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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. 2187

Songwon Industrial Co., Ltd.

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: Songwon International AG
Manufacturer/Supplier: Songwon Industrial Co., Ltd.
Intended Use: As a stabilizer and 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 B through H.
  2. polypropylene (PP) and PP copolymers at levels not to exceed 0.12 percent by weight of finished articles in contact with all food types under Conditions of Use B through H.
  3. 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 Conditions of Use B through H.
  4. 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: Jan 22, 2022
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment (in PDF, 115 kB)
FDA Decision: Finding of No Significant Impact (FONSI) (in PDF, 137 kB)

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