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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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