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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. 1587

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: Tris(2-ethylhexyl) trimellitate (CAS Reg. No. 3319-31-1).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: The FCS is intended for use as a plasticizer in repeated-use food-contact vinyl chloride polymers, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS is intended to be used as a plasticizer at levels not to exceed 30% by weight in repeated-use food-contact vinyl chloride polymers intended to contact all types of food. The finished product is not for use in contact with infant formula and breast milk. Such uses are not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 27, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo