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, and common food contact materials include adhesives, antimicrobials, coatings, plastics, and paper. Within 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, proposition 65 support, and in contaminants such as bisphenol A and PFAS will help clients meet their needs.
Toxicology Consulting for Food Contact Material
For a food packaging manufacturer, Gradient provided toxicological risk support in a food contact notification 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 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 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.