Safety Assessment: Outcome of assessment of Cetylated Fatty Acids as a Novel Food

Abstract

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Pharmaneutra S.p.a., Italy (“the applicant”) for the authorisation of cetylated fatty acids as a novel food. The novel food is a mixture of cetylated fatty acids, cetyl myristate and cetyl oleate, which are synthesised from cetyl alcohol with myristic acid and, cetyl alcohol with oleic acid, respectively. These two cetylated fatty acids are then blended with olive oil to give a finished product containing 70 – 80% cetylated fatty acids. The application is a new application, seeking to use cetylated fatty acids within the food category: food supplements. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The Committee concluded that the applicant had provided sufficient information to assure the novel food, cetylated fatty acids, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in foods and food supplements was not considered to be nutritionally disadvantageous and does not mislead consumers. The views of the ACNFP have been taken into account in this safety assessment which represents the opinion of the FSA and FSS on cetylated fatty acids.