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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. 2014

Kaneka Belgium NV

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, 2-methyl-, 1-methyl-1,3-propanediyl ester, polymer with 1,3-butadiene, butyl 2-propenoate, ethenylbenzene, and methyl-2-methyl-2-propenoate (CAS Reg. No. 143646-08-6 or 25101-28-4).REPLACES FCN 1508
Notifier: Kaneka Belgium NV
Manufacturer/Supplier: Kaneka Belgium NV
Intended Use: As an impact modifier in styrene acrylonitrile copolymer (SAN) and poly(methyl methacrylate) (PMMA) copolymers used in repeat-use food contact articles only, except for contact with infant formula and human milk.
Limitations/Specifications: The FCS will be used in repeat-use articles in contact with Food Types I, II, IV-B, VI-A, VI-B and VI-C (<20 percent alcohol), VII-B, and VIII as described in Table 1, and at a maximum temperature of 40°C. The FCS will be used at levels up to 40 percent by weight in the SAN/PMMA blend. The composition of the SAN/PMMA blend will range between 50:50 percent by weight to 60:40 percent by weight. Articles containing the FCS will have a maximum thickness of 3.0 mm. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 20, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo