3M Dyneon PFE 7502BZ Perfluoroelastomer meets FDA standards
Perfluoroelastomers for use in food and drug applications
The product has been tested as part of compliance procedures laid down by the Food and Drug Administration (FDA), the US government agency responsible for regulating the safety of food, drugs, cosmetics, biological products, medical devices and consumer products that emit radiation.
PFE 7502BZ ChemShield is now suitable for use in sealing applications in production and handling processes for food and pharma that require FDA compliance. In addition, the material also meets USP VI requirements.
The full compliance of the test results have been confirmed by an external law consultant with the following statement:
"PFE 7502BZ has a suitable FDA status for use in O-rings and other sealing rings for food processing equipment for repeated use, food contact applications in connection with all food types under Condition of Use A (High temperature, heat sterilised or retorted at about 121°C), and more specifically under maximum sterilisation temperatures of up to 150°C for short periods of time (less than two hours). This status is based on extremely low levels of maximum potential migration for all components of PFE 7502BZ based on surface to volume ratio typical of these industrial applications."
It remains the responsibility for the manufacturer of the finished article, which is intended to be brought into contact with food, to verify if that finished article causes any deterioration to the organoleptic properties of the food with which it is in contact in the application concerned.
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Dyneon GmbH, a 3M Company and part of the Advanced Materials Division, is a major supplier of fluoropolymers and is focusing on development, production and sales at its headquarters in Burgkirchen, Germany. The product portfolio of fluoroelastomers, fluorothermoplastics, Polytetrafluoroethylene (PTFE) and specialty additives, is available through the 3M sales organisation or representations in more than 50 countries. For more information please visit www.dyneon.eu