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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. 2061

INEOS Styrolution Group GmbH

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, C14-C20, esters with pentaerythritol (CAS Reg. Nos. 68440-28-8 and 85116-93-4).
Notifier: INEOS Styrolution Group GmbH
Manufacturer/Supplier: INEOS Styrolution Group GmbH
Intended Use: For use as a release agent in acrylonitrile-butadiene-styrene copolymers (ABS) and in styrene-methyl methacrylate copolymer blended with methyl-methacrylate-butadiene-styrene copolymer (SMMA-MBS), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a level up to 0.8% by weight of the finished ABS and SMMA-MBS polymers in contact with all types of food under Conditions of Use C-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: Jul 16, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo

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