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177.1680 Polyurethane resins.

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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: 21CFR177.1680]

[Page 317-318]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 177_INDIRECT FOOD ADDITIVES: POLYMERS--Table of Contents
 
Subpart B_Substances for Use as Basic Components of Single and Repeated 
                        Use Food Contact Surfaces
 
Sec.  177.1680  Polyurethane resins.

    The polyurethane resins identified in paragraph (a) of this section 
may be safely used as the food-contact surface of articles intended for 
use in contact with bulk quantities of dry food of the type identified 
in Sec.  176.170(c) of this chapter, table 1, under Type VIII, in 
accordance with the following prescribed conditions:
    (a) For the purpose of this section, polyurethane resins are those 
produced when one or more of the isocyanates listed in paragraph (a)(1) 
of this section is made to react with one or more of the substances 
listed in paragraph (a)(2) of this section:
    (1) Isocyanates:

Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4).
Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2).
4,4'-Diisocyanato-3,3'-dimethylbiphenyl (bi-tolylene diisocyanate).
Diphenylmethane diisocyanate.
Hexamethylene diisocyanate.
3-Isocyanatomethyl - 3,5,5 - tri methyl cyclo hexyl isocyanate.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate.

    (2) List of substances:

Adipic acid.
1,4-Butanediol.
1,3-Butylene glycol.
1,4-Cyclohexane dimethanol (CAS Reg. No. 105-08-8).
2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6-Hexanediol (CAS Reg. No. 629-11-8).[alpha]-Hydro-[omega]-
hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1).
[alpha]-Hydro-omega-hydroxypoly (oxy tetra methyl ene).
[alpha],[alpha]'-(Isopropylidenedi-p-phenylene)bis[omega-hydroxypoly 
(oxy pro pylene)(3-4 moles)], average molecular weight 675.
Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS Reg. No. 9003-11-6).
Methyl oxirane polymer with oxirane, ether with 1,2,3-propanetriol (CAS 
Reg. No. 9082-00-2).
[alpha],[alpha]'[alpha]'',[alpha]'''-Neopentanetetrayltetrakis [omega-
hydroxypoly (oxypropylene) (1-2 moles)], average molecular weight 400.
Pentaerythritol-linseed oil alcoholysis product.
Phthalic anhydride.
Polybutylene glycol.
Polyethyleneadipate modified with ethanolamine with the molar ratio of 
the amine to the adipic acid less than 0.1 to 1.
Poly(oxycarbonylpentamethylene).
Polyoxypropylene ethers of 4.4'-isopropyl-idenediphenol (containing an 
average of 2-4 moles of propylene oxide).
Polypropylene glycol.
[alpha],[alpha]',[alpha]''-1,2,3-Propanetriyltris [omega-hydroxypoly 
(oxypropylene) (15-18 moles)], average molecular weight 3,000.
Propylene glycol.
[alpha],[alpha]',[alpha]''-[Propylidynetris (methylene)] tris [omega-
hydroxypoly (oxypropylene) (minimum 1.5 moles)], minimum molecular 
weight 400.
[alpha]-[[rho](1,1,3,3-Tetramethylbutyl) - phenyl]-omega-
hydroxypoly(oxyethylene) (5 moles), average molecular weight 425.
Trimethylol propane.

    (b) Optional adjuvant substances employed in the production of the 
polyurethane resins or added thereto to impart desired technical or 
physical properties may include the following substances:

------------------------------------------------------------------------
           List of substances                      Limitations
------------------------------------------------------------------------
1-[(2-Aminoethyl)amino]2-propanol......  As a curing agent.
1-(3-Chloroallyl)-3,5,7-triaza-1-        As a preservative.
 azoniaadamantane chloride.
Colorants used in accordance with Sec.
  178.3297 of this chapter..
Dibutyltin diacetate...................  As a catalyst.
Dibutyltin dichloride..................   Do.
Dibutyltin dilaurate...................   Do.
N,N-Dimethyldodecylamine...............   Do.
N-Dodecylmorpholine....................   Do.
a,a'-[Isopropylidenebis[p-               As a stabilizer.
 phenyleneoxy(2-hydroxytrimethylene)
 ]]bis[omega-hydroxypoly-(oxyethylene)
 (136-170 moles)], average molecular
 weight 15,000.
4,4'-Methylenedianiline................  As a curing agent.
1,1',1''-Nitrilotri-2-propanol.........   Do.

[[Page 318]]


2,2'-(p-Phenylenedioxy) diethanol......   Do.
Polyvinyl isobutyl ether...............
Polyvinyl methyl ether.................
Soyaalkyd resin........................  Conforming in composition with
                                          Sec.   175.300 of this chapter
                                          and containing litharge not to
                                          exceed that residual from its
                                          use as the reaction catalyst
                                          and creosol not to exceed that
                                          required as an antioxidant.
Tetrakis [methylene-(2,5-di-tert-butyl-  Stabilizer.
 4-hydroxy hydro cinna mate)]methane
 (CAS Reg. No. 6683-19-8).
N,N,N'N'-Tetrakis (2-                    As a curing agent.
 hydroxypropyl)ethylenediamine.
Triethanolamine........................   Do.
Trimethyleneglycol di (p-aminobenzoate)  As a curing agent.
 (CAS Reg. No. 57609-64-0).
------------------------------------------------------------------------

    (c) An appropriate sample of the finished resin in the form in which 
it contacts food, when subjected to ASTM method D968-81, ``Standard Test 
Methods for Abrasion Resistance of Organic Coatings by the Falling 
Abrasive Tester,'' which is incorporated by reference (Copies may be 
obtained from the American Society for Testing Materials, 100 Barr 
Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be 
examined at the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030, or go to: http://www.archives.gov/federal--register/code--of--
federal--regulations/ibr--locations.html.), using No. 50 Emery abrasive 
in lieu of Ottawa sand, shall exhibit an abrasion coefficient of not 
less than 20 liters per mil of film thickness.

[42 FR 14572, Mar. 15, 1977, as amended at 46 FR 57033, Nov. 20, 1981; 
49 FR 10110, Mar. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR 15278, 
Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 1680


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