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Following the harmonization of European laws and ordinances, new regulations have come into effect for food contact plastics.
Our VESTAMID® L base grades of the PA 12 series are approved in the European Union for food contact because the base monomer laurolactam and the used additives are on the positive list in Commission Regulation (EU) No 10/2011. A migration limit of five milligrams per kilogram food has been specified for laurolactam, which must be tested and complied with on the finished article itself.
It must be noted that the unstabilized molding compounds can be sterilized in hot air at temperatures up to 120°C for a maximum of 30 minutes. Should stabilization or the use of certain additives be necessary, we would be happy to advise you in any individual case.
The VESTAMID® D base grades of the PA 612 series such as VESTAMID® D16, D18, D22, and D26 are also approved in the European Union for food contact because the base monomers hexamethylenediamine and decanedioic acid and used additives are on the positive list in Commission Regulation (EU) No 10/2011. A migration limit of 2.4 milligrams per kilogram food has been specified for hexamethylenediamine, which must be tested and complied with on the finished article itself.
Heat-stabilized (S1) VESTAMID® E molding compounds (PA 12 elastomers) may be used in contact with foods if they comply with migration limits. There monomers and additves also are on the positive list in Commission Regulation (EU) No 10/2011.
Under 21 CFR §177.1500 (Nylon Resins) of the Food and Drug Administration (FDA), PA 12 is approved in the U.S. for films of thickness up to 40 micrometers. This approval applies to the base products VESTAMID® L1600, L1700, L1800, L1901, and L2101F.
Also under 21 CFR §177.1500 (Nylon Resins) of the FDA, PA 612 is approved in the U.S. for articles for repeated use in contact with food up to a maximum temperature of 100°C. The restrictions of paragraph b(8) must be observed, however. Cold sterilization is permitted.
For more detailed information and specific queries please contact our experts or our Customer Service Center. Our Environment, Health, Safety & Quality department will check and confirm the approval for your selected compound.
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