Regulatory compliance

meliflex is carefully designed in accordance with customer requirements and to comply with relevant regulatory standards for pharmaceutical packaging and medical devices.

meliflex regulatory compliance

meliflex is designed to meet the following standards:

  • REACH (1907/2006/EC)
  • EC directive 10/2011 on plastic materials and articles intended to come into contact with foodstuffs
  • FDA CFR 21 part 177
  • Additives according to European Pharmacopoeia (e.g. monograph 3.1.3) - subject to material type

In addition, meliflex reference materials are tested with independent international test institutes to certify that meliflex materials comply with:

  • ISO 10993-5 / USP 87 (Cytotoxicity in Vitro)
  • USP 88 (Class VI)
  • USP 661 (Physicochemical tests for plastics)

Regulatory certification on customized grades are offered as per agreements with our customers.

Detailed Regulatory Data Sheets are avaialble for all meliflex grades on request.