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178.3860 Release agents.

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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR178.3860]

[Page 440-441]
 
                        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).

[[Page 441]]


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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 178, Section 3860


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