Scientific Opinion on the safety of 'Cetyl Myristoleate Complex' as a food ingredient

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to carry out the additional assessment for „Cetyl Myristoleate Complex’ as a food ingredient in the context of Regulation (EC) No. 258/97. Cetyl Myristoleate Complex (CMC) powder consists of 50 % of cetylated fatty acids (CFA, including 20 % of cetyl myristoleate), 48 % of corn starch and 2 % of silicon dioxide. CMC is produced in an industrial process where a fatty acid mixture extracted from beef tallow is esterified with cetyl alcohol obtained from palm oil. The applicant suggests a daily dose of 3.3 g CMC corresponding to approximately 660 mg of cetyl myristoleate and of cetyl myristate, the two main compounds of the CFAs of CMC and to approximately 1.65 g of CFAs. From the information provided in a rat study on the absorption and distribution of 14C-labelled CFA in rats after oral and topical administration, it appears that a small amount of CFA is absorbed intact. The Panel notes the limitations of this study in the design and the test substance used with respect to the proposed novel food ingredient. No information is provided on the extent of intestinal hydrolysis of the CFA after oral intake, limited information is provided on the distribution of absorbed unhydrolysed CFA, and no information is provided on the metabolism and excretion of such intact CFA. The Panel considers that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data are insufficient. Only one human trial studied safety endpoints but had considerable limitations, i.e. lower dose used compared to the proposed use, and a different product was tested. The Panel concludes that the safety of 'Cetyl Myristoleate Complex' has not been established