FDA
Learn more about the legislation applicable to plastic food contact materials in the United States.
The American Food and Drug Administration (FDA) regulates the safety of ingredients added directly to food and substances that come into contact with food, such as those added to packaging materials, cooking utensils and food storage containers.
In general, an indirect food additive comes into contact with food as part of packaging, maintenance or processing, but is not intended to be directly added to, become a component of or have a technical effect in or on food.
Indirect food additives listed in Title 21 of the US Code of Federal Regulations (21 CFR) used in food contact articles include adhesives and coating components (Part 175), paper and cardboard components (Part 176), polymers (Part 177), and adjuvants and production aids (Part 178).
The food contact substance is a single substance, such as a polymer or an antioxidant in a polymer. As a substance, it is reasonably pure (chemical definition of substance). Although a polymer may be composed of several monomers, it still has a well-defined composition.
The food contact material is manufactured with the food contact substance and (usually) others. Often, but not necessarily, it is a mixture, such as an antioxidant in a polymer. The composition of a material can be variable.
The food contact article is the film, bottle, tray or final article that is formed from the food contact material.
Standards and testing
The overall regulatory status of a food contact material is dictated by the regulatory status of each individual substance that makes up the article. The individual substance that is reasonably expected to migrate into food due to its intended use in the food contact material will be covered by one of the following options:
- a regulation listed in Title 21 of the CFR
- it meets the criteria for Generally Recognized As Safe (GRAS) status
- a letter of prior sanction (listed as Prior Sanctioned)
- an application for exemption from the Threshold of Regulation (TOR)
- an effective Food Contact Notification (FCN).
AIMPLAS can help you determine the conformity of the components of an article in contact with food by reviewing the letter of guarantee on the raw materials used and advising you, if necessary, to carry out the final tests indicated in regulations 21 CFR 177 (Polymers), 21 CFR 175 (Coatings) and 21 CFR 176 (Paper and Paperboard).
