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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. 2340

Rianlon Corporation

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: Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No. 2082-79-3).
Notifier: Rianlon Corporation
Manufacturer/Supplier: Rianlon Corporation
Intended Use: As a stabilizer in (1) styrene block polymers with 1,3-butadiene, hydrogenated (SEBS; CAS Reg. No. 66070-58-4), (2) olefin polymers, and (3) flexible polyvinyl chloride (PVC), except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used:
  1. at levels not to exceed 0.07 percent by weight of SEBS authorized for the intended use in contact with all food under Conditions of Use (COU) A through H;
  2. in olefin polymers complying with 21 CFR 177.1520(c), item 3.6, at levels not to exceed 0.25 percent by weight of the finished articles that may contact all food under COU A through H; and
  3. at levels not to exceed 0.006 percent by weight of flexible PVC film (thickness shall not exceed 1 mil) that may contact food types I, II, IV-B, VI-B, VII-B and VIII under COU A through H as described in Tables 1 and 2.
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: May 22, 2024
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 309 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 199 kB)

*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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