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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. 1045

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: Copolymer of dimethyl terephthalate or terephthalic acid, with ethylene glycol and poly(tetramethylene glycol) (CAS Reg. No. 9084-36-0 or 900151-37-3), in conjunction with either cobalt stearate (CAS Reg. No. 13586-84-0) or cobalt acetate (CAS Reg. No. 71-48-7).
Notifier: Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Manufacturer: Indorama Ventures USA Inc. and its stewarded affiliates around the world.
Intended Use: As a modifier for polyethylene terephthalate (PET) complying with an applicable food additive regulation or food contact notification.
Limitations/Specifications*: The FCS is intended for use at levels up to 3 percent by weight of the finished food-contact article, in conjunction with up to 0.015 percent by weight of either cobalt stearate (measured as cobalt) or cobalt acetate (measured as cobalt) of the finished food-contact article, in contact with all Food Types under Conditions of Use C through H, as described in Tables 1 and 2.
Effective Date: Feb 18, 2011
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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