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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. 1292

ADEKA 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: Benzenepropanamide, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, N-C16-18 alkyl derivatives (CAS Reg. No. 1235487-96-3).
Notifier: ADEKA Corporation
Manufacturer: ADEKA Corporation
Intended Use: The FCS will be used as an antioxidant in polypropylene according to 21 CFR 177.1520 at a maximum level of 150 ppm (0.015 wt.-%). The food contact articles will be films, coatings, and molded articles for single as well as repeat use.
Limitations/Specifications*:

Polypropylene articles may contact all types of foods under Conditions of Use A through H.

FDA did not make the determination that usage of the subject FCS in the processing, packaging, holding or delivery of infant food (food for infants of 0-6 months of age) or its ingredient is safe. As such, this notification does not permit the use of the FCS in contact with infant food.

Effective Date: Oct 19, 2013
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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