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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. 1231

Heubach Colour Pvt. 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: 5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione (C.I. Pigment Red 122, CAS Reg. No. 980-26-7) also known as 2,9-Dimethylquinacridone.
Notifier: Heubach Colour Pvt. Ltd.
Manufacturer: Heubach Colour Pvt. Ltd.
Intended Use: As a colorant in food contact polymers, subject to the provisions and definitions set forth in 21 CFR 178.3297 (Colorants for polymers).
Limitations/Specifications*: For use in all food-contact polymers as follows: 1) at levels not to exceed 1 weight-percent of finished polymers in contact with food types I, II, IV-B, VI-A, VI-B, VI-C (containing up to 15 percent alcohol, v/v), VII-B, and VIII under Conditions of Use D through G; 2) at levels not to exceed 0.5 weight-percent of finished polymers in contact with food types III, IV-A, V, VI-C (containing greater than 15 percent alcohol, v/v), VII-A, and IX under Conditions of Use D through G; 3) at levels not to exceed 0.2 weight-percent of finished polymers in contact with all food types under Conditions of Use A through H. The food types and Conditions of Use are described in Tables 1 and 2.
Effective Date: Mar 2, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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