Safety assessment of ‘waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity’ for use in food contact materials - Anses - Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail Access content directly
Journal Articles EFSA Journal Year : 2023

Safety assessment of ‘waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity’ for use in food contact materials

Claude Lambré
  • Function : Author
José Manuel Barat Baviera
  • Function : Author
Claudia Bolognesi
  • Function : Author
Andrew Chesson
  • Function : Author
Pier Sandro Cocconcelli
  • Function : Author
Riccardo Crebelli
  • Function : Author
David Michael Gott
  • Function : Author
Konrad Grob
  • Function : Author
Evgenia Lampi
  • Function : Author
Marcel Mengelers
  • Function : Author
Alicja Mortensen
  • Function : Author
Inger‐lise Steffensen
  • Function : Author
Christina Tlustos
  • Function : Author
Henk van Loveren
  • Function : Author
Laurence Vernis
  • Function : Author
Holger Zorn
  • Function : Author
Laurence Castle
  • Function : Author
Emma Di Consiglio
  • Function : Author
Roland Franz
  • Function : Author
Nicole Hellwig
  • Function : Author
Stefan Merkel
  • Function : Author
Maria Rosaria Milana
  • Function : Author
Eric Barthélémy
  • Function : Author
Daniele Comandella
  • Function : Author
Gilles Rivière

Abstract

Abstract The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) assessed the safety of the ‘waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity’ (FCM No. 93), for which the uses were requested to be extended for articles in contact with fatty foods. Migration from low‐density polyethylene samples containing 1% w/w of a representative wax was tested in food simulants. In fatty food simulants, the migration of mineral oil saturated hydrocarbons (MOSH) ≤ C35 was 142 mg/kg food, exceeding the overall migration limit for plastic FCM. Mineral oil aromatic hydrocarbons (MOAH) with at least two rings are largely removed during the manufacturing process. Based on various lines of evidence, the Panel concluded that any concern for the potential presence of MOAH with two or more conjugated aromatic rings can be ruled out. Based on the genotoxicity studies and on the content of polycyclic aromatic hydrocarbons (PAHs), the substance does not raise a concern for genotoxicity. Available toxicokinetic data showed a limited accumulation of MOSH. No adverse effects were observed up to the highest tested dose of 9 g/kg body weight per day in a 90‐day repeated oral toxicity study in Sprague–Dawley rats. The available results showed that FCM No. 93 is devoid of endocrine activity. The provided information on chronic toxicity and carcinogenicity was limited and inadequate to reach conclusions on these endpoints. Therefore, the CEP Panel concluded that under the intended and tested conditions of uses, the substance does not raise safety concern for the consumer if used to a level ensuring that its migration into food is no more than 5 mg/kg.

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anses-03997119 , version 1 (20-02-2023)

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Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, et al.. Safety assessment of ‘waxes, paraffinic, refined, derived from petroleum‐based or synthetic hydrocarbon feedstock, low viscosity’ for use in food contact materials. EFSA Journal, 2023, 21 (2), pp.19. ⟨10.2903/j.efsa.2023.7761⟩. ⟨anses-03997119⟩

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