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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. 116

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: Benzene propanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy, C13-C15 branched and linear alkyl esters (CAS Reg. No. 171090-93-0).
Notifier: Addivant
Manufacturer: Addivant
Intended Use: As a stabilizer in food-contact polymers.
Limitations/Specifications*: 1. At levels not to exceed 1 percent by weight of all polymers in contact with Food Types I, II, IV-B, VI-A, VI-B, VII-B, and VIII under Conditions of Use A through H, as described in Tables 1 and 2, respectively. 2. At levels not to exceed 0.2 percent by weight of all repeat-use polymers (except low-density and linear low-density polyethylene) in contact with Food Types III, IV-A, V, VII-A, and IX under Conditions of Use A through H as described in Tables 1 and 2, respectively.
Effective Date: Mar 15, 2001
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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