Safety evaluation of certain food additives - ipcs inchem

80 ETHYL LAUROYL ARGINATE
expressed as the active component, ethyl-N -lauroyl-L-arginate HCl. Studies of
potential developmental effects have been conducted in rats and rabbits given ethyl
lauroyl arginate by oral gavage during pregnancy. The material used in these
studies did not meet the proposed specifications for the content of the active
ingredient. There were no adverse effects on fetal survival or development.
Respiratory distress reported in some rats and rabbits at higher doses was
considered to be an artefactual effect resulting from gavage dosing with the irritant
solution and thus was not considered to be of relevance for dietary exposure.
Long-term studies of carcinogenicity were not available. However, the
absence of preneoplastic lesions in the 52-week study and the absence of genotoxic
activity do not suggest that ethyl lauroyl arginate has carcinogenic potential.
4.2 Assessment of dietary exposure
The Committee evaluated data submitted by the sponsor, as well as
published information on an evaluation of ethyl lauroyl arginate completed by EFSA.
Additionally, the Committee prepared international estimates of dietary exposure
using GEMS/Food cluster diets.
Ethyl lauroyl arginate is used in many food types, with a maximum level for
the active ingredient of 200 mg/kg. Carbonated beverages could be treated at
concentrations of up to 100 mg/kg. The Committee noted that use levels based on
the active ingredient are approximately 15% lower than those based on the article
of commerce (i.e. the use level for the article of commerce is up to 225 mg/kg).
The current GEMS/Food international diets, derived from 13 clusters, were
used to prepare international estimates of dietary exposure. They ranged from 1.0
(cluster J) to 4.5 (cluster B) mg/kg bw per day. A few food types not expected to
contribute significantly to the overall dietary exposure were not included in the
international estimates.
The sponsor submitted an estimate of dietary exposure to ethyl lauroyl
arginate using data on food consumption from the USA. 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 noted that EFSA reviewed the safety of ethyl lauroyl arginate
in a variety of food matrices in 2007. Using the DAFNE database, the mean dietary
exposure 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. Using individual
dietary records from the United Kingdom, the mean dietary exposure ranged from
0.11 mg/kg bw per day in the elderly to 0.83 mg/kg bw per day in children aged
1.5–4.5 years. At the 97.5th percentile, dietary exposure ranged from 0.37 mg/kg
bw per day in the elderly to 2.9 mg/kg bw per day in children aged 1.5–4.5 years.
The Committee noted for comparison that treatment of all solid food in the
diet (default value, 1500 g/day from the USA) at 200 mg/kg would result in a dietary
exposure of 5 mg/kg bw per day. Including treatment of carbonated beverages at
100 mg/kg (default value, 500 g/day from the USA) would make the total