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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. 1417

Galata Chemicals

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: Fatty acids, soya, epoxidized, 2-ethylhexyl esters (CAS Reg. No. 68082-34-8).
Notifier: Galata Chemicals
Manufacturer/Supplier: Galata Chemicals
Intended Use: The FCS is intended for use as a plasticizer in polyvinyl chloride, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used in polyvinyl chloride at levels up to 15 percent by weight of the finished article in contact with food types I, II, IVB, VIA, VIB, VIC (up to 15% alcohol), VIIB, and VIII under Conditions of Use C through G. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: May 6, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 550 kB)
FDA Decision: Finding of No Significant Impact (FONSI)

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