Food Contact Substances that are No Longer Effective
-
FCN No. 1493
Archroma Management GmbH
This substance is no longer effective.
| Notifier: | Archroma Management GmbH |
|---|---|
| Manufacturer/supplier: | Archroma Management GmbH |
| No longer effective food contact substance: | Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate (CAS Reg. 1440528-04-0) |
| 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 |
| Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) | |
| Acknowledgement Receipt to Archroma Management GmbH Commitment Letter Regarding FCN No. 1493 (July 2020) | |
| Archroma Management GmbH First Annual Update Letter Regarding FCN No. 1493 (January 2022) | |
| Archroma Management GmbH Second Annual Update Letter Regarding FCN No. 1493 (January 2023) | |
| Archroma Management GmbH Mid Year Update Letter Regarding FCN No. 1493 (July 2023) | |
| Archroma Management GmbH Final Annual Update Letter Regarding FCN No. 1493 (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.
-
