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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. 1926

Total Corbion PLA bv

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: (3R,6R)-3,6-dimethyl-1,4-dioxane-2,5-dione, polymer with rel-(3R,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione and (3S,6S)-3,6-dimethyl-1,4-dioxane-2,5-dione (aka polylactide (PLA) polymers), optionally containing up to 16 weight percent D?lactic acid polymer units (CAS Reg. No. 9051-89-2).
Notifier: Total Corbion PLA bv
Manufacturer/Supplier: Total Corbion PLA bv
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: Nov 30, 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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