[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: 21CFR177.2260]
[Page 333-335]
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. 177.2260 Filters, resin-bonded.
Resin-bonded filters may be safely used in producing, manufacturing,
processing, and preparing food, subject to the provisions of this
section.
(a) Resin-bonded filters are prepared from natural or synthetic
fibers to which have been added substances required in their preparation
and finishing, and which are bonded with resins prepared by condensation
or polymerization of resin-forming materials, together with adjuvant
substances required in their preparation, application, and curing.
(b) The quantity of any substance employed in the production of the
resin-bonded filter does not exceed the amount reasonably required to
accomplish the intended physical or technical effect or any limitation
further provided.
(c) Any substance employed in the production of resin-bonded filters
that is the subject of a regulation in parts 174, 175, 176, 177, 178 and
Sec. 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the production of resin-bonded filters
include the following, subject to any limitations provided:
List of Substances and Limitations
(1) Fibers:
Cellulose pulp.
Cotton.
Nylon. (From nylon resins complying with the provisions of applicable
regulations in subchapter B of this chapter.
Polyethylene terephthalate complying in composition with the provisions
of Sec. 177.1630; for use in inline filtration only as provided for in
paragraphs (e) and (f) of this section.
Rayon (viscose).
(2) Substances employed in fiber finishing:
BHT.
Butyl (or isobutyl) palmitate or stearate.
2,5-Di-tert-butyl hydroquinone for use only in lubricant formulations
for rayon fiber finishing and at a usage level not to exceed 0.1 percent
by weight of the lubricant formulations.
Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate for use only as a
lubricant in the manufacture of polyethylene terephthalate fibers
specified in paragraph (d)(1) of this section at a level not to exceed
0.03 percent by weight of the finished fibers.
Fatty acid (C10-C18) diethanolamide condensates.
Fatty acids derived from animal or vegetable fats and oils, and salts of
such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Triethanolamine.
Fatty acid (C10-C18) mono- and diesters of
polyoxyethylene glycol (molecular weight 400-3,000).
Methyl esters of fatty acids (C10-C18).
Mineral oil.
Polybutene, hydrogenated; complying with the identity prescribed under
Sec. 178.3740 (b) of this chapter.
Polyoxyethylene (4 mols) ethylenediamine monolauramide for use only in
lubricant formulations for rayon fiber finishing and
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at a usage level not to exceed 10 percent by weight of the lubricant
formulations.
Ricebran oil.
Titanium dioxide.
(3) Resins:
Acrylic polymers produced by polymerizing ethyl acrylate alone or with
one or more of the monomers: Acrylic acid, acrylonitrile, N-
methylolacrylamide, and styrene. The finished copolymers shall contain
at least 70 weight percent of polymer units derived from ethyl acrylate,
no more than 2 weight percent of total polymer units derived from
acrylic acid, no more than 10 weight percent of total polymer units
derived from acrylonitrile, no more than 2 weight percent of total
polymer units derived from N-methylolacrylamide, and no more than 25
weight percent of total polymer units derived from styrene. For use only
as provided in paragraph (m) of this section.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the amine
catalysts identified in Sec. 175.300(b)(3)(xiii) of this chapter.
Melamine-formaldehyde chemically modified with methyl alcohol.
Melamine-formaldehyde chemically modified with urea; for use only as
provided for in paragraphs (e), (f), (g), (h), and (i) of this section.
Phenol-formaldehyde resins.
Polyvinyl alcohol.
Polyvinyl alcohol with the copolymer of acrylic acid-allyl sucrose.
Polyvinyl alcohol with melamine formaldehyde.
Polyvinyl acetate with melamine formaldehyde.
p--Toluenesulfonamide-formaldehyde chemically modified with one or more
of the amine catalysts identified in Sec. 175.300 (b)(3)(xiii) of this
chapter.
(4) Adjuvant substances:
Dimethyl polysiloxane with methylcellulose and sorbic acid (as an
antifoaming agent).
Phosphoric acid.
(5) Colorants: Colorants used in accordance with Sec. 178.3297 of
this chapter.
(e) Resin-bonded filters conforming with the specifications of
paragraph (e) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 100 [deg]F for 2 hours, yields total extractives not
to exceed 2.8 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 100 [deg]F.
(f) Resin-bonded filters conforming with the specifications of
paragraph (f) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 145 [deg]F for 2 hours, yields total extractives not
to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 145 [deg]F.
(g) Resin-bonded filters conforming with the specifications of
paragraph (g) (1) of this section are used as provided in paragraph
(g)(2) of this section:
(1) Total extractives. The finished filter, when exposed to n-hexane
at reflux temperature for 2 hours, yields total extractives not to
exceed 0.5 percent by weight of the filter.
(2) Conditions of use. It is used to filter edible oils.
(h) Resin-bonded filters conforming with the specifications of
paragraph (h) (1) of this section are used as provided in paragraph
(h)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 212 [deg]F for 2 hours, yields total extractives not
to exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk, coffee, tea, and
potable water at temperatures not to exceed 212 [deg]F.
(i) Resin-bonded filters conforming with the specifications of
paragraph (i) (1) of this section are used as provided in paragraph
(i)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water for 2 hours at a temperature equivalent to, or higher
than, the filtration temperature of the aqueous food, yields total
extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH above 5.0.
(j) Resin-bonded filters conforming with the specifications of
paragraph (j) (1) of this section are used as provided in paragraph
(j)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 5
percent (by weight) acetic acid for 2 hours at a temperature equivalent
to, or higher than, the filtration temperature of the
[[Page 335]]
aqueous food, yields total extractives not to exceed 4 percent, by
weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH of 5.0 or below.
(k) Resin-bonded filters conforming with the specifications of
paragraph (k) (1) of this section are used as provided in paragraph
(k)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 8
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing not more than 8 percent
alcohol.
(l) Resin-bonded filters conforming with the specifications of
paragraph (l) (1) of this section are used as provided in paragraph
(l)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 50
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing more than 8 percent
alcohol.
(m) Resin-bonded filters fabricated from acrylic polymers as
provided in paragraph (d)(3) of this section together with other
substances as provided in paragraph (d), (1), (2), and (4) of this
section may be used as follows:
(1) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 100 [deg]F, provided that the
finished filter when exposed to distilled water at 100 [deg]F for 2
hours yields total extractives not to exceed 1 percent by weight of the
filter.
(2) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 145 [deg]F, provided that the
finished filter when exposed to distilled water at 145 [deg]F for 2
hours yields total extractives not to exceed 1.2 percent by weight of
the filter.
(n) Acrylonitrile copolymers identified in this section shall comply
with the provisions of Sec. 180.22 of this chapter.
[42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30, 1991]
Additives that reference this regulation: |
