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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. 1979

Braskem S.A.
Braskem Affiliates
Braskem Netherlands B.V.
Tetra Pak Inc.
Tetra Pak Canada Inc.

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: N,N-bis(2-hydroxyethyl)alkyl(C13-C15)amine (CAS Reg. No. 70955-14-5).
Notifier: Braskem S.A.
Braskem Affiliates
Braskem Netherlands B.V.
Tetra Pak Inc.
Tetra Pak Canada Inc.
Manufacturer/Supplier: Braskem S.A.
Braskem Affiliates
Braskem Netherlands B.V.
Tetra Pak Inc.
Tetra Pak Canada Inc.
Intended Use: As an antistatic agent in molded and extruded high density polyethylene used in caps and closures for containers of infant formula and human milk.
Limitations/Specifications*: For use at levels not to exceed 850 ppm in high density polyethylene having a density greater than or equal to 0.95 g/cm3 under Conditions of Use E through G as described in Table 2. Caps and closures containing the FCS are separated from the food by an aseptic or other type of seal prior to initial opening of the container.
Effective Date: Jun 4, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

679661  

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