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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. 1381

Orion Engineered Carbons GmbH, Germany

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: Carbon black (amorphous, lamp black) (CAS Reg. No. 1333-86-4).
Notifier: Freudenberg Sealing Technologies GmbH & Co. KG, Germany
Manufacturer/Supplier: Orion Engineered Carbons GmbH, Germany
Intended Use: To improve the physical properties like tensile strength of repeat-use elastomeric articles, including o-rings and gaskets, which may contact food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used at levels not to exceed 50% by weight in the finished articles in compliance with 21 CFR 177.2600. The safety of usage of the FCS in contact with infant formula and breast milk has not been evaluated.
Effective Date: Mar 4, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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