Portal de Periódicos da CAPES

Safety evaluation of long‐chain glycolipids from Dacryopinax spathularia

2021; Wiley; Volume: 19; Issue: 6 Linguagem: Inglês

10.2903/j.efsa.2021.6609

1831-4732

Maged Younes, Gabriele Aquilina, Karl–Heinz Engel, Paul Fowler, María José Frutos Fernández, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Melania Manco, Wim Mennes, Sabina Passamonti, Peter Moldéus, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle, Matthew Wright, José Manuel Barat Baviera, Gisela H. Degen, Jean‐Charles Leblanc, Lieve Herman, Alessandra Giarola, Camilla Smeraldi, Alexandra Tard, Giorgia Vianello, Laurence Castle,

Effects and risks of endocrine disrupting chemicals

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.