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

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where possible the corresponding batch number) or the laboratory report shouldclearly establish which articles it refers to.6.2 Sampling approachSampling shall be performed at the point of first introduction in the EU.In accordance with Regulation (EU) No. 284/2011 identity and physical checks,including laboratory analysis should be carried out on 10% of consignments. If aconsignment consists of more than one lot of polyamide and/or melamine plastickitchenware then each lot should be sampled.Identity checks are a means a visual inspection to ensure that the documentsaccompanying the consignment tally with the contents of the consignment.Samples for physical checks (i.e. laboratory analysis) should be taken according tothe approaches described below.A consignment may consist of one or more lots. Different lots may be produced bythe same or different manufacturers. Each lot should be sampled.6.2.1 General recommendationsSampling should be performed by authorised personnel as designated by theMember State Competent Authority.In the course of sampling and preparation of the samples, precautions should betaken to ensure the safety of the personnel taking the samples.For lots consisting of a number of cartons or packing bags, sampling should beperformed from a representative number of cartons/packing bags.Each sample taken should be placed in a clean bag/container offering adequateprotection from contamination and against damage during transport. All necessaryprecautions should be taken to avoid any change in or damage to the sample, whichmight arise during transport or storage.Each sample taken for official use should be sealed at the place of sampling. Arecord should be kept of each sample taken, with clear reference to the consignmentand lot identity and indicating the date and place of sampling together with anyadditional information likely to be of assistance for official controls following the rulesof the Member State.6.2.2 Sample sizeThe following sample size should be taken for each lot:- 5 articles (or 5 sets of articles) as laboratory test specimens for enforcementpurposes, and- 5 articles (or 5 sets of articles) for trade purposes (defence, e.g. repeat analysis incase of dispute)If required according to the rules of the Member State Competent Authority then afurther:- 5 articles (or 5 sets of articles) should be taken for reference (referee)The samples for trade and reference purposes should be retained securely followingthe rules of the Member State, unless such a procedure conflicts with MemberStates’ rules as regards the rights of the food business operator.8
7 LABORATORY TESTING7.1 Number of test specimens5 test specimens (articles or sets) should be taken for enforcement purposes:1 test specimen for the identification of the polymer type1 test specimen for the surface area calculation3 test specimens (individual articles or sets of articles) for the migration test7.2 Identification of the polymer typeIf doubts exist as to the identity of the material of which the articles are made thenthe polymer type should be determined. Different methods can be applied todetermine polymer type such as Fourier transform infra-red spectroscopy (FT-IR)methods and/or pyrolysis methods.The FT-IR spectrum of the polymer should be acquired and compared to thestandard spectra for either polyamide or melamine. This can be done usingAttenuated Total Reflectance (ATR), by Diffuse Reflectance Infrared FourierTransform (DRIFT) or by preparation of potassium bromide (KBr) pellet.Descriptions of tests by flame and by pyrolysis can be found detailed in: Von A.Krause, A. Lange and M. Ezrin; Plastics analysis guide: chemical and instrumentalmethods; ISBN 3-446-12587-1. Hanser Publ. (Munich), 1983, as well as D. Braun:Simple Methods for Identification of Plastics, with the plastics identification table, 4Edition, Hanser (Munich), 1999.If the identity of the polymer is confirmed for the article, then the migration testingdescribed below should be carried out.If the polymer type is not polyamide/melamine then this should be reported and nomigration tests needs to be conducted.7.3 Surface area calculation of a test specimenIn the case of kitchenware, the surface area in contact with foods for the test can becalculated from the measured dimensions of the test specimen. For the calculation ofthe surface area, the surface area can be seen as the sum of all the areas that makeup the food contact surface of an article. Empirical methods can be used to calculatethe surface area by placing the article on a piece of millimetric or plain paper ofsufficient size. The paper is then wrapped around the contour of the article and cut tosize. The contact area is then calculated by either counting the area based onmillimetric measurements or by weighing the paper and converting the weight to thesurface area.Note: for articles tested by immersion the area of both sides should be included in the calculation ofthe contact area.7.4 Rules on testing conditions7.4.1 Type of contact: total immersion or article fillingAccording to the type of article the test should be performed by total immersion or by9
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: processed in a single process or se
Page 11 and 12: Other:Testing conditions should be
Page 13 and 14: The simulant from the first and sec
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Page 17 and 18: For articles that:- are fillable an
Page 19 and 20: April 2004 on official controls per
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......
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Page 56 and 57: European CommissionEUR 24815 EN - J
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The mission of the JRC is to provid
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