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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. 886

Plastipak Packaging, 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: 2-2'-[1,3-phenylenebis(methylene)]bis[2,3-dihydro-1H-isoindol-1-one] (CAS Reg. No. 935739-41-6) (also known as m-Xylylenediamine-bis(phthalamide), MXBP), used in conjunction with cobalt neodecanoate (CAS Reg. No. 27253-31-2).
Notifier: Plastipak Packaging, Inc.
Manufacturer: Plastipak Packaging, Inc.
Intended Use: As an oxygen scavenger in polyethylene terephthalate (PET) polymers
Limitations/Specifications*: MXBP will be used at levels not to exceed 1.45 wt-% of finished food-contact article in conjunction with cobalt neodecanoate used at levels not to exceed 0.02 wt-% (200 ppm) (measured as cobalt) of finished food-contact article. The modified polymers may be used to manufacture containers for contact with all food types, except for carbonated soft drinks and water, under the Conditions of Use C through G.
Effective Date: Jul 22, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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