Smoke Flavoring-a case study demonstrating the value of using Benefit-risk analysis for foods (BRAFO) to provide transparency for risk management decisions.

Efforts to renew existing authorizations of smoke flavoring primary products (SFPPs) were recently finalized in the European Union. Herein, a Benefit Risk Assessment for Foods (BRAFO) was conducted for smoke flavorings using three specific SFPPs. Four metrics were evaluated between a reference scenario (legislation allowing both conventional smoking of foods and SFPPs) and an alternative scenario (SFPPs in meat, fish, and cheese are scheduled to be removed from the market after July 1, 2029, and only conventional smoking of foods is allowed): 1) whole mixture risk, 2) risk from polycyclic aromatic hydrocarbons (PAHs), 3) risk from constituents other than PAHs, and 4) environmental considerations. Systematic literature searches were used to identify information pertinent to each metric and scenario; direct testing data for the SFPPs was also used. All metrics were assessed qualitatively; quantitative assessment was also conducted when sufficient data were available. For each metric, the reference scenario prevailed, presenting the benefit of less risk than the alternative scenario. Key considerations involved the robust characterization of the SFPPs and direct testing data to inform safety, which are less controlled in conventional smoking of foods. The results of this assessment demonstrate the importance of risk-benefit considerations and should be helpful to policy makers globally.