Online Edition: "Residues of some veterinary drugs in foods and animals"

Online help Terminology

This database contains the most recent information on maximum residue levels for veterinary drugs as recommended by JECFA. All monographs published in the FAO Food and Nutrition Papers 41 can be accessed in an electronic format. These monographs are available only in English although some parts of the database, the query page as well as the background information are provided in English, French, Spanish, Arabic and Chinese.

Veterinary Drug

Fenbendazole

Functional class

Antiparasitic

Latest evaluation

1998

JECFA meeting

ADI

0-7 µg/kg bw

ADI status

Full

Residue monographs

41-4-fenbendazole.pdf

41-8-fenbendazole.pdf

41-11-febantel_fenbendazole_oxfendazole.pdf

Marker residue

Sum of fenbendazole+oxfendazole+oxfendazole sulfone, expressed as oxfendazole sulfone equivalents

Maximum residue limits
(MRL) recommended

Cattle	Fat	100 µg/kg	F
Cattle	Kidney	100 µg/kg	F
Cattle	Liver	500 µg/kg	F
Cattle	Milk	100 µg/l	F
Cattle	Muscle	100 µg/kg	F
Goat	Fat	100 µg/kg	F
Goat	Kidney	100 µg/kg	F
Goat	Liver	500 µg/kg	F
Goat	Muscle	100 µg/kg	F
Horse	Fat	100 µg/kg	F
Horse	Kidney	100 µg/kg	F
Horse	Liver	500 µg/kg	F
Horse	Muscle	100 µg/kg	F
Pig	Fat	100 µg/kg	F
Pig	Kidney	100 µg/kg	F
Pig	Liver	500 µg/kg	F
Pig	Muscle	100 µg/kg	F
Sheep	Fat	100 µg/kg	F
Sheep	Kidney	100 µg/kg	F
Sheep	Liver	500 µg/kg	F
Sheep	Milk	100 µg/l	F
Sheep	Muscle	100 µg/kg	F

Other remarks

Summary of the evaluation

In reaching its decision on MRLs for febantel, fenbendazole and oxfendazole, the Committee took into account the following factors:
- An ADI of 0-7 µg per kg of body weight was established. This would result in a maximum ADI of 420 µg for a 60 kg person.
- The data on metabolism, pharmacokinetics and residue depletion are similar in cattle, sheep, goats, pigs and horses.
- The correlation between residues in plasma and milk is similar in sheep and cows.
- The data on analytical performance provided by the sponsor show that the highest limit of quantification for any of the edible tissues or milk is well below the recommended MRLs.
- The residues in tissues and milk in all species are calculated as oxfendazole sulfone equivalents.
- The MRLs are expressed as the sum of the three principal metabolites (fenbendazole, oxfendazole and oxfendazole sulfone), calculated as oxfendazole sulfone equivalents.
The MRLs would result in a maximum daily intake of 240 µg of residues of febantel, fenbendazole and oxfendazole, based on a daily food intakeof 300 g of muscle, 100 g of liver, 50 g each of kidney and fat, and 1.5 l of milk.
TRS 888