ANNEX 4
Acceptable Daily Intakes, other toxicological information, and
information on specifications
Adrenoceptor agonists
Clenbuterol
Acceptable daily intake (ADI): 0-0.004 µg per kg of body weight
Recommended maximum residue limits (MRLs)1
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 0.2 0.6 0.6 0.2 0.05
Horses 0.2 0.6 0.6 0.2
1 MRLs are expressed as the parent drug.
Xylazine
The Committee was unable to establish an ADI for xylazine because it
concluded that a metabolite, 2,6-xylidine, is genotoxic and
carcinogenic.
The Committee was unable to establish MRLs for xylazine because of the
lack of information on metabolism and residue depletion in edible
tissues.
The following information would be required for further review:
* Data on xylazine metabolism in target species sufficient to
identify a suitable marker residue and target tissues.
* Additional data on residue depletion of xylazine and its
metabolites in target species. These data should include evidence
to show, in particular, whether 2,6-xylidine is present at the
recommended withdrawal times.
* A suitable analytical method for determining the marker residue
in target tissues.
Anthelminthic agents
Abamectin
ADI: 0-1 µg per kg of body weight1
Recommended maximum residue limits (MRLs)2
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 100 50 100
1 This ADI, which applies to the parent drug abamectin, was
established by the 1995 Joint FAO/WHO Meeting on Pesticide
Residues (JMPR; FAO Plant Production and Protection
Paper 133, 1996).
2 MRLs are expressed as avermectin B1a.
Moxidectin
ADI: 0-2 µg per kg of body weight1
Recommended maximum residue limits (MRLs)2
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 20 100 50 500
Sheep 503 100 50 500
Deer4 20 100 50 500
1 This ADI was established at the forty-fifth meeting of the
Committee.
2 MRLs are expressed as the parent drug.
3 This MRL was established at the present meeting. All other MRLs
were established at the forty-fifth meeting of the Committee. At
that meeting the Committee noted the high concentration of
residues at the injection site over a 35-day period after
subcutaneous or intramuscular administration of the drug at the
recommended dose.
4 Temporary MRLs (see the report of the forty-fifth meeting of the
Committee).
Antimicrobial agents
Chlortetracycline, oxytetracycline and tetracycline
ADI: 0-3 µg per kg of body weight1
Recommended maximum residue limits (MRLs)2
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 100 300 600 100
Pigs 100 300 600
Sheep 100 300 600 100
Poultry 100 300 600 200
Giant
prawn 1003
(Penaeus
monodon)
1 This ADI was established at the forty-fifth meeting of the
Committee.
2 MRLs are expressed as the parent drug.
3 This MRL applies only to oxytetracycline.
Neomycin
ADI: 0-60 µg per kg of body weight
Recommended maximum residue limits (MRLs)1
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 500 500 10 000 500 500
Pigs 500 500 10 000 500
Sheep 500 500 10 000 500
Goats 500 500 10 000 500
Chickens 500 500 10 000 500 500
Ducks 500 500 10 000 500
Turkeys 500 500 10 000 500
1 MRLs are expressed as the parent drug.
Spiramycin
ADI: 0-50 µg per kg of body weight1
Recommended maximum residue limits (MRLs)
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle2 200 600 300 300 100
Pigs3 200 600 300 300
Chickens2 200 600 800 300
1 The ADI was established at the forty-third meeting of the
Committee.
2 MRLs are expressed as the sum of spiramycin and neospiramycin.
3 MRLs are expressed as spiramycin equivalents (antimicrobially
active residues).
Thiamphenicol
ADI: 0-6 µg per kg of body weight1
Recommended maximum residue limits (MRLs)2
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 40 40 40 40
Chickens 40 40 40 40
1 Temporary ADI.
2 Temporary MRLs, expressed as the parent drug.
The following information is required for evaluation in 1999:
* Detailed reports of the carcinogenicity study in rats on which
the summary report was available at the present meeting and the
range-finding study used to establish dose levels in that study.
* Residue depletion studies with radiolabelled and unlabelled
thiamphenicol for identification of the marker residue and target
tissues in non-ruminant cattle, chickens and pigs.
Tilmicosin
ADI: 0-40 µg per kg of body weight
Recommended maximum residue limits (MRLs)1
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 100 1000 300 100
Pigs 100 1500 1000 100
Sheep 100 1000 300 100 502
1 MRLs are expressed as the parent drug.
2 Temporary MRL. The results of a study in lactating sheep with
radiolabelled drug for estimation of the relationship between
total residues and parent compound in milk are required for
evaluation in 1999.
Insecticides
Cypermethrin
ADI: 0-50 µg per kg of body weight
Recommended maximum residue limits (MRLs)1
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 200 200 200 1000 50
Sheep 200 200 200 1000
Chickens 200 200 200 1000 100
1 Temporary MRLs, expressed as the parent drug.
The following information is required for evaluation in 2000:
* The results of radiodepletion studies that extend beyond the
recommended withdrawal times using the drug in its topical
formulation. The study should determine the depletion of the
total residues and the parent drug in target species.
* Evidence to verify that no interconversion of isomeric forms
occurs during metabolism in the target species.
* Further information on the validation of analytical methods,
particularly data on the derivation of the limits of
determination and limits of quantification.
alpha-Cypermethrin
ADI: 0-20 µg per kg of body weight
Recommended maximum residue limits (MRLs)1
Muscle Liver Kidney Fat Eggs Milk
(µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/kg) (µg/l)
Cattle 100 100 100 500 25
Sheep 100 100 100 500
Chickens 100 100 100 500 50
1 Temporary MRLs, expressed as the parent drug.
The following information is required for evaluation in 2000:
* The results of radiodepletion studies in sheep and chickens that
extend beyond the recommended withdrawal times using the drug in
its topical formulation. The study should determine the depletion
of the total residues and the parent drug.
* The radiodepletion study submitted for cattle should he
reassessed to determine the depletion of the total residues and
the parent drug.
* Evidence to verify that no interconversion of the cis-isomeric
forms to the trans-isomeric forms occurs during metabolism in the
target species.
* Further information on the validation of analytical methods,
particularly data on the derivation of the limits of
determination and limits of quantification.
See Also:
Toxicological Abbreviations