Safety evaluation of certain food additives - ipcs inchem

10 ASPARAGINASE FROM ASPERGILLUS NIGER
Table 3. Estimated daily dietary exposure to asparaginase in the Netherlands
Processed food Concentration of
TOS in food (mg/kg)
90th-percentile
consumption level
(g food/person
per day) a
Estimated
90th-percentile
daily exposure
(mg TOS/kg bw) b
Bread c 1.48–9.97 270 0.007–0.045
Cereal-based
products d
Potato-based
products e
0.14–23.1 170 0.0004–0.065
2.85–428 228 0.011–1.63
Savoury ingredients f 2.68–3.54 340 0.015–0.020
Total 0.033–1.76
a The consumption level of the average Dutch population is taken from the Dutch food
consumption survey (Voedingscentrum, 1998), and the 90th-percentile consumption intake
is assumed to be 2 times the average consumption level (Center for Food Safety and Applied
Nutrition, 2006).
b Calculated for a 60-kg person; 90th-percentile daily dietary exposures for each commodity
have been summed for the total.
c Food category: bread (not further specified).
d Food categories: i) cereals and cereal products, ii) cake and biscuits.
e Food category: potatoes, which includes—apart from crisps and cookies made from potato
dough—cooked potatoes and fries (not further specified).
f Food categories: i) soups, ii) fats, oils and savoury sauces, iii) mixed dishes and iv) processed
cheese.
The consumption data for potato-based products include potatoes and fries,
whereas asparaginase is meant to be used merely in crisps and cookies made from
potato meal. As a result, the estimated daily dietary exposure is considered to be
conservative.
An estimate of dietary exposure to (denatured) asparaginase was made by
the Committee at the present meeting based on the Concise European Food
Consumption Database for the adult population (16–64 years old), published by the
European Food Safety Authority (EFSA) in 2008 (European Food Safety Authority,
2008). This database compiles mean and high percentiles of individual food
consumption for 15 broad food categories from the majority of European countries
(n = 17). Mean and high consumption amounts of cereals and cereal products and
starchy root or potato products by European Union (EU) member states were
combined with the maximum use levels proposed by the petitioner for the
corresponding food commodities (Table 2). According to the guidance document
for the use of the concise database provided by EFSA in doing exposure
assessment calculations, the dietary exposure for high-level consumers was
derived by summing the 95th-percentile consumption for two food groups and the
mean consumption for all other food groups (EFSA, 2008). Here, as only two food