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.
MICROBIAL GLUCOSE OXIDASE* (Aspergillus niger)
This enzyme preparation has been evaluated for acceptable daily
intake by the Joint FAO/WHO Expert Committee on Food Additives (see
Annex 1, Ref. No. 27) in 1971.
Since the previous evaluation additional data have become
available and are summarized and discussed in the following monograph.
The previously published monograph has been expanded and is reproduced
in its entirety below.
No data available.
Three groups of 10 male and 10 female Charles River rats were fed
0, 5 and 10% of Aspergillus niger mycelial preparation in their diet
for 90 days. There were no overt signs of toxicity, and food
consumption and growth were not affected. There was a drop in the
efficiency of food utilization for all dosed groups, it was
significant for the males in the high dose group. The haematological,
the clinical and the ophthalmoscopic data revealed no significant
differences between the groups. There were significant increases in
the relative kidney weight of females in both dosage groups. The gross
and microscopic findings were mostly related to chronic respiratory
disease and kidney lesions including hydropelvis or hydronephrosis,
which did not appear to be treatment-related (Swann & Cox, 1973).
* This enzyme preparation is prepared from some varieties of
Groups of five ducklings received in their diet either 0, 1, 5 or
10% of enzyme for 29 days. Growth, feed efficiency, behaviour and
survival were similar in all groups except the 10% level which showed
some growth retardation. No gross liver lesions or differences in mean
liver weight were noted. Histopathology was normal. No toxic element
was noted (FDRL., 1963).
Aspergillus niger is a common contaminant of food. The
available information indicates that it is not pathogenic to man. A
duckling study was done and a 90-day study in rats is now available
showing no toxicological effects at 10% in the diet. This meets the
requirements as laid down by the Committee.
Acceptable daily intake not specified.*
FDRL (1963) Unpublished report No. 84600d of the Food and Drug
Research Laboratories submitted by Miles Chemical Co.
Swann, H. E. & Cox, G. E. (1973) Unpublished report la. No. 1223
submitted by Searle Biochemicals
* 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 an acceptable
daily intake (ADI) in mg per kg of body weight is not deemed