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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. 558

Stanelco Plc

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: 1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 1,4-butanediol, adipic acid, hexamethylene diisocyanate and not more than 1 percent by weight of a polyhydric alcohol, as described in FCN 372.
Notifier: Stanelco Plc
Manufacturer/Supplier: Stanelco Plc
Intended Use: For use in blends with food-contact polylactide polymers used to produce single use food-contact trays.
Limitations/Specifications: The FCS will be used at levels not to exceed 25 percent by weight of the finished food-contact trays. The finished food-contact trays may be used in contact with all types of food under Conditions of Use D through G as described in Table 2.
Effective Date: Feb 10, 2006
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 195 kB)
FDA Decision: Finding of No Significant Impact (FONSI)