[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3860]
[Page 441-442]
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
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).
[[Page 442]]
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]
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