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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. 2295

Alcresta Therapeutics, Inc.

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: Copolymer of ethylene glycol dimethacrylate, butyl methacrylate, and glycidyl methacrylate (CAS Reg. No. 133396-60-8).
Notifier: Alcresta Therapeutics, Inc.
Manufacturer/Supplier: Alcresta Therapeutics, Inc.
Intended Use: As a fixing agent for the immobilization of lipase enzyme preparations, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS-enzyme complex will be used at a level not to exceed 10.75g of FCS-enzyme complex/person/day in contact with food type IV-B under Condition of Use E as described in Tables 1 and 2. The use is limited to supplemental enteral nutrition applications only. The FCS-enzyme complex is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 26, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 219 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 217 kB)

*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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