2023 FDA Science Forum
Hazard Identification of Printing Ink Substances Used on the Exterior of Food Packaging
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Contributing OfficeCenter for Food Safety and Applied Nutrition
Abstract
Photoinitiators are molecules that create reactive species when exposed to radiation and are widely used in UV-cured printing inks applied to the exterior of food contact materials (e.g., coatings and varnishes). New data indicates that, for some intended uses, photoinitiators applied to the exterior of food packaging may migrate to food. The purpose of this project is to perform hazard identification of ~100 photoinitiators potentially used in printing ink substances applied on food packaging in U.S. markets. A new approach methodology (NAM) was applied using the ChemTunes-ToxGPS database and in silico workflows to determine the Cramer classification and genotoxicity predictions for each of the identified photoinitiators. The Cramer Decision Tree uses chemical structure and predicted chemical reactivity of a substance to categorize substances into three classifications with Class III substances representing the highest predicted toxicological hazard. Based on the Cramer classifications and predicted genotoxicity, the photoinitiators were prioritized for further analysis to identify existing toxicity data in FDA’s Chemical Evaluation and Risk Estimation System (CERES) and available literature. This analysis helped determine those photoinitiators that may need further investigation for their intended use, potential migration into food, and possible consideration for further regulation. This qualitative hazard identification approach supports the Agency’s mission of incorporating the 3 R’s into safety assessments (i.e., Replacement, Reduction, and Refinement) for promoting ethical research, testing, and education using animals. Future work will be to use this NAM approach to characterize and prioritize an estimated >5,000 ink substances and ink components potentially used in printing inks applied on the exterior of food packaging in U.S. markets.
