Compliance with public authorisation as well as national and international regulations are a critical topic for us and our customers. These include requirements for food, drug and potable water contact and medical device applications.

Many of our TOPAS® COC products comply with these requirements. In addition, Drug and Device Master Files have been deposited with the Food and Drug Administration (FDA).

For specific compliance information on any product or grade, please contact Gunther Appel (please see box "contact" for more information).

FDA food contact approval:

• FCN (Food Contact Notification) No. 405 (http://vm.cfsan.fda.gov/~dms/opa-fcn.html)
• Complies with 21 CFR 177.1520 "Polyolefins", section 3.9

FDA: regulatory status for contact with medicines and in the medical devices sector:

• FDA Drug Master File (DMF 12132) and Device Master File (MAF 1043) established
• Biocompatibility meets requirements of USP Class VI and cytotoxicity protocols

EU food contact :

• Monomers and additives are listed in the EU Plastics Directive 2002/72/EC (previously 90/128/EC)

EU pharmaceutical products and medical devices:

• Complies with European Pharmacopoeia, sections 3.1.3 and 3.2.2.1
• Biocompatibility meets requirements of ISO 10993

Contact us Today!

US, Canada, Mexico:
Phone:  +1 (859) 746-6447 x4400
eMail:   info@topas.com

Europe & South America:
Phone: +49 (0) 1805-1-TOPAS*
Phone: +49 (0) 1805-1-86727*
eMail:    info@topas.com
0,14€/minute (net provider: T-Com)

Asia: Polyplastics Co., Ltd.  
Phone:  +81-3 6711 8615
eMail: topas.info@polyplastics.com