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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. 1993

Matsumura Sangyo Co., Ltd.
Goo 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: 1,3-Benzenedicarboxylic acid, 5-sulfo-, 1,3-dimethyl ester, sodium salt (1:1), polymer with dimethyl 1,4-benzenedicarboxylate and 1,2-ethanediol (CAS Reg. No. 27937-63-9).
Notifier: Matsumura Sangyo Co., Ltd.
Manufacturer/Supplier: Matsumura Sangyo Co., Ltd.
Goo Chemical Co., Ltd.
Intended Use: As a surface treatment agent for talc added to inhibit hydrolysis of food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is used at a level not to exceed 1% by weight of talc. The FCS-containing talc is used at a level not to exceed 5% by weight of polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polylactic acid (PLA) polymer. The finished polymer may contact all food types under Condition of Use A through H, as described in Tables 1 and 2. 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: Oct 29, 2019
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 152 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 117 kB)

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