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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR177.2550]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

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).

(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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