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

with other intense sweeteners. As beverages covered by Food Category 14.1.4
are major contributors to dietary exposure to intense sweeteners, the concentration
of cyclamates in these products can considerably influence total
dietary exposures.
Most reported mean dietary exposures to cyclamates were below the ADI
of 0–11 mg/kg bw; however, several studies reported population subgroups
for which exposures for high consumers approached or exceeded the ADI
when cyclamate levels in beverages covered by Food Category 14.1.4 were
400 mg/kg or over, particularly for children and in one study for people with
diabetes. Theoretical models for the Australian population indicated that
maximum use levels for cyclamates of 500 mg/kg and under in all foods with
Codex GSFA provisions and in beverages in Food Category 14.1.4 would be
protective of all populations, except for young children who were high consumers.
However, these estimates were likely to overestimate dietary exposure,
as it was assumed that all low-joule soft drinks contained cyclamates
and that all fruit juices, juice nectars and fine bakery wares contained cyclamates,
which in reality would not be the case. A more accurate estimate for
the Australian population using typical use levels for cyclamates indicated
that maximum use levels for cyclamates of 400 mg/kg and above in beverages
covered by Food Category 14.1.4 would result in dietary exposures to cyclamates
that exceeded the ADI of 0–11 mg/kg bw for children up to 11 years
of age who were high consumers.
Conclusion
Of the four maximum use levels (250, 500, 750 and 1000 mg/kg) that the
Committee considered at the request of CCFA for cyclamates in beverages
covered by Codex GSFA Food Category 14.1.4, only the lowest level of
250 mg/kg was not likely to lead to dietary exposures exceeding the ADI for
high consumers, including children. Moreover, it was noted that a maximum
use level of 350 mg/kg also resulted in dietary exposures for high consumers,
including children, that were less than the ADI.
A dietary exposure monograph was prepared.
3.1.4 Cyclotetraglucose and cyclotetraglucose syrup
At its sixty-eighth meeting (Annex 1, reference 187), the Committee evaluated
cyclotetraglucose and cyclotetraglucose syrup for use as a stabilizer and
carrier. Cyclotetraglucose and cyclotetraglucose syrup are produced from
hydrolysed food-grade starch by the action of a mixture of 6-GT and IMT
derived from Sporosarcina globispora and cyclodextrin glycosyltransferase
derived from Bacillus stearothermophilus. The Committee allocated a temporary
ADI “not specified” for cyclotetraglucose and cyclotetraglucose syrup
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