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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. 1980

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 high density polyethylene, except for use in contact with infant formula and human milk (see Limitations and Specifications).
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 in contact with all food types under Conditions of Use E through G as described in Table 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 4, 2019
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

679663  

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