Table 1: Summary of Zonyl® Fluoroadditives Complying with FDA Regulations1
|
Zonyl® Product
|
21 CFR
177.1550
|
21 CFR
177.1520
|
21 CFR
177.2600
|
21 CFR
175.300
|
21 CFR
175.105
|
21 CFR
176.170
|
21 CFR
176.180
|
MP 1500
MP 1600N
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
|
MP 1400
|
Yes2
|
2000 ppm
maximum
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
MP 1000
MP 1300
|
No
|
2000 ppm
maximum
|
No
|
Yes
|
Yes
|
Yes
|
Yes
|
MP 1100
MP 1150
MP 1200
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
| 1 See accompanying text and FDA refulations for any limitations or conditions of use. It is the customer's responsibility to test finished articles to ensure compliance with the extractives limitations of applicables regulations. |
| 2 Limited to components of articles for repeated use in contact with food. |
Articles Intended to Contact Food
Reference: 21 CFR 177.1550 Perfluorocarbon Resins
Zonyl® MP 1500 and MP 1600N fluoroadditives may be used as articles or components of articles intended to contact food in compliance with this regulation.
Some fluoroadditive resins are irradiated to facilitate 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 processed and restricts their use to components of articles intended for repeated use in contact with food. Zonyl® MP 1400 fluoroadditive complies with this paragraph.
Processing Aids for Polyolefins
Reference: 21 CFR 177.1520 Olefin Polymers
Zonyl® fluoroadditives MP 1500 and MP 1600N and up to 2000 ppm of Zonyl® fluoroadditives MP 1000, MP1300, and MP1400 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 Resinous and Polymeric Coatings
Reference: 21 CFR 175.300 Resinous and Polymeric Coatings
The Zonyl® fluoroadditives indicated in Table 1 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 Zonyl® fluoroadditives 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.
Components of Paper and Paperboard
Reference: 21 CFR 176.170 Components of Paper and Paperboard in Contact with Aqueous and Fatty Foods
The Zonyl® fluoroadditives indicated in Table 1 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 Zonyl® fluoroadditives 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.
Reference: 21 CFR 176.180 Components of Paper and Paperboard in Contact with Dry Food
The Zonyl® fluoroadditives indicated in Table 1 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 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
Zonyl® fluoroadditives MP 1000, MP 1300, MP1400, MP 1500, and MP 1600N may be used as components of adhesives in compliance with this regulation.
Housewares Exemption
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.
Medical Use
DuPont does Not make surgical or medical grades of Zonyl® fluoroadditives and does Not guarantee continuity of process in our manufacturing operations, as changes may occur from time to time.
