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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. 1483

Watson Standard Company

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: 2-Propenoic acid, 2-methylpropyl ester, polymer with 1,1-dimethylethyl propionate (CAS Reg. 186454-07-9)
Notifier: Watson Standard Company
Manufacturer/Supplier: Watson Standard Company
Intended Use: As a component of resinous and polymeric coatings as described in 21 CFR 175.300, on metal substrates for single use food contact articles, or on any suitable substrate for repeat use food contact articles, except for use in contact with infant formula and breast milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at a maximum level of 0.003 mg/in 2 on a dry weight basis. The finished coatings will otherwise comply with FDA regulations for their intended use. The finished coatings may be used in contact with all food types under Conditions of Use A through H as described in Tables 1 and 2, subject to any limitations on the use of other components of the coating. The FCS is not for use in contact with infant formula and breast milk. Such use was not included as part of the intended use of the substance in the FCN.
Effective Date: Dec 3, 2014
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo