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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. 1119

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: Butanoic acid, 3-hydroxy-, (3R)-, polymer with 4-hydroxybutanoic acid (CAS Reg. No. 125495-90-1) and butanoic acid, 3-hydroxy-, (3R)-, homopolymer (CAS Reg. No. 29435-48-1). REPLACES FCN 943.
Notifier: Metabolix, Inc.
Manufacturer: Metabolix, Inc.
Intended Use: As components of polymers used in articles that may contact food.
Limitations/Specifications*: The FCS may contain up to 16 weight percent units derived from 4-hydroxybutanoic acid. The FCS will be used as a single-use polymer that may contact all food under Conditions of Use B through H, as identified in the Table 2.
Effective Date: Jan 21, 2012
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (880 kB)
FDA Decision: Finding of No Significant Impact (FONSI)