Scientific Opinion on the safety assessment of the substance, 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol, β3,β3,β9,β9-tetramethyl-, CAS No 1455-42-1, for use in food contact materials

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Article
Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
EFSA Journal
EFSA Journal 2014;12(10):3863 [8 pp.].
doi
10.2903/j.efsa.2014.3863
Panel members at the time of adoption
Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, Roland Franz, 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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Food Contact Materials: Mona-Lise Binderup, Laurence Castle, Riccardo Crebelli, Alessandro Di Domenico, Roland Franz, Nathalie Gontard, Ragna Bogen Hetland, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Tavares Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion.

Possible conflict of interest
One member of the Panel did not participate in the discussion on the subject referred to above because of potential conflicts of interest identified in accordance with the EFSA policy on declarations of interests.
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Member State - United Kingdom
Question Number
EFSA-Q-2012-00708
Adopted
24 September 2014
Published
20 October 2014
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids deals with the safety assessment of the substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol, β3,β3,β9,β9-tetramethyl- (SPG), CAS No 1455-42-1, FCM No 1052, for use as a co-monomer in polyesters. The polyesters are intended for contact with all food types for long-term storage at room temperature including hot-fill/sterilisation conditions. Migration of the substance into 10 % ethanol was 0.009 mg/kg food and no migration was detected (<0.003 mg/kg food) in 3 % acetic acid. No migration of the oligomers was detectable (< 0.2 mg/kg food). Based on three negative in vitro tests, the Panel considered that the substance does not raise a concern related to genotoxicity, while from a 90-day oral toxicity study in rats not providing a dose-response relationship of the incidental changes, it was concluded that the NOAEL is 2000 mg SPG/kg b.w. per day, the highest dose tested. The substance does not raise concern for accumulation in man. The Panel concluded that the use of the substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (SPG) as a monomer in the production of polyesters, does not raise a safety concern for the consumer when the migration of the substance itself does not exceed 5 mg/kg food and the migration of the oligomers of less than 1000 Da does not exceed 50 µg/kg food (expressed as SPG).

Summary

Within the general task of evaluating substances intended for use in materials in contact with food according to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with foodstuffs, the CEF Panel received a request from the Food Standards Agency, UK, for safety assessment of the substance 2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl- (SPG) following a corresponding application submitted on behalf of Mitsubishi Gas Chemical Company, Inc.

The substance is intended for use as a co-monomer at a maximum content of 50 mole % of the diol component for manufacturing polyesters specifically in partial replacement of ethylene glycol in poly(ethylene terephthalate) (PET). The final articles are intended to be in contact with all types of foodstuffs for long-term storage at room temperature including hot-fill/sterilisation for up to 30 min at 100 °C or for 2 hours at 70 °C.

Specific migration of the substance was determined using a modified PET and using test conditions simulating hot-fill followed by long-term storage. Migration into 10 % ethanol was 0.009 mg/kg food whereas no migration was detected (< 0.003 mg/kg food) into 3 % acetic acid. In the same tests, there was no detectable migration of oligomers (0.2 mg/kg food). Migration of both the substance itself and the oligomers was considerably higher into 50 % ethanol but it is considered that this simulant has too strong and unrepresentative interactions with polyesters of this type under the test conditions employed.

Based on three in vitro tests, the Panel considered that SPG does not raise a concern related to genotoxicity. Following a 90-day oral toxicity study in rats that did not provide a dose-response relationship of the incidental changes, it was concluded that the no-observed-adverse-effect level (NOAEL) is 2000 mg/kg b.w. per day, the highest does tested.

In consideration of the structure and the log PO/W value, the substance does not raise concern for accumulation in man, in addition the substance is acid-labile and will be decomposed in the stomach in highly hydrophilic components.

The Panel concluded that the use of the substance SPG as a monomer in the production of polyesters, does not raise a safety concern for the consumer when the migration of the substance itself does not exceed 5 mg/kg food and the migration of the oligomers of less than 1000 Da does not exceed 50 µg/kg food (expressed as SPG).

Keywords
2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol,β3,β3,β9,β9-tetramethyl-, CAS No 1455-42-1, FCM substance No 1052, food contact materials, plastics, polyesters, safety assessment
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Number of Pages
8