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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. 2052

Dairen Chemical Corporation
Chang Chun Plastics 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: Tricyclodecanedimethanol (CAS Reg. No. 26896-48-0 and 26160-83-8).
Notifier: Chang Chun Plastics Co., Ltd.
Manufacturer/Supplier: Dairen Chemical Corporation
Chang Chun Plastics Co., Ltd.
Intended Use: As a monomer in otherwise authorized polyester can coatings or polyester adhesives in contact with food, except for contact with infant formula or human milk (see Limitations/Specifications).
Limitations/Specifications: (1) Polyester can coatings containing the FCS may contact non-alcoholic food under Conditions of Use A through H, as described in Table 2. (2) Polyester-based adhesives containing the FCS shall comply with 21 CFR 175.105(a)(2) and will be used at room temperature or below. 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 20, 2020
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo