2023 FDA Science Forum
Updating Packaging Factors used to estimate dietary exposure to food contact substances
- Authors:
- Center:
-
Contributing OfficeCenter for Food Safety and Applied Nutrition
Abstract
FDA’s safety assessment for premarket approval of food contact substances (FCS) relies on evaluating probable dietary exposure to the FCS, its constituents, and its impurities from the proposed use and other authorized uses of the FCS, and ensuring that they are supported by the available toxicological information.
Probable dietary exposure is typically determined by combining migrant levels in food with information on packaging uses. For single use packaging, FDA recommends using packaging factors (PF), which includes consumption factors (CF) and food-type distribution factors (fT), to estimate dietary exposures to migrants from the intended use of the FCS. FDA developed many of the PFs contained in the 2007 Chemistry Guidance for premarket submissions for FCSs over 40 years ago and may no longer reflect the current packaging market.
As part of updating the 2007 Chemistry Guidance, FDA has drafted updated PFs using several data sources, focusing primarily on the Euromonitor International (EI) data on consumer goods, specifically food poundage data in Packaging and Packaged Food. EI captures data according to their own defined categories and organizational structure. As such, FDA had to restructure the data to remove duplication and recategorize the data to align with FDA definitions. Additionally, the EI data contained limited information on the specific polymer used in many packaging type, so FDA consulted other data sources to assign the polymer types for each packaging type. FDA then calculated PFs for general packaging categories as well as for specific polymers.
Once the updated chemistry guidance is made available, the update PFs may be used to calculate dietary exposures that are more reflective of current packaging technology. Also, this method of developing PFs would make it feasible to update PFs more frequently in the future and make it easier to calculate new or refined CFs from the available dataset.
