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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. 1423

Indorama Ventures USA LLC and its Steward 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: Copolymers of ethylene glycol and isophthalic acid with dimethyl terephthalate (CAS Reg. No. 26006-30-4) or terephthalic acid (CAS Reg. No. 24938-04-3).
Notifier: INVISTA Resins & Fibers GmbH
Manufacturer/Supplier: Indorama Ventures USA LLC and its Steward Affiliates Around the World
Intended Use: To be used as articles or components of articles that may contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: For use in contact with all food types, under Conditions of Use A through H as described in Table 2. The use level of isophthalic acid (IPA) is (A) greater than 3 weight percent polymer units derived from ethylene from ethylene isophthalate but less than 17 weight percent derived from ethylene isophthalate, or (B) greater than 23 weight percent up to a maximum of 38 weight percent from ethylene isophthalate, polymer units derived from ethyleneisophthalate. The high-IPA copolymers (>23%) will not be used in/on bottles. Adjuvant substances authorized under 21 CFR 177.1630 may be used in the FCS, in accordance with the use conditions and limitations prescribed. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 3, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 531 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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