FDA Food Packaging Material Registration

FDA Food Packaging Material Registration is a requirement by the FDA for any packaging or equipment that contacts food if their chemical components are deemed to be indirect food additives or food contact substances. In 1997, the Food and Drug Administration Modernization Act (FDAMA), amended the Food Drug and Cosmetic Act (FD&C Act) and among other things, included procedures for the notification process for food-contact substances. This procedure allows the FDA to authorize new uses of food additives that are food-contact substances. A food-contact substance is “any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.”

Our services for FDA Food Packaging Material Registration include:

  • Consulting on registration strategies
  • Design of test programs for migration and toxicological studies
  • Evaluation of test reports and data gap analysis
  • Study monitoring & coordination
  • Dossier compilation & submission
  • Negotiations with authorities
  • Preparation of expert reports and safety assessments

dicentra will provide the necessary guidance through the registration process for approval of new substances in food contact materials and the type and quality of chemistry data that the U.S. FDA needs to establish the safety of the intended use of the new substance and to issue an effective Food Contact Notification (FCN).