Scientific Opinion on the safety evaluation of the substance, 1,4:3,6-dianhydrosorbitol, CAS No 652-67-5, for use in food contact materials

1,4:3,6-Dianhydrosorbitol; CAS number 652-67-5; Reference No 15404; FCM Substance No 364; Food contact materials; Safety assessment; Evaluation
First published in the EFSA Journal
6 June 2013
15 May 2013
Scientific Opinion

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety evaluation of 1,4:3,6-dianhydrosorbitol, CAS No 652-67-5 and FCM Substance No 364, for use as a co-monomer at 1 to 40 diol mole% in the production of polyesters along with ethylene glycol and 1,4-bis(hydroxymethyl)cyclohexane as the diol components and terephthalic acid. The final material is intended to be used for single and repeated contact with all types of foodstuffs, for short term contact at temperatures up to 100 ºC and/or for long term storage at ambient temperatures or below. Specific migration in aqueous simulants and olive oil under adequate conditions were below the current specific migration limit of 5 mg/kg food. Due to the aggressiveness of 50 % ethanol, the Panel considered that this type of polymer is not suitable for contact with high alcohol content foods. Given that all of the co-monomers have already been evaluated and considered not to raise a concern of genotoxicity, the Panel concluded that there is no concern for genotoxicity of the oligomers. Therefore, the low individual migration for low molecular weight oligomers containing both 1,4:3,6-dianhydrosorbitol and 1,4-bis(hydroxymethyl)cyclohexane, estimated to be up to 0.06 mg/kg into 10 % ethanol, does not raise a safety concern. The CEF Panel, concluded that the substance 1,4:3,6-dianhydrosorbitol does not raise a safety concern for the consumer if it is used as a co-monomer at levels of up to 40 mole% of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane for the production of polyesters. The existing migration limit of 5 mg/kg food should not be exceeded. In addition, polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane should not be used in contact with foods containing more than 15 % alcohol.

Panel members at the time of adoption
Ulla Beckman Sundh, Mona-Lise Binderup, Claudia Bolognesi, Leon Brimer, Laurence Castle, Alessandro Di Domenico, Karl-Heinz Engel, Roland Franz, Nathalie Gontard, Rainer Gürtler, Trine Husøy, Klaus-Dieter Jany, Martine Kolf-Clauw, Catherine Leclercq, Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá, and Detlef Wölfle.
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
cef [at]
EFSA Journal 2013;11(6):3244 [8 pp.].
Question Number
On request from
Food Standards Agency, United Kingdom