ANNEX 4
RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA
Substances Acceptable Daily Recommended Maximum
Intake (ADI) for Residue Limit (MRL)
human beings and
other
toxicological
recommendations
Anthelminthic agents
Closantel Not evaluated1 Muscle and liver
(sheep): 1500 µg/kg2
Kidney (sheep): 5000 µg/kg2
Fat (sheep): 2000 µg/kg2
Muscle and liver
(cattle): 1000 µg/kg2
Kidney and fat
(cattle): 3000 µg/kg2
Flubendazole 0-12 µg per kg Muscle and liver
of body weight (pigs): 10 µg/kg2
Muscle (poultry): 200 µg/kg2
Liver (poultry): 500 µg/kg2
Eggs: 400 µg/kg2
Ivermectin 0-1 µg per kg of Liver (cattle): 100 µg/kg3
body weight Fat (cattle): 40 µg/kg3
Tiabendazole 0-100 µg per kg Edible tissues4 (cattle, pigs,
(Thiabendazole) of body weight goats and sheep) and milk
(cattle and goats):
100 µg/kg5
RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA
Substances Acceptable Daily Recommended Maximum
Intake (ADI) for Residue Limit (MRL)
human beings and
other
toxicological
recommendations
Triclabendazole 0-3 µg per kg of Muscle (cattle): 200 µg/kg6
body weight Liver and kidney (cattle):
300 µg/kg6
Fat (cattle): 100 µg/kg6
Edible tissues4 (sheep):
100 µg/kg6
Antimicrobial agents
Furazolidone Not allocated7 No MRLs allocated8
Nitrofural
(Nitrofurazone) Not allocated9 No MRLs allocated8
Production aids
Bovine Not specified10 Milk and edible
somatotropins tissues4
(cattle): Not specified11
Ractopamine Not allocated12 No MRLs allocated13
Trypanocide
Isometamidium 0-100 µg per kg of body Muscle, fat, and milk
weight (cattle): 100 µg/kg2
Liver (cattle): 500 µg/kg2
Kidney (cattle): 1000 µg/kg2
Notes to Annex 4
1 An ADI of 0-30 µg per kg of body weight was established at the
thirty-sixth meeting of the Committee (WHO Technical Report
Series 799, 1990).
2 Expressed as parent drug.
3 Expressed as 22,23-dilydroavermectin B1a (H2B1a)
4 Edible tissues are defined as muscle, fat, liver, and kidney.
5 Expressed as the sum of thiabendazole and 5-hydroxythiabendazole.
6 Expressed as 5-chloro-6-(2',3'-dichlorophenoxy)-benzimadazole-2-one.
7 An ADI could not be established because of evidence of genotoxicity
and carcinogenicity and lack of information on the nature of the
metabolites.
8 MRLs were not allocated because:
a. No ADI was established;
b. Data on residues were not sufficient for the Committee to
identify a marker residue; and
c. Insufficient information was available on the quantity and nature
of the total residues.
9 An ADI could not be established because no-effect levels were not
observed for the tumorigenic effects.
10 The ADI applies to somagrebove, sometribove, somavubove, and somidobove.
ADI "not specified" means that available data on the toxicity and
intake of the veterinary drug indicate a large margin of safety
for the consumption of its residues in food when the drug is used
according to good practice in the use of veterinary drugs. For that
reason, and for the reasons stated in the individual evaluation, the
Committee has concluded that use of the veterinary drug does not represent
a hazard to human health and that there is no need to specify a numerical
ADI.
11 The MRLs apply to somagrebove, sometribove, somavubove, and somidobove.
MRL "not specified" means that available data on the identity and
concentration of residues of the veterinary drug in animal tissues
indicate a large margin of safety for consumption of residues in food
when the drug is used according to good practice in the use of veterinary
drugs. For that reason, and for the reasons stated in the individual
evaluation, the Committee has concluded that the presence of drug residues
in the named animal product does not present a health concern and that
there is no need to specify a numerical MRL.
12 An ADI could not be established because a clear no-effect level was
observed for pharmacological effects and the issue of carcinogenicity has
not been resolved.
13 MRLs were not allocated because:
a. An ADI was not established, and
b. Sufficient information was not available for the Committee to
establish a marker residue in animal tissues.
See Also: Toxicological Abbreviations