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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. 41

Evonik 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: Silicone acrylate resins produced by the addition of ω-hydroxyalkenes and/or propenyloxy-2,3-dihydroxypropane, mono- or diester with acrylic acid, acetic acid, or other saturated monocarboxylic acid, to dimethyl polysiloxane, methylhydrogen polysiloxane, or dimethyl-methylhydrogen polysiloxane. The cured resins may include substances permitted for use by regulation in 21 CFR 170-189, substances generally recognized as safe, substances used in accordance with prior sanction approval, and the following substances as photoinitiators: 2-hydroxy-2-methyl-1-phenyl-1-propanone (CAS Reg. No. 7473-98-5) and/or oligomeric -2-hydroxy-2-methyl-1-[4-(1-methylvinyl)phenyl]-1-propanone (CAS Reg. No. 163702-01-0). The total photoinitiator levels shall not exceed 3 percent by weight of silicone acrylate resin in coatings.
Notifier: Goldschmidt Chemical Corporation
Manufacturer: Evonik Corporation
Intended Use: As coatings or components of coatings on polymeric substrates and on paper and paperboard, at a maximum level of 1.3 milligrams per square inch (mg/in2), in contact with all food types under conditions of use E, F, G, and H as defined in Table 2.
Limitations/Specifications*: The resins shall be cured by the use of electron beam or ultraviolet light such that the finished coating, when extracted with 50 percent ethanol at 100°C for 2 hours, yields total chloroform-soluble nonvolatile extractives not to exceed 0.02 milligram per square inch (mg/in2).
Effective Date: Jun 7, 2000
National Environmental Policy Act (NEPA)** Submission: Environmental Assessment
FDA Decision: Finding of No Significant Impact (FONSI)
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