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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. 963

Zhejiang Hisun 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: (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 (CAS Reg. No. 9051-89-2) (aka polylactide polymers), manufactured and characterized as described in the notification.
Notifier: Zhejiang Hisun Biomaterials Co. Ltd.
Manufacturer: Zhejiang Hisun Biomaterials Co. Ltd.
Intended Use: As components of food-contact articles.
Limitations/Specifications*: The finished polymers are intended to contact all food types under Conditions of Use B through H, as described in Table 2.
Effective Date: May 11, 2010
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (81 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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