EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2013 . S tatement on the safety of ' Cetyl Myristoleate Complex ' as an ingredient in food supplements

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Abstract

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.
© European Food Safety Authority, 2013
Original languageEnglish
Place of PublicationParma, Italy
PublisherEuropean Food Safety Authority
Number of pages9
DOIs
Publication statusPublished - 2013
SeriesEFSA Journal
Number6
Volume11
ISSN1830-5458

Keywords

  • Cetyl myristoleate complex
  • Cetyl myristoleate
  • Cetyl myristate
  • Cetylated fatty acid
  • Ingredient
  • Novel food

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