The Food and Drug Administration (FDA) is proposing to change the methods for determining whether or not a premarket notification for a food contact substance (FCN) is still valid. If finalized, the proposed regulation would ensure that manufacturers and suppliers have the chance to submit input before we determine that an FCN is no longer functional, among other things. Additional grounds would be provided in the proposed regulation that could be used by FDA to establish that an FCN is no longer effective. These modifications are being proposed to better enable FDA to respond to new information on the safety and use of food contact substances, as well as manufacturers’ business decisions, while also improving the efficiency of our FCN program.

The Food and Drug Administration

Proposes Changes to the FCN Program

While some may think of the FDA as strictly regulating the food supply, the agency actually oversees a plethora of products that come in contact with food, like coatings and wrappings. A new proposed FDA regulation would allow for more input on premarket notifications- or requests to use substances during manufacturing that are not yet on FDA’s list of approved substances. If finalized, the proposed regulation would outline how manufacturers and suppliers can submit input before we determine that an FCN is no longer functional. We think this will provide better protection for human health by improving our ability to respond quickly to new information about the safety and use of different FCNs.

Methods for Determining Whether or Not a Premarket Notification is Still Valid

The FDA is proposing to change the methods for determining whether or not a premarket notification for a food contact substance (FCN) is still valid. If finalized, the proposed regulation would ensure that manufacturers and suppliers have the chance to submit input before we determine that an FCN is no longer functional, among other things. Additional grounds would be provided in the proposed regulation that could be used by FDA to establish that an FCN is no longer effective. These modifications are being proposed to better enable FDA to respond to new information on the safety and use of food contact substances, as well as manufacturers’ business decisions, while also improving the efficiency of our FCN program.

Additional Grounds Provided in the Proposed Regulation

The proposed regulation would provide additional grounds that could be used by FDA to establish that an FCN is no longer effective.

This change will benefit both manufacturers and suppliers by giving them the opportunity to submit evidence before we determine that an FCN is no longer functional. This new process will help make our program more efficient while still providing avenues for manufacturers and suppliers to ensure their products are safe.

New Information on the Safety and Use of Food Contact Substances

One of the main reasons why the FDA is proposing these changes is due to new information on the safety and use of FCN’s.

While many food contact substances have been determined to be safe for use over time, newer evidence may suggest that they are no longer effective. The proposed regulation would provide FDA with an additional ground for determining that a FCN is no longer functional, which would better enable us to respond quickly to new information on the safety or effectiveness of an FCN.

The FDA ensures that food contact substances are safe by establishing conditions under which they can be used in food packaging materials. These conditions include expiration dates, based on data submitted by manufacturers and suppliers of FCNs. The proposed regulation would provide more flexibility in the methods for determining whether or not an FCN is still functional. This would ensure that FCNs continue to be safe for use over time, while also maintaining their effectiveness.

Manufacturer’s Business Decisions

One of the more technical modifications proposed in the regulation is to clarify FDA’s ability to take into account manufacturers’ business decisions when deciding whether or not an FCN is no longer functional. One example of a business decision that could be taken into account is a manufacturer’s decision not to manufacture or market a food contact substance. This change would help ensure that FDA takes into account what can happen when manufacturers make changes that are outside of its control, while still being able to consider information related to toxicology and other scientific data.

This proposed modification would be helpful for manufacturers who have discontinued marketing a substance due to changing consumer preferences, increased competition or other factors. A manufacturer may discontinue marketing a substance for any number of reasons, including increasing competition, changing consumer preferences or increased production costs. If these substances are no longer available on the market, they will not be subject to our review process. For example, if only one company produces titanium dioxide (TiO2), then there is no need for us to review that substance because the product isn’t available on the market anymore.

Proposed Changes to Better Enable FDA to Respond to New Information on the Safety and Use of Food Contact Substances 

The Food and Drug Administration is proposing changes to the methods for determining whether or not a premarket notification for a food contact substance (FCN) is still valid. If finalized, the proposed regulation would ensure that manufacturers and suppliers have the chance to submit input before we determine that an FCN is no longer functional, among other things. Additional grounds would be provided in the proposed regulation that could be used by FDA to establish that an FCN is no longer effective. These modifications are being proposed to better enable FDA to respond to new information on the safety and use of food contact substances, as well as manufacturers’ business decisions, while also improving the efficiency of our FCN program.

Conclusion

The Food and Drug Administration (“FDA”) is proposing a new regulation for how it will determine whether a premarket notification is still valid. The proposed regulation would provide additional grounds for FDA to determine if a food contact substance is “no longer safe,” and require manufacturers to provide new information on the safety and use of food contact substances as they become available. Comments concerning the proposal are due March 26, 2022.