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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. 1895

Evonik Resource Efficiency GmbH
Evonik Degussa GmbH
Evonik Specialty Chemicals (Shanghai) Co., Ltd.

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: Dodecanedioic acid, polymer with 4,4'-methylenebis[cyclohexanamine] (CAS Reg. No. 25038-97-5).
Notifier: Evonik Resource Efficiency GmbH
Manufacturer/Supplier: Evonik Resource Efficiency GmbH
Evonik Degussa GmbH
Evonik Specialty Chemicals (Shanghai) Co., Ltd.
Intended Use: As a base polymer used in the production of repeat-use food-contact articles, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The article may contact all types of food at temperatures up to 100°C for a maximum of 120 minutes. 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 24, 2018
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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