evaluation of certain food additives - libdoc.who.int - World Health ...

SOE type II tested negative in a reverse mutation assay in bacterial cells. No
genotoxicity data were available for SOE type I.
Assessment of dietary exposure
SOE type I and type II are used as emulsifiers in fats and oils, chocolate,
cream, seasonings and condiments, and some tablet forms of hard sweets and
dietary supplements, with typical use levels ranging from 2000 to 10 000 mg/
kg and a maximum use level of 20 000 mg/kg. There are several other additives
available that perform the same function in foods, so SOE type I and
type II are expected to capture only a small proportion of the total market for
emulsifiers (10%). As the functional uses of SOE type I and type II are
similar and there is common use across some food categories, the dietary
exposure was estimated for SOE type I and type II combined.
Use of the budget method indicated that detailed dietary exposure estimates
were required for SOE type I and type II, as the theoretical maximum permitted
use level of 4800 mg/kg was less than that expected to be used in some
food categories (maximum 20 000 mg/kg).
Per capita estimates of dietary exposure to SOE type I and type II from use
as an emulsifier based on poundage data were 60 and 110 mg/day for the USA
and Japan, respectively. The Committee noted that this was an overestimate
for Japan owing to the inclusion of sucrose esters of fatty acids in the reported
data. The estimate for the USA assumed 10% of all production of emulsifiers
to be SOE type I and type II, which was supported by the industry submission
that indicated that SOE type I and type II would capture no more than 10%
of the emulsifier market in the USA.
From the limited data submitted by the sponsor on the dietary exposure to
SOE type I and type II based on national nutrition survey food consumption
data, estimated mean dietary exposures for two populations where a wide
range of processed foods are available, Japan and the USA, ranged from 115
to 150 mg/day (1.9–2.5 mg/kg bw per day), assuming typical SOE use across
different food categories. Estimated mean dietary exposures for Japan and
the USA, assuming maximum SOE type I and type II use levels across different
food categories, ranged from 220 to 270 mg/day (3.7–4.6 mg/kg bw
per day). However, the Committee considered these dietary exposures
predicted for Japan and the USA to be overestimates because of assumptions
made in the calculations, as not all products in each category will contain
SOE type I or type II, and consumers will not consistently select those foods
containing SOE type I and type II over a lifetime.
Another estimation of dietary exposures based on individual dietary records
for the population in the USA was evaluated, where mean dietary exposure
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