The U.S. Food and Drug Administration (FDA) proposed a new rule to amend regulation (21 CFR 170.105) on how and when the FDA may determine that a pre-market notification for a food contact substance is no longer effective. A list of effective food contact notifications (FCNs) can be found on FDA’s website.
If finalized, the proposed rule would, among other things, allow the FDA additional flexibility in how it determines that an FCN is no longer effective and help ensure that FDA’s inventory of effective FCNs is current based on use and safety. Primarily, this rule would enable the FDA to determine that an FCN is no longer effective when the manufacturer discontinues its use based on reasons other than safety, for example, they no longer produce, supply, or use the food contact substance. In addition, the rule would give manufacturers or suppliers an opportunity to provide input before the FDA determines that an FCN is no longer effective. The proposed rule would also increase the FDA’s ability to reduce redundancy across FCNs, food additive regulations, and threshold of regulation exemptions. The FDA will continue to have the ability to revoke authorizations if, based on new information, they are no longer able to conclude that there is a reasonable certainty of no harm from the authorized use, or take other steps to ensure the protection of public health.
Food additives, including food contact substances, require pre-market review and authorization for their intended use. A “food contact substance” is any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have any technical effect in such food. Manufacturers must notify the FDA of their intent to use a food contact substance via a food contact substance notification (FCN). The FDA has 120 days to complete its review of the scientific data to ensure the food contact substance is safe for its intended use. If the FDA does not object within 120 days, the FCN becomes “effective” (i.e., the use is authorized). FCNs are manufacturer specific and therefore, there are currently multiple FCNs for the same food contact substance with the same intended use. Examples of uses include coatings, plastics, paper, adhesives, antimicrobials, and antioxidants contained in or on food packaging and processing equipment.
For more information, including deadlines for submitting comments to the proposed rule, please see the Federal Register Notice.