Inventory of Effective Food Contact Substance (FCS) Notifications
-
FCN No. 2384
Ingenia Polymers Corporation
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 16 weight percent D-lactic acid polymer units (CAS Reg. No. 9051-89-2). |
|---|---|
| Notifier: | Ingenia Polymers Corporation |
| Manufacturer/Supplier: | Ingenia Polymers Corporation |
| Intended Use: | As a component 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 Tables 1 and 2. The FCS may additionally be used under Condition of Use A as a polymer processing aid in polyolefins at a maximum level of 750 parts per million by weight of the finished polymer. 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: | Dec 13, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment (in PDF, 211 kB) |
| FDA Decision: | Finding of No Significant Impact (FONSI) (in PDF, 400 kB) |
-
