Petrochemicals

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 applications

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)

Food contact applications

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

Toys

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

Other applications

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)