Safety evaluation of certain food additives - ipcs inchem

POLYDIMETHYLSILOXANE (addendum) 179
on dietary exposures were required based on the current version of GSFA
acceptable maximum use levels for PDMS.
Poundage data were not available for PDMS. Potential mean dietary
exposure for the Australian population based on individual dietary records was
11 mg/day (0.2 mg/kg bw per day) for consumers of foods containing PDMS; for
high consumers (at the 90th percentile) of PDMS, dietary exposure was 27 mg/day
(0.5 mg/kg bw per day). Potential mean dietary exposure for the New Zealand adult
population was 10 mg/day (0.1 mg/kg bw per day); for high consumers (at the 90th
percentile) of PDMS, potential dietary exposure was 26 mg/day (0.3 mg/kg bw per
day). Major contributors to total potential dietary exposure were water-based
flavoured drinks, alcoholic beverages, flour products, desserts, and fruit and
vegetable preparations.
To determine whether these results were typical of other countries with
similar levels of production of processed foods, potential dietary exposures to
PDMS were estimated for 17 European countries using information on diets from
the Concise European Food Consumption Database for the adult population aged
16–64 years, assuming PDMS was used at the GSFA acceptable maximum levels.
Potential mean dietary exposures to PDMS for European populations ranged from
17 to 30 mg/day (0.2–0.4 mg/kg bw per day); for high consumers (95th percentile),
potential dietary exposures ranged from 35 to 83 mg/day (0.5–1.1 mg/kg bw per
day). Major contributors were cereal and cereal products and non-alcoholic and
alcoholic beverages. However, it should be noted that basing potential dietary
exposures on the amounts of food consumed for 15 broad food categories will
overestimate the dietary exposure to PDMS, as use is often restricted to specific
subgroup categories within the broader food groups.
For Australia and New Zealand, potential mean dietary exposures to PDMS
for consumers only of foods containing PDMS were 19% and 17% of the temporary
ADI of 0–0.8 mg/kg bw, respectively; for 90th-percentile consumers, potential
dietary exposures were 66% and 43% of the temporary ADI, respectively. Potential
mean dietary exposures to PDMS for European countries were similar to those
for Australia and New Zealand, although somewhat higher for high consumers
(potential mean dietary exposure, 28–49% of the temporary ADI; high consumers’
dietary exposure, 66–138% of the temporary ADI).
The limited data available indicate that there may be potential to exceed the
temporary ADI for high consumers of PDMS; however, all dietary exposures are
likely to be overestimates, as maximum levels of use for PDMS were assumed and,
for the European countries, it was assumed that PDMS was used in broader food
categories than those listed in the GSFA. In reality, this is unlikely, as alternative
food additives will be used in some foods, and use levels may be lower than the
acceptable maximum level.
5. EVALUATION
Absorption studies on the 10 cSt and 350 cSt material indicated that neither
product was absorbed to any significant extent. Also, the new toxicological studies