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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. 2409

Stora Enso Oyj

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: Microfibrillated cellulose pulp (CAS Reg. No. 65996-61-4).
Notifier: Stora Enso Oyj
Manufacturer/Supplier: Stora Enso Oyj
Intended Use: As an additive, raw material component, or coating in the manufacture of polymer-coated food contact paper and paperboard. The FCS is not for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels up to 100% in contact with all food types under Conditions of Use A through H, as described in Tables 1 and 2. The FCS 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: Feb 8, 2025
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32 (r)
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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