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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. 1928

BASF SE

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: Fatty acids, C18-unsatd., dimers, polymers with caprolactam and hexamethylenediamine [Nylon 6/6.36] (CAS Reg. No 2068097-08-3).
Notifier: BASF SE
Manufacturer/Supplier: BASF SE
Intended Use: As a component in food-contact films, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications*: Films containing the FCS may contact all food types under Conditions of Use A through H as described in Tables 1 and 2. The film layer containing the FCS should not exceed a maximum thickness of 2 mil (0.002 inch). 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: Dec 5, 2018
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF)
FDA Decision: Finding of No Significant Impact (FONSI) and EA Revision Sheet (in PDF)

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