Scientific Opinion on the safety of use of dimethyl ether as an extraction solvent under the intended conditions of use and the proposed maximum residual limits

extraction solvent, dimethyl ether, CAS Registry Numbers 115-10-6
First published in the EFSA Journal
14 July 2015
Adopted
24 June 2015
Type
Scientific Opinion
Abstract

Dimethyl ether was previously evaluated by the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) and considered to give rise to no safety concerns under the conditions of use and the maximum residual limits proposed by the applicant. The present scientific opinion of the EFSA CEF Panel deals with the re-evaluation of the safety of dimethyl ether as an extraction solvent under new intended conditions of use and new maximum residual limits. The applicant requests a change in the residual limit of dimethyl ether in defatted animal protein products (in particular collagen) from 0.009 mg/kg to 3 mg/kg, and a new use for the extraction of protein products to yield gelatin with a residual limit of 0.009 mg/kg is also requested. The Panel notes the maximum residual limit requested by the applicant is much higher than the existing limit. Nonetheless, the margin of exposure for this new application is considered to be adequate. No new toxicity data were provided for dimethyl ether and, since the previous EFSA evaluation, only two in vitro genotoxicity studies have become available. These studies do not indicate any genotoxic potential for the assessed substance. The Panel thus considers that the use of dimethyl ether as an extraction solvent, under the intended conditions of use and with the proposed residual limits of 3 mg/kg in the defatted protein products and 9 μg/kg specifically in gelatin, is of no safety concern.

Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Konrad Grob, Rainer Gürtler, Trine Husøy, Wim Mennes, Maria Rosaria Milana, André Penninks, Vittorio Silano, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Fidel Toldrá, Detlef Wölfle and Holger Zorn.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
Contact
fip [at] efsa.europa.eu
doi
10.2903/j.efsa.2015.4174
EFSA Journal 2015;13(7):4174 [13 pp.].
Question Number
On request from
European Commission