Scientific Opinion on the safety assessment of the substance, 2,2,4,4-tetramethylcyclobutane-1,3-diol (TMCD), CAS No 3010-96-6, for use in food contact materials


Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2013;11(10):3388 [9 pp.].
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 (until July 2013), Jean-Claude Lhuguenot (until November 2012), Wim Mennes, Maria Rosaria Milana, Maria de Fátima Poças, Iona Pratt, Kettil Svensson, Fidel Toldrá and Detlef Wölfle.

The Panel wishes to thank the members of the Working Group on Food Contact Materials for the preparation of this opinion: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Roland Franz, Nathalie Gontard, Eugenia Lampi, Jean-Claude Lhuguenot (until November 2012), Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Opinion of the Scientific Committee/Scientific Panel
On request from
Food Standards Agency, UK
Question Number
25 September 2013
Published in the EFSA Journal
16 October 2013
Last Updated
17 February 2014. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy

This scientific opinion of EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety re-evaluation of 2,2,4,4-tetramethylcyclobutane with the CAS No 3010-96-6, the Ref. No 25187 and the FCM substance No 881 for use as monomer in the manufacture of polyesters. Final articles are intended to be used in contact with non-fatty foods for long time storage at room temperature or below and hot fill. This application represents an extension for single use excluding fatty foods. Migration of the substance, reaction products related to the manufacturing process and oligomers from two typical polyester samples into 3 % acetic acid and 10 % ethanol was considered. Migration of the substance was found to be up to 2 µg/kg in food simulants. Migration of the reaction products was in the range from 1 to 40 µg/kg. Migration of each oligomer containing the substance moiety is estimated to be approximately 10 µg/kg food. The substance was previously evaluated and considered non-genotoxic. No genotoxicity is anticipated for the reaction products and oligomeric species. Therefore the CEF Panel concluded that for single uses, the substance 2,2,4,4-tetramethylcyclobutane-1,3-diol is not of safety concern for the consumer if the substance is used as co-monomer in the production of polyesters at use levels up to 35 mol % of the diol component, in contact with all food types other than spirits and highly fatty foods simulated by D2, for long time storage at room temperature or below and hot fill.

2,2,4,4-tetramethylcyclobutane-1,3-diol, CAS No 3010-96-6 ; ref.No 25187 ; FCM substance number 881 ; food contact materials; safety assessment; evaluation
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