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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. 1865

Indorama Ventures USA Inc. and its stewarded affiliates around the world

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: Isophthalic acid (CAS Reg. No. 121-91-5).
Notifier: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Manufacturer/Supplier: Indorama Ventures USA Inc. and its stewarded affiliates around the world
Intended Use: As a monomer in the manufacture of ethylene terephthalate-isophthalate copolymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The finished copolymers must contain from 3 to 17 weight percent ethylene isophthalate units. The finished copolymers must also meet specifications in 21 CFR 177.1630(f) - (j) appropriate to their intended use. 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: Apr 21, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 47 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 104 kB)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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