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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: 21CFR178.3860]



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 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

Subpart D--Certain Adjuvants and Production Aids

Sec. 178.3860 Release agents.

Substances listed in paragraph (b) of this section may be safely used as release agents in petroleum wax complying with 178.3710 and in polymeric resins that contact food, subject to the provisions of this section.

(a) The quantity used shall not exceed the amount reasonably required to accomplish the intended technical effect or any limitations prescribed in this section.

(b) Release agents:

List of substances Limitations
Erucamide (erucylamide)
Formaldehyde, polymer with 1-naphthalenol (CAS Reg. No. 25359-91-5)For use only as an antiscaling or release agent, applied on the internal parts of reactors employed in the production of polyvinyl chloride and acrylic copolymers, provided that the residual levels of the additive in the ploymer do not exceed 4 parts per million.
N,N'-DioleoylethylenediamineFor use only in polyvinyl chloride films in amounts such that the concentration of the substance in these films in the form in which the films contact food shall not exceed 0.055 milligram of the substance per square inch of film.
Oleyl palmitamide
Polybutene, hydrogenated; complying with the identity prescribed under 178.3740(b)For use only subject to the limitations prescribed for hydrogenated polybutene under 178.3740(b).
Poly(vinyl acetate/vinyl N-octadecylcarbamate) (CAS Reg. No. 70892-21-6) produced by the reaction between stoichiometrically equivalent amounts of octadecyl isocyanate and vinyl alcohol/vinyl acetate copolymer; minimum average molecular weight is 500,000For use only in application to the backing of pressuresensitive adhesive tapes at levels not to exceed 0.2 milligram per square centimeter (1.29 milligrams per square inch) of backing.
rice bran waxFor use only in plastics intended for contact with dry foods identified as Type VIII in table 1 of 176.170(c) of this chapter, at levels not in excess of 1.0 percent by weight of the polymer.
Saturated fatty acid amides manufactured from fatty acids derived from animal, marine, or vegetable fats and oils
Stearyl erucamide

[42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979; 46 FR 51902, Oct. 23, 1981; 61 FR 25396, May 21, 1996; 61 FR 42381, Aug. 15, 1996]

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