Safety evaluation of certain food additives - ipcs inchem

40 ETHYL LAUROYL ARGINATE
under which it would be evaluated. Ethyl lauroyl arginate was evaluated by the
Committee at its present meeting at the request of the Codex Committee on Food
Additives at its Thirty-ninth Session (Codex Alimentarius Commission, 2007). The
Committee was asked to evaluate all data necessary for the assessment of the
safety, dietary intake and specifications of ethyl lauroyl arginate. The Committee
had not previously evaluated ethyl lauroyl arginate.
In 2007, the European Food Safety Authority (EFSA) established an
acceptable daily intake (ADI) for ethyl lauroyl arginate of 0.5 mg/kg body weight (bw)
per day (European Food Safety Authority, 2007). On 1 September 2005, the United
States Food and Drug Administration issued a letter indicating that it had no
questions regarding a Notice that ethyl lauroyl arginate is Generally Recognized as
Safe (GRAS) (GRAS Notice No. GRN 000164) for use as an antimicrobial agent at
concentrations of up to 225 mg/kg in the categories specified (United States Food
and Drug Administration, 2005).
The Committee received a submission containing unpublished information
on ethyl lauroyl arginate, including studies on N -lauroyl-L-arginine and a commercial
formulation containing 19.5% ethyl-N -lauroyl-L-arginate hydrochloride
(HCl) and 73% propylene glycol. Some of the results of these studies have been
published in the open literature. A search of the scientific literature was conducted,
but no additional information was identified.
1.1 Chemical and technical considerations
Ethyl lauroyl arginate is synthesized by first esterifying L-arginine with
ethanol to obtain ethyl arginate HCl, which is then reacted with lauroyl chloride to
form the active ingredient ethyl-N -lauroyl-L-arginate HCl. Ethyl-N -lauroyl-Larginate
HCl, which is present in the product in the range of 85–95%, is a cationic
surfactant that has a wide spectrum of activity against bacteria, yeasts and moulds.
N -Lauroyl-L-arginine, a by-product in the manufacture of ethyl-N -lauroyl-Larginate
HCl, is also formed by enzymatic action in fresh food. The intended use of
ethyl lauroyl arginate is as a food preservative to prevent microbial growth and
spoilage in a range of foods and drinks, to be used at concentrations of up to
225 mg/kg.
2. BIOLOGICAL DATA
2.1 Biochemical aspects
2.1.1 Absorption, distribution and excretion
(a) Rats
The plasma pharmacokinetics of ethyl lauroyl arginate (purity, 91.9% ethyl-
N -lauroyl-L-arginate HCl) and its by-product and metabolite, N -lauroyl-L-arginine,
were determined in Sprague-Dawley (Crl:CD (SD)) rats with different oral (gavage)
dose and formulation conditions. All experiments were carried out in compliance
with Good Laboratory Practice (GLP) and Organisation for Economic Co-operation