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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. 1461

OQ Chemicals 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: Tricyclodecanedimethanol (CAS Reg. No. 26160-83-8).
Notifier: DSM Resins B.V.
Manufacturer/Supplier: OQ Chemicals GmbH
Intended Use: As a monomer in otherwise authorized polyester can coatings or polyester adhesives in contact with food, except for contact with infant formula and breast 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 1. (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 breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Oct 14, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

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