In the United States, the safety of materials that come into contact with food—collectively known as food contact substances (FCS)—is stringently regulated to ensure public health.
These substances encompass a wide array of items, including food packaging materials, processing equipment, cookware, and even substances like adhesives and colorants applied to packaging surfaces.
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The U.S. Food and Drug Administration (FDA) oversees the approval and monitoring of these substances to prevent any harmful effects on consumers.
Understanding food contact substances
A food contact substance is defined as any material intended for use in manufacturing, packing, packaging, transporting, or holding food, where its use is not intended to have any technical effect on the food itself.
This includes items like plastic containers, metal cans, paper wrappers, and coatings on cookware. The primary concern is the potential migration of chemicals from these materials into food, which could pose health risks over time.
Regulatory framework for food contact substances
The FDA’s regulatory framework for FCS is primarily governed by the Federal Food, Drug, and Cosmetic
Act (FFDCA). Under this act, any substance that is reasonably expected to become a component of food is classified as a food additive and must undergo premarket approval by the FDA, unless it is generally recognized as safe (GRAS) among qualified experts.
The approval process involves a rigorous scientific safety assessment, including toxicological data and migration studies, to ensure that any potential exposure is within safe limits.
The food contact notification process
One of the primary mechanisms for authorizing new FCS is the Food Contact Notification (FCN) process. Introduced as part of the FDA Modernization Act of 1997, the FCN process allows manufacturers or suppliers to notify the FDA of their intent to use a new food contact substance.
The notification must include comprehensive data demonstrating the substance’s safety for its intended use. The FDA then has 120 days to review the notification; if the agency does not object within this period, the notification becomes effective, and the substance is authorized for the specified use.
It’s important to note that an effective FCN is specific to the manufacturer or supplier who submitted it and their customers; other manufacturers must submit their own FCNs for the same substance.
Exemptions and the GRAS concept
Some substances may be exempt from the FCN process if they are considered GRAS. The GRAS designation applies to substances that are generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of their intended use.
This recognition can be based on either a history of safe use in food prior to 1958 or on scientific data and information.
However, the GRAS process has faced criticism for allowing companies to self-certify the safety of additives without mandatory FDA review, leading to concerns about the potential introduction of unsafe substances into the food supply.
Challenges and ongoing debates
Despite the established regulatory framework, challenges remain in ensuring the safety of food contact substances. One significant issue is the presence of substances that, while approved in the past, have since been linked to health concerns.
For example, per- and polyfluoroalkyl substances (PFAS), commonly used for their grease-resistant properties in food packaging, have been associated with adverse health effects, including cancer and hormone disruption.
Recent research has detected over 3,600 chemicals from food packaging and processing equipment in human samples, underscoring the need for ongoing evaluation and regulation.
Moreover, discrepancies between U.S. and international regulations have sparked debate.
Certain additives banned in Europe due to health concerns remain permitted in the U.S., highlighting differences in regulatory approaches and the need for harmonization to protect consumers globally.
Recent regulatory developments
In response to these challenges, there have been efforts to strengthen the regulatory oversight of food contact substances.
For instance, Robert F. Kennedy Jr., as head of the U.S. Department of Health and Human Services, has advocated for closing the GRAS loophole to enhance FDA oversight and ensure transparency for consumers.
This proposed change would require companies to inform the FDA about any new ingredients or modifications to their formulations, including safety data, thereby improving food safety.
