Validation and application of an LC-MS/MS method for the determination of cyclic oligomers originating from polyamide 6 and polyamide 66 in food simulant

References

• Abe Y, Mutsuga M, Ohno H, Kawamura Y, Akiyama H. 2016. Isolation and quantification of polyamide cyclic oligomers in kitchen utensils and their migration into various food simulants. PLoS One. 11(7):e0159547.
   PubMed Web of Science ®Google Scholar
• Becker GW, Braun D, Bottenbruch L, Binsack R. 1998. Polyamide. Kunststoff Handbuch 3/4. Technische Thermoplaste. München (Wien): Carl Hanser.
   Google Scholar
• Begley TH, Gay ML, Hollifield HC. 1995. Determination of migrants in and migration from nylon food packaging. Food Addit Contam. 12(5):671–676.
   PubMed Web of Science ®Google Scholar
• Bratinova S, Raffael B, Simoneau C 2009. Guidelines for performance criteria and validation procedures of analytical methods used in controls of food contact materials. JRC Scientific and Technical Report. EUR 24105 EN.
   Google Scholar
• [DIN] Deutsches Institut für Normung [German Institute for Standardization]. 2008. DIN 32645 Chemical analysis – decision limit, detection limit and determination limit under repeatability conditions – terms, methods, evaluation. Berlin: Beuth Publishing.
   Google Scholar
• [DIN] Deutsches Institut für Normung [German Institute for Standardization]. 2013. DIN 32633 Chemical analysis – methods of Standard addition – procedure, evaluation, with CD-ROM. Berlin: Beuth Publishing.
   Google Scholar
• [EC] European Commission. 2004. Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. Off J Eur Union European Commission (EC). L 338:4–17.
   Google Scholar
• [EC] European Commission. 2011a. Commission regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food. Off J Eur Union. L 12/1:1–89.
   Google Scholar
• [EC] European Commission. 2011b. Commission regulation (EU) No 284/2011 of 22 March 2011 laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China. Off J Eur Union. L 77/25:25–29.
   Google Scholar
• [EC] European Commission. 2016. SANTE/11945/2015. Guidance document on analytical quality control and method validation procedures for pesticides residues analysis in food and feed. EU Reference Laboratories for Residues of Pesticides.
   Google Scholar
• [EFSA] European Food Safety Authority. 2008. Note for guidance for the preparation of an application for the safety assessment of a substance to be used in plastic food contact materials. Efsa J. 6(7):1–41.
   Google Scholar
• [EFSA] European Food Safety Authority. 2012. Scientific opinion on exploring options for providing advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). Efsa J. 10(7):2750.
   Google Scholar
• [EFSA, WHO] European Food Safety Authority, World Health Organization. 2016. Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree. EFSA Supporting publication. Efsa J. 13(3):1006E.
   Google Scholar
• Gramshaw JW, Soto-Valdez H. 1998. Migration from polyamide ‘microwave and roasting bags’ into roast chicken. Food Addit Contam. 15(3):329–335.
   PubMedGoogle Scholar
• Guaita C. 1984. HPLC analysis of cyclo-oligoamides 6 and 66. Makromolekulare Chemie. 185(3):459–465.
   Web of Science ®Google Scholar
• Heimrich M, Bonsch M, Nickl H, Simat TJ. 2012. Cyclic oligomers in polyamide for food contact material: quantification by HPLC-CLND and single-substance calibration. Food Addit Contam Part A Chem Anal Control Expo Risk Assess. 29(5):846–860.
   PubMed Web of Science ®Google Scholar
• Heimrich M, Nickl H, Bönsch M, Simat TJ. 2015. Migration of cyclic monomer and oligomers from polyamide 6 and 66 food contact materials into food and food simulants: direct food contact. Packaging Technol Sci. 28(2):123–139.
   Web of Science ®Google Scholar
• Hoppe M, Voogt P, De, Franz R. 2016. Identification and quantification of oligomers as potential migrants in plastics food contact materials with a focus in polycondensates – A review. Trends Food Sci Technol. 50:118–130.
   Web of Science ®Google Scholar
• Jenke D, Poss M, Sadain S, Story J, Smith W, Reiber D. 2005. Identification of caprolactam oligomers and related compounds in aqueous extracts of nylon-6. J Appl Polym Sci. 95(5):1262–1274.
   Web of Science ®Google Scholar
• Klun U, Andrenšek S, Kržan A. 2001. Electrospray mass spectrometry determination of linear and cyclic oligomers of polyamide-6. Polymer. 42(16):7095–7099.
   Web of Science ®Google Scholar
• Koster S, M-H B-E, Bonuomo M, Bradley E, Chagnon M-C, Garcia ML, Godts F, Gude T, Helling R, Paseiro-Losada P et al. 2015. Guidance on best practices on the risk assessment of Non Intentionally Added Substances (NIAS) in food contact materials and articles. International Life Sciences Institute (ILSI). ILSI Europe Report Series 7/16/2015.
   Google Scholar
• Kromidas S. 1999. Validierung in der Analytik. In: Gruber U, Klein W., editors. Die Praxis der instrumentellen Analytik. Weinheim: Wiley-VCH.
   Google Scholar
• Langhammer M, Lüderwald I, Weingärtner M. 1986. Formation of large cyclic amides by catalytic depolymerization of polyamides. Makromolekulare Chemie. 187(4):829–835.
   Web of Science ®Google Scholar
• Mori S, Takeuchi T. 1970. Gel permeation chromatography of the cyclic monomers and oliglmers in nylon 6 and nylon 66. J Chromatogr. 49:230–238.
   Google Scholar
• Säger S, Lenius M, Simat T. 2013. Untersuchung zum gehalt und der migration zyklischer polyamidoligomere von polyamid-küchenutensilien. Poster. 42 Braunschweig: Deutscher Lebensmittelchemikertag.
   Google Scholar
• Säger S, Mieth J, Siemat T. 2014a. Darstellung und charakterisierung von referenzstandards zur analytik von zyklischen polyamidoligomeren verschiedener PA-typen. Poster. 43 Gießen: Deutscher Lebensmittelchemikertag.
   Google Scholar
• Säger S, Mieth J, Siemat T. 2014b. Worst case oder realität? Betrachtungen der zeitabhängigen migration zyklischer polyamidoligomere aus PA-küchenutensilien in wasser. Poster. 43 Gießen: Deutscher Lebensmittelchemikertag.
   Google Scholar
• Säger S, Nachtigall C, Simat T. 2015. Simulierter gastrointestinaler verdau zyklischer polyamid-oligomere. Poster. 44 Deutscher Lebensmittelchemikertag, Karlsruhe.
   Google Scholar
• Schubert J, Kappenstein O, Luch A, Schulz TG. 2011. Analysis of primary aromatic amines in the mainstream waterpipe smoke using liquid chromatography-electrospray ionization tandem mass spectrometry. J Chromatogr. 1218:5628–5637.
   PubMed Web of Science ®Google Scholar
• Simoneau C, Hoekstra E, Bradley E, Bustos J, Golja V, Kappenstein O, Kalsbeek D, Keegan J, Milana MR, Cwiek-Ludwicka K, et al. 2011. Technical guidelines on testing the migration of primary aromatic amines from polyamide kitchenware and of formaldehyde from melamine kitchenware. 1st ed. Luxembourg: Publications Office of the European Union. EUR 24815 EN 2011.
   Google Scholar
• Soto-Valdez H, Gramshaw JW, Vandenburg HJ. 1997. Determination of potential migrants present in nylon ‘microwave and roasting bags’ and migration into olive oil. Food Addit Contam. 14(3):309–318.
   PubMed Web of Science ®Google Scholar
• Zar JH. 1999. Biostatistical Analysis. 4th ed. Upper Saddle River (NJ): Prentice-Hall.
   Google Scholar