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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. 1903

Solvay Specialty Polymers

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: Poly(glycolic acid-co-isophthalic acid-co-trimethylolpropane).
Notifier: Solvay Specialty Polymers
Manufacturer/Supplier: Solvay Specialty Polymers
Intended Use: For use (1) in multilayer structures where the FCS will be separated from food by a layer of polyethylene terephthalate (PET) with a minimum thickness of 60 microns, and (2) at levels of up to 0.5% in blends with PET for direct contact with food, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: For use in contact with all food types under Conditions of Use C through G, as described in Table 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: Oct 19, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF)

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