Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation (EU) 2015/2283.
Résumé
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods andFood Allergens (NDA) was asked to deliver an opinion on an application for cetylated fatty acids as anovel food (NF) pursuant to Regulation (EU) 2015/2283. The NF concerns primarily a mixture ofcetylated myristic acid and cetylated oleic acid synthesised from cetyl alcohol, myristic acid and oleicacid, and to a lesser degree, other cetylated fatty acids and other compounds from olive oil. The NF isintended for use in food supplements for the general adult population. The highest dose tested in asubchronic 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 EFSAScientific Committee (2012), and considering a default body weight of 70 kg for the adult targetpopulation, this would result in an intake of 1.6 g per day, which is lower than the maximum intakeproposed 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.
Fichier principal
EFSA Journal - 2021 - - Safety of Cetylated Fatty Acids as a Novel Food pursuant to Regulation EU 2015 2283.pdf (1.48 Mo)
Télécharger le fichier
| Origine | Fichiers éditeurs autorisés sur une archive ouverte |
|---|
