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

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For articles that:– are fillable and have a volume in <strong>the</strong> range <strong>of</strong> 500 ml up to 10 l– are (intended to be) in c<strong>on</strong>tact with food for infants and young children<strong>the</strong> analytical result needs to be corrected for <strong>the</strong> difference in surface-to-volumeratio between <strong>the</strong> experiment and <strong>the</strong> real food c<strong>on</strong>tact c<strong>on</strong>diti<strong>on</strong>s.For articles that:– fillable articles that have a volume below 500 ml or higher than 10 l.– articles for which it is not practical to estimate <strong>the</strong> relati<strong>on</strong>ship between <strong>the</strong>surface <strong>of</strong> that material and <strong>the</strong> volume <strong>of</strong> food.<strong>the</strong> analytical result needs to be corrected for <strong>the</strong> difference in surface-to-volumeratio between <strong>the</strong> experiment and <strong>the</strong> food c<strong>on</strong>tact c<strong>on</strong>diti<strong>on</strong>s <strong>of</strong> 6 dm 2 /kg.The analytical results have to be reported toge<strong>the</strong>r with <strong>the</strong> expanded measurementuncertainty at <strong>the</strong> legislative limit, as referred in <strong>the</strong> EU-RL-NRL Network (EUR24105, 2009).9.2 Establishment <strong>of</strong> complianceAs regards polyamide kitchenware, <strong>the</strong> specific migrati<strong>on</strong> limit for PAAs is set as n<strong>on</strong>detectableexcept for those <strong>on</strong> <strong>the</strong> positive list <strong>of</strong> <strong>the</strong> relevant legislati<strong>on</strong> (CAS 108-45-2, CAS 1477-55-0, CAS 106246-33-7). They should not release into foods or foodsimulants PAAs in a detectable quantity. The detecti<strong>on</strong> limit applies to <strong>the</strong> sum <strong>of</strong><strong>primary</strong> <strong>aromatic</strong> amines. For <strong>the</strong> purpose <strong>of</strong> <strong>the</strong> analysis <strong>the</strong> detecti<strong>on</strong> limit for PAAsis set at 0.01 mg/kg food or food simulants.As regards melamine kitchenware, <strong>the</strong> specific migrati<strong>on</strong> limit for formaldehyde withhexamethylenetetramine is 15 mg /kg food.Compliance with maximum levels should be established <strong>on</strong> <strong>the</strong> basis <strong>of</strong> <strong>the</strong> levelsdetermined in <strong>the</strong> laboratory samples.The limit is exceeded when <strong>the</strong> analytical result is higher than <strong>the</strong> relevant specificmigrati<strong>on</strong> limit (SML) taking into account measurement uncertainty.9.3 Quality and safety9.3.1 Internal quality c<strong>on</strong>trol and pr<strong>of</strong>iciencyOfficial c<strong>on</strong>trol laboratories must comply with Regulati<strong>on</strong> (EC) No 882/2004 <strong>on</strong> <strong>the</strong>subject <strong>of</strong> additi<strong>on</strong>al measures c<strong>on</strong>cerning <strong>the</strong> <strong>of</strong>ficial c<strong>on</strong>trol <strong>of</strong> foodstuffs.Laboratories should be able to dem<strong>on</strong>strate that <strong>the</strong>y have internal quality c<strong>on</strong>trolprocedures in place. Examples <strong>of</strong> <strong>the</strong>se are <strong>the</strong> "ISO/AOAC/IUPAC Guidelines <strong>on</strong>Internal Quality C<strong>on</strong>trol in Analytical Chemistry Laboratories".Participati<strong>on</strong> in appropriate pr<strong>of</strong>iciency <strong>testing</strong> schemes which comply with <strong>the</strong>"Internati<strong>on</strong>al Harm<strong>on</strong>ised Protocol for <strong>the</strong> Pr<strong>of</strong>iciency Testing <strong>of</strong> (Chemical)Analytical Laboratories" developed under <strong>the</strong> auspices <strong>of</strong> IUPAC/ISO/AOAC and ISO17043.17

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