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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2019]
[CITE: 21CFR177.1585]



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. 177.1585 Polyestercarbonate resins.

Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, or holding food, in accordance with the following prescribed conditions:

(a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced by the condensation of 4,4'-isopropylidenediphenol, carbonyl chloride, terephthaloyl chloride, and isophthaloyl chloride such that the finished resins are composed of 45 to 85 molepercent ester, of which up to 55 mole-percent is the terephthaloyl isomer. The resins are manufactured using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1 and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or greater. The resins are also properly identified by CAS Reg. No. 114096-64-9 when produced with the use of greater than 2 but not greater than 5 weight percent p -cumylphenol (CAS Reg. No. 599-64-4), as an optional adjuvant substance in accordance with paragraph (b)(2) of this section.

(b) Optional adjuvants. The optional adjuvant substances required in the production of resins identified in paragraph (a) of this section may include:

(1) Substances used in accordance with 174.5 of this chapter.

(2) Substances identified in 177.1580(b).

(3) Substances regulated in 178.2010(b) of this chapter for use in polycarbonate resins complying with 177.1580:

Provided, That the substances are used in accordance with any limitation on concentration, conditions of use, and food types specified in 178.2010(b) of this chapter.

(c) Polyestercarbonate resins shall conform to the specifications prescribed in paragraph (c)(1) of this section and shall meet the extractive limitations prescribed in paragraph (c)(2) of this section.

(1) Specifications. Polyestercarbonate resins identified in paragraph (a) of this section can be identified by their characteristic infrared spectrum. The resins shall comply with either or both of the following specifications:

(i) The solution intrinsic viscosity of the polyestercarbonate resins shall be a minimum of 0.44 deciliter per gram, as determined by a method entitled "Intrinsic Viscosity (IV) of Lexan Polyestercarbonate Resin by a Single Point Method Using Dichloromethane as the Solvent," developed by the General Electric Co., September 20, 1985, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-215), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or 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: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.

(ii) A minimum weight-average molecular weight of 27,000, as determined by gel permeation chromatography using polystyrene standards.

(2) Extractives limitations. The polyestercarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. 6 and that will be held on U.S. standard sieve No. 10.

(i) Polyestercarbonate resins, when extracted with distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.

(ii) Polyestercarbonate resins, when extracted with 50 percent (by volume) ethyl alcohol in distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.

(iii) Polyestercarbonate resins, when extracted with n -heptane at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.002 percent by weight of the resins.

(3) Residual methylene chloride levels in polyestercarbonate resins. Polyestercarbonate resin articles in the finished form shall not contain residual methylene chloride in excess of 5 parts per million as determined by a method titled "Analytical Method for Determination of Residual Methylene Chloride in Polyestercarbonate Resin," developed by the General Electric Co., July 23, 1991, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 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: http://www.archives.gov/federalregister/codeoffederalregulations/ibrlocations.html.

[57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999; 81 FR 5594, Feb. 3, 2015]

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