The Food and Drug Administration (FDA) is one of the executive agencies under the Department of Health and Human Services (DHHS) of the United States government.
As a scientific regulatory agency, the responsibility of the US FDA is to ensure the safety of food (including food additives), food contact materials, medical devices, radiation products, and drugs produced or imported in the United States.
Definition of Food Contact Materials:
Food Contact Substance (FCS): Any substance intended for use in the manufacture, packaging, boxing, transportation, or storage of food, and used without intending to have any technical impact on the food.
Food contact substances are single substances, such as antioxidants, stabilizers, additives in plastics or paper.
Food Contact Material (FCM): Made from food contact substance FCS and other substances, usually a mixture or material such as resin, adhesive, and ink.
Food Contact Article: Finished products made from food contact materials, such as bottles, packaging bags, trays, etc.
Food contact materials certified by the US FDA
The regulatory requirements of the FDA for food contact materials and products depend on the single substance (FCS) contained in the product.
Food contact materials and products that will migrate to food as a single substance during their intended use should meet one of the following conditions:
1) Regulated under Chapter 21 of the Federal Regulations (21 CFR)
2) Generally recognized as safe (GRAS)
3) Belonging to Prior Approved Substances
4) Meet the Threshold of Regulation (TOR) exemption
5) Have received a Food Contact Substance Notification (FCN)
Post time: Mar-17-2025