ANNEX 4
Recommendations on compounds on the agenda
Acceptable Acceptable
Substance Daily Residue
Intake for Level
Human Beings
Antimicrobial agent
Chloramphenicol Not allocated1 Not allocated1
Growth promoters
Endogenous
Estradiol-17ß Unnecessary2 Unnecessary2
Progesterone Unnecessary2 Unnecessary2
Testosterone Unnecessary2 Unnecessary2
Xenobiotic
Trenbolone 0-0.01 µg/kg of 1.4 µg/kg
acetate body weight3 (bovine
tissue) for ß-
trenbolone; 3,4
14 µg/kg (bovine
liver and kidney)
for alpha-
trenbolone3,5
Zeranol 0-0.5 µg/kg of 10 µ/kg (bovine
body weight liver;6
2 µg/kg (bovine
muscle)7
1 No ADI or Acceptable Residue Level could be established because
it was not possible to give an assurance that residues would be
safe for sensitive subjects, who could develop aplastic anaemia.
2 Establishing an ADI and an Acceptable Residue Level for a hormone
that is produced endogenously at variable levels in human beings
was considered unnecessary by the Committee. Residues resulting
from the use of this substance as a growth promoter in accordance
with good animal husbandry practice are unlikely to pose a hazard
to human health.
3 Temporary acceptance. The following information was requested,
to be submitted by 1990: (a) the final reports, with supporting
data, for the tissue residue studies in which trenbolone acetate
was ministered to heifers and trenbolone acetate in combination
with estradiol-17ß was administered to steers; (b) data on
individual animals from the three hormonal studies in pigs that
were reviewed by the Committee; and (c) results from a 90-day
study in an appropriate species with orally administered
alpha-trenbolone.
4 Based on consumption of 500 g meat per day by a 70 kg person.
5 Based on the finding that alpha-trenbolone had one-tenth of the
hormonal activity of ß-trenbolone in a study in pigs.
6 Based on a level consistent with good animal husbandry practice,
as determined by studies with radiolabelled zeranol, since this
level is lower than that calculated from the ADI as the maximum
permissible on toxicological grounds.
7 Based on the lowest level consistent with the practical
analytical methods available for routine residue analysis.