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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. 2055

Emery Oleochemicals GmbH

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: Ethylene glycol dipalmitate (CAS Reg. No. 624-03-3).
Notifier: Emery Oleochemicals GmbH
Manufacturer/Supplier: Emery Oleochemicals GmbH
Intended Use: As a processing aid in rigid polyvinyl chloride (PVC), polycarbonate (PC), and polylactic acid (PLA), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in rigid PVC at levels up to 0.4 percent by weight in the finished article. In PC and PLA, the FCS will be used at levels up to 0.2 percent by weight in the finished article. Articles made from rigid PVCand PC will contact all food types under Conditions of Use C through G. Articles made from PLA will contact all food types under Conditions of Use E through G. 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: Oct 9, 2020
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 220 kB)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF, 110 kB)

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