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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. 2312

Pliith Biomaterials Co. Ltd.

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 (Polylactic acid; PLA) optionally containing up to 4 weight percent D-lactic acid polymer units (CAS Reg. No. 9051-89-2).
Notifier: Pliith Biomaterials Co. Ltd.
Manufacturer/Supplier: Pliith Biomaterials Co. Ltd.
Intended Use: As components of food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The finished polymers are intended to contact all types of food under Conditions of Use B through H, 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 24, 2023
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 149 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 182 kB)

*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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