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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. 1312


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: Fatty acids, C14-18 and C16-18-unsatd., polymers with adipic acid and triethanolamine, di-methyl sulfate-quaternized (CAS Reg. No. 1211825-32-9).
Notifier: BASF SE
Manufacturer/Supplier: BASF SE
Intended Use: As a floatation agent in the floatation process of mineral slurries (calcite), used as a filler in the manufacture of food-contact paper and paperboard.
Limitations/Specifications: For use at levels not to exceed 850 ppm of dry matter in the floatation process of calcite. Calcite is used at levels of 15-40 weight-percent in the manufacture of food contact paper and paperboard. The finished paper and paperboard containing the FCS may contact all food types under Conditions of Use A through H as described in Table 2.
Effective Date: Oct 12, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo