FCN No. 2290

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: 1,2-Bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamoyl)hydrazine (CAS Reg. No. 32687-78-8)
• Notifier: Rianlon Corporation
• Manufacturer/Supplier: Rianlon Corporation
• Intended Use: As an antioxidant in polyolefin polymers and copolymers, except for use in contact with infant formula and human milk (see Limitations/Specifications).
• Limitations/Specifications: The FCS may be used in:
  1. High density polyethylene (HDPE) at levels not to exceed 0.12 percent by weight of finished articles in contact with all food types under Conditions of Use (COU) B through H, as described in Tables 1 and 2;
  2. Polyethylene copolymers as described in 21 CFR 177.1520(c), item 3.2a at levels not to exceed 0.18 percent by weight of finished articles in contact with aqueous and acidic foods under COU B through H; and
  3. polyolefin at levels not to exceed 0.12 percent by weight of finished repeat-use articles in contact with all food types.
  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: Jul 22, 2023
• National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 836 kB)
• FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 208 kB)

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*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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