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.