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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. 369

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: Siloxanes and silicones, di-Me, hydrogen-terminated, reaction products with acrylic acid and 2-ethyl-2-[(2-propenyloxy)methyl]-1,3-propanediol (CAS Reg. No. 155419-56-0). The cured resins may include the photoinitiator 2-hydroxy-2-methyl-1-phenyl-propanone (CAS Reg. No. 7473-98-5).
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 1.5 grams per square meter (g/m2), in contact with all food types under Conditions of Use E, F, G, and H as defined in Table 2.
Limitations/Specifications*: 1) The resins shall be cured by the use of 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). 2) The photoinitiator should be used at a maximum level not to exceed 3 percent by weight of the silicone acrylate resin in coatings.
Effective Date: Dec 18, 2003
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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