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

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The samples should then be subjected to the third migration test but individually (1test specimen in 1 beaker) (see below).Exposure 1 Exposure 2 Exposure 3AnalysesimulantDo not analysesimulantAnalysesimulantCompliantNo further testingrequiredThe three portions of simulant derived from exposure 3 should be tested for PAAs.Note: when data is available to demonstrate that the presence of cut edges does not have asignificant effect on the migration results, then test specimens may be cut into a few pieces prior tomigration testing.For example, the following approach has been found to be suitable:Melamine Materials: kitchenware articles that require testing by immersion [under Directive2002/72/EC 3 beakers (cylindrical and under flask) of Regulation diameter as narrow (EU) as 10/2011]possible whilst accommodating the width of the article(usually 500 ml and 800 ml long necks have been found adequate), and 3 glass or tightly fitted aluminium foilThe covers. three Hotplate test (or specimens oven or Bunsen for burner), the migration cutting implement, test are a timer, tested 10 anti-bumping together granules/ in one beads beaker forSolution of 3% w/v aqueous acetic acid in sufficient amount for the test (10 litres)the first exposure. The simulant is removed and a second successive migration testperformed in the same way (i.e. all three kitchenware articles immersed together).Test protocol:The Take simulant one beaker from (cylindrical the flask) first of and diameter second as narrow test as is possible discarded. whilst accommodating The samples the width should for thenbe containing subjected 3 articles to together the third fully exposed. migration Take test three but samples individually and cut for each (1 article the handle in at 1 the beaker) height of the (seebeaker minus 1 cm. Prepare a solution of 3% w/v aqueous acetic acid and heat up a portion to the testingbelow).temperature. Fill the beaker with the simulant equilibrated at the test temperature to a volume able to submerge atleast the entire “food contact surface area” of the test specimen (1cm of the handle can be included if desired).Add 2-3 anti-bumping granules to the beaker. Immerse all 3 articles together in one beaker of solution, covering theExposure 1 Exposure 2 Exposure 3top of the beaker with a glass plate or hour glass or aluminium foil in order to reduce the loss of the simulant byevaporation. When temperature reaches testing temperature, start the timer to record time and set to 2 hrs. After 2hrs, stop the timer. Remove the test specimens from the simulant. Determine the simulant volume/weight (or addsimulant till original volume/weight) and analyse the exposed simulant for PAAs. If the results of this test are belowthe limit, then the set is considered to be compliant and no further testing is required. If the articles fail the test,then conduct a second migration in the same way (i.e. with all 3 test specimens exposed together in the sameportion of fresh simulant). It is not necessary to analyse the simulant from this second exposure.Separate the articles. Proceed with the third migration test with fresh simulant (previously equilibrated at the testtemperature). Immerse each test specimen in a separate beaker; cover the top of the beaker with a glass plate orhour glass in order to reduce the loss of the simulant by evaporation. When the temperature reaches testingDo not analysesimulantDo not analysesimulantAnalysesimulanttemperature start the timer to record time and set to 2 hrs. After 2 hrs, stop the timer. Remove the test specimensfrom the simulant and allow the simulant to cool to room temperature before proceeding. Determine the simulantvolume. Determine the concentration of PAAs in each of the three exposed simulant samples. Retain enoughsimulant to repeat the analysis if necessary.Melamine kitchenware articles that require testing by immersionThe three test specimens for the migration test are tested together in one beaker forthe first exposure. The simulant is removed and a second successive migration testperformed in the same way (i.e. all three kitchenware articles immersed together).12
The simulant from the first and second test is discarded. The samples should thenbe subjected to the third migration test but individually (1 article in 1 beaker).Exposure 1 Exposure 2 Exposure 3Do not analysesimulantDo not analysesimulantAnalysesimulantThe three portions of simulant derived from exposure 3 should be tested for migrationof formaldehyde.Melamine kitchenware articles that require testing by fillingEach test specimen is filled to 0.5 cm below the rim and exposed to the simulant.The simulant is removed and a second and third successive migration testsperformed in the same way. The simulant from the first and second test can bediscarded.Exposure 1 Exposure 2 Exposure 3Do not analysesimulantDo not analysesimulantAnalysesimulantThe three portions of simulant derived from exposure 3 should be tested forformaldehyde.7.6.2 Lot(s) of sets of articlesA lot of grouped articles sold in sets (e.g. with different shapes in one set)Polyamide kitchenware articles that require testing by immersionThe three sets of test specimens for the migration test are tested together in onebeaker for the first exposure as shown below and the simulant is analysed for PAAs.If the test specimens are compliant in this first test assuming that all of the PAAsmeasured in the simulant have migrated from the article with the smallest surfacearea (i.e. the worst case), then no further testing is required.Note: Migration tests are normally conducted three times for repeat use articles, and the results ofthe third migration taken into account. However, the migration of PAAs is known to decrease afterthe first migration, therefore in this scheme the simulant from the 1 st migration is analysed for PAAsand if results are compliant then no further testing is required.If the sample sets are not compliant a second exposure should be carried out in the same way (i.e.the three sets of test specimens exposed together in one beaker).13
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: Other:Testing conditions should be
Page 15 and 16: The sets of test specimens should t
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......
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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