Any new material that is to be marketed for an application that has direct or indirect contact with food in the US requires a pre-marketing approval from the FDA. This includes new packaging materials, new baking or cooking materials, coatings for beverage cans and other drinkable liquid containers, and inks and adhesives that go on plastic packages. The Center for Food Science and Nutrition (CFSAN) at the FDA oversees the Food Contact Notification Program which allows manufacturers of the new materials or manufacturers that use the new materials in their products to notify the FDA of the new use.
The Role of the Food Contact Notification Program
The Food Contact Notification Program ensures that manufacturers that bring new products that contact food do not create a risk to public health by doing so. The FDA requires a migration study to ensure that the analytes that migrate from the material do not raise the cancer rate in the population by more than one additional case per 100,000 people. This migration study and the food chemistry calculations that lead to the safety assessment are outlined in the agency’s guidance on the matter: Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations. Analytical techniques for measuring analytes at trace levels include HPLC, LC-MS, GC-FID, and GC-MS.
How Avomeen Can Support Your Premarket Submission for Food Contact Substances
Avomeen has broad and deep expertise in the regulations and testing of new food contact substances. We can recommend the submission strategy, perform the necessary analytical testing per the FDA Guidance to Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations, prepare the Food Contact Notification (FCN), hold prenotification consultations with the FDA, and respond to any deficiencies in the dossier.
Establishing Methods & Measuring the Food Contact Substance
Method development and migration screening will establish methods for measuring the food contact substance (FCS) as well as all impurities in the food simulant. The migration study will involve triplicate analysis as well as method validation per guidance which include fortification and recovery experiments using three (3) sets of triplicate samples of the test simulants with each set fortified at a separate level. The fortification levels will be at one-half (1/2), one (1), and two (2) times the measured concentration of the analyte in the food simulant. In the event that the analyte is not detected, the detection limit will be measured.
If the migration results in less than 0.5 ppb of any analyte in the diet, it may be more appropriate for a request for exemption under the threshold of regulation. This request for a letter of no objection may be a more rapid, but non-proprietary regulatory path. If migration results indicate dietary exposures between 0.5 ppb and 50 ppb, Ames and Chromosomal Aberration studies will need to be performed in order to support the safety narrative. Above 50 ppb in the diet multi-generational feeding studies on rodents will be required.
FDA Review & Timeline for FCN Filing Decisions
When the dossier is submitted, the reviewer at the FDA will conduct a phase 1 review typically within a month. Questions will be asked and the submitter will be required to respond. A final decision must be made on the application within a statutory 120 days. The 120 days starts from the original submission date and if the FDA does not provide a specific objection, the notification will become effective on day 120 regardless of any actual affirmation. Typical procedure will involve sending a letter to the submitter some time after the 120 day period passes.
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Our expert blogger is Dr. Andrew Kolbert, Avomeen’s President/Chief Technical Officer. Andrew has over 20 years of experience executing and managing analytical and product development programs in highly regulated areas, both internally and in external organizations.
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