Safety assessment of the substance ‘Tungsten Oxide’ for use in food contact materials

Vittorio Silano, Claudia Bolognesi, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler , Roland Franz, Konrad Grob, Rainer Guertler, Trine Husøy, Sirpa Kärenlampi, Wim Mennes, Maria Rosaria Milana, André Penninks, Andrew Smith, Maria de Fátima Tavares Poças, Christina Tlustos, Detlef Wölfle , Holger Zorn, Corina-Aurelia Zugravu, Martine Kolf-ClauwEugenia Lampi, Kettil Svensson, Cristina Croera , Laurence Castle, Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)

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This scientific opinion of EFSA Panel on Food Con tact Materials, Enzymes, Flavourings and ProcessingAids (CEF Panel) deals with the risk assessment of the additive tungsten oxide, CAS No 39318-18-8and FCM No 1064, for use in food contact materials as a reheat agent in polyethylene terephthalate(PET) at a maximum use level of 75 ppm (75 mg/kg PET). The substance is a mixture of tungstenoxides with tungsten at different oxidative levels. The average oxidation level of tungsten in the oxidesis 2.86 corresponding to 19.93% oxygen content. Detailed information on impurities is provided asconfidential. Specific migration from PET plaques with the substance at 150 mg/kg (double themaximum inte nded use level of 75 mg/kg) was determined into 95% ethan ol, as a worst-case simulantfor PET due to its swelling effect. Under these test conditions, the specific migration, measured astungsten using ICP-MS, was at the level of 1 lg/kg. The Panel considered that due to the insolubilityof the substance, this low migration will be typical for any foreseeable use as a reheat additive in PET.Two in vitro genotoxicity studies, a bacterial gene mutation test and an in vitro micronucleus assay,performed in accordance w ith the OECD Guidelines and in compliance with GLP, were provided by theapplicant for the substance tungsten oxide and were considered negative by the CEF Panel. Accordingto a scientific opinion on strategy for genotoxicity testing (EFSA, 2011), the three genotoxic endpoints,gene mutation, chromosomal and numerical aberrations, are covered by these two tests. The CEFPanel concluded that the substance tungsten oxide is not of safety concern for the consumer if theadditive is used as a reheat agent in PET. For other technical functions or for use in other polymers,the migration should not exceed 50 lg/kg (expressed as tungsten).
Original languageEnglish
Specialist publicationEFSA Journal
Publication statusPublished - 13 Jan 2017


  • Tungsten oxide
  • CAS number 39318-18-8
  • FCM substance No 1064
  • food contact material
  • safety assessment
  • evaluation


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