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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. 2158

Trust Chem 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: Quino[2,3-b]acridine-7,14-dione, 5,12-dihydro-2,9-dimethyl-, also known as 2,9-dimethylquinacridone and C.I. Pigment Red 122 (CAS Reg. No. 980-26-7).
Notifier: Trust Chem Co., Ltd.
Manufacturer/Supplier: Trust Chem Co., Ltd.
Intended Use: As a colorant for food-contact polymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a maximum level of 1.5 weight percent of the finished polymer. The FCS is intended for use only in finished food-packaging and the finished polymers may be used in contact with all food types under Conditions 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: Sep 14, 2021
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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