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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. 2510

Setaş Kimya Sanayi A.Ş.

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 and 26896-48-0).
Notifier: Setaş Kimya Sanayi A.Ş.
Manufacturer/Supplier: Setaş Kimya Sanayi A.Ş.
Intended Use: As a monomer in the manufacture of (1) polyester or polyester/polyurethane resins for use as components of coatings for use on metal substrates and repeated-use food-contact surfaces, or (2) polyester resins for use in adhesives, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications:
  1. The level of the FCS in the final coating may not exceed 46.1 percent by weight. Coatings containing the FCS may contact all food types under Conditions of Use A through H, as described in Tables 1 and 2.
  2. Polyester-based adhesives containing the FCS shall comply with 21 CFR 175.105 or 21 CFR 175.125 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 2, 2026
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)

*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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