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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. 1486

Nalco, Ecolab Company

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: 2-Propenoic acid, polymer with ethanedial and 2-propenamide (CAS Reg. 65505-03-5) containing acrylamide and acrylic acid which is then reacted with not more than 30 weight percent glyoxal.
Notifier: Nalco, Ecolab Company
Manufacturer/Supplier: Nalco, Ecolab Company
Intended Use: For single use as a dry-and wet-strength, drainage and dewatering agent employed prior to the sheet-forming operation in the manufacture of paper and paperboard in contact with all food types, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 1.0 percent by weight of the dry fibers in the finished paper and paperboard. The finished articles may be used under Conditions of Use A through H. The finished paper and paperboard containing the FCS is not for use in contact with infant formula or breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 6, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 706 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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