Opinion of the Scientific Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) related to an application on the use of ethyl lauroyl arginate as a food additive

Abstract

SUMMARYThe Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food has been asked to evaluate the safety in use of ethyl lauroyl arginate as a food preservative for use in the food categories specified in the dossier.The active ingredient of ethyl lauroyl arginate, ethyl-N α -lauroyl-L-arginate HCl, is the hydrochloride salt of an N-fatty acylsubstituted amino acid ethyl ester. Ethyl lauroyl arginate is intended to be used as a preservative. The anti-microbial activity of ethyl lauroyl arginate is due to the cationic surfactant properties of its active ingredient ethyl-N α -lauroyl-L-arginate.Ethyl lauroyl arginate has been shown by in vivo and in vitro studies in rats and humans to be rapidly metabolised by hydrolysis of the ethyl ester and lauroyl amide to the intermediate products, arginine ethyl ester and N α -lauroyl-L-arginine, and then to ethanol, lauric acid and arginine. Arginine undergoes natural amino acid catabolism to urea and ornithine. Ornithine can then be further metabolised to CO 2 and urea. Lauric acid is a fatty acid that can enter normal fatty acid metabolism. Ethanol can be converted by alcohol dehydrogenase and aldehyde dehydrogenase to acetate, which can enter normal biochemical pathways. It is concluded that, on ingestion by humans, ethyl lauroyl arginate will be broken down to products of normal metabolism.The Panel considered the bacterial reverse mutation assay study could not be used for evaluation of mutagenicity due to the high toxicity of ethyl-N α -lauroyl-L-arginate towards the bacterial cells. The Panel noted that this toxicity was predictable since ethyl-N α -lauroyl-Larginate is a preservative with antimicrobial activity. Based on the results from the mouse lymphoma L5178Y cell mutation test and from the test for chromosomal aberrations in human lymphocytes it is concluded that ethyl-N α -lauroyl-L-arginate is not genotoxic in mammalian cells. It showed no evidence of a genotoxic effect in the in vivo mouse micronucleus test. Lauric arginate The EFSA Journal (2007) 511, p. 2 of 27According to the available evidence, ethyl lauroyl arginate is devoid of reproductive and developmental toxicity. Long-term carcinogenicity studies are lacking. However, the rapid metabolism of ethyl-N α -lauroyl-L-arginate to compounds endogenously present in much higher levels, the absence of preneoplastic toxic effects in the in vivo studies performed, together with the absence of genotoxic activity in the mouse lymphoma assay, the human lymphocyte assay and the micronucleus test, does not suggest a carcinogenic potential. Therefore the Panel concludes that there is no need to perform carcinogenicity studies.The Panel notes that effects on white blood cells were seen in different rat strains and in different sexes in two 90-day studies and in the 52-week study and concludes that these effects cannot be disregarded. Therefore the Panel concludes, given the fact that the effects on white blood cell counts at 26 weeks are significant for all dose groups, th...

Comparative analysis of blend and bilayer films based on chitosan and gelatin enriched with LAE (lauroyl arginate ethyl) with antimicrobial activity for food packaging applications

“…LAE acts as a cationic surfactant on the cytoplasmic membrane of microorganisms and inhibits the growth of microorganisms without causing cell lysis (Muriel-Galet, Carballo, Hernández-Muñoz, & Gavara, 2016). LAE has been evaluated for food safety as an antimicrobial compound by the U.S. Food and Drug Administration (FDA, 2005b) and as a food preservative by the European Food Safety Authority (EFSA, 2007). This compound has been classified as GRAS at concentrations up to 200 ppm, since it is hydrolyzed in the human body by chemical and metabolic pathways and quickly broken into its natural components such as lauric acid, L-arginine and ethanol (Asker, Weiss, & McClements, 2009).…”

Ethyl lauroyl arginate: An update on the antimicrobial potential and application in the food systems: a review

“…Lauric acid is a saturated fat widely found in many vegetable fats and can enter normal fatty acid metabolism. Alcohol can be degraded to CO 2 and water via some normal metabolic processes (EFSA, 2007;Hawkins et al, 2009). These data suggest that LAE is primarily and rapidly metabolized in vivo.…”

“…60372-77-2) is a white hygroscopic powder with a melting point at 50.5°C to 58°C. LAE has a molecular weight of 421.023 g/mol and has good water solubility (greater than 247 g/kg at 20°Cl; EFSA, 2007). The pKa of LAE is at about 10-11 and the isoelectric point is above pH 12 (Czakaj et al, 2021).…”

“…LAE is stable for more than 2 years at room temperature when protected in a closed container. The half-life of LAE is greater than 1 year at pH 4, 57 d at pH 7, and 34 h at pH 9 during 25°C storage, indicating that the hydrolysis of LAE is accelerated in alkaline conditions (EFSA, 2007). However, LAE has a bitter taste above 50 ppm in food and beverage products (Zheng, 2014), which may adversely influence the taste and flavor of food products.…”

“…However, the observed delay in vaginal opening is of no long-term toxicological relevance. The research data suggest that LAE has very low mammalian toxicity (Ruckman et al, 2004;EFSA, 2007). More toxicological metabolic investigations are reviewed by Ruckman et al (2004).…”