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177.2420 Polyester resins, cross-linked.

Home > Regulations > Indirect food additives: Polymers > 177.2420 Polyester resins, cross-linked.



[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: 21CFR177.2420]

[Page 338-340]
 
                        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 C_Substances for Use Only as Components of Articles Intended for 
                              Repeated Use
 
Sec.  177.2420  Polyester resins, cross-linked.

    Cross-linked polyester resins may be safely used as articles or 
components of articles intended for repeated use in contact with food, 
in accordance with the following prescribed conditions:
    (a) The cross-linked polyester resins are produced by the 
condensation of one or more of the acids listed in paragraph (a)(1) of 
this section with one or more of the alcohols or epoxides listed in 
paragraph (a)(2) of this section, followed by copolymerization with one 
or more of the cross-linking agents listed in paragraph (a)(3) of this 
section:
    (1) Acids:

Adipic.
Fatty acids, and dimers thereof, from natural sources.
Fumaric.
Isophthalic.
Maleic.
Methacrylic.
Orthophthalic.
Sebacic.
Terephthalic.
Trimellitic.

    (2) Polyols and polyepoxides:

Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epi chloro hydrin.
Mannitol.
a-Methyl glucoside.

[[Page 339]]

Pentaerythritol.
Polyoxypropylene ethers of 4,4'-isopropylide-nediphenol (containing an 
average of 2-7.5 moles of propylene oxide).
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
2,2,4-Trimethyl-1,3-pentanediol.

    (3) Cross-linking agents:

Butyl acrylate.
Butyl methacrylate.
Ethyl acrylate.
Ethylhexyl acrylate.
Methyl acrylate.
Methyl methacrylate.
Styrene.
Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in 
coatings contacting bulk quantities of dry food of the type identified 
in Sec.  176.170(c) of this chapter, table 1, under type VIII.
Vinyl toluene.

    (b) Optional adjuvant substances employed to facilitate the 
production of the resins or added thereto to impart desired technical or 
physical properties include the following, provided that the quantity 
used does not exceed that reasonably required to accomplish the intended 
physical or technical effect and does not exceed any limitations 
prescribed in this section:

------------------------------------------------------------------------
                                         Limitations (limits of addition
           List of substances             expressed as percent by weight
                                                of finished resin)
------------------------------------------------------------------------
1. Inhibitors:                           Total not to exceed 0.08
                                          percent.
  Benzoquinone.........................  0.01 percent.
  tert-Butyl catechol..................
  TBHQ.................................
  Di-tert-butyl hydroquinone...........
  Hydroquinone.........................
2. Accelerators:                         Total not to exceed 1.5
                                          percent.
  Benzyl trimethyl ammonium chloride...  0.05 percent.
  Calcium naphthenate..................
  Cobalt naphthenate...................
  Copper naphthenate...................
  N, N-Diethylaniline..................  0.4 percent.
  N, N-Dimethylaniline.................   Do.
  Ethylene guanidine hydrochloride.....  0.05 percent.
3. Catalysts:                            Total not to exceed 1.5
                                          percent, except that methyl
                                          ethyl ketone peroxide may be
                                          used as the sole catalyst at
                                          levels not to exceed 2
                                          percent.
  Azo-bis-isobutyronitrile.............
  Benzoyl peroxide.....................
  tert-Butyl perbenzoate...............
  Chlorbenzoyl peroxide................
  Cumene hydroperoxide.................
  Dibutyltin oxide (CAS Reg. No. 818-08- For use in the polycondensation
   6).                                    reaction at levels not to
                                          exceed 0.2 percent of the
                                          polyester resin.
  Dicumyl peroxide.....................
  Hydroxybutyltin oxide (CAS Reg. No.    For use in the polycondensation
   2273-43-0).                            reaction at levels not to
                                          exceed 0.2 percent of the
                                          polyester resin.
  Lauroyl peroxide.....................
  p-Menthane hydroperoxide.............
  Methyl ethyl ketone peroxide.........
  Monobutyltin tris(2-ethylhexoate)      For use in the polycondensation
   (CAS Reg. No. 23850-94-4).             reaction at levels not to
                                          exceed 0.2 percent of the
                                          polyester resin.
4. Solvents for inhibitors,
 accelerators, and catalysts:
  Butyl benzyl phthalate (containing
   not more than 1.0 percent by weight
   of dibenzyl phthalate).
  Dibutyl phthalate....................
  Diethylene glycol....................  As a solvent for benzyl
                                          trimethyl ammonium chloride or
                                          ethylene guanidine
                                          hydrochloride only.
  Dimethyl phthalate...................
  Methyl alcohol.......................
  Styrene..............................
  Triphenyl phosphate..................
5. Reinforcements:
  Asbestos.............................
  Glass fiber..........................
  Polyester fiber produced by the
   condensation of one or more of the
   acids listed in paragraph (a)(1) of
   this section with one or more of the
   alcohols listed in paragraph (a)(2)
   of this section.
6. Miscellaneous materials:
  Castor oil, hydrogenated.............
  [alpha]-Methylstyrene................

[[Page 340]]


  Polyethylene glycol 6000.............
  Silicon dioxide......................
  Wax, petroleum.......................  Complying with Sec.   178.3710
                                          of this chapter.
------------------------------------------------------------------------

    (c) The cross-linked polyester resins, with or without the optional 
substances described in paragraph (b) of this section, and in the 
finished form in which they are to contact food, when extracted with the 
solvent or solvents characterizing the type of food and under the 
conditions of time and temperature characterizing the conditions of 
their intended use, as determined from tables 1 and 2 of Sec.  
176.170(c) of this chapter, shall meet the following extractives 
limitations:
    (1) Net chloroform-soluble extractives not to exceed 0.1 milligram 
per square inch of food-contact surface tested when the prescribed food-
simulating solvent is water or 8 or 50 percent alcohol.
    (2) Total nonvolatile extractives not to exceed 0.1 milligram per 
square inch of food-contact surface tested when the prescribed food-
simulating solvent is heptane.
    (d) In accordance with good manufacturing practice, finished 
articles containing the cross-linked polyester resins shall be 
thoroughly cleansed prior to their first use in contact with food.

[42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 
54 FR 48858, Nov. 28, 1989]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 2420


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