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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. 155

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: Silicon dioxide (CAS Reg. No. 7631-86-9).
Notifier: Tetra Pak, Inc.
Manufacturer/Supplier: Tetra Pak, Inc.
Intended Use: The FCS will be used as an amorphous plasma-deposited silicon coating on the food-contact surface of polyethylene terephthalate (PET) food packaging articles.
Limitations/Specifications: The finished FCS will be used as a thin coating for PET articles complying with the provisions of applicable food additive regulations or FCNs, in contact with all types of food under Conditions of Use C through G, as described in Tables 1 and 2. The average thickness of the coating shall not exceed 440 angstroms and the maximum thickness of the coating shall not exceed 500 angstroms.
Effective Date: Aug 31, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo with Categorical Exclusion Supplement