Inventory of Effective Food Contact Substance (FCS) Notifications
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FCN No. 2377
Valtris Specialty Chemicals
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: | Fatty acids, soya, epoxidized, 2-ethylhexyl esters (CAS Reg. No. 68082-34-8) |
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| Notifier: | Valtris Specialty Chemicals |
| Manufacturer/Supplier: | Valtris Specialty Chemicals |
| Intended Use: | The FCS is intended for use as a plasticizer in polyvinyl chloride, except for use in contact with infant formula and human milk (see Limitations/Specifications). |
| Limitations/Specifications: | The FCS will be used at levels up to 20 percent by weight in polyvinyl chloride food contact articles with a thickness of 0.5 mil to 2 mil (0.0005 inch to 0.02 inch) in contact with Food Type I under Conditions of Use C through G. 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: | Sep 18, 2024 |
| National Environmental Policy Act (NEPA)** Submission: | Environmental Assessment |
| FDA Decision: | Finding of No Significant Impact (FONSI) |
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