Safety evaluation of certain food additives - ipcs inchem

ETHYL LAUROYL ARGINATE 77
About 99% of the population aged 2 years and older reported consumption
of foods in one or more of the food categories listed. Based on the assumption that
ethyl lauroyl arginate is present at the proposed level in all foods within all the food
categories listed, the mean dietary exposure to ethyl lauroyl arginate for the general
population in the USA would be 3.0 mg/kg bw per day, and consumption at the 90th
percentile would be 5.6 mg/kg bw per day.
The Committee was aware that both the USA and the European Union (EU)
have issued evaluations of the use of ethyl lauroyl arginate in food. In the USA, a
GRAS notice was submitted by Laboratorios Miret S.A. for ethyl lauroyl arginate use
in foods, including meat and poultry products, at levels up to 200 mg/kg. The mean
estimated dietary exposure contained in the GRAS document was 2.2 mg/kg bw
per day, with consumption at the 90th percentile estimated to be 4.2 mg/kg bw per
day. These estimates are consistent with those contained in the dossier submitted
to the Committee.
EFSA reviewed the safety of ethyl lauroyl arginate use in a variety of food
matrices in 2007. The uses reviewed included beverages, heat-treated and dried
meat products, dried fish, rehydrated legumes, fish roe and prepared salads. For
this ensemble of treated products, national estimates of dietary exposure were
considered for 13 European countries using the Dose Adjustment for Normal Eating
(DAFNE) database. These are household budget or expenditure data from Belgium,
France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Norway, Poland,
Portugal, Spain and the United Kingdom. For the total population, the estimated
mean potential exposure to ethyl lauroyl arginate from all proposed food uses
combined ranged from 0.14 mg/kg bw per day (France) to 0.50 mg/kg bw per day
(Luxembourg), with an overall average of 0.32 mg/kg bw per day. The overall
principal contributors to potential exposure were non-alcoholic flavoured drinks
containing fruit juice (51%) and meat products (33%). An additional analysis was
available using individual dietary records from the United Kingdom National Diet
and Nutrition Survey. The mean potential exposure to ethyl lauroyl arginate for
consumers ranged from 0.11 mg/kg bw per day in the elderly to 0.83 mg/kg bw per
day in children 1.5–4.5 years old. Dietary exposure at the 97.5th percentile in
consumers only ranged from 0.37 mg/kg bw per day in the elderly to 2.89 mg/kg bw
per day in children aged 1.5–4.5 years. The Committee attributed the lower
estimates evaluated by EFSA to the reduced list of food categories proposed for
treatment with ethyl lauroyl arginate.
The Committee prepared a bounding estimate of dietary exposure to ethyl
lauroyl arginate based on default assumptions of food and beverage consumption
combined with the proposed ethyl lauroyl arginate use levels. If all solid food in the
diet, 1500 g/day (default estimate used in the USA), were treated at 200 mg ethyl
lauroyl arginate/kg, exposure would be 300 mg/day or 5 mg/kg bw per day for a
60-kg individual. The addition of 500 g/day (default estimate, USA) of beverages
treated at 100 mg/kg would result in an overall exposure of 350 mg/day or 6 mg/kg
bw per day. These bounding estimates are only slightly higher than the international
estimates of dietary exposure and the national estimate for the USA submitted to
the Committee.