Safety evaluation of certain food additives - ipcs inchem

POLYDIMETHYLSILOXANE (addendum) 173
0–0.8 mg/kg bw per day (see section 5), that 50% of PDMS is used in solid food
and 50% in beverages and that only 25% of the total amount of solid food and
beverages in the food supply contain the food additive, the theoretical maximum
level of PDMS would be 64 mg/kg for food and 16 mg/kg for beverages. The
theoretical maximum levels for solid food and beverages were lower than the
relevant GSFA maximum use level of 110 mg/kg for solid food and 20 mg/kg for
beverages. Hence, data on dietary exposures were required based on the current
version of GSFA acceptable maximum use levels for PDMS.
3.2 Dietary exposure based on individual dietary records
Poundage data were not available for PDMS. Potential dietary exposure
estimates from Australia and New Zealand were submitted, based on individual
dietary records for these populations, individual body weights and GSFA maximum
levels of use. PDMS is permitted at Good Manufacturing Practice (GMP) levels
in Australia and New Zealand; no other use level data were available (Food
Standards Australia New Zealand, 2008). Potential mean dietary exposures for
the whole population were 11 mg/day for Australia and 10 mg/day for New Zealand.
For those people who reported consuming foods assigned a PDMS concentration
level, potential mean dietary exposures were the same as those for the whole
population, as PDMS can be used in a wide range of foods. For high consumers
(90th percentile), potential dietary exposures to PDMS were 27 mg/day in Australia
and 26 mg/day in New Zealand (Table 3). The major contributors to total potential
dietary exposure, assuming PDMS to be used in all food categories in the GSFA
listed in Table 2, were water-based flavoured drinks (45% Australia, 37% New
Zealand), alcoholic beverages (18% Australia, 21% New Zealand), flour products
(14% Australia, 20% New Zealand), desserts (6% New Zealand) and fruit and
vegetable preparations (6% Australia).
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 several countries using information on diets from the Concise
European Food Consumption Database (European Food Safety Authority, 2008).
Potential mean dietary exposures to PDMS were calculated for the whole adult
population aged 16–64 years for the 17 countries in the database, assuming PDMS
was used at the GSFA maximum levels. Potential mean dietary exposures for
each country ranged from 17 to 30 mg/day; for high consumers of PDMS, potential
dietary exposures ranged from 35 to 83 mg/day (Table 4). High-consumer dietary
exposures were estimated by taking the consumption for the two food categories
with the highest dietary exposure at the 95th percentile plus the mean for the
population for all other food categories (European Food Safety Authority, 2008).
Major contributors were “cereal and cereal-based products”, “non-alcoholic
beverages” 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 the use of PDMS is
often restricted to specific subgroup categories within the broader food groups. This
is true in particular for the “cereal and cereal-based products”, “fruit and fruit
products” and “vegetables and vegetable products” food categories.