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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. 538

Solvay Specialty Polymers Italy S.p.A.

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: Perfluoropolyether dicarboxylic acid (CAS Reg. No. 69991-62-4), ammonium salt.
Notifier: Solvay Specialty Polymers Italy S.p.A.
Manufacturer: Solvay Specialty Polymers Italy S.p.A.
Intended Use: As an oil and water repellent employed in the manufacture of food-contact paper and paperboard either prior to the sheet-forming operation or at the size press.
Limitations/Specifications*: When applied prior to the sheet-forming operation the FCS is to be used at a level not to exceed 1 percent by weight of the finished dry paper and paperboard to be used in contact with all food types. When applied at the size press the total use level of the FCS is not to exceed 0.5 percent by weight of the finished dry paper and paperboard to be used in contact with aqueous foods and 1 percent by weight of the finished dry paper and paperboard to be used in contact with all other food types. Paper and paperboard containing the FCS are to be used under Conditions of Use B through H as described in Table 2.
Effective Date: Nov 19, 2005
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo
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