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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: 21CFR177.1440]



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. 177.1440 4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000.

4,4'-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum molecular weight of 10,000 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) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins consist of basic resins produced by the condensation of equimolar amounts of 4,4'-isopropylidenediphenol and epichlorohydrin terminated with phenol, to which may have been added certain optional adjuvant substances required in the production of the resins.

(b) The optional adjuvant substances required in the production of the resins 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
Butyl alcoholNot to exceed 300 p.p.m. as residual solvent in finished resin.
Ethyl alcohol
TolueneNot to exceed 1,000 p.p.m. as residual solvent in finished resin.

(c) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet the following nonvolatile extractives limitations:

(1) Maximum extractable nonvolatile fraction of 2 parts per million when extracted with distilled water at 70 deg. C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(2) Maximum extractable nonvolatile fraction of 3 parts per million when extracted with n- heptane at 70 deg. C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(3) Maximum extractable nonvolatile fraction of 6 parts per million when extracted with 10 percent (by volume) ethyl alcohol in distilled water at 70 deg. C for 2 hours, using a volume-to-surface ratio of 2 milliliters per square inch.

(d) The provisions of this section are not applicable to 4,4'-isopropylidene-diphenol-epichlorohydrin resins listed in other sections of subchapter B of this chapter.

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