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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. 1777

Galentis S.r.l.

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: Poly[(chloro-1,4-phenylene)-1,2-ethanediyl] film (CAS Reg. No. 9052-19-1).
Notifier: Specialty Coating Systems
Manufacturer/Supplier: Galentis S.r.l.
Intended Use: As a coating for coffee dispenser flowmeter magnets and seals; except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS will be used as a coating on magnets and on seals that surround those magnets that are used in flowmeters in commercial coffee dispensers and excluding coffee machines for home use. The maximum thickness of the coating will be 15 μm. Coffee dispensers containing the coating will have operating temperature up to 100°C. The FCS is not for use in contact with infant formula and human milk. Such uses were not included as part of the intended use of the substance in the FCN.
Effective Date: Aug 17, 2017
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo

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