APPENDIX IV. PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS

(Advanced to Step 5 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: Carazolol

2 Acceptable Daily Intake (ADI) as established by JECFA

0-0.1 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle and fat/skin (pigs)

(b) MRL:

(b) 5 µg/kg (The concentration at the injection site may exceed the ADI.)

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

(c) Carazolol

3.2 (a) Commodity:

(a) Liver and kidney (pigs)

(b) MRL:

(b) 25 µg/kg (The concentration at the injection site may exceed the ADI.)

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

(c) Carazolol

4. Reference to recommended method(s) of analysis

Keuken, H.J. and Aerts, M.M.L. "Determination of Residues of Carazolol and a Number of Tranquilizers in Swine Kidney by High-Performance Liquid Chromatography with Ultraviolet and Fluorescence Detection" (1989) J. Chromatography, 464, 149-161 (kidney/pigs) (provisional)
Vogelgesang, J. "Determination of Carazolol in Tissues of Pigs by High-Performance Liquid Chromatography" (1989) Dtsch. Lebensmittel Runfsch., 85, 251-258 (liver/pigs) (provisional)
Rudolph, M, & Steinhart, H. "Determination of Carazolol in Tissues of Pigs by High Performance Liquid Chromatography" (1987) J. Chromatography, 392, 371-378 (liver, kidney/pigs) (provisional)
Rose, M.D. and Shearer, G., "Determination of Tranquilizers and Carazolol Residues in Animal Tissue Using High-Performance Liquid Chromatography with Electrochemical Detection (1992) J. Chromatography, 624, 471-477 (liver, kidney/pigs) (provisional)

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 93/31A
Appendix V, ALINORM 95/31

1. Substance: Ceftiofur sodium

2 Acceptable Daily Intake (ADI) as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle & pigs)

(b) MRL:

(b) 200 µg/kg

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

(c) Desfuroylceftiofur

3.2 (a) Commodity:

(a) Liver (cattle & pigs)

(b) MRL:

(b) 2000 µg/kg

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

(c) Desfuroylceftiofur

3.3 (a) Commodity:

(a) Kidney (cattle & pigs)

(b) MRL:

(b) 4000 µg/kg

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

(c) Desfuroylceftiofur

3.4 (a) Commodity:

(a) Fat (cattle & pigs)

(b) MRL:

(b) 600 µg/kg

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

(c) Desfuroylceftiofur

3.5 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l

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

(c) Desfuroylceftiofur

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: Doramectin

2 Acceptable Daily Intake (ADI) as established by JECFA

0-0.5 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle)

(b) MRL:

(b) 10 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)

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

(c) Doramectin

3.2 (a) Commodity:

(a) Liver (cattle)

(b) MRL:

(b) 100 µg/kg(High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)

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

(c) Doramectin

3.3 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 30 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)

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

(c) Doramectin

3.4 (a) Commodity:

(a) Fat (cattle)

(b) MRL:

(b) 150 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)

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

(c) Doramectin

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: Moxidectin

2 Acceptable Daily Intake (ADI) as established by JECFA

0-2 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle, sheep)

(b) MRL:

(b) 20 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)

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

(c) Moxidectin

3.2 (a) Commodity:

(a) Liver (cattle, sheep)

(b) MRL:

(b) 100 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)

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

(c) Moxidectin

3.3 (a) Commodity:

(a) Kidney (cattle, sheep)

(b) MRL:

(b) 50 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)

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

(c) Moxidectin

3.4 (a) Commodity:

(a) Fat (cattle, sheep)

(b) MRL:

(b) 500 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)

(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: Spiramycin

2 Acceptable Daily Intake (ADI) as established by JECFA

0-50 µg/kg body weight

3.1 (a) Commodity:

(a) Muscle (cattle)

(b) MRL:

(b) 100 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.2 (a) Commodity:

(a) Muscle (pigs)

(b) MRL:

(b) 200 µg/kg

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

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

3.3 (a) Commodity:

(a) Muscle (chickens)

(b) MRL:

(b) 200 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.4 (a) Commodity:

(a) Liver (cattle)

(b) MRL:

(b) 300 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.5 (a) Commodity:

(a) Liver (chickens)

(b) MRL:

(b) 400 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.6 (a) Commodity:

(a) Kidney (cattle)

(b) MRL:

(b) 200 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.7 (a) Commodity:

(a) Kidney (chickens)

(b) MRL:

(b) 800 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.8 (a) Commodity:

(a) Fat (cattle, chickens)

(b) MRL:

(b) 300 µg/kg

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

(c) Sum of spiramycin and neospiramycin

3.9 (a) Commodity:

(a) Milk (cattle)

(b) MRL:

(b) 100 µg/l

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

(c) Sum of spiramycin and neospiramycin

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

1. Substance: Carazolol
2 Acceptable Daily Intake (ADI) as established by JECFA	0-0.1 µg/kg body weight
3.1 (a) Commodity:	(a) Muscle and fat/skin (pigs)
(b) MRL:	(b) 5 µg/kg (The concentration at the injection site may exceed the ADI.)
(c) Definition of residue on which MRL was set:	(c) Carazolol
3.2 (a) Commodity:	(a) Liver and kidney (pigs)
(b) MRL:	(b) 25 µg/kg (The concentration at the injection site may exceed the ADI.)
(c) Definition of residue on which MRL was set:	(c) Carazolol
4. Reference to recommended method(s) of analysis	Keuken, H.J. and Aerts, M.M.L. "Determination of Residues of Carazolol and a Number of Tranquilizers in Swine Kidney by High-Performance Liquid Chromatography with Ultraviolet and Fluorescence Detection" (1989) J. Chromatography, 464, 149-161 (kidney/pigs) (provisional) Vogelgesang, J. "Determination of Carazolol in Tissues of Pigs by High-Performance Liquid Chromatography" (1989) Dtsch. Lebensmittel Runfsch., 85, 251-258 (liver/pigs) (provisional) Rudolph, M, & Steinhart, H. "Determination of Carazolol in Tissues of Pigs by High Performance Liquid Chromatography" (1987) J. Chromatography, 392, 371-378 (liver, kidney/pigs) (provisional) Rose, M.D. and Shearer, G., "Determination of Tranquilizers and Carazolol Residues in Animal Tissue Using High-Performance Liquid Chromatography with Electrochemical Detection (1992) J. Chromatography, 624, 471-477 (liver, kidney/pigs) (provisional)
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 93/31A Appendix V, ALINORM 95/31

1. Substance: Ceftiofur sodium
2 Acceptable Daily Intake (ADI) as established by JECFA	0-50 µg/kg body weight
3.1 (a) Commodity:	(a) Muscle (cattle & pigs)
(b) MRL:	(b) 200 µg/kg
(c) Definition of residue on which MRL was set:	(c) Desfuroylceftiofur
3.2 (a) Commodity:	(a) Liver (cattle & pigs)
(b) MRL:	(b) 2000 µg/kg
(c) Definition of residue on which MRL was set:	(c) Desfuroylceftiofur
3.3 (a) Commodity:	(a) Kidney (cattle & pigs)
(b) MRL:	(b) 4000 µg/kg
(c) Definition of residue on which MRL was set:	(c) Desfuroylceftiofur
3.4 (a) Commodity:	(a) Fat (cattle & pigs)
(b) MRL:	(b) 600 µg/kg
(c) Definition of residue on which MRL was set:	(c) Desfuroylceftiofur
3.5 (a) Commodity:	(a) Milk (cattle)
(b) MRL:	(b) 100 µg/l
(c) Definition of residue on which MRL was set:	(c) Desfuroylceftiofur
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: Doramectin
2 Acceptable Daily Intake (ADI) as established by JECFA	0-0.5 µg/kg body weight
3.1 (a) Commodity:	(a) Muscle (cattle)
(b) MRL:	(b) 10 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)
(c) Definition of residue on which MRL was set:	(c) Doramectin
3.2 (a) Commodity:	(a) Liver (cattle)
(b) MRL:	(b) 100 µg/kg(High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)
(c) Definition of residue on which MRL was set:	(c) Doramectin
3.3 (a) Commodity:	(a) Kidney (cattle)
(b) MRL:	(b) 30 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)
(c) Definition of residue on which MRL was set:	(c) Doramectin
3.4 (a) Commodity:	(a) Fat (cattle)
(b) MRL:	(b) 150 µg/kg (High concentration of residues at the injection site during the 35 day period after parenteral administration of the recommended dose.)
(c) Definition of residue on which MRL was set:	(c) Doramectin
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: Moxidectin
2 Acceptable Daily Intake (ADI) as established by JECFA	0-2 µg/kg body weight
3.1 (a) Commodity:	(a) Muscle (cattle, sheep)
(b) MRL:	(b) 20 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)
(c) Definition of residue on which MRL was set:	(c) Moxidectin
3.2 (a) Commodity:	(a) Liver (cattle, sheep)
(b) MRL:	(b) 100 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)
(c) Definition of residue on which MRL was set:	(c) Moxidectin
3.3 (a) Commodity:	(a) Kidney (cattle, sheep)
(b) MRL:	(b) 50 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)
(c) Definition of residue on which MRL was set:	(c) Moxidectin
3.4 (a) Commodity:	(a) Fat (cattle, sheep)
(b) MRL:	(b) 500 µg/kg (The high concentrations and great variation in the level of residues at the injection site over a 49-day period after dosing cattle.)
(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: Spiramycin
2 Acceptable Daily Intake (ADI) as established by JECFA	0-50 µg/kg body weight
3.1 (a) Commodity:	(a) Muscle (cattle)
(b) MRL:	(b) 100 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.2 (a) Commodity:	(a) Muscle (pigs)
(b) MRL:	(b) 200 µg/kg
(c) Definition of residue on which MRL was set:	(c) Total antimicrobially-active residues expressed as spiramycin equivalents
3.3 (a) Commodity:	(a) Muscle (chickens)
(b) MRL:	(b) 200 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.4 (a) Commodity:	(a) Liver (cattle)
(b) MRL:	(b) 300 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.5 (a) Commodity:	(a) Liver (chickens)
(b) MRL:	(b) 400 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.6 (a) Commodity:	(a) Kidney (cattle)
(b) MRL:	(b) 200 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.7 (a) Commodity:	(a) Kidney (chickens)
(b) MRL:	(b) 800 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.8 (a) Commodity:	(a) Fat (cattle, chickens)
(b) MRL:	(b) 300 µg/kg
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
3.9 (a) Commodity:	(a) Milk (cattle)
(b) MRL:	(b) 100 µg/l
(c) Definition of residue on which MRL was set:	(c) Sum of spiramycin and neospiramycin
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