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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. 970

Metabolix, Inc.

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: Boron nitride (CAS Reg. No. 10043-11-5).
Notifier: Metabolix, Inc.
Manufacturer: Metabolix, Inc.
Intended Use: As a nucleating agent in the subject of FCN 001119.
Limitations/Specifications*: The FCS will be used at no more than 1 weight percent in single-use polymers that may contact all food under Conditions of Use B through H, as identified in Table 2.
Effective Date: May 11, 2010
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo