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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. 2176

Sumitomo Chemical Co., Ltd.

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: Phenol, 4,4’-sulfonylbis-, polymer with 1,1’-sulfonylbis(4-chlorobenzene) (CAS Reg. No. 25667-42-9 and 25608-63-3).
Notifier: Sumitomo Chemical Co., Ltd.
Manufacturer/Supplier: Sumitomo Chemical Co., Ltd.
Intended Use: The FCS will be used in repeated-use food-contact applications, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used in contact with all food types without temperature limitation. Adjuvant substances permitted for use in polyether sulfone resins complying with 21 CFR 177.2440 may be used in the subject copolymer subject to any limitations regarding conditions of use, food types, or any other limitation in the authorizing regulation. 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: Dec 7, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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