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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. 316

Addivant

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: Addivant
Manufacturer: Addivant
Intended Use: For use as a stabilizer in polyolefin polymers and copolymers.
Limitations/Specifications*: For use (1) at a maximum level of 0.12 percent in polyolefin, repeat-use, food-contact articles with no temperature limitation, (2) at a maximum level of 0.12 percent in high-density polyethylene (HDPE) under Conditions of Use B through H as described in Table 2, and (3) at a maximum level of 0.12 percent in polypropylene (PP) and PP copolymers under Conditions of Use B through H. The finished food-contact articles may contact all food types.
Effective Date: Jul 8, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i) and (j)
FDA Decision: Categorical Exclusion Memo
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