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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 2018.

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, 2018]
[CITE: 21CFR177.1580]



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. 177.1580 Polycarbonate resins.

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

(a) Polycarbonate resins are polyesters produced by:

(1) The condensation of 4,4'-iso-propylidenediphenol and carbonyl chloride to which may have been added certain optional adjuvant substances required in the production of the resins; or by

(2) The reaction of molten 4,4'-iso-propylidenediphenol with molten diphenyl carbonate in the presence of the disodium salt of 4,4'-isopropylidenediphenol.

(3) The condensation of 4,4'-isopro- pylidenediphenol, carbonyl chloride, and 0.5 percent weight maximum of a 2,a 6-bis (6-hydroxy-m- tolyl) mesitol to which may have been added certain optional adjuvant substances required in the production of branched polycarbonate resins.

(b) The optional adjuvant substances required in the production of resins produced by the methods described in paragraph (a)(1) and (3) of this section may include substances generally recognized as safe in food, substances used in accordance with a prior sanction or approval, and the following:

List of substances Limitations
p-tert-Butylphenol
Chloroform
p-Cumylphenol (CAS Reg. No. 599-64-4)For use only as a chain terminator at a level not to exceed 5 percent by weight of the resin.
Ethylene dichloride
Heptane
Methylene chloride
MonochlorobenzeneNot to exceed 500 p.p.m. as residual solvent in finished resin.
Pentaerythritol tetrastearate (CAS Reg. No. 115-83-3)For use only as a mold release agent, at a level not to exceed 0.5 percent by weight of the finished resin.
Phenol (CAS Reg. No. 108-95-2)
Pyridine
Toluene: (CAS Reg. No. 108-88-3)Not to exceed 800 parts per million as residual solvent in finished resin.
Triethylamine

(c) Polycarbonate resins shall conform to the specification prescribed in paragraph (c)(1) of this section and shall meet the extractives limitations prescribed in paragraph (c)(2) of this section.

(1) Specification. Polycarbonate resins can be identified by their characteristic infrared spectrum.

(2) Extractives limitations. The polycarbonate 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 a U.S. standard sieve No. 10.

(i) Polycarbonate resins, when extracted with distilled water at reflux temperature for 6 hours, shall yield total extractives not to exceed 0.15 percent by weight of the resins.

(ii) Polycarbonate resins, when extracted with 50 percent (by volume) ethyl alcohol in distilled water at reflux temperature for 6 hours, shall yield total extractives not to exceed 0.15 percent by weight of the resins.

(iii) Polycarbonate resins, when extracted with n- heptane at reflux temperature for 6 hours, shall yield total extractives not to exceed 0.15 percent by weight of the resins.

(d) Polycarbonate resins may be used in accordance with this section except in infant feeding bottles (baby bottles) and spill-proof cups, including their closures and lids, designed to help train babies and toddlers to drink from cups (sippy cups).

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24, 1981; 49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR 29656, Aug. 8, 1988; 59 FR 43731, Aug. 25, 1994; 77 FR 41902, July 17, 2012]

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