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Product Inform tion

T e f l o n / T e f z e l / Z o n y l ® ® ®

fluoropolymer resins and fluoroadditives

Teflon®/Tefzel® Fluoropolymer Resins and Zonyl® Fluoroadditives in Applications Regulated by the Food and Drug Administration

This data sheet pertains to the U.S. Federal Food and Drug Administration (FDA) regulations governing the use of fluoropolymers as articles or components of articles intended for use in contact with food.

Articles Intended to Contact Food

Components of Resinous and Polymeric Coatings

Reference: 21 CFR 177.1550 Perfluorocarbon Resins

Reference: 21 CFR 175.300 Resinous and Polymeric Coatings

Most Teflon® PTFE and FEP fluoropolymer resins may be used as articles or components of articles intended to contact food in compliance with this regulation. A partial list of resins that meet the requirements of this regulation is given in Table 1.

Teflon® PFA type fluoropolymer resins listed in Table 1 have been approved by the FDA for repeated-use food contact articles such as tubing, hoses, components of valves, etc., as well as for coatings for articles intended for repeated food contact use in compliance with this regulation.

As indicated in Table 1, most Teflon® fluoro- polymer resins and Zonyl® fluoroadditives may be used as release agents in compliance with this regulation as long as the finished coating meets the extractives limitations of the regulation. Both because of the small amount required for a release agent and its insolubility, the PTFE would be expected to contribute a negligible amount to the extractables, but it is the customer’s responsibility to measure extractives on finished coating to ensure compliance.

Some fluoropolymer resins are irradiated to facili- tate grinding into fine powders for applications needing a very small particle size. Paragraph (c) specifies the allowable dose of radiation and maximum particle size for PTFE resins so pro- cessed and restricts their use to components of articles intended for repeated use in contact with food. Table 1 shows the Zonyl® fluoroadditives that comply with this paragraph.

Processing Aids for Polyolefins Reference: 21 CFR 177.1520 Olefin Polymers

Z o n y l ® f l u o r o a d d i t i v e s M P 1 5 0 0 J a n d M P 1 6 0 0 N ; T e f l o n ® P T F E a n d F E P r e s i n s l i s t e d i n T a b l e 1 ; a n d up to 2,000 ppm of Zonyl® fluoroadditives MP 1000, MP 1300, and MP 1400 may be used as extrusion aids for polyolefins in compliance with this regulation as long as the polyolefin resin complies with the regulation.

Components of Paper and Paperboard

Reference: 21 CFR 176.170 Components of Paper and Paperboard in Contact with Aqueous and Fatty Foods

As indicated in Table 1, most Teflon® fluoro- polymer resins and Zonyl® fluoroadditives may be used as release agents in compliance with this regulation as long as the finished coating meets the extractives limitations of this regulation. Both because of the small amount required for a release agent and its insolubility, the PTFE would be expected to contribute a negligible amount to the extractables, but it is the customer’s responsibility to measure extractives on finished coating to ensure compliance.

Teflon®, Tefzel®, and Zonyl® are registered trademarks of DuPont.

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