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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. 2136

DuPont Teijin Films

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: Polyethylene terephthalate-azelate copolyester resin (CAS Reg. No. 25609-72-7).
Notifier: DuPont Teijin Films
Manufacturer/Supplier: DuPont Teijin Films
Intended Use: The FCS will be used in coatings applied to authorized polyethylene terephthalate (PET) polymer films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The coated films may be used in contact with food under Conditions of Use A though H and J 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: Jul 6, 2021
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 123 kB)
FDA Decision: Finding of No Significant Impact (FONSI) & EA Revision Sheet (in PDF, 138 kB)
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