21 C.F.R. § 178.3860   Release agents.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 178—INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
Subpart D—Certain Adjuvants and Production Aids

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§ 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-     For use only as an antiscaling or naphthalenol (CAS Reg. No.        release agent, applied on the 25359-91-5).                      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[prime]-                       For use only in polyvinyl chloride Dioleoylethylenediamine.          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;         For use only subject to the complying with the identity       limitations prescribed for prescribed under §           hydrogenated polybutene under § 178.3740(b).                      178.3740(b).Poly(vinyl acetate/vinyl N-       For use only in application to the octadecylcarbamate) (CAS Reg.     backing of pressuresensitive adhesive No. 70892-21-6) produced by the   tapes at levels not to exceed 0.2 reaction between                  milligram per square centimeter (1.29 stoichiometrically equivalent     milligrams per square inch) of amounts of octadecyl isocyanate   backing. and vinyl alcohol/vinyl acetate copolymer; minimum average molecular weight is 500,000.Rice bran wax...................  For 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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