INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF SOME
FOOD COLOURS, ENZYMES, FLAVOUR
ENHANCERS, THICKENING AGENTS, AND
CERTAIN FOOD ADDITIVES
WHO FOOD ADDITIVES SERIES 6
The evaluations contained in this publication were prepared by the
Joint FAO/WHO Expert Committee on Food Additives which met in Rome,
4-13 June 19741
World Health Organization Geneva 1975
1 Eighteenth Report of the Joint FAO/WHO Expert Committee on
Food Additives, Wld Hlth Org. techn. Rep. Ser., 1974, No. 557.
FAO Nutrition Meetings Report Series, 1974, No. 54.
No information available.
Special studies on reproduction
From the 32 rats treated with betanin to a level of 17 g/animal
was produced an F2 generation of 24 pups. These received a total of
25 g betanin per animal and showed a mean life span of 800 days. Only
2 mammary fibro adenomata and no other adverse effects were seen in
the test group (Druckrey, 1959).
No death could be obtained on oral administration of high doses
A group of 32 male and female rats received betanin in their
drinking water to a total dose of 17 g per animal. The mean life span
was 845 days, the last animal dying at 1220 days. A group of 56 rats
acted as controls. In the test group occurred 1 intraperitoneal
sarcoma and 1 mammary fibro adenoma, in the controls 2 sarcomas and 2
fibro adenomata (Druckrey, 1959).
A group of 27 male and female rats received s.c. injections of
betanin (concentration not stated) and a control group of 56 rats was
also studied. The mean life span of the test animals was similar to
that of controls at 800 days, the maximum life span 1250 days. The
test animals developed 5 fibro adenomata of the breast and 2
unidentified tumours, the controls had 4 fibro adenomata of the
breast, 1 renal adenoma, 1 sarcoma and 3 unidentified tumours
There is no information available on the metabolism of this
naturally occurring betanin. The available long-term and reproduction
studies are inadequate because only a few parameters were examined and
many other essential observations have not been reported. No specific
information is available on embryotoxicity including teratogenicity.
This colour is, however, a normal constituent of food. Although the
primary criteria are the same for evaluating the safety of food
colours whether of natural or synthetic origin, consideration must be
given to the quantities of food colour ingested as a result of
technological use relative to its ingestion as an ingredient of food.
This and the availability of an adequate specification permits
evaluation in the absence of a full range of toxicological
ADI not specified.*,**
FURTHER WORK OR INFORMATION
Required by June 1978
(a) metabolic studies preferably including man;
(b) adequate long-term study in one acceptable species.
Druckrey, H. (1959) Personal communication
* The statement "ADI not specified" means that, on the basis of the
available data (toxicological, biochemical, and other), the total
daily intake of the substance, arising from its use or uses at the
levels necessary to achieve the desired effect and from its acceptable
background in food, does not, in the opinion of the Committee,
represent a hazard to health. For this reason, and for the reasons
stated in individual evaluations, the establishment of any acceptable
daily intake (ADI) in mg per kg of body weight is not deemed