Title: Scientific Opinion on the safety evaluation of the substance zinc oxide, nanoparticles, uncoated and coated with [3‐(methacryloxy)propyl] trimethoxysilane, for use in food contact materials
Abstract: EFSA JournalVolume 13, Issue 4 4063 OpinionOpen Access Scientific Opinion on the safety evaluation of the substance zinc oxide, nanoparticles, uncoated and coated with [3-(methacryloxy)propyl] trimethoxysilane, for use in food contact materials EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF)Search for more papers by this author First published: 13 April 2015 https://doi.org/10.2903/j.efsa.2015.4063Citations: 8 Panel members: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Karl-Heinz Engel, Paul Fowler, 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. Correspondence: [email protected] Acknowledgement: The Panel wishes to thank the members of the Working Group on Food Contact Materials: Claudia Bolognesi, Laurence Castle, Jean-Pierre Cravedi, Roland Franz, Konrad Grob, Martine Kolf-Clauw, Eugenia Lampi, Maria Rosaria Milana, Maria de Fátima Poças, Philippe Saillard, Kettil Svensson and Detlef Wölfle for the preparatory work on this scientific opinion. Adoption date: 18 March 2015 Published date: 13 April 2015 Question number: EFSA-Q-2014-00308 On request from: Ministerie van Volksgezondheid Welzijn en Sport, the Netherlands AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Abstract This scientific opinion of the EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF Panel) deals with the safety assessment of zinc oxide, nanoparticles, uncoated (FCM No 1050) and coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 1046), for use as a transparent ultraviolet light absorber in all polyolefins at a maximum content of 2 % and 3 % for the uncoated and the coated species, respectively. The substance is used as a powder in nanoform. In the final polymer, nanoparticles are still present but largely aggregated. The specific migration of the substance was tested from low-density polyethylene films, containing the maximum use level of the substance, into 3 % acetic acid and 10 % and 50 % ethanol for 10 days at 60 °C. Data from a stress test with iso-octane for 10 days at 20 °C was provided. Migration values into the different simulants and the microscopic analysis of swollen polymers demonstrate that there is no mass transfer of the zinc oxide in nanoform. In 2003 the Scientific Committee on Food established for zinc a no observed adverse effect level of 50 mg/day and an upper limit of 25 mg/person per day was recommended. The CEF Panel concluded that zinc oxide, nanoparticles, uncoated or coated with [3-(methacryloxy)propyl]trimethoxysilane, does not migrate in nanoform, and therefore the safety evaluation focuses on the migration of soluble ionic zinc. Available migration data for ionic zinc coming from the intended application are in compliance with the current specific migration limit (SML), but in combination with the dietary exposure from other sources the upper limit of 25 mg/person per day could be exceeded. For use of the coated form of zinc oxide, migration of [3-(methacryloxy)propyl]trimethoxysilane should be within the existing SML for this substance of 0.05 mg/kg. References Bonham M, O'Connor JM, Walsh PM, McAnena LB, Downes CS, Hannigan BM and Strain JJ, 2003a. Zinc supplementation has no effect on lipoprotein metabolism, hemostasis and putative indices of copper status in healthy men. Biological Trace Element Research, 93, 75– 86. Bonham M, O'Connor JM, Alexander HD, Coulter SJ, Walsh PM, McAnena LB, Downes CS, Hannigan BM and Strain JJ, 2003b. Zinc supplementation has no effect on circulating levels of peripheral blood leucocytes and lymphocyte subsets in healthy adult men. British Journal of Nutrition, 89, 695– 703. Bott J, Störmer A and Franz R, 2014a. A comprehensive study into the migration potential of nano silver particles from food contact polyolefins. In: Chemistry of food and food contact materials: from production to plate. 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Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior its authorisation. Available online: http://ec.europa.eu/food/fs/sc/scf/out82_en.pdf. EC (European Commission), 2003. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Zinc (expressed on 5 March 2003). Available online: http://ec.europa.eu/food/fs/sc/scf/out177_en.pdf. EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2014. Scientific Opinion on Dietary Reference Values for zinc. EFSA Journal 2014; 12(10): 3844, 76 pp. doi:10.2903/j.efsa.2014.3844. EFSA Scientific Committee and NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies), 2006. Tolerable upper intake levels for vitamins and minerals. Available online: http://www.efsa.europa.eu/en/ndatopics/docs/ndatolerableuil.pdf. Milne DB, Davis CD and Nielsen FH, 2001. Low dietary zinc alters indices of copper function and status in post-menopausal women. Nutrition, 17, 701– 708. Citing Literature Volume13, Issue4April 20154063 ReferencesRelatedInformation