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

average intakes to 30-day averages using a factor calculated from the number
of days on which a food was reported to be consumed over an additional 30-
day survey period. The adjusted mean dietary exposure was 2.7 mg/kg bw
per day; at the 90th percentile, dietary exposure was 5.4 mg/kg bw per day.
The Committee concluded that the estimated 90th-percentile dietary exposure
to cassia gum from the proposed uses would be less than 6 mg/kg bw per day.
Evaluation
Comparing the conservative exposure estimate of 6 mg/kg bw per day with
the lowest reported NOAEL of 1000 mg/kg bw per day (the highest dose
tested) derived from the developmental toxicity studies in rats and rabbits,
the margin of exposure is at least 160. The Committee noted that in a 28-day
study in rats, in 90-day studies in dogs and cats and in a two-generation study
in rats, no adverse effects were observed at doses up to, respectively, 4590,
3290, 2410 and 5280 mg/kg bw per day, the highest doses tested in these
studies.
Considering the low toxicity and the negative genotoxicity results, the
Committee allocated an ADI “not specified” for cassia gum that complies
with the tentative specifications established at the current meeting, when used
in the applications specified and in accordance with Good Manufacturing
Practice.
As the method for determination of anthraquinones at a level of 0.5 mg/kg
and below was not considered to be suitable for inclusion in the specifications,
the Committee decided to make the specifications tentative pending submission
of data on a suitable and validated method by the end of 2010.
A toxicological monograph was prepared. A Chemical and Technical Assessment
and new tentative specifications were prepared.
3.1.3 Cyclamic acid and its salts: dietary exposure assessment
Explanation
Cyclamic acid and its sodium and calcium salts are food additives commonly
termed “cyclamates”. Cyclamates are used in over 50 countries as intense
sweeteners in a range of food categories.
The fortieth session of CCFA in 2008 (7) requested an evaluation by JECFA
of the impact on dietary exposures to cyclamates of different maximum
levels of use of cyclamates in the Codex GSFA Food Category 14.1.4,
Water-based flavoured drinks, including “sport”, “energy” or “electrolyte”
drinks and particulated drinks, which includes all carbonated and noncarbonated
varieties and concentrates, products based on fruit and vegetable
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