Food Contact Substances that are No Longer Effective
-
FCN No. 599
Asahi Glass Co., Ltd. (Manufacturer) and AGC Chemicals Americas, Incorporated
This substance is no longer effective.
| Notifier: | AGC Chemicals Americas, Incorporated |
|---|---|
| Manufacturer/supplier: | Asahi Glass Co., Ltd. (Manufacturer) and AGC Chemicals Americas, Incorporated |
| No longer effective food contact substance: | Copolymer of perfluorohexylethyl methacrylate, 2-N,N-diethylaminoethyl methacrylate, 2-hydroxyethyl methacrylate, and 2,2'-ethylenedioxydiethyl dimethacrylate, acetic acid salt (CAS Reg. No. 863408-20-2) or malic acid salt (CAS Reg. No. 1225273-44-8). |
| 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, FDA acknowledgement, and annual update letter |
| AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) | |
| Acknowledgement Receipt to AGC Chemicals Americas, Inc Commitment Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (July 2020) | |
| AGC Chemicals Americas, Inc First Annual Update Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (January 2022) | |
| AGC Chemicals Americas, Inc Second Annual Update Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (January 2023) | |
| AGC Chemicals Americas, Inc Mid Year Update Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (August 2023) | |
| AGC Chemicals Americas, Inc Final Annual Update Letter Regarding FCN Nos. 599, 604, 1186, and 1676 (January 2024) |
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.
-
