Understanding Food Packaging Compliance for Pigments

摘要

Over the years the requirements of the Food and Drug Administration (FDA) for the use of pigments in food packaging were well addressed in previous presentations. This included the history of different FDA laws, Threshold of Regulations (TOR), Generally Recognized as Safe (GRAS) list, Prior Sanction and Food Contact Notifications (FCN). This presentation will only address the pigments that fall in the definition of indirect food additive with direct and indirect food contact. The focus will be on how to understand and ensure compliance of pigments with the different regulations. How to ensure that not only the pigment is in compliance but that all components in the final product -- such as the carrier, surfactants and other process aids, are in compliance. Also to be presented is a practical approach to the process of how to obtain FDA compliance for the use of pigments in food packaging. Preliminary studies and the protocol design of one migration study that will result in the pigment being compliant in all polymers will be discussed. This presentation will also address issues such as functional barrier and the difference between no migration and 100% migration assumptions. Finally, questions will be addressed, such as when FDA review is needed and when self-assessment is appropriate.