Tech Center / Performance Data

Exceptional Purity

TOPAS® COC is a polymer of exceptional purity, with low extractables. Avoid controversial ingredients by choosing high-purity TOPAS resin for your next product.

TOPAS COC does not use in its process or formulations:

  • Plasticizers, including phthalates
  • BPA (bisphenol A)
  • CONEG heavy metals, including lead, cadmium, chromium, etc.
  • Halogens, including chlorine and fluorine
  • Fluorochemicals or fluoropolymers, including PFOA (“C8”)
  • Flame retardants, including brominated compounds
  • Vinyl chloride monomer or polymer
  • Conflict minerals
  • RoHS substances
  • California Proposition 65 substances
  • SARA 313 substances
  • Ozone-depleting chemicals
  • Natural rubber or latex compounds

TOPAS polymers comply with key US regulations for packaging and medical applications, including:

  • FDA regulation 21 CFR § 177.1520 “Olefin polymers” (3.9)
  • FDA Food Contact Notification #405, effective 2004, covers all applications including bottles
  • FDA FCN #1104 covers Elastomer E-140 for many conditions of use
  • FDA Drug Master File — DMF #12132
  • FDA Device Master File — MAF #1043

We have obtained Health Canada clearance for our leading grades.

In Europe, the monomers and additives are listed in the EU Plastics Regulation 10/2011 (PIM – Plastic Implementation Measure).

More TOPAS regulatory info is available here. Please see our Packaging and Medical brochures.

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