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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. 1473

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: 1,4-bis(2-ethylhexyl) benzenedicarboxylate (CAS Reg. No. 6422-86-2).
Notifier: BASF Corporation
Manufacturer/Supplier: BASF Corporation
Intended Use: The FCS will be used as follows: as a component of 1) plasticized vinyl chloride formulations, 2) paper or paperboard or coatings of such paper and paperboard, 3) adhesives, and 4) pressure sensitive adhesives (PSA) in contact with food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used as follows:1) In contact with all food types at levels not exceeding 55 percent by weight of finished plasticized vinyl chloride polymer formulations used in repeated-use, food-contact applications at temperatures no greater than 100°C;2) As a component of paper or paperboard, or coatings for such paper and paperboard intended for use in contact with dry foods with no free surface fats or oil in compliance with 21 CFR 176.180;3) As a component of adhesives complying with the provisions of 21 CFR 175.105; and,4) As a component of pressure sensitive adhesives complying with the provisions of 21 CFR 175.125.The finished food contact articles containing the FCS are not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Nov 4, 2014
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 675 kb)
FDA Decision: Finding of No Significant Impact (FONSI)

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