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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. 254

Rohm and Haas Company

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: Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether terpolymer, aminolyzed with dimethylaminopropylamine and partially quaternized with methyl chloride. (CAS Reg. No. 65997-24-2).
Notifier: Rohm and Haas Company
Manufacturer: Rohm and Haas Company
Intended Use: For use in treating water and aqueous food only of the types identified under categories I, II, and VI-B in Table 1.
Limitations/Specifications*: a) The temperature of the water or food passing through the FCS must be maintained at 50°C or less, and the flow rate of the water or food passing through the FCS must not be less than 0.5 gallon per cubic foot per minute; or b) Extracts of the FCS will be found to contain no more than 1 mg/kg dimethylaminopropylamine in each of the food simulants, distilled water and 10 percent ethanol, when, following washing and pretreatment of the resin in accordance with 21 CFR 173.25 (Ion- exchange resins)(c)(1), the resin is subjected to the test described in 21 CFR 173.25(b)(2)(ii)(B).
Effective Date: Aug 31, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo
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