Food Contact Substances that are No Longer Effective

The database lists premarket notifications for food contact substances that have been determined to no longer be effective based on provisions listed in 21 CFR 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective. This list includes the food contact substance (FCS), the notifier, the manufacturer or supplier of the FCS, the intended use, the limitations and specifications on the condition of use for the FCS, the date the notification is no longer effective, citation to the Federal Register Notice announcing this determination, and the basis for this determination. Under section 409(h)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348 (h)(2)(C)) a food contact substance notification (FCN) is only effective for the food contact substance, intended use, and manufacturer or supplier identified in the notification. As such, determinations listed in this database are limited to the notification number specified and the specific food contact substance produced or supplied by the listed manufacturer or supplier for the listed intended use. Other authorizations for the same food contact substance produced or supplied by a different manufacturer or supplier for the same intended use, or produced or supplied by the same manufacturer or supplier but for a different intended use, may still be effective.

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.

Additional information about Food Contact Substances and the definitions of Food Types and Conditions of Use are available on the FCS Program page.

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