Safety evaluation of certain food additives - ipcs inchem

12 ASPARAGINASE FROM ASPERGILLUS NIGER
Asparaginase was evaluated for potential allergenicity according to the
bioinformatics criteria recommended by the FAO/WHO Expert Consultation (2001).
The amino acid sequence of asparaginase was compared with the amino acid
sequences of known allergens. No sequence homology that would suggest that
asparaginase is an allergen was identified.
4.2 Assessment of dietary exposure
An estimate of dietary exposure was made by the Committee based on the
13 Consumption Cluster Diets of the GEMS/Food categorization and on the Concise
European Food Consumption Database for the adult population (age 16–64 years).
The European database compiles mean and high percentiles of individual food
consumption for 15 broad food categories from the majority of European countries
(n = 17). The GEMS/Food cluster diets report per capita daily consumption of food
commodities. In these estimates, reported consumption data have been combined
with the maximum use levels recommended. This corresponds to 23 mg TOS/kg
food for cereal-based products and 428 mg TOS/kg food for potato-based products.
For the GEMS/Food data, the food categories used in the calculation were cereals
and root and tuber commodities. For the European database, the food categories
used were cereals and cereal products and starchy root or potato products.
The potential dietary exposure to asparaginase from A. niger based on
international and national conservative estimates for the adult population, assuming
a body weight of 60 kg, range from 0.5 to 3.7 mg TOS/kg bw per day (0.5–1.7 mg
TOS/kg bw per day for Europe and 0.8–3.7 mg TOS/kg bw per day based on GEMS/
Food cluster diets) for mean consumers and from 1.1 to 4.1 mg TOS/kg bw per day
for high-percentile consumers (95th percentile) in Europe.
The Committee noted that these results were conservative because they
assume the consumption of foods from two (of the 15) broad food categories, both
of which contained asparaginase at the highest reported use levels.
5. EVALUATION
Comparing the most conservative estimate of exposure (i.e. 4.1 mg TOS/kg
bw per day) with the NOEL of 1038 mg TOS/kg bw per day from the 13-week study
of oral toxicity, the margin of exposure is about 250. The Committee allocated an
acceptable daily intake (ADI) “not specified” for asparaginase from A. niger
expressed in A. niger used in the applications specified and in accordance with good
manufacturing practice.
6. REFERENCES
Center for Food Safety and Applied Nutrition (2006) Estimating dietary intake of substances
in food. College Park, MD, USA, United States Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Office of Food Additive Safety (http://
www.cfsan.fda.gov/~dms/opa2cg8.html).
Codex Alimentarius Commission (2007) Report of the Thirty-ninth Session of the Codex
Committee on Food Additives, Beijing, China, 24–28 April. Rome, Italy, Food and