Food Contact Substances that are No Longer Effective
FCN No. 518
Solenis LLC
Notifier: | Hercules Inc. |
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Manufacturer/supplier: | Solenis LLC |
No longer effective food contact substance: | 2-propen-1-ol, reaction products with pentafluoroiodoethane-tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine (CAS Reg. No 464178-90-3). |
Date no longer effective: | Jan 6, 2025 |
Citation: | 90 FR 653 |
Basis*: | 21 CFR 170.105(a)(2) |
Environmental Assessment NEPA submission**: | Categorical Exclusion 25.32(m) |
FDA decision: | Categorical Exclusion Memo |
Additional information: | Company commitment letter |
Solenis LLC Cessation of Sales Letter Regarding FCN Nos 314, 487, 518, 542, 746, 783 (September 2023) |
NOTES
* In 21 CFR 170.105, FDA lists four bases for which we may determine a premarket notification for a food contact substance (FCN) is no longer effective. These bases are summarized below and the specific basis upon which FDA reached its determination that an FCN is no longer effective is indicated in the listings in this database.
- In 21 CFR 170.105(a)(1), FDA may determine an FCN is no longer effective based on data or other information available to FDA that demonstrates that the intended use of a food contact substances is no longer safe.
- In 21 CFR 170.105(a)(2), FDA may determine an FCN is no longer effective based on data or other information available to FDA that demonstrates that the manufacturer or supplier specified in the FCN has ceased or intends to cease producing, supplying, or using a food contact substance for the intended use.
- In 21 CFR 170.105(a)(3), FDA may determine an FCN is no longer effective based on the intended use of the food contact substance identified in the FCN is authorized by a food additive regulation.
- In 21 CFR 170.105(a)(4), FDA may determine an FCN is no longer effective based on the intended use of the food contact substance identified in the FCN is the subject of an issued threshold of regulation exemption.
** More about Environmental Decisions and Definitions of Environmental Terms.