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 Accéder directement au contenu
Article Dans Une Revue EFSA Journal Année : 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
  • Fonction : Auteur
José Manuel Barat Baviera
  • Fonction : Auteur
Claudia Bolognesi
  • Fonction : Auteur
Andrew Chesson
  • Fonction : Auteur
Pier Sandro Cocconcelli
  • Fonction : Auteur
Riccardo Crebelli
  • Fonction : Auteur
David Michael Gott
  • Fonction : Auteur
Konrad Grob
  • Fonction : Auteur
Evgenia Lampi
  • Fonction : Auteur
Marcel Mengelers
  • Fonction : Auteur
Alicja Mortensen
  • Fonction : Auteur
Inger‐lise Steffensen
  • Fonction : Auteur
Christina Tlustos
  • Fonction : Auteur
Henk van Loveren
  • Fonction : Auteur
Laurence Vernis
  • Fonction : Auteur
Holger Zorn
  • Fonction : Auteur
Laurence Castle
  • Fonction : Auteur
Emma Di Consiglio
  • Fonction : Auteur
Roland Franz
  • Fonction : Auteur
Nicole Hellwig
  • Fonction : Auteur
Stefan Merkel
  • Fonction : Auteur
Maria Rosaria Milana
  • Fonction : Auteur
Eric Barthélémy
  • Fonction : Auteur
Daniele Comandella
  • Fonction : Auteur
Gilles Rivière

Résumé

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.

Dates et versions

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

Licence

Paternité - Pas de modifications

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Citer

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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