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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. 2021

Kemira 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: Kemira Oyj
Manufacturer/Supplier: Kemira Oyj
Intended Use: As a dry- and wet-strength agent employed prior to the sheet-forming operation in the manufacture of coated and uncoated food-contact paper and paperboard.
Limitations/Specifications: The FCS will be used at levels not to exceed 5.0 percent by weight of the dry fibers in the finished paper and paperboard in contact with all food types under Conditions of Use A through H, as described in Table 2. Permitted uses in contact with infant formula: coated paper and paperboard manufactured with the FCS may be used in contact with powdered and liquid infant formula.
Effective Date: Jan 9, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo