Food Contact Substances — FDA Regulations

Food contact substances (FCS) include any substance used in materials for manufacturing, packing, packaging, transporting, or holding food. These substances must meet FDA requirements.

21 CFR Part 170FCS NotificationFood SafetySince 2009

About Food Contact Substances

The FD&C Act (United States, 1998a) defines a food-contact substance as “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.”

The U.S. Food and Drug Administration (FDA) established the Division of Food Contact Notifications within the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN), to ensure that components of food-contact articles — including food packaging and processing equipment — are safe for their intended use. These articles are composed of food-contact materials that contain or are made of food contact substances (FCSs). FCSs typically include coatings, plastics, paper, adhesives, colorants, antimicrobials, and antioxidants. FCSs are evaluated primarily through the food contact notification (FCN) program. A food contact notification is required only for a new use of an FCS that is a food additive. A notification is not required for a food contact substance that is Generally Recognized as Safe (GRAS) or prior-sanctioned for its intended use in contact with food.

It is the responsibility of the manufacturer of an FCS to ensure that food-contact materials comply with the specifications and limitations in all applicable authorizations.

LMG can help you to:

Determine whether the use of the component is an appropriately regulated indirect additive.
Determine whether the use of the component is prior-sanctioned.
Determine whether the use of the component is Generally Recognized as Safe (GRAS).
Submit a Threshold of Regulation exemption request.
Submit a Food Contact Notification (FCN).