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 | European Food Safety Authority Skip to main content

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

Metadata

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.

Competing interests: 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.

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).