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U.S. Department of Health and Human Services

Inventory of Effective Food Contact Substance (FCS) Notifications

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FCN No. 290

TOSOH Corporation

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

Food Contact Substance: 2-propenoic acid, 2-methyl-,1,2-ethanediyl ester, polymer with oxiranylmethyl 2-methyl-2-propenoate, hydrogen sulfate (CAS Reg. No. 117163-06-1).
Notifier: TOSOH Corporation
Manufacturer: TOSOH Corporation
Intended Use: For use as an ion exchange resin to remove cationic substances from skim milk in order to manufacture milk protein concentrate (MPC).
Limitations/Specifications*: (I). The temperature of aqueous milk solutions passing through the FCS must be maintained at 20°C or less. The flow of the aqueous milk solutions passing through the FCS must not be less than 140 kg per liter resin, and the contact time must be less than 10 minutes.
(II). The resin must be washed and preconditioned prior to use as follows:
A. Pre-washing of the resin prior to the first loading of the milk solution. (1) With water (60°C) at ≥ 20 kg/L of the resin. (2) With 20% (v/v) ethanol in water at ≥ 50kg/L of the resin. (3) With water at ≥ 10 kg/L of the resin.
B. Washing of the resin after loading of the milk solution. (1) With water (10°C) at > 5 kg/L of the resin. (2) With 1.0-1.5 mol/L sodium chloride solution (10°C) at > 5 kg/L of the resin. (3) With water at (50°C) at > 10 kg/L of the resin. (4) With 0.1 mol/L sodium hydroxide solution (40°C) at > 3 kg/L of the resin. (5) With water (40°C) at > 4 kg/L of the resin. (6) With 0.5 mol/L hydrochloric acid solution (40°C) at > 2 kg/L of the resin. (7) With water (40°C) at > 2 kg/L of the resin. (8) With 1.0 mol/L sodium chloride solution (40°C) at > 2 kg/L of the resin. (9) With water (10-40°C) at > 22 kg/L of the resin.
(III). The resin may not be used to process MPC for use in infant formula.
Effective Date: Jan 29, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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