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U.S. Department of Health and Human Services

Food Contact Substances that are No Longer Effective
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FCN No. 187

Solvay Specialty Polymers Italy S.p.A.

This substance is no longer effective.
Notifier: Solvay Specialty Polymers Italy S.p.A.
Manufacturer/supplier: Solvay Specialty Polymers Italy S.p.A.
No longer effective food contact substance: Fluorinated polyurethane anionic resin (CAS Reg. No. 328389-91-9) prepared by reacting perfluoropolyether diol (CAS Reg. No. 88645-29-8), isophorone diisocyanate (CAS Reg. No. 4098-71-9), 2,2-dimethylolpropionic acid (CAS Reg. No. 4767-03-7), and triethylamine (CAS Reg. No. 121-44-8).
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
Solvay Specialty Polymers USA LLC Cessation of Sales Letter Regarding FCN Nos 187, 195. 398, 416, 538, 962 (August 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
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