Approvals & Certificates
Hexamoll® DINCH is approved and certified for sensitive applications worldwide
It is suitable for use in end-products that need to comply with the following:
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 FDA
- Chinese Industry Standard for Medical Devices
- Korean FDA
- Japan Ministry of Health, Labor and Welfare
Hexamoll® DINCH won the Solvin Award and Medical Device Award for the project:
”Medical Devices without DEHP in blood product applications“
>> Click here to learn more about Hexamoll® DINCH in medical applications.
Food Contact Applications
- European Commission Regulation (EU) No 10/2011
- Swiss Ordinance on Materials and Articles in Contact with Food (consumer goods from plastics and printing inks)
- Chinese GB Standard GB9685-2016
- Japan Hygienic PVC Association (JHPA)
- Korean FDA
- Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS)
- 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
- Human biomonitoring (HBM) data confirm safe exposure
>> Click here to learn more about Hexamoll® DINCH in food contact applications.
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
>> Click here to learn more about Hexamoll® DINCH in toys and childcare applications.
Other
- Hexamoll® DINCH is REACH registered
- Hexamoll® DINCH can be used in printing inks as the substances listed in "Exclusion Policy for Printing Inks and related products" according to EuPIA (European Printing Ink Association) 11/2016 3rd edition (corrigendum Dec 2018) have not been used in the manufacture of Hexamoll® DINCH and have not been intentionally added to the product
- Hexamoll® DINCH can be used as ingredient in products that shall be certified with Oeko-Tex® Standard 100 (textiles)
- Hexamoll® DINCH can be used as ingredient in products that shall be certified with the German ecolabel "Blue Angel"
If you are interested in more Hexamoll® DINCH data, please see the download on the right. This list shows the available studies concerning Hexamoll® DINCH. Feel free to contact us in case of questions.
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