In the US, the regulatory status of food contact material is determined by the regulatory status of each individual substance that constitutes the material. Substances intended for use as a component of materials used in food contact are regulated by Title 21 Code of Federal Regulations (also known as 21 CFR) and the Food Drug and Cosmetic Act (FD&C Act). The individual substances that are reasonably expected to migrate to food because of its intended use in the food contact material shall be covered by one of the following:
• a regulation listed in 21 CFR
• meeting the criteria for GRAS status (including but not limited to a GRAS regulation or GRAS notice)
• a prior sanction letter
• a Threshold of Regulation (TOR) exemption request
• or an effective Food Contact Substance Notification (FCN)
An FCN should be submitted to the FDA if the substance has not been authorized for food contact use. Information required by FDA to support an FCN includes a migration study, estimation of dietary exposure, toxicological review and environmental impact assessment. The information should be collected following “Guidance for industry, preparation of premarket submissions for food contact substances: Chemistry recommendations” issued by the Office of Food Additive Safety. Assuming the FCN is granted, it will be published in the FDA’s inventory.
Jordi Labs have extensive experience in materials analysis and we offer the highest quality analytical testing with the most advanced analytical techniques. We help our clients with migration testing, packaging analysis and materials characterization.