Open AccessSafety assessment of the mixture of methyl‐branched and linear C 14 –C 18 alkanamides, derived from fatty acids, for use in food contact materials
Author(s) -
Silano Vittorio,
Bolognesi Claudia,
Cravedi JeanPierre,
Engel KarlHeinz,
Fowler Paul,
Franz Roland,
Grob Konrad,
Gürtler Rainer,
Husøy Trine,
Kärenlampi Sirpa,
Mennes Wim,
Milana Maria Rosaria,
Penninks André,
Smith Andrew,
Tavares Poças Maria de Fátima,
Tlustos Christina,
Wölfle Detlef,
Zorn Holger,
Zugravu CorinaAurelia,
KolfClauw Martine,
Lampi Eugenia,
Svensson Kettil,
Barthélémy Eric,
Castle Laurence
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4724
Subject(s) - polymer science , chemistry , library science , philosophy , computer science
This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of the mixture of methyl‐branched and linear C 14 –C 18 alkanamides, derived from fatty acids, for use in food contact materials as a slip or release agent at up to 1% w/w in polyolefins. The final materials are intended for contact with foodstuffs other than fatty foods for long‐term storage at room temperature including short heating. No thermal degradation of the substance is expected under manufacturing process conditions of polyolefins. Specific migration from low‐density polyethylene (LDPE) made with 0.37% of the substance into 3% acetic acid and 10% ethanol was up to 0.68 mg/kg. Based on negative results in a bacterial mutation test and in an in vivo micronucleus test, there was no evidence of a genotoxic potential of the substance. Impurities were determined and the main ones were tested in a bacterial mutation test giving negative results. Along with the negative results from the in vivo micronucleus test on the substance containing the impurities, there was no evidence of a genotoxic potential of the impurities. Based on a 28‐day study on the substance, the Panel noted that there is sufficient margin of safety between the no observed adverse effect level (NOAEL) and the maximum exposure of consumers that could occur at a migration level of 5 mg/kg food, to cover uncertainties about toxic effects due to potential accumulation of slowly hydrolysed branched amide species of the substance during chronic exposure. The CEF Panel concluded that the substance is not of safety concern for consumers if it is used in the manufacture of polyolefin articles intended for contact with all foodstuffs other than fatty foods and the migration does not exceed 5 mg/kg food. The 5 mg/kg food migration should not apply to n ‐stearamide.