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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. 1778

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: As a plasticizer in nitrile rubber intended for repeated-use food-contact applications, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: For use at levels up to 15% by weight in repeated-use nitrile rubber articles for contact with all types of food under Conditions of Use A through H, as described in Tables 1 and 2. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jun 14, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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