Food Packaging Material Registrations

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.” We can 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).

In Canada Food Packaging Material Registration is a voluntary process to have your food packaging materials approved for safety by the Food Directorate of Health Canada. However, there are some mandatory requirements in other legislation and certification programs that fall under the purview of the CFIA (e.g. Meat Inspection Act and Regulations, HACCP). Under Division 23, Section B.23.001 of the Food and Drugs Act and Regulations, the onus is placed on the food seller to determine that all materials used for packaging foods is safe. This regulation applies to any type of material whether in finished product or single additive form.

Although food packaging registration in Canada is voluntary, a successful application will receive a No Objection Letter which can be provided to your potential customers, as a marketing tool, to assure them that your packaging materials have been reviewed by the Food Directorate and have received a favorable opinion with respect to chemical safety. No Objection Letters have no expiry date and can be used for the same packaging material provided that no changes to the packaging composition are made. Additionally, approved food packaging materials are added to the “Reference Listing of Accepted Construction Materials, Packaging Materials and Non-Food Chemical Products” database on the CFIA’s website.

Our services for Food Packaging Material Registration include:

  • Consult on registration strategies
  • Evaluate test reports and perform a documentation gap analysis
  • Prepare expert report and safety assessments
  • Coordinate a pre submission meeting with the FDA or Health Canada if deemed necessary
  • Compile dossiers for submission
  • Liaise and negotiate with authorities on the client’s behalf