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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. 2328

Senoptica Technologies Ltd.

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: Tris(4,7-diphenyl-1,10-phenanthroline)ruthenium(II) dichloride (CAS Reg. No. 36309-88-3).
Notifier: Senoptica Technologies Ltd.
Manufacturer/Supplier: Senoptica Technologies Ltd.
Intended Use: As a component of an oxygen sensor utilized in modified atmosphere food packaging, except for use in contact with infant formula and human milk (see Limitations/Specifications).
Limitations/Specifications: The FCS may be used at levels not to exceed 0.41 weight percent within ethylcellulose oxygen sensors. The polymer formulation containing the FCS will be applied as single or multiple oxygen sensor squares at a maximum coating rate of 2.2 g/m2, with a maximum total surface area of 3 cm2 for products up to 250 g and 5 cm2 for products above 250 g. The FCS may be used in contact with aqueous, acidic, and fatty foods under Conditions of Use (COU) E through G, as described in Table 2. 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: Mar 15, 2024
National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(i)
FDA Decision: Categorical Exclusion Memo

*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.
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