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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. 2332

3M Purification Inc.
3M Healthcare US Opco LLC

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: Poly(2-ethyl-2-oxazoline) (CAS Reg. No. 25805-17-8).
Notifier: 3M Purification Inc.
Manufacturer/Supplier: 3M Purification Inc.
3M Healthcare US Opco LLC
Intended Use: For use as a component of filtration membranes for repeat-use, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in repeat-use filtration membranes in contact with beer, wine, hard seltzer, and water for bottled water or soft drinks, at levels not to exceed 40% by dry weight in the finished membrane. The FCS is not for use in contact with infant formula or human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Feb 9, 2024
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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