Food contact substances or substances that come into contact with food through food packaging, storage or other handling that are food additives must be authorized through either a food contact notification or a food additive regulation, or be the subject of a Threshold of Regulation exemption.

The food contact notification process was established by an amendment to the Federal Food Drug & Cosmetic Act (FD&C Act) in 1997, for the pre-market review of food contact substances. This notification process is intended to replace the food additive petition process as the primary means for authorizing new uses of food additives that are food contact substances. However, the FDA has discretion to decide the appropriate regulatory pathway for a food contact use. For example, the FDA may determine the food additive petition process is more appropriate for evaluating data about a food contact substance to provide an adequate assurance of safety. Food contact notifications are specific to the company submitting the notification and to the specified intended use of the substance. Manufacturers must ensure that food contact substances follow the specifications and limitations in all applicable authorizations.

The FDA may also grant a substance used in a food-contact article (for example, food-packaging or food-processing equipment) that migrates, or that may be expected to migrate, into food an exemption from regulation as a food additive. Through rulemaking, the FDA established a process in 21 CFR 170.39 by which a manufacturer can request a threshold of regulation exemption. This exemption is based on the premise that, below a certain dietary exposure level the use of a non-carcinogenic substance in a food-contact article is so negligible that it does not pose any public health concerns. Threshold of regulation exemptions may be used by any manufacturer or supplier for the specified uses of the food contact substance under the intended conditions of use. The threshold of regulation exemptions database lists these exemptions.

The FDA’s Safety Review of Food Contact Substances through the Food Contact Notification Program

Through the food contact notification program, the FDA conducts a rigorous scientific safety assessment of information a manufacturer or sponsor submits to the FDA, and considers other relevant information available to the FDA, to ensure that the intended use of a food contact substance is safe. This process includes analyzing testing data that demonstrates the amount of migration of a food contact substance to food because of its intended use, and toxicological data to ensure that the consumer exposure resulting from this migration is safe. The FDA also reviews data submitted under the National Environmental Policy Act to ensure that the use of the food contact substance does not have a significant impact on the environment.

The FDA evaluates three key factors about this migration:

• nature of the migrating components;
• potential consumer cumulative dietary exposure of the substance through food and beverages; and
• safe levels of dietary exposure.

When the FDA estimates dietary exposure to a food contact substance, we assume that the food contact substance will capture 100 percent of the market for which it is intended for use. By using this assumption, we overestimate actual dietary exposure, which provides an added margin of safety for comparison to the safe level of exposure established from toxicology studies. If a food contact substance is authorized for multiple food contact or dietary ingredient uses, the FDA will add all of these uses together to determine a cumulative dietary exposure for the food contact substance. The safety assumptions embedded in our exposure assessments mean that the actual dietary exposure from the approved food contact use is well below our cumulative dietary exposure estimate.

To determine the safety of a food contact substance, the FDA compares the cumulative dietary exposure estimate with available toxicological information on the substance. The FDA has robust minimum safety data requirements that are determined based on the cumulative dietary exposure to the substance. In addition to the FDA’s minimum safety data requirements, a pre-market submission must also discuss all available related information relevant to the safety assessment of a food contact substance. The FDA applies safety factors to this information to determine a safe level of exposure and compares this level to the cumulative dietary exposure estimate to determine if the use of the food contact substance is safe.

The FDA applies the same safety standard to all food additives, including food contact substances. The information must demonstrate that there is a reasonable certainty of no harm to consumers when the food contact substance is proposed or intended for use in contact with food. Because of inherent limitations of science, the FDA can never be absolutely certain of the absence of any risk from the use of any substance.

Post-market Assessment Related to Food Contact Substances

The FDA may reassess the safe use of food contact substances and take action based on that reassessment. The FDA has strict data requirements that must be met to establish safe conditions of use during review of a pre-market submission, and as new scientific information becomes available, we re-evaluate the safety assessments. This includes reviewing published scientific literature and studies from other regulatory and health agencies in the U.S. and in other countries, and updated information when the same substance is the subject of a new food contact notification. In some of our assessments, we identify areas where additional information is needed. We may work with research partners on studies to help fill these data gaps. However, we generally must rely on information about marketed products that is submitted voluntarily because manufacturers are generally not required to submit this post-market information under our current authorities. This includes issuing a Request for Information for more information on a food contact substance, such as unpublished information on safety and current use. We are exploring how to obtain better information on the post-market use of food contact substances from industry and other stakeholders.

If, after the FDA’s assessment of a food contact substance, we have determined its use meets our safety standard, the regulatory status of the food contact substance would remain unchanged. When new information raises safety questions, the FDA can revoke authorizations if the agency is no longer able to conclude that there is a reasonable certainty of no harm from the authorized use. A recent example is the agency’s work with manufacturers on the phase out of Per- and Polyfluoroalkyl Substances (PFAS).