ENZYME PREPARATIONS
Problems in evaluating the safety of enzymes in food processing
were discussed at the fifteenth, eighteenth and twenty-ninth meetings
of the Expert Committee, when principles relating to their evaluation
were elaborated (Annex 1, references 26, 35, and 70). At its present
meeting, the Committee reaffirmed those principles, which have been
consolidated in Annex III of "Principles for the Safety Assessment of
Food Additives and Contaminants in Food" (Annex 1, reference 76).
For the purpose of toxicological evaluation, the enzyme
preparations under present consideration were grouped into the
following classes:
- Class III - Enzymes derived from Aspergillus oryzae;
- Class IV - Enzymes derived from Aspergillus niger; and
- Class V - Enzymes derived from Trichoderma reesei, Trichoderma
harzianum, Penicillium funiculosum, Aspergillus
alliaceus.
The guidelines established by JECFA for these classes of enzymes
provide a basis for the toxicological studies required for their
evaluation.
At the twenty-ninth meeting the Committee concluded that, when
enzyme preparations from either class IV or class V are added directly
to food but not subsequently removed, an acceptable daily intake
should be established to ensure that levels of the enzyme preparations
in food are safe. In order to evaluate the information received on the
estimate of the amount of enzyme preparations used in the
toxicological studies and levels of consumption resulting from their
use in food, the Committee adopted the concept of enzyme total organic
solids (TOS), which is defined as follows; % TOS = 100-(A+W+D), where
A = Z ash, W = % water, and D = % diluent and carrier (Ad hoc
Enzyme Technical Committee, 1981; Pariza & Foster, 1983). This concept
overcomes the problem that enzyme preparations of different activities
and forms were used in the toxicological studies. It also takes into
account that most of the organic solids in this fraction are not the
enzyme per se.
In establishing acceptable daily intakes for the enzymes in
classes IV and V, the Committee noted that the animal feeding studies
were primarily of short-term duration. It, therefore, concluded that
it would be appropriate to use a safety factor greater that the usual
100.
REFERENCES
Ad hoc Enzyme Technical Committee 41981). The 1978 enzyme survey,
summarized data, National Academy of Sciences/National Research
Council/Food and Nutrition Board, Committee on GRAS List Survey,
Phase III, National Academy Press, Washington, D.C.
Pariza, M.W. & Foster, E.M. 41983). Determining the Safety of Enzymes
used in Food Processing, J. Food Protection, 46: 453-468.