Annex 4
Recommendations on compounds on the agenda
Substance Acceptable daily Recommended maximum
intake (ADI) and other residue limit (MRL)
toxicological
recommendations
Anthelminthic agents
Abamectin 0-0.2 µg per kg of No MRLs recommendedb
body weighta
Doramectin 0-0.5 µg per kg of Muscle (cattle): 10 µg/kgc,d
body weight Liver (cattle): 100 µg/kgc,d
Kidney (cattle): 30 µg/kgc,d
Fat (cattle): 150 µg/kgc,d
Moxidectin 0-2 µg per kg of Muscle (cattle, sheep & deere)
body weight 20 µg/kgc,f
Liver (cattle, sheep & deere):
100 µg/kgc,f
Kidney (cattle, sheep & deere):
50 µg/kgc,f
Fat (cattle, sheep & deere):
500 µg/kgc,f
Febantel, 0-4 µg per kg of Muscle, kidney & fat (cattle, pigs
fenbendazole, and body weightg & sheep): 100 µg/kge,h
oxfendazole Liver (cattle, pigs & sheep):
500 µg/kge,h
Milk (cattle): 100 µg/le,h
Antimicrobial agents
Ceftiofur 0-50 µg per kg of Muscle (cattle & pigs): 200 µg/kgi
body weight Liver (cattle & pigs): 2000 µg/kgi
Kidney (cattle & pigs): 4000 µg/kgi
Fat (cattle & pigs): 600 µg/kgi
Milk (cattle): 100 µg/li
Annex 4 (cont'd)
Recommendations on compounds on the agenda
Substance Acceptable daily Recommended maximum
intake (ADI) and other residue limit (MRL)
toxicological
recommendations
Chlortetracycline and 0-3 µg per kg of Muscle (cattle, pigs & poultry):
tetracycline body weightj 100 µg/kgc,e
Liver (cattle, pigs, sheep &
poultry): 300 µg/kgc,e
Kidney (cattle, pigs, sheep &
poultry): 600 µg/kgc,e
Eggs (poultry): 200 µg/kgc,e
Oxytetracycline 0-3 µg per kg of Edible tissue (Penaeus
body weightj monodon): 100 µg/kgc,e
Antiprotozoal agent
Diclazuril 0-20 µg per kg of Muscle (sheep, rabbits & poultry):
body weightk 500 µg/kgc,l
Liver (sheep, rabbits & poultry):
3000 µg/kgc,l
Kidney (sheep, rabbits & poultry):
2000 µg/kgc,l
Fat (sheep & rabbits):
1000 µg/kgc,l
Skin/fat (poultry): 1000 µg/kgc,l
Notes to Annex 4
a. The ADI for abamectin was established by the 1994 Joint FAO/WHO Meeting on
Pesticide Residues (JMPR) (FAO Plant Production and Protection Paper
No. 127, 1995; for the corresponding toxicological monograph, see Pesticide
residues in food - 1994 evaluations. Part II Toxicology
(WHO/PCS/95.2, 1995)).
b. Several issues relating to differences in the approaches adopted by the
Joint FAO/WHO Expert Committee on Food Additives (JECFA) and JMPR in
recommending MRLs in animal products arose at the meeting. In addition, the
ADI established by JMPR for abamectin incorporated a safety factor of 500
to take into account the teratogenicity of the Delta-8,9 isomer, a
metabolite that does not occur when abamectin is used as a veterinary drug.
For this reason, the Committee did not recommend MRLs for abamectin used as
a veterinary drug but recommended that consultations should be held between
representatives of JECFA and JMPR to resolve these differences.
c. Expressed as parent drug.
d. The Committee noted the high concentration of residues at the injection
site 35 days after subcutaneous or intramuscular administration of the drug
at the recommended dose.
e. Temporary MRL.
f. The Committee noted the very high concentrations and great variation in the
level of residues at the injection site in cattle over a 49-day period.
g. Group temporary ADI for febantel, fenbendazole and oxfendazole, based on
the no-observed-effect level (NOEL) for oxfendazole identified at the
thirty-eighth meeting of the Committee (WHO Technical Report Series,
No. 815, 1991).
h. Determined as the sum of fenbendazole, oxfendazole and oxfendazole sulfone,
expressed as oxfendazole sulfone equivalents.
i. Expressed as desfuroylceftiofur.
j. Group ADI for chlortetracycline, oxytetracycline and tetracycline, based on
the NOEL for oxytetracycline identified at the thirty-sixth meeting of the
Committee (WHO Technical Report Series, No. 799, 1990).
k. Temporary ADI.
l. The MRL is temporary because the ADI is temporary.
See Also:
Toxicological Abbreviations