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

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article filling.If the article is intended to be immersed partially or totally in the food (e.g.spatulas, spoons, ladles, etc), then the test is performed by immersion. The testspecimens should be immersed in the simulant to cover entirely the functional partthat comes into contact with the foodstuff.[Note: the functional part means for example the round part of the spoon]If the article is intended to be filled with food (e.g. plates, cups etc) then the testshould be performed by article filling.The surface area and simulant volume should be recorded.7.4.2 Repeated use article testingUntil 31/12/2012 the rules for testing repeated use articles given in Directive2002/72/EC should be applied. The provisions in Directive 2002/72/EC require threesuccessive migration tests to be carried out for all articles intended for repeated useand the results of the third test are taken. Therefore for polyamide and melaminekitchenware three successive migration tests should be performed.As of 01/01/2013 the rules under Regulation (EU) No 10/2011 will apply. Theseprovisions include that:- For primary aromatic amine migration from polyamide kitchenware only onemigration test will be carried out (for non-detectable substances, itscompliance will be checked on the basis of the level of the migration found inthe first test).- For formaldehyde migration from melamine kitchenware, three migration testsare carried out. Its compliance shall be checked on the basis of the level ofthe migration found in the third test.7.4.3 SimulantsThe test is conducted with simulant B 3% (w/v) acetic acid, as it has beendemonstrated that this simulant represents the worst case for the migration of PAAsfrom polyamide kitchenware and for formaldehyde from melamine kitchenware.7.4.4 Time-temperature exposure conditionsTime and temperature conditions should be in accordance with the relevantlegislation (Directive 82/711/EEC, as amended, and Regulation (EU) No 10/2011), onthe basis of the specific function of the kitchenware article(s).Recommendations on time-temperature exposure conditions for kitchenware havebeen described in Guidelines on testing conditions for articles in contact withfoodstuffs (EUR 23814 EN 2009). The test conditions defined in the aforementioned<strong>guidelines</strong> were selected based on the relevant Directives or Regulation for foodcontact materials and articles. These are harmonised for plastics at EU level.Articles that could be used or foreseeably used during cooking, (e.g. ladles,spatulas, spoons) the test conditions should be 2 hours (– 0, + 5 minutes) at theboiling point of the simulant (tolerance is +/- 3°C at 100°C).Articles that could not foreseeably be used for cooking, (e.g. bowls, cups, plates,potato mashers, tongs) the test conditions should be 2 hours (– 0, + 5 minutes) at70°C measured in the simulant itself (+/- 2°C).10
Other:Testing conditions should be carefully chosen based on expert judgment andlabelling to reflect the worst case scenario based on the use and function of thearticle. In addition, if a specific labelling information/instruction contains a maximumtemperature for use, the temperature conditions will be chosen accordingly from thecorresponding temperature exposures in the relevant legislation. In any case theminimum contact time for the migration test should be at least 30 minutes. 17.5 Preparation of laboratory samplesComplete traceability from the sample to the test result should be ensured.Dust may be removed by wiping the sample with a lint-free cloth or brushing with asoft brush. If articles are labelled with an instruction that they should be cleanedbefore use then this instruction should be followed before testing.7.6 Procedure for repeat use kitchenware – 3 successivemigration testsNote: Although Commission Directive 2002/72/EC is repealed by Regulation EC No 10/2011 as from1 May 2011, the provisions on verification of compliance with migration limits for repeated usearticles (Article 23) should be applied until 31/12/2012.Depending on the article type the migration test is performed either by immersion orby filling.The experimental set-up must limit the evaporation that occurs during the exposurephase. The volume or weight of the simulant should be recorded following thecompletion of the test.7.6.1 Lot(s) of individual articlesPolyamide kitchenware articles that require testing by immersionThe three test specimens for the specific migration test are tested together in onebeaker for the first exposure 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 samples are not compliant a second exposure should be carried out in the same way (i.e. allthe three test specimens exposed together in one beaker).1 A minimum contact time should be 30 minutes because it cannot be demonstratedthat home or catering use would always be less than 5 minutes.11
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: 7 LABORATORY TESTING7.1 Number of t
Page 13 and 14: The simulant from the first and sec
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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