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177.2550 Reverse osmosis membranes.

Home > Regulations > Indirect food additives: Polymers > 177.2550 Reverse osmosis membranes.



[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: 21CFR177.2550]

[Page 348-349]
 
                        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 349]]

    (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]





Additives that reference this regulation:


Source: U.S. Code of Federal Regulations - CFR Title 21, Part 177, Section 2550


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