Polymer colorants and antimicrobial food additives: A look at the complexities of food contact notifications

Food contact colorants and antimicrobial food additives present unique challenges for manufacturers seeking regulatory compliance. Food contact notifications for polymer colorants typically require complicated chemical analysis and safety assessment due to the potential for multiple impurities. Antimicrobial food additives are regulated by different jurisdictions and identifying the correct regulatory pathway can be challenging. In this paper, TSG Consulting’s Leslie Patton, PhD, Senior Scientific Consultant, provides an overview of the Food Contact Notification (FCN) program and identifies how to navigate the complexities of polymer colorants and antimicrobial food additives.

Initial challenges

Colorants are regulated as food contact substances (FCS) by the US Food & Drug Administration (FDA), and new colorants can be brought to market through FDA’s Food Contact Notification (FCN) program. As with all FCS, polymer colorants used in food packaging must be characterized chemically and evaluated for safety. Polymer colorants often require rigorous chemical analysis that can be complicated by multiple impurities, all of which must be identified, quantified, and assessed for safety.

Antimicrobial food additives may be regulated by multiple agencies, including the FDA, US Environmental Protection Agency (EPA) and the US Department of Agriculture (USDA), depending on their intended use. Most food contact antimicrobials are regulated by both FDA under the Federal Food Drug & Cosmetic Act (FFDCA) and EPA under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA). USDA’s Food Safety Inspection Service (FSIS) has additional jurisdiction over antimicrobials applied to meat and poultry carcasses.