Open AccessSafety evaluation of long‐chain glycolipids from Dacryopinax spathularia
Author(s) -
Younes Maged,
Aquilina Gabriele,
Engel KarlHeinz,
Fowler Paul,
Frutos Fernandez Maria Jose,
Fürst Peter,
Gürtler Rainer,
GundertRemy Ursula,
Husøy Trine,
Manco Melania,
Mennes Wim,
Passamonti Sabina,
Moldeus Peter,
Shah Romina,
WaalkensBerendsen Ine,
Wölfle Detlef,
Wright Matthew,
Barat Baviera José Manuel,
Degen Gisela,
Leblanc JeanCharles,
Herman Lieve,
Giarola Alessandra,
Smeraldi Camilla,
Tard Alexandra,
Vianello Giorgia,
Castle Laurence
Publication year - 2021
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2021.6609
Subject(s) - bioavailability , no observed adverse effect level , zoology , tolerable daily intake , acceptable daily intake , toxicology , glycolipid , chemistry , body weight , toxicity , food science , biology , pesticide , biochemistry , endocrinology , pharmacology , organic chemistry , agronomy
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of long‐chain glycolipids from Dacryopinax spathularia (also called AM‐1) as a food additive. AM‐1 is a purified mixture of long‐chain glycolipid congeners obtained by fermentation of the edible non‐genetically modified fungus Dacryopinax spathularia . AM‐1 glycolipids have very low oral bioavailability and overall available toxicology data do not demonstrate any adverse effects of the proposed food additive. Considering the available data set the Panel established an ADI of 10 mg/kg bw per day based on a range of NOAELs between 1,000 and 1,423 mg/kg bw per day (the highest doses tested), from the reproductive and a prenatal developmental toxicity studies in rats and 90‐day studies in rat and dog. At the proposed maximum use levels, the exposure estimates ranged at the mean from 0.01 to 1.07 mg/kg bw per day and at the p95 from 0 to 3.1 mg/kg mg/kg bw per day. At the proposed typical use levels, the exposure estimates ranged at the mean from < 0.01 mg/kg bw per day to 0.23 mg/kg bw per day and at the p95 from 0 to 0.64 mg/kg bw per day. The Panel noted that the highest estimate of exposure of 3.1 mg/kg bw per day (in toddlers) is within the established ADI of 10 mg/kg bw per day and concluded that the exposure to long‐chain glycolipids from Dacryopinax spathularia does not raise a safety concern at the uses and use levels proposed by the applicant.