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

to SOE type I and type II was 45 mg/day (0.8 mg/kg bw per day) and 90thpercentile
exposure was 98 mg/day (1.6 mg/kg bw per day), assuming a
maximum use level of 5000 mg/kg for all food categories included in the
assessment. This mean dietary exposure estimate for the USA was of the same
order of magnitude as the per capita estimates for the population in the USA
based on poundage data.
Evaluation
The available ADME data for the components of SOE type I and for lowrange
sucrose esters of fatty acids indicate that only the lower esters were
hydrolysed to any appreciable extent. The Committee concluded that these
data and the results of the newly available 12-month toxicity study and 2-year
carcinogenicity study on SOE type I did not identify any effects of toxicological
concern at the highest dose tested.
The Committee noted that some of the components of sucrose esters of fatty
acids may be present in significant amounts in SOE type I and type II. The
Committee also noted that the group ADI of 0–30 mg/kg bw allocated to
sucrose esters of fatty acids and sucroglycerides was based on a potential
laxative effect in humans. The Committee therefore considered that it was
appropriate to include SOE type I and type II in a group ADI of 0–30 mg/kg
bw for sucrose esters of fatty acids, sucroglycerides and SOE type I and type
II. Estimated dietary exposures to SOE type I and type II combined for mean
and high consumers, based on typical or maximum use levels, were well
below the ADI of 0–30 mg/kg bw, with estimates ranging from 3% to 15%
of the ADI.
The Committee emphasized that this evaluation is valid only for the material
as specified. A toxicological monograph was prepared. New specifications
and a Chemical and Technical Assessment were prepared for SOE type I and
type II.
3.2 Revision of specifications
3.2.1 Diacetyltartaric and fatty acid esters of glycerol
Diacetyltartaric and fatty acid esters of glycerol (DATEM) were placed on
the agenda of the present meeting for revision of specifications at the request
of CCFA at its fortieth session (7). The Committee was informed that the
existing procedure for determining free fatty acids was not appropriate for
analysing the content of free fatty acids in DATEM, as it also captures other
acids present in the product, thereby producing incorrect results. The Committee
agreed to delete the criteria for free fatty acids and to replace them
with the criteria for acid value. Minor editorial revisions were also made.
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