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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. 918

Evonik Degussa 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: Evonik Degussa GmbH
Manufacturer/Supplier: Evonik Degussa GmbH
Intended Use: 1) As a monomer, alone or in combination with the polyhydric alcohols listed in 21 CFR 175.300(b)(3)(vii)(c), in the production of polyester can coatings used in the manufacture of articles or components of articles for contact with food. 2) As a monomer in the production of polyester resins used as components of adhesives for food contact applications, compliant with 21 CFR 175.105 and 175.125.
Limitations/Specifications: 1) Polyester can coatings containing the FCS may contact non-alcoholic food types under Conditions of Use A through H, as described in Table 2. 2) Polyester resins containing the FCS used as components of adhesives complying with 21 CFR 175.105 and 175.125 may be used at room temperature or below. For use of the FCS in adhesives at temperatures not to exceed 120°F, we assume that the adhesive either will be separated from the food by a functional barrier or will contact the food only in trace amounts at the seams and at the edges between packaging laminates.
Effective Date: Oct 28, 2009
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i), (j), and Environmental Assessment (in PDF, 450 kB)
FDA Decision: Categorical Exclusion Memo/Finding of No Significant Impact (FONSI)