Food Chemical Safety Is In The News

Food manufacturers have a responsibility to ensure the safety and regulatory status of the chemical substances they use in food or that come into contact with food. They are required to implement preventive controls as needed to significantly minimize or prevent exposure to chemicals in foods that are hazardous to human health. The FDA assists the food industry through guidance documents, programs such as FDA’s Closer to Zero initiative that focuses on reducing childhood exposure to contaminants from food and pre-market approval programs that authorize the use of several categories of food chemicals before they enter the marketplace.

The FDA recently issued a final rule to amend their regulations (21 CFR 170.105 and 21 CFR 170.102) on how and when the FDA may determine that a food contact notification (FCN) is no longer effective. An effective FCN authorizes the use of a food contact substance from the manufacturer or supplier identified in the FCN. A list of effective FCNs can be found on the FDA’s website.

With respect to food contact substances such as those used in packaging, the FDA can now determine an FCN is no longer effective for safety reasons or reasons other than safety. For example, the manufacturer may no longer produce, supply, or use the food contact substance. The final rule also gives manufacturers or suppliers an opportunity to provide input before the FDA determines that an FCN is no longer effective.

The final rule keeps in place the FDA's ability to revoke an authorization based on safety concerns. The FDA can still declare an FCN no longer effective if the manufacturer or supplier does not provide the necessary data or information to address safety concerns. Also, the FDA can still revoke authorizations based on safety concerns even if the notifier decides to abandon the authorized use. The FDA publishes a notice of their determination in the Federal Register. The date of publication is when an FCN is no longer effective. When an FCN is no longer effective, the use of the food contact substance as described in the FCN is no longer authorized. In addition, the FDA intends to update its list of effective FCNs on the FDA’s website.

To obtain this authorization, a manufacturer of a food contact substance is required to submit pre-market information to the FDA that demonstrates its use meets safety standards. The FDA has established several programs to help manufacturers demonstrate that a chemical is not harmful when used as proposed (described below).

• Food Contact Substances: Food contact substances are substances that come into contact with food, such as through food packaging, processing, storage, or other handling. Companies who wish to use a food contact substance that is a food additive are required to ensure that the food contact substance is authorized by the FDA before marketing the product in the U.S. It should be noted that only those food contact substances that migrate into the food and become a component of the food are regarded as indirect food additives and require FDA pre-market clearance. If a substance is separated from food by a functional barrier and prevented from migration, the substance is not considered to be an indirect food additive and will not require FDA clearance. Information about a food contact substance is typically submitted to the FDA through a food contact notification for review and determination that the substance and its intended use are safe. This process includes providing test data that determine the level of migration of a food contact substance into a specific food and toxicological data to ensure that the consumer exposure resulting from this migration is safe. If the FDA determines that the intended use of the substance is safe, the use is authorized under an effective FCN. Food contact notifications are specific to the company submitting the notification and to the specified intended use of the substance. Manufacturers of food packaging provide evidence to their customers that materials are acceptable for their intended food-contact use, typically through a letter of guarantee.
• Food additives and color additives: Food additives and color additives require pre-market review and approval by the FDA. Manufacturers are required to supply evidence that establishes each chemical is safe at its intended level of use before it may be added to foods. In the case of food additives and color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the ingredient for a specific intended use. The FDA evaluates the petition, and other existing data and information to determine if the data available demonstrate that the chemical is safe under the proposed conditions of use. If the FDA determines that the intended use of the additive is safe, the FDA publishes a regulation authorizing its use as a food additive or color additive. That authorization can be relied on by any manufacturer for that intended use.
• Generally Recognized as Safe: The definition of food additive in the Federal Food, Drug, and Cosmetic Act excludes the uses of substances that are Generally Recognized as Safe (GRAS) and therefore they do not require pre-market review by the FDA. For the use of a substance to be considered GRAS, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts. In addition, GRAS uses must meet the same safety standard as for food additives, a reasonable certainty of no harm under the conditions of its intended use and have the same quantity and quality of information that would support the safety of a food additive. The FDA has established a voluntary GRAS notification program to help ensure that these substances are safe under their intended use and to help industry meet its responsibility for ensuring the GRAS status of substances they intend to use in food.