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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. 1901

Toyobo 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: Copolymer of adipic acid, dimethylolpropionic acid, ethylene glycol, isophthalic acid, neopentyl glycol, sebacic acid, and terephthalic acid (CAS Reg. No. 725725-21-3), cross-linked with hexamethylene diisocyanate homopolymer (CAS Reg. No. 28182-81-2).
Notifier: Toyobo Co., Ltd.
Manufacturer/Supplier: Toyobo Co., Ltd.
Intended Use: As a coating on polyethylene terephthalate (PET) film that will be used in multilayer articles in contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Articles containing the FCS may be used in contact with all types of food under Conditions of Use A through H, as described in Table 2. The FCS is not intended 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: Jul 31, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo