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

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.