Statement on the safety of 'Cetyl Myristoleate Complex' as an ingredient in food supplements


Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(6):3261 [9 pp.].
Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Panel Members
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen.

The Panel wishes to thank the members of the Working Group on Novel Foods: Karl-Heinz Engel, Ines Golly, Marina Heinonen, Pagona Lagiou, Rosangela Marchelli, Bevan Moseley, Monika Neuhäuser-Berthold, Annette Pöting, Seppo Salminen, Hendrik Van Loveren and Hans Verhagen for the preparatory work on this scientific opinion, and EFSA staff Wolfgang Gelbmann for the support provided to this scientific opinion.

Statement of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
31 May 2013
Published in the EFSA Journal
21 June 2013
European Food Safety Authority (EFSA), Parma, Italy

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to update its opinion on the safety of ‘Cetyl Myristoleate Complex’ (CMC) as a novel food ingredient in the light of a new repeated dose 90-day oral toxicity study in mice. In its previous opinion of 2010, the Panel concluded that based on the available data, the safety of CMC as an ingredient in food supplements has not been established. This conclusion was based on the considerations that in the absence of appropriate data on absorption, distribution, metabolism and excretion, the provided toxicological data were insufficient. Whereas the applicant considers that the NOAEL of CMC in this new 90-day study was 1000 mg/kg body weight (bw), the highest dose tested, the Panel considers that this study and study report has many shortcomings to be a reliable source of information supporting the absence of adverse effects of the parent material CMC. The Panel concludes that the safety of 'Cetyl Myristoleate Complex' has not been established.

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