Properties

Date:

16.05.2008 - 18:27

Listings

The VESTOSINT® polyamide 12 powders have been approved for direct contact with foodstuffs by the European Community. The directive specifies a limit migration value of 5 milligrams per kilogram for laurolactam, which must be tested and complied with on the finished article itself.

According to 21 CFR, § 177.1500 (Nylon Resins), of the Food and Drug Administration (FDA), PA 12 powder is currently licensed in the U.S. for repeated-use coatings. The license excludes contact with alcohol-containing foods and beverages.

Directive 93/42/EEC applies to the use of materials in medical applications within the European Community. In August 1994, this directive was incorporated into German law by passage of the Medizinproduktegesetz (Medical Devices Act). The pertinent international and national standards, such as ISO 10993 and DIN EN 30993-1, cover the details of the approval process. The most current Deutsche Arzneibuch (DAB) (German Pharmacopoeia) and European Pharmacopoeia, Eur. Ph., current edition 1998, can be used as supplementary regulatory works to make the decision in special cases. In cases of doubt, workpieces shall be tested by the manufacturer or user under the conditions of use.