Safety and Food Packaging
The Food and Drug Administration (FDA) is responsible for ensuring the safety of all food packaging, including components of packaging materials that are expected to migrate into food. The agency refers to these materials as “food contact substances.” Examples include coatings on cans, plastics, paper, and sealants for lids and caps.
The Office of Food Additive Safety in FDA’s Center for Food Safety and Applied Nutrition is charged with ensuring that food contact substances are safe. “Safe” is defined in the law as a reasonable certainty that a substance is not harmful under the intended conditions of use. FDA regulates components of food packaging under the laws governing the use of food additives.
Requiring High Safety Standards
Manufacturers are required to obtain approval from FDA for all packaging components that may migrate to food before they can be marketed unless those components are considered “generally recognized as safe” (GRAS).
To obtain approval for a new food contact substance, manufacturers submit detailed information to FDA about the substance and its impurities. This includes safety and chemical information, as well as potential environmental effects. FDA does not approve food contact substances if they have been shown to cause cancer in humans or animals.
Though packaging components that are considered generally recognized as safe for use in food or food packaging do not require FDA approval under the law, they are required to meet the same safety standards as other food contact substances.
These same standards also are required for other components of packaging that were authorized informally (”prior sanctioned”) before FDA gained premarket approval authority over food contact substances in 1958.
Evaluating Consumer Exposure
Safety assessments ensure that consumers are only exposed to food contact substances at levels far below those that might have any health consequences.
As part of the review process, FDA scientists consider the amount of a substance that’s expected to migrate into food relative to its safety profile. Agency scientists assess the amount of a substance migrating into food using a variety of data and information, including:
Conducting migration testing: FDA scientists have developed tests to assess the migration of compounds from a food contact substance into food. These migration tests mimic the conditions under which food is prepared and stored in contact with packaging materials. Migration tests also model the most severe conditions of use of the material.
Assessing cumulative dietary exposure: FDA scientists consider other uses of a food contact substance and/or its components to determine a cumulative dietary exposure. Additionally, when FDA scientists assess consumer exposure they assess exposure to the food contact substance and all of its components that may migrate to food from the proposed use.
Reviewing stability data: Data on the relative stability of food contact substances are an important part of FDA’s safety review of new packaging and other food contact materials. FDA requests stability data from manufacturers to ensure that breakdown of the food contact substance does not occur under the conditions of use. If it does occur, all breakdown products from the food contact substance must be appropriately identified and quantified. Approval is only granted with appropriate limitations and specifications to ensure that the food contact substance is safely used.
Evaluating research: FDA reviews all pertinent safety data. Agency toxicologists perform searches for additional data in the published literature and within FDA’s own files. Any and all relevant data are then considered in determining whether the intended use of the food contact substance is safe.
If Concerns are Raised Later
As with any FDA regulated product, safety assessments of food contact substances are made in the context of the science at the time the decision is made. For this reason, FDA scientists also monitor new information that may relate to the safety of already authorized food contact substances.
When the science evolves or new information becomes available that causes FDA to question a previous safety decision, the agency may take one or more of several actions:
- contacting the manufacturer and ensuring that corrective action is taken
- removing the food contact substance from the market completely or imposing limits to ensure its safe use
- requiring that industry develop data or information to address a concern
- imposing additional limitations or specifications to ensure safe conditions of use
- prohibiting the use of a food contact substance that is no longer considered safe
The specific action that FDA takes generally depends on the likely public health risk. Any imminent danger to health is acted upon immediately with a recall or regulatory action.
