Revised exposure assessment for ethyl lauroyl arginate for the proposed uses as a food additive
Following a request from the European Commission, the European Food Safety Authority (EFSA), carried out a revised exposure assessment of ethyl lauroyl arginate (LAE) from its use as a food additive, for children and adults, based on the revised proposed uses presented in the terms of reference. Revised exposure estimates have been calculated with revised proposed use levels and individual food consumption data from the EFSA Comprehensive Database. When considering consumers only, the anticipated dietary exposure to LAE ranges from 0.06 to 0.50 mg/kg bw/day at the mean, and from 0.15 to 0.91 mg/kg bw/day at the 95th percentile. For high consumers (95th percentile), all population groups except the elderly, have an exposure above the ADI. The main contributor to the total anticipated dietary exposure to LAE is the category of heat-treated meat products. In 2011 by the SCCS estimated the systemic exposure to LAE resulting from its use in cosmetics around 0.0322 mg/kg bw/d. With the assumptions that oral exposure results in a corresponding systemic exposure to all released metabolites and that following dermal absorption and uptake into the circulation LAE will be rapidly and completely converted to the same metabolites as those generated following oral exposure, a comparison between the dietary exposure and the systemic exposure resulting from cosmetic products was made. This exposure is similar to the lowest range of the mean estimates from diet for the total population. For all populations, the additional exposure resulting from the use of LAE in cosmetics could be considered as minor compared to high level dietary exposure and would not change the status of the different population groups regarding the exceedance of the ADI.