[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: 21CFR177.1680]
[Page 318-319]
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 319]]
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]
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