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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)
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