Reference: 21 CFR 176.180 Components of Paper and Paperboard in Contact with Dry Food
As indicated in Table 1, most Teflon® fluoro- polymer resins and Zonyl® fluoroadditives may be used as release agents in compliance with this regulation.
Lubricant for Rubber Articles
Reference: 21 CFR 177.2600 Rubber Articles Intended for Repeated Use
The Teflon® PTFE and FEP resins and the Zonyl® fluoroadditives indicated in Table 1 can be used as lubricants for rubber articles intended for repeated use in contact with food in compliance with this regulation.
Components of Adhesives Reference: 21 CFR 175.105 Adhesives
The Teflon® PTFE resins listed in Table 1 and Zonyl® fluoroadditives MP 1000, MP 1300, MP 1400, MP 1500J, and MP 1600N may be used as components of adhesives in compliance with this regulation.
Tefzel® 200, 210, 220, and 280 may be used as articles or components of articles intended for repeat-use food processing applications, in contact with all food types at temperatures up to 121C (250F) in compliance with the Federal Food, Drug, and Cosmetic Act and the applicable regulations.
Colorants in Polymers
Reference: 21 CFR 178.3297 Colorants for Polymers
This regulation permits certain colorants for use in polymers intended for food contact use. Included are TiO2, iron oxides, all-gas channel black, and ultramarine colorants.
Reference: Food Drug Cosmetic Law Journal, Vol. 42, No. 1, January 1987, p. 45
The housewares exemption holds that substances sold for use in housewares such as dinnerware or eating utensils need no FDA clearance. This exclusion flows from the legislative history of the 1958 Amendment to the FD&C Act, and FDA’s position has been that it will not require Food
Additives Amendment-type clearance of materials used to manufacture empty containers, utensils, or appliances sold to the consumer for home use.
The United States Department of Agriculture (USDA) has accepted Teflon® PTFE, FEP, and PFA fluoropolymer resins that comply with 21 CFR 177.1550 as components of materials in direct contact with meat or poultry food products prepared under Federal inspection. Resins that comply with this regulation are shown in Table 1.
3-A Sanitary Standards
Teflon® PTFE, FEP, PFA, and Tefzel® fluoropolymer resins comply with the Criteria in “3-A Sanitary Standards for Multiple-Use Plastic Materials Used as Product Contact Surfaces for Dairy Equipment, Number 20-17,” published by the 3-A Secretary, Dairy and Food Industries Supply Association, Inc.
US Pharmacopeia Class VI
Representative samples of Teflon® PTFE, FEP, PFA, and Tefzel® fluoropolymers have been tested in accordance with USP protocol, and all meet the requirements of a USP Class VI plastic. These tests on representative samples may not reflect results on articles made from these fluoropolymers, especially if other substances are added during fabrication. Testing of the finished article is the responsibility of the manufacturer or seller of the finished product if certification that it meets USP standards is required.
USP testing was done to support use of these fluoropolymers in pharmaceutical processing and food processing applications. While USP Class VI certification is not required for pharmaceutical processing, many pharmaceutical customers seeking ISO-9000 certification have requested it.
Caution: Do not use Teflon® or Tefzel® fluoropoly- mers or Zonyl® fluoroadditives in medical applica- tions involving permanent implantation in the human body. For other medical applications, see “DuPont Medical Caution Statement,” H-50102.
DuPont does not make surgical or medical grades of Teflon® or Tefzel® resins and does not guarantee continuity of process in our manufacturing opera- tions as changes may occur from time to time.