Re‐evaluation of oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (E 479b) as a food additive

thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids,TOSOM, E 479b, food additive
First published in the EFSA Journal
10 October 2018
Adopted
11 September 2018
Type
Scientific Opinion

Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion re‐evaluating the safety of thermally oxidised soya bean oil interacted with mono‐ and diglycerides of fatty acids (TOSOM) (E 479b) when used as a food additive. The Scientific Committee on Food (SCF) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) derived an acceptable daily intake (ADI) of 25 and 30 mg/kg body weight (bw) per day, respectively. There was no reliable information regarding the absorption, distribution, metabolism, excretion (ADME) for TOSOM. No adverse effects have been detected in a limited subchronic toxicity study in pigs. The Panel identified a no observed adverse effect level (NOAEL) of 5,400, the highest dose tested, from a chronic and carcinogenicity study in rats. No genotoxicity data were available. No reliable studies for reproductive or developmental toxicity were available. From the chronic and carcinogenicity study, no lesions in reproductive organs were described and the lack of carcinogenic effect alleviated the concern for genotoxicity at the first site of contact. The Panel concluded that the available toxicological data were insufficient to support the current ADI, in particular, due to the lack of ADME data and absence of developmental toxicity studies TOSOM (E 479b) is only authorised in one food category and only one reported use level that equals the maximum permitted level was submitted. The estimated high (P95) exposure reached an upper value of 10.1 mg/kg bw per day for toddlers. When comparing the highest estimated exposure of 10 mg/kg bw per day in toddlers with the NOAEL of 5,400 mg/kg bw per day (the highest dose tested), the margin of safety (MoS) would be 540. Therefore, the Panel considered the use of TOSOM (E 479b) to be of no safety concern, in particular when considering the limited current use of this food additive. The Panel also recommended some modifications of the EU specifications for E 479b.

Panel members at the time of adoption

Gabriele Aquilina, Laurence Castle, Karl‐Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert‐Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Sandra Rainieri, Romina Shah, Dina Hendrika Waalkens‐Berendsen, Detlef Wölfle and Maged Younes.
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2018.5420
EFSA Journal 2018;16(10):5420
Question Number
On request from
European Commission