a) Fat (sheep, rabbits & poultry)

(b) MRL:

(b) 1000 µg/kg (Temporary) (MRL is temporary because of the temporary ADI)

(c) Definition of residue on which MRL was set:

(c) Diclazuril

4. Reference to recommended method(s) of analysis

Van Leemput, L., Jannsen Pharmaceutical, Belgium (muscle, liver, kidney, fat/poultry, rabbits, sheep)(provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS in preparation
WHO FAS 35 in preparation
FAO FNP 41/8 in preparation

6. Reference to previous Codex Reports:

None


1. Substance: Dihydrostreptomycin and streptomycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-30 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle, liver and fat (cattle, pigs, chickens & sheep)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrostreptomycin and streptomycin

3.2 (a) Commodity:

(a) Kidney (cattle, pigs, chickens and sheep)

(b) MRL:

(b) 1000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrostreptomycin and streptomycin

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 200 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of dihydrostreptomycin and streptomycin

4. Reference to recommended method(s) of analysis


5. Reference to JECFA Reports:

WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

None


1. Substance: Febantel/Fenbendazole/Oxfendazole


2 Acceptable Daily Intake (ADI) as established by JECFA

0-4 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle, kidney and fat (cattle, pigs & sheep)

(b) MRL:

(b) 100 µg/kg(Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

3.2 (a) Commodity:

(a) Liver (cattle, pigs & sheep)

(b) MRL:

(b) 500 µg/kg(Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

3.3 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Sum of fenbendazole, oxfendazole and oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

4. Reference to recommended method(s) of analysis

Ellis, R.L., et al, USDA Food Safety and Inspection Service, Analytical Chemistry Laboratory Guidebook - Residue Chemistry, 1991, Method BNZ (muscle & liver)

5. Reference to JECFA Reports:

WHO TRS 815 (1991)
WHO FAS 29 (1991)
FAO FNP 41/4 (1991)
WHO TRS in preparation
WHO FAS 35 in preparation
FAO FNP 41/8 in preparation

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31
Appendix V, ALINORM 93/31A
Appendix V, ALINORM 95/31


1. Substance: Gentamicin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-4 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle & fat (cattle & pigs)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.2 (a) Commodity:

(a) Liver (cattle & pigs)

(b) MRL:

(b) 200 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.3 (a) Commodity:

(a) Kidney (cattle & pigs)

(b) MRL:

(b) 1000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Gentamicin

4. Reference to recommended method(s) of analysis

Gugginsberg, D., Koch, H., Mitt. Gebiete Lebensm. Hyg. (1995) 86, 14 (muscle, liver, kidney/cattle, pigs)(provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

None


1. Substance: Moxidectin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-2 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (deer)

(b) MRL:

(b) 20 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.2 (a) Commodity:

(a) Liver (deer)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.3 (a) Commodity:

(a) Kidney (deer)

(b) MRL:

(b) 50 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

3.4 (a) Commodity:

(a) Fat (deer)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Moxidectin

4. Reference to recommended method(s) of analysis


5. Reference to JECFA Reports:

WHO TRS in preparation
WHO FAS 35 in preparation
FAO FNP 41/8 in preparation

6. Reference to previous Codex Reports:

None


1. Substance: Neomycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-30 µg/kg body weight (Temporary)

3.1 (a) Commodity:

(a) Muscle, liver & fat (cattle, chickens, ducks, goats, pigs, sheep & turkeys)

(b) MRL:

(b) 500 µg/kg (Temporary)(MRL is temporary because of the temporary ADI.)

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.2 (a) Commodity:

(a) Kidney (cattle, chickens, ducks, goats, pigs, sheep & turkeys)

(b) MRL:

(b) 5000 µg/kg (Temporary)(MRL is temporary because of the temporary ADI.)

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.3 (a) Commodity:

(a) Eggs (chickens)

(b) MRL:

(b) 500 µg/kg (Temporary)(MRL is temporary because of the temporary ADI.)

(c) Definition of residue on which MRL was set:

(c) Neomycin

3.4 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 500 µg/l (Temporary)(MRL is temporary because of the temporary ADI.)

(c) Definition of residue on which MRL was set:

(c) Neomycin

4. Reference to recommended method(s) of analysis

Gugginsberg, D., Koch, H., Mitt. Gebiete Lebensm. Hyg. 86, 449 (1995)(liver, kidney/cattle, pigs)(provisional; 1995)

5. Reference to JECFA Reports:

WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

None


1. Oxytetracycline


2 Acceptable Daily Intake (ADI) as established by JECFA

0-3 µg/kg body weight (Group ADI for chlortetracycline, oxytetracycline and tetracycline)

3.1 (a) Commodity:

(a) Giant prawn (Penaeus monodon)

(b) MRL:

(b) 100 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Oxytetracycline

4. Reference to recommended method(s) of analysis


5. Reference to JECFA Reports:

WHO TRS 799 (1990)WHO
FAS 27 (1991)FAO FNP 41/3 (1991)
WHO TRS in preparation
WHO FAS 35 in preparation
FAO FNP 41/8 in preparation

6. Reference to previous Codex Reports:

None for the above MRL
See Codex Alimentarius, Second Edition, Volume 3 for the existing Codex MRLs.


1. Substance: Spectinomycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-40 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle, pigs & chickens)

(b) MRL:

(b) 300 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.2 (a) Commodity:

(a) Liver (cattle, pigs & chickens)

(b) MRL:

(b) 2000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.3 (a) Commodity:

(a) Kidney (cattle, pigs & chickens)

(b) MRL:

(b) 5000 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.4 (a) Commodity:

(a) Fat (cattle, pigs & chickens)

(b) MRL:

(b) 500 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

3.5 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 200 µg/l (Temporary)

(c) Definition of residue on which MRL was set:

(c) Spectinomycin

4. Reference to recommended method(s) of analysis


5. Reference to JECFA Reports:

WHO TRS 851 (1995)
WHO FAS 33 (1994)
FAO FNP 41/6 (1994)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 95/31


1. Substance: Spiramycin


2 Acceptable Daily Intake (ADI) as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Liver (pigs)

(b) MRL:

(b) 600 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Total antimicrobially-active residues expressed as spiramycin equivalents

3.2 (a) Commodity:

(a) Kidney (pigs)

(b) MRL:

(b) 300 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Total antimicrobially-active residues expressed as spiramycin equivalents

3.3 (a) Commodity:

(a) Fat (pigs)

(b) MRL:

(b) 200 µg/kg (Temporary)

(c) Definition of residue on which MRL was set:

(c) Total antimicrobially-active residues expressed as spiramycin equivalents

4. Reference to recommended method(s) of analysis

Weil, A., Rhone Merieux, Toulouse, France (muscle, liver, kidney, fat/cattle, poultry)

5. Reference to JECFA Reports:

WHO TRS 815 (1991)
WHO FAS 29 (1991)
FAO FNP 41/4 (1991)
WHO TRS 855 (1995)
WHO FAS 34 (1995)
FAO FNP 41/7 (1995)

6. Reference to previous Codex Reports:

Appendix V, ALINORM 93/31
Appendix V, ALINORM 93/31
Appendix V, ALINORM 95/31


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