FDA Food Contact Substance Requirements

FDA Food Contact Substance Requirements

FDA food contact substance requirements are detailed and robust. Packaging or equipment that contacts food may be subject to FDA regulation if their chemical components are deemed by FDA to be “indirect food additives,” also known as “Food Contact Substances.”

The determination of how a particular food contact substance is regulated by FDA depends on its chemical composition. It also depends on how the material is used. The food contact substance requirements incude this threshold question:

Food contact notifications are required only for new uses of FCSs that are food additives. Although a notification is not required for a food contact substance that is GRAS or prior sanctioned for its intended use in contact with food, some companies do choose to notify the Agency in order to clarify the regulatory status of such substances. Manufacturers may also use FCNs to notify FDA of new uses of FCSs that are GRAS or prior sanctioned.

It may be worth considering a Food Contact Formula notification before starting a FCS petition. The process is detail and time intensive. There are two review stages once a petition is submitted and both must be completed before using the food contact substance on packaging materials. The FDA food contact substance requirements provide the following description of the phases of review.

A “phase one” review meeting is held within the first three weeks after receipt of the FCN to ensure that the basic data and informational elements are present and that the submission meets the administrative requirements set forth in the FD&C Act and FDA’s regulations. If the submission is complete it is accepted and FDA sends the notifier an acknowledgment letter. The acknowledgment letter initiates formal communication between FDA and the notifier and gives the notifier an opportunity to comment on the Agency’s understanding of the identity and intended use of the food contact substance that is the subject of the notification. Notifiers who disagree with FDA’s description of the FCS should respond as quickly as possible to this acknowledgment letter. The acknowledgment letter also establishes the date of receipt of the notification, which indicates when the 120-day FCN review period began, and that the review team is entering into “phase two” review.
During “phase two” the team evaluates the safety of the food contact substance as it is proposed for use. If there are no concerns during “phase two” review, the FCN automatically becomes effective on the 120-day date and the consumer safety officer sends a letter to the notifier confirming the effective date. Information about the notification is then added to the Inventory of Effective Premarket Notifications for Food Contact Substances posted on CFSAN’s web page.

Please contact our Charlotte or Washington D.C. office for a complimentary consultation on food contact substances.