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Revised exposure assessment for ethyl lauroyl arginate for the proposed uses as a food additive

EFSA Journal 2012;10(4):2652 [14 pp.]. doi:10.2903/j.efsa.2012.2652
European Food Safety Authority Acknowledgment EFSA wishes to thank the Food Ingredients & Packaging Unit, A. Tard, H. Kenigswald and the Dietary & Chemical Monitoring Unit, D. Arcella for the preparatory work on this scientific output and C. Tlustos and J.C. Leblanc for the support provided to this scientific output. Contact ans@efsa.europa.eu
Type: Statement of EFSA On request from: European Commission Question number: EFSA-Q-2011-00030 Approved: 04 April 2012 Published: 26 April 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

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.

© European Food Safety Authority, 2012

Summary

Following a request from the European Commission, the European Food Safety Authority is asked to carry out an overall refined dietary exposure assessment of ethyl lauroyl arginate (LAE) from all sources, taking into account the newly revised conditions of uses and use levels of LAE as food additive proposed by the applicant and taking into account the overall exposure of LAE from cosmetic products.

A revised exposure assessment of LAE from its use as a food additive was carried out, for five population groups from toddlers to the elderly, based on the revised proposed uses presented in the terms of reference.

The EFSA Comprehensive European Food Consumption Database (Comprehensive Database) was used to conduct the revised dietary exposure assessment.

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 (p95), all population groups except the elderly, have an exposure above the ADI.

Therefore, the ADI of 0.5 mg/kg bw/d is reached for toddlers at the mean intake while the mean intakes for all other population groups are lower than the ADI. For the high consumers (p95), the intakes for all population groups except the elderly population are above the ADI.

The main contributor to the dietary exposure is the category of heat-treated meat products (from 30 to 100% depending on the population group). To a lesser extent, the dried fish category can contribute also for an important part of the exposure (from 0 to 70% depending on the population group). The prepared salads contribute only marginally to the total exposure.

In 2011, the Scientific Committee on Consumer Safety (SCCS) calculated a revised estimate of the systemic exposure to LAE resulting from the use of cosmetic products. The SCCS estimated that the use of LAE at 0.4% as a preservative in cosmetics products (excl. oral products) and 0.8 % in soap, shampoos and non-spray deodorant would lead to a total systemic exposure of 0.0322 mg/kg/d.

The AFC Panel concluded that LAE is well absorbed and rapidly metabolised into arginine, lauric acid and ethanol following oral exposure. It can thus be assumed that oral exposure results in a corresponding systemic exposure to all released metabolites. The systemic exposure to LAE estimated by the SCCS is based on the results of an in vitro dermal penetration study and corresponds to a quantity of LAE penetrating the skin to the circulation. Based on the toxicokinetics data available, it can reasonably be assumed that following uptake into the circulation LAE will be rapidly and completely converted to the same metabolites as those generated following oral exposure. With these assumptions, a comparison can be made between the dietary exposure to LAE and the systemic exposure resulting from its use in cosmetic products.

The level of exposure to LAE metabolites resulting from its use in cosmetic products is in the lowest range of the mean intake from the diet for total population and that for high consumers of food containing LAE: the dietary exposure is from 5 times up to 30 times more important than the systemic exposure resulting from the use in cosmetics. In all population groups, the additional LAE exposure resulting from cosmetic uses would not change the status regarding the exceedance of the ADI: if the ADI is not already exceeded by the dietary exposure, the combined exposure will not exceed it either.

Keywords

Ethyl lauroyl arginate, revised uses, revised use levels, exposure