U.S – The U.S. Food and Drug Administration (FDA) has proposed a new rule to amend the regulations on the method and circumstances for determining the lack of effectiveness of a food contact substance.
The proposal if confirmed will among other things, allow the FDA additional flexibility in how it determines that food contact substance notification (FCN) is no longer effective besides safety, and help ensure that FDA’s inventory of effective FCNs is current based on use and safety.
The authority’s current regulations provide the process by which they may determine that an FCN is no longer effective based on data or other information at their disposal that demonstrate that the intended use of the food contact substance is no longer safe.
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.
Food additives, including food contact substances, require pre-market review and authorization for their intended use.
Manufacturers must notify the FDA of their intent to use a food contact substance via an 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.
Primarily, this rule will 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.
Furthermore, the rule will provide manufacturers or suppliers an opportunity to air their views prior to the FDA determining the FCN’s ineffectiveness.
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 retain its mandate 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.
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.
The proposed changes are also expected to result in cost savings and other benefits to manufacturers and suppliers of food contact substances, as well as to FDA.
“We expect the costs of the proposed rule to be minimal and, therefore, do not believe that the proposed rule will have a significant economic impact on a substantial number of small entities,” said FDA.
The proposal is open for public feedback till 11 April 2022.