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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. 2195

Comotomo, Inc.

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: Amorphous silicon dioxide coating (SiOxCyHz) made using plasma-enhanced chemical vapor-deposition of hexamethyldisiloxane.
Notifier: Comotomo, Inc.
Manufacturer/Supplier: Comotomo, Inc.
Intended Use: As a coating on polyphenylsulfone (PPSU) parts of repeated-use baby bottles, excluding baby bottle nipples.
Limitations/Specifications: The FCS coating with a thickness not to exceed 400 nm is separated from direct contact with infant formula and human milk by a silicone barrier layer having a minimum thickness of 0.5 mm. The PPSU-FCS-silicone multi-layer may contact infant formula and human milk at temperatures up to 100°C.
Effective Date: Apr 9, 2022
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
FDA Decision: Categorical Exclusion Memo