Regulatory and compliance requirements of Mitsubishi Chemical Advanced Materials


Regulatory and compliance requirements represent a fundamental value to us as MCAM. Over the past several years, requirements for specific markets like Food & Pharma, Healthcare, Oil&Gas / Energy, Semicon and Aerospace have increased and changed significantly.

To ensure the highest level of controls and meeting specific requirements, we need to position our products accordingly.
As a result we herewith notify you that certain compliance and regulatory statements need to be changed for following grades:

  • Ketron® HPV PEEK
  • Ketron® CA30 PEEK
  • Ketron® GF30 PEEK

Following statements will need to be withdrawn:
FDA, California proposition 65, RoHS, halogens, PAH, latex, nanomaterials, ODS, POP, phthalates, PMUC, radioactive substances, silicones, and WRAS.

Following statements will be continued:
Biocides, TSE/BSE, conflict minerals.

This change will become effective May 1st, 2021, and is relevant for all stock items of affected grades.
In case there are specific needs regarding certain statement categories, we offer industry specific grades like Ketron® LSG CA30 PEEK.

For certain requirements we offer made-to-order solutions and boutique manufacturing capabilities.

Please contact your sales representative, our regulatory team - Mrs. Mieke Meire for EMEA and Mr. James Kohler for NA - or submit your questions to regulatorysupport@mcam.com.


Hilde Devroe, European Compliance & Regulatory Affairs Manager, Mitsubishi Chemical Advanced Materials Europe NV
Joey Inmon, Quality Manager, North America, Mitsubishi Chemical Advanced Materials Inc.