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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. 1754

Newlight Technologies, 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-, (R)-, homopolymer (CAS Reg. No. 29435-48-1).
Notifier: Newlight Technologies, Inc.
Manufacturer/Supplier: Newlight Technologies, Inc.
Intended Use: As a component of food contact materials, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: Finished articles that contain the FCS may contact all food types under Conditions of Use B through H as described in Tables 1 and 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: Jul 22, 2017
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 960 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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