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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. 2220

Harima Chemicals, Inc., Plasmine Technology, 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: Copolymer of styrene (CAS Reg. No. 100-42-5), α-methylstyrene (CAS Reg. No. 98-83-9), methacrylic acid (CAS Reg. No. 79-41-4), n-butyl acrylate (CAS Reg. No. 141-32-2), methyl methacrylate (CAS Reg. No. 80-62-6), and, optionally, acrylic acid (CAS Reg. No. 79-10-7) and/or α-methylstyrene dimer (CAS Reg. No. 6362-80-7).
Notifier: Harima Chemicals, Inc., Plasmine Technology, Inc.
Manufacturer/Supplier: Harima Chemicals, Inc., Plasmine Technology, Inc.
Intended Use: As an emulsifier for wet end chemicals in the production of food-contact paper and paperboard, including infant formula and human milk.
Limitations/Specifications: For use at a level not to exceed 0.163% by weight in the finished paper and paperboard that contact all food types, including infant formula and human milk, under Conditions of Use A through H, as described in Tables 1 and 2.
Effective Date: Jun 7, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 898 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 279 kB)

*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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