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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. 475

NatureWorks LLC

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: Polylactide (PLA) polymers containing from 6 to 16 weight percent D-lactic acid polymer units (High D PLA; CAS Reg. No. 9051-89-2). The polymers will be manufactured and characterized as further described in the notification.
Notifier: NatureWorks LLC
Manufacturer/Supplier: NatureWorks LLC
Intended Use: As a component in the manufacture of articles intended to contact food.
Limitations/Specifications: The FCS is intended to contact all types of food under Conditions of Use C through G, as described in Table 2.
Effective Date: Feb 11, 2005
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 660 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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