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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. 239

BASF Corporation

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 mixture consisting of 63-72 percent oxidized bis(hydrogenated tallow alkyl)amines, 12-15 percent bis(hydrogenated tallow alkyl)amines, 4-8 percent (hydrogenated tallow alkyl)nitrones, and 5-12 percent (hydrogenated tallow alkyl)oximes.
Notifier: Ciba Specialty Chemicals Corp.
Manufacturer: BASF Corporation
Intended Use: The FCS will be used as an acetaldehyde scavenger in polyethylene phthalate (PET) water bottles.
Limitations/Specifications*: (1) The FCS will be used in polyethylene phthalate (PET) water bottles at levels not to exceed 0.25 percent by weight of the polyethylene phthalate. (2) Tne finished polymer may be used in contact with nonacid food Type I as listed in Table 1 under Conditions of Use C through G as described in Table 2.
Effective Date: Jul 31, 2002
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo