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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. 415

Tetra Pak, 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: A blend of LDPE and LDPE grafted with vinyltrimethoxysilane (LDPE/VTMOS-LDPE) containing up to 50 percent LDPE grafted with vinyltrimethoxysilane (VTMOS-LDPE).
Notifier: Tetra Pak, Inc.
Manufacturer: Tetra Pak, Inc.
Intended Use: For use in fabricating beverage containers.
Limitations/Specifications*: The amount of VTMOS incorporated into the LDPE shall not exceed 0.48 moles VTMOS per 1000 moles of ethylene units. The finished copolymer blend is intended only for incidental contact with Food Types I, II, IVB and VIB in Table 1, at seams and edges under Condition of Use E, F, and G in Table 2.
Effective Date: Sep 11, 2004
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF) (340 kB)
FDA Decision: Finding of No Significant Impact (FONSI)
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