Approvals & certificates

Hexamoll® DINCH is REACH-registered, approved and certified for sensitive applications by many authorities and institutions worldwide. Click on your application of interest to get further information on application-specific approvals and certificates that Hexamoll® DINCH complies with or for which it fulfills the requirements.

  • Medical Device Regulation (EU) 2017/745
  • European Pharmacopoeia
  • DIN EN ISO 10993
  • US FDA Medical Device Master Files (No. 1484; 16323)
  • US Pharmacopeia (Monograph 88, Class VI)
  • Chinese Food and Drug Administration (CFDA)
  • Chinese Industry Standard for Medical Devices
  • Korean Food and Drug Administration (KFDA)
  • Japan Ministry of Health, Labor and Welfare (MHLW)

Hexamoll® DINCH won the Solvin Award and Medical Device Award for the project: ”Medical Devices without DEHP in blood product applications“ (2013)

  • European Commission Regulation (EU) No 10/2011
  • 21st Amendment of the German Consumer Goods Regulation (printing inks)
  • Swiss Ordinance on Materials and Articles in Contact with Food (consumer goods from plastics and printing inks)
  • Chinese GB Standard GB 9685-2016
  • Korean Food and Drug Administration (KFDA)
  • Australian Industrial Chemical Introduction Scheme (AICIS)
  • US National Sanitation Foundation, Standard 61 for drinking water system components
  • Health Canada’s Health Products and Food Branch (HPFB)
  • Safe for its intended use in Mexico and MERCOSUR
  • Human biomonitoring (HBM) data confirm safe exposure levels

  • EU Toy Safety Directive 2009/48/EC
  • European Toys Standards: DIN EN 71-3, EN 71-5, DIN EN 71-9
  • US-CPSC toy safety specification ASTM F963
  • GB 6675-2014 Chinese Toy Safety Standard

Hexamoll® DINCH is REACH registered and not listed in:

  • EuPIA (European Printing Ink Association)
  • Directive 2011/65/EU (RoHS-Requirements) incl. 2015/863
  • Regulation (EC) No 850/2004 (POP)