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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. 1604

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: Isotridecanol phosphite condensation product with butylidenebis(2-(1,1-dimethylethyl)-5-methyl-4,1-phenylene).
Notifier: ADEKA Corporation
Manufacturer/Supplier: ADEKA Corporation
Intended Use: As an antioxidant and/or stabilizer for styrene/isoprene/styrene (SIS), high impact polystyrene (HIPS), styrene/butadiene, impact methacrylic styrene, acrylonitrile/butadiene, and acrylonitrile/butadiene/styrene (ABS) copolymers intended for contact with all types of food, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 1.0 percent by weight of the finished copolymer under Conditions of Use B through H as described in Table 2. The FCS is not for use in contact with infant formula and breast milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Jan 9, 2016
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*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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