[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: 21CFR177.2550]
[Page 349-350]
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. 177.2550 Reverse osmosis membranes.
Substances identified in paragraph (a) of this section may be safely
used as reverse osmosis membranes intended for use in processing bulk
quantities of liquid food to separate permeate from food concentrate or
in purifying water for food manufacturing under the following prescribed
conditions:
(a) Identity. For the purpose of this section, reverse osmosis
membranes may consist of either of the following formulations:
(1) A cross-linked high molecular weight polyamide reaction product
of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS
Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The membrane
is on the food-contact surface, and its maximum weight is 62 milligrams
per square decimeter (4 milligrams per square inch) as a thin film
composite on a suitable support.
(2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6),
identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and
1,2-dichloroethane, whose surface is the reaction product of this
copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final
polymer is 99811-80-0) for use as the food-contact surface of reverse
osmosis membranes used in processing liquid food. The composite membrane
is on the food-contact surface and its maximum weight is 4.7 milligrams
per square decimeter (0.3 milligrams per square inch) as a thin film
composite on a suitable support. The maximum weight of the 2,4-
toluenediisocyanate component of the thin film composite is 0.47
milligrams per square decimeter (0.03 milligrams per square inch).
(3) For the purpose of this section, the reverse osmosis membrane
consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid,
calcium salt (2:1) polymer with 1,3-benzenediamine, 1,3-
benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride (CAS
Reg. No. 39443-76-0). The membrane is the food contact surface and may
be applied as a film on a suitable support. Its maximum weight is 512
milligrams per square decimeter (33 milligrams per square inch).
(4) A cross-linked high molecular weight polyamide reaction product
of poly(N-vinyl-N-methylamine) (CAS Reg. No. 31245-56-4), N,N'-bis(3-
aminopropyl)ethylenediamine (CAS Reg. No. 10563-26-5), 1,3-
benzenedicarbonyl dichloride (CAS Reg. No. 99-63-8) and 1,3,5-
benzenetricarbonyl trichloride (CAS Reg. No. 4422-95-1). The membrane is
the food-contact surface. Its maximum weight is 20 milligrams per square
decimeter (1.3 milligrams per square inch) as a thin film composite on a
suitable support.
(5) A polyamide reaction product of 1,3,5-benzenetricarbonyl
trichloride polymer (CAS Reg. No. 4422-95-1) with piperazine (CAS Reg.
No. 110-85-0) and 1,2-diaminoethane (CAS Reg. No. 107-15-3). The
membrane is the food-contact layer and may be applied as a film on a
suitable support. Its maximum weight is 15 milligrams per square
decimeter (1 milligram per square inch).
(b) Optional adjuvant substances. The basic polymer identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymer. These optional
adjuvant substances may include substances permitted for such use by
regulations in parts 170 through 186 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) Supports. Suitable supports for reverse osmosis membranes are
materials permitted for such use by regulations in parts 170 through 186
of this chapter, substances generally recognized as safe in food, and
substances used in accordance with a prior sanction or approval.
(d) Conditions of use. (1) Reverse osmosis membranes described in
paragraphs (a)(1), (a)(2), (a)(3), and (a)(5) of this section may be
used in contact with all types of liquid food at temperatures up to 80
[deg]C (176 [deg]F).
[[Page 350]]
(2) Reverse osmosis membranes described in paragraph (a)(4) of this
section may be used in contact with all types of liquid food, except
food containing more than 8 percent alcohol, at temperatures up to 80
[deg]C (176 [deg]F).
(3) Reverse osmosis membranes shall be maintained in a sanitary
manner in accordance with current good manufacturing practice so as to
prevent microbial adulteration of food.
(4) To assure their safe use, reverse osmosis membranes and their
supports shall be thoroughly cleaned prior to their first use in
accordance with current good manufacturing practice.
[49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11, 1987;
53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR 8139, Mar.
7, 1990; 59 FR 9925, Mar. 2, 1994]
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