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).