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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. 1500

BASF SE

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 butyl 2-propenoate, ethenylbenzene, N-(hydroxymethyl)-2-methyl-2-propenamide and 2-methyl-2-propenamide (CAS Reg. No. 71477-85-5)
Notifier: BASF SE
Manufacturer/Supplier: BASF SE
Intended Use: As a pigment binder in coatings on paper and paperboard intended to contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level not to exceed 6 percent by weight of the final food contact paper and paperboard. Paper containing the FCS may be used in contact with all food types, excepting VI (beverages), under Conditions of Use C through G, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 5, 2015
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
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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