Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283

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http://hdl.handle.net/10138/340734

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EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) , Turck , D & Heinonen , M 2021 , ' Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283 ' , EFSA Journal , vol. 19 , no. 7 , 6670 . https://doi.org/10.2903/j.efsa.2021.6670

Title: Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283
Author: EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA); Turck, Dominique; Heinonen, Marina
Contributor organization: Department of Food and Nutrition
Helsinki One Health (HOH)
Food Quality & Safety
Date: 2021-07
Language: eng
Number of pages: 14
Belongs to series: EFSA Journal
ISSN: 2314-9396
DOI: https://doi.org/10.2903/j.efsa.2021.6670
URI: http://hdl.handle.net/10138/340734
Abstract: Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on an application for cetylated fatty acids as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns primarily a mixture of cetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleic acid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil. The NF is intended for use in food supplements for the general adult population. The highest dose tested in a subchronic toxicity study in rats, i.e. 4,500 mg/kg per day, was considered to be the no-observed-adverse effect level. By applying the default uncertainty factor of 200 as suggested by the EFSA Scientific Committee (2012), and considering a default body weight of 70 kg for the adult target population, this would result in an intake of 1.6 g per day, which is lower than the maximum intake proposed by the applicant (i.e. 2.1 g per day). The Panel concludes that the NF, cetylated fatty acids, is safe at an intake of 1.6 g per day for the intended target population, i.e. adults. (C) 2021 European Food Safety Authority.
Subject: Novel Foods
cetylated fatty acids
palmitoyl myristate
palmitoyl oleate
cetyl alcohol
hexadecane-1-ol
food supplements
CONTACT-DERMATITIS
416 Food Science
Peer reviewed: Yes
Rights: cc_by_nd
Usage restriction: openAccess
Self-archived version: publishedVersion


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