Food packaging protects food from contamination and helps preserve food from spoiling. Food contact substances (FCS) are materials intended to come into contact with food, including adhesives, antimicrobials, coatings, plastics, and paper. In the US, the US FDA has established a Food Contact Notification (FCN) Program within the Center for Food Safety and Applied Nutrition’s (CFSAN) Office of Food Additive Safety, which regulates and approves FCS. Gradient’s extensive expertise in toxicological risk assessment, California Proposition 65 support, and contaminants such as bisphenol A and per- and polyfluorinated substances (PFAS) helps to meet our client’s needs effectively.
Toxicology Consulting for Food Contact Material
For a food packaging manufacturer, Gradient provided toxicological risk support in a Food Contact Notification (FCN) submission for an ink used on aluminum beverage cans. Gradient identified toxicological data for relevant endpoints and used it to derive chemical- and device-specific safety margins. For data-poor compounds, we conducted weight-of-evidence analyses and applied read-across data where appropriate. Gradient partnered with an analytical testing laboratory for the device analyses. Our client used our report to submit to US FDA for product approval.
Acute Dermal Toxicity Estimate for a New Packaging Product
For a food manufacturer, Gradient provided toxicological risk support for the constituents of a coating used in food packaging to determine if the packaging posed a health risk if inadvertently exposed to skin. We determined if the constituents would act as acute dermal toxicants and/or dermal sensitizers in the event that a consumer’s skin was incidentally exposed to flakes of the package coating.
Tolerable Daily Intake for Coating Materials Used in Food Packaging
For a food manufacturer, Gradient provided toxicological risk support for the constituents of a coating used in food packaging to determine if the packaging posed a health risk if inadvertently ingested. We prepared toxicological profiles for identified chemicals using a Globally Harmonized System of Classification and Labelling of Chemicals (GHS)-based approach. For data-poor compounds, Gradient applied read-across data where appropriate. We determined a tolerable daily intake in the event that a consumer incidentally ingested the coating.