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聚四氟乙烯PTFE FDA 21 CFR 177.1550, Perfluorocarbon resins

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[Code of Federal Regulations]  
[Title 21, Volume 3]  
[Revised as of April 1, 2013]  
[CITE: 21CFR177.1550]  
 



TITLE 21--FOOD AND DRUGS  
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
 
 
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)  
 

PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

Subpart B--Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces

Sec. 177.1550 Perfluorocarbon resins.  

Perfluorocarbon resins identified in this section may be safely used as articles or components of articles intended to contact food, subject to the provisions of this section:

(a)Identity. For the purpose of this section, perfluorocarbon resins are those produced by: (1) The homopolymerization and/or copolymerization of hexafluoropropylene and tetrafluoroethylene, and (2) the copolymerization of perfluoropropylvinylether and tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the extractives limitations in paragraph (d) of this section.

(b)Optional components. The perfluorocarbon resins identified in paragraph (a) of this section as well as articles or coating made from these resins may include the following optional components except that the resin identified in paragraph (a)(2) of this section may not be used with the optional component, lithium polysilicate, mentioned in paragraph (b)(4) of this section.

(1) Substances generally recognized as safe (GRAS) in food or food packaging subject to any limitations cited on their use.

(2) Substances used in accordance with a prior sanction or approval, subject to any limitations cited in the prior sanction or approval.

(3) Substances authorized under applicable regulations in this part and in parts 175 and 178 of this chapter and subject to any limitations prescribed therein.

(4) The following substances, subject to any limitations prescribed:

List of substances Limitations
Lithium polysilicate containing not more than 20 weight percent silica, not more than 2.1 percent lithium oxide and having a maximum mole ratio of Si02/Li20 of 8.5 to 1   For use only as a component of repeated-use coatings not exceeding 0.030 millimeter (0.0012 inch) in thickness where the coatings are thermally cured at minimum sintering temperatures of 371 deg. C (700 deg. F). Lithium extractives shall not exceed 1.55 milligrams per square decimeter (0.1 milligram per square inch) of coating surface when tested in accordance with paragraph (e)(2) of this section.  
Naphthalene sulfonic acid formaldehyde condensate, sodium salt   For use only:1. As a component of repeated-use coatings, based on the perfluorocarbon resin identified in paragraph (a)(1) of this section, not to exceed 0.030 millimeter (0.0012 inch) in thickness, and at a level not to exceed 0.4 weight percent of the coating.2. As a component of repeated-use coatings, based on the perfluorocarbon resin identified in paragraph (a)(2) of this section, not to exceed 0.10 millimeter (0.004 inch) in thickness, and at a level not to exceed 0.4 weight percent of the coating.  

(c)Optional processing. Poly- tetrafluoroethylene resins may be irradiated by either a cobalt-60 sealed source, at a maximum dose of gamma radiation not to exceed 7.5 megarads, or an electron beam at energy levels not to exceed 2.5 million electron volts with a maximum dosage of 7.5 megarads, to produce lubricant powders having a particle diameter of not more than 20 microns for use only as components of articles intended for repeated use in contact with food.

(d)Specifications --(1)Infrared identification. Perfluorocarbon resins can be identified by their characteristic infrared spectra.

(2)Melt-viscosity. (i) The perfluorocarbon resins identified in paragraph (a)(1) of this section shall have a melt viscosity of not less than 104poises at 380 deg. C (716 deg. F) as determined by ASTM method D1238-82, "Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer," which is incorporated by reference. Copies may be obtained from the American Society for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:The melt viscosity of the perfluorocarbon resins identified in paragraph (a)(1) of this section shall not vary more than 50 percent within one-half hour at 380 deg. C (716 deg. F).

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