[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: |
