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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. 1582

Imerys Minerals, 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: Microfibrillated cellulose pulp
Notifier: Imerys Minerals, Inc.
Manufacturer: Imerys Minerals, Inc.
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 types of food, as described in Table 1, 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: Nov 6, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) & ( r )
FDA Decision: Categorical Exclusion Memo
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