Re‐evaluation of name of hydrogenated poly‐1‐decene (E 907) as food additive

hydrogenated poly‐1‐decene, E 907, food additive, safety, risk assessment, dietary exposure, acceptable daily intake
First published in the EFSA Journal
28. Februar 2020
Adopted
30. Januar 2020
Type
Scientific Opinion

Abstract

The Panel on Food Additives and Flavourings added to food (FAF) provided a scientific opinion re‐evaluating the safety of hydrogenated poly‐1‐decene (E 907) when used as a food additive. Hydrogenated poly‐1‐decene (E 907) is authorised as a food additive in the EU in accordance with Annex II to Regulation (EC) No 1333/2008. Hydrogenated poly‐1‐decene is of low acute toxicity and does not raise concern for genotoxicity. Toxicity and carcinogenicity, as well as reproductive and developmental toxicological studies, were not available; therefore, the Panel based the derivation of the acceptable daily intake (ADI) on the no observed adverse effect level (NOAEL) identified in the subchronic study in rats and established an ADI of 20 mg/kg bw per day. Dietary exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive was calculated based on regulatory maximum level exposure assessment scenario. Mean exposure to hydrogenated poly‐1‐decene (E 907) from its use as a food additive ranged from no exposure in infants to 2.35 mg/kg bw per day in toddlers. The high exposure to hydrogenated poly‐1‐decene (E 907) ranged from 0 mg/kg bw per day in infants and adults to 6.69 mg/kg bw per day in toddlers. The exposure estimates in the regulatory maximum level exposure assessment scenario did not exceed the ADI of 20 mg/kg bw per day for all population groups. The Panel concluded that the exposure to hydrogenated poly‐1‐decene (E 907) does not raise a safety concern when used at the maximum permitted levels.

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, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle and Maged Younes.
Panel on Food Additives and Flavourings
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6034
EFSA Journal 2020;18(2):6034
Question Number
On request from
European Commission