[Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR178.3860] [Page 423] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS--Table of Contents 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 Sec. 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'-Dioleoylethylenediamine.... For 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; For use only subject to the complying with the identity limitations prescribed for prescribed under Sec. hydrogenated polybutene under Sec. 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 Sec. 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]