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

The Committee concluded that the estimated dietary exposure to OSA modified
gum arabic from the proposed uses would be less than 20 mg/kg bw
per day.
Evaluation
Only limited data were available for OSA modified gum arabic. The Committee
concluded that the available data on OSA modified gum arabic indicate
a very low toxicity, comparable with the toxicities of traditional gum arabic
and starch sodium octenyl succinate (OSA modified food starch), both of
which were previously reviewed by the Committee and allocated ADIs “not
specified”.
Comparing the exposure estimate of 20 mg/kg bw per day with the NOEL
from the 90-day study of oral toxicity in rats (3410 mg/kg bw per day, the
highest dose tested), the margin of exposure is at least 170. The Committee
decided to allocate a temporary ADI “not specified” to OSA modified gum
arabic, used in the applications specified and in accordance with Good Manufacturing
Practice. The Committee decided to make the ADI temporary
pending submission of data by the end of 2011 showing hydrolysis of OSA
modified gum arabic to confirm the validity of using gum arabic data in the
evaluation of OSA modified gum arabic.
A toxicological monograph was prepared. A Chemical and Technical Assessment
and new specifications were prepared.
3.1.12Sodium hydrogen sulfate
Explanation
At the present meeting, the Committee evaluated sodium hydrogen sulfate
for use as an acidifier, at the request of CCFA at its fortieth session (7). The
Committee was asked for a safety assessment and revision of specifications.
At its sixty-eighth meeting, the Committee considered sodium hydrogen sulfate
for use in the preparation of acidified sodium chlorite, an antimicrobial
washing solution, and established specifications, but did not evaluate it for
safety (Annex 1, reference 187). At its ninth and twenty-third meetings, the
Committee evaluated a large number of food acids and salts and was of the
opinion that ADIs for ionizable salts should be based on previously accepted
recommendations for the constituent cations and anions (Annex 1, references
11 and 50).
The sulfate ion was evaluated at the twenty-ninth meeting of the Committee
(Annex 1, reference 70), when an ADI “not specified” was established, as
sulfate is a natural constituent of food and is a product of sulfur metabolism
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