Statement on the evaluation of the new information provided on the food additive ethyl lauroyl arginate [1]

Ethyl lauroyl arginate, food additive, lauramide arginine ethyl ester, CAS Registry Number 60372-77
First published in the EFSA Journal
13 Octubre 2009
Adopted
24 Septiembre 2009
Last Updated
30 Noviembre 2009. This version replaces the previous one/s.
Type
Statement

Abstract

Following a request from the European Commission to the European Food Safety Authority (EFSA), the Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to determine whether the new information provided on ethyl lauroyl arginate constitutes new scientific evidence compared to that originally submitted and considered in the AFC Panel opinion, and to evaluate the extent to which this additional information addresses the concerns and uncertainties expressed in the opinion of the AFC Panel. The ANS Panel has considered the opinions of three experts on the white blood cell data from a series of toxicity studies with ethyl lauroyl arginate, which conclude separately that the haematological findings are toxicologically not significant. The Panel concludes that the new information provided is the expression of the opinions of three individual experts presenting a re-examination of some of the original results provided in the application dossier for ethyl lauroyl arginate and that it does not contain new scientific evidence. The Panel concludes that scientific evidence of a plausible mechanism for the alterations in white blood cell counts has not been provided and therefore concludes that the concerns and uncertainties expressed in the opinion of the AFC Panel have not been addressed by the new information provided.

Panel members at the time of adoption

F. Aguilar, U.R. Charrondiere, B. Dusemund, P. Galtier, J. Gilbert, D.M. Gott, S. Grilli, R. Guertler, J. Koenig, C. Lambré, J-C. Larsen, J-C. Leblanc, A. Mortensen, D. Parent-Massin, I. Pratt, I.M.C.M. Rietjens, I. Stankovic, P. Tobback, T. Verguieva, R.A. Woutersen
Panel on Food Additives and Nutrient Sources Added to Food
Contact
Unit-ANS [at] efsa.europa.eu
doi
10.2903/j.efsa.2009.1333
EFSA Journal 2009; 7(10):1333
Question Number
On request from
European Commission