Technical guidelines on testing the migration of primary aromatic ...

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9.3.2 Health and SafetySuitable protective clothing, eye protection and gloves should be worn at all times.Refer to the Material Safety Data Sheets for all relevant chemicals. Some chemicalsare toxic compounds and/or suspected human carcinogens. All solids, standardsolutions and samples should be treated with the utmost care.Appropriate laboratory care and precautions should be exercised at all times.Appropriate disposal of exposed simulants, solvents and used kitchenware must beexercised.10 TEST REPORTThe test report should be at minimum provided in the English languageThe test report should contain, as a minimum, the following:Identification of the sample (i.e. consignment number, lot number, sample number);Date and method of obtaining the laboratory sample;Name of laboratory; Name of person responsible for analysis; Date of report;Analyte(s); A reference to the method(s) used; Performance characteristics of themethod(s) used as in Regulation (EC) No 882/2004 and EUR 24105, 2009. Theparameters must include limit of detection [for each substance in the case of PAAs,limit of quantification (for formaldehyde), and measurement uncertainty.All information necessary for complete identification of the sample, e.g. chemicaltype, trade mark, grade, batch number, dimensions, shape etc – pictures should beincluded together with a rulerThe type of the migration test (i.e. immersion or article fill, number of exposures);The duration and temperature;The surface area exposed and volume of food simulant used;Any departures from the standard methods presented here, reasons for thedepartures;Any relevant comments on the test results;Details of any confirmation procedure(s), if any.11 REFERENCESRegulation (EC) No 1935/2004 of the European Parliament and of the Council of 27October 2004 on materials and articles intended to come into contact with food andrepealing Directives 80/590/EEC and 89/109/EEC.Commission Regulation (EC) No 2023/2006 on good manufacturing practice formaterials and articles intended to come into contact with foodRegulation (EC) No 882/2004 of the European Parliament and of the Council of 2918
April 2004 on official controls performed to ensure the verification of compliance withfeed and food law, animal health and animal welfare rules.Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials andarticles intended to come into contact with foodstuffs.Council Directive 85/572/EEC laying down the list of simulants to be used for testingmigration of constituents of plastic materials and articles intended to come intocontact with foodstuffs.Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulantsto be used for testing migration of constituents of plastic materials and articlesintended to come into contact with foodstuffs.Council Directive 82/711/EEC of 18 October 1982 laying down the basic rulesnecessary for testing migration of the constituents of plastic materials and articlesintended to come into contact with foodstuffs.EN 13130-1 Materials and articles in contact with foodstuffs: Plastics substancessubject to limitation Part 1: Guide to test methods for the specific migration ofsubstances from plastics to foods and food simulants and the determination ofsubstances in plastics and the selection of conditions of exposure to food simulants.EN 13130-23 Materials and articles in contact with foodstuffs: Plastics substancessubject to limitation Part 23: Determination of formaldehyde andhexamethylenetetramine in food simulant.Guidelines for Performance Criteria and Validation Procedures of Analytical Methodsused in Controls of Food Contact Materials, JRC Scientific and <strong>Technical</strong> Reports, S.Bratinova, B. Raffael, C. Simoneau, 1st Edition, EUR 24105 EN 2009Guidelines on Testing Conditions for Articles in Contact with Foodstuffs (with a focuson kitchenware) JRC Scientific and <strong>Technical</strong> Reports, C. Simoneau, EUR 23814 EN2009.Guidance document on fat reduction factor, plastic functional barrier, phthalates andprimary aromatic amines - Introduced in the fourth amendment of Directive2002/72/EC and taken over by Regulation (EU) No 10/2011 on food contactmaterials JRC Scientific and <strong>Technical</strong> Reports, E.J. Hoekstra, J.H. Petersen, J.Bustos, (in print) 2011.Mortensen, S.K., Trier, X.T., Foverskov, A., Petersen, J.H. (2005), Specificdetermination of 20 primary aromatic amines in aqueous food simulants by liquidchromatography-electrospray ionization-tandem mass spectrometry. J. Chromatogr.A, 1091, 40–50.Sendón, R., Bustos, J., Sánchez, J.J., Paseiro, P., Cirugeda, E. (2010) Validation ofa liquid chromatography-mass spectrometry method for determining the migration ofprimary aromatic amines from cooking articles and its application to actual samplesFood Add. and Contam. - Part A, 27(1), 107-117.Potter, E.L.J., Bradley, E.L., Davies, C.R., Barnes, K.A., and Castle, L. (2010),Migration of formaldehyde from melamine-ware: UK 2008 survey results. Food Add.and Contam. - Part A, 27(6), 879-883.Bradley, E.L., Boughtflower, V., Smith, T. L., Speck, D.R. and Castle, L. (2005).Survey of the migration of melamine and formaldehyde from melamine food contactarticles available on the UK market, Food Add. and Contam. - Part A, 22(6), 597-606.Lund, K.H., & Petersen, J.H. (2006). Migration of formaldehyde and melaminemonomers from kitchen- and tableware made of melamine plastic. Food Add. andContam. - Part A, 23(9), 948-955.19
Page 1 and 2: Technical
Page 3 and 4: Executive SummaryComparability of r
Page 5 and 6: 1 CONTEXTUnder Regulation EC No 882
Page 7 and 8: processed in a single process or se
Page 9 and 10: 7 LABORATORY TESTING7.1 Number of t
Page 11 and 12: Other:Testing conditions should be
Page 13 and 14: The simulant from the first and sec
Page 15 and 16: The sets of test specimens should t
Page 17: For articles that:- are fillable an
Page 21 and 22: Annex 1 - Primary aromatic aminesTh
Page 23 and 24: 1 PROTOCOL A BY LC-MS1.1 PrincipleT
Page 25 and 26: litre of methanol.Mobil phase B: Pr
Page 27 and 28: 1.3.4 Quantification of analyte lev
Page 29: 2 PROTOCOL B BY LC-MSThis procedure
Page 32 and 33: Gradient (linear):Time % A % B0.0 m
Page 34 and 35: 2.4.2 Detection limitsDL estimated
Page 36 and 37: 3.2.1.13 4,4'-Methylenedianiline (4
Page 38 and 39: Samples) the concentration (C) of t
Page 40 and 41: Appendix A: UPLC ConditionsColumn:A
Page 42 and 43: 4.2 Materials and chemicalsNOTE: Re
Page 44: Dwell volume0,9 ml4.3.3 HPLC calibr
Page 48 and 49: Table of contents1 PROTOCOL A......
Page 50 and 51: Repeat the procedure to obtain a se
Page 52 and 53: prepared stock solutions shall be c
Page 54 and 55: food simulant, depending on the typ
Page 56 and 57: European CommissionEUR 24815 EN - J
Page 58: The mission of the JRC is to provid

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