Human health risk assessment of three smoke flavoring primary products
Year: 2025
Type: article
Abstract: As part of a mandatory 10-year re-authorization process, the safety of three Smoke Flavoring Primary Products (SFPPs) was assessed based on EFSA’s guidance. Data available for three SFPPs included OECD guideline studies for in vivo genotoxicity, reproductive/developmental screening, and subchronic toxicity. Genotoxicity potential of individual constituents (∼50/SFPP) was also evaluated using existing data identified systematically or via in silico methods as required by EFSA. No constituents were determined to pose a genotoxic risk under conditions of intended use. Whole mixture genotoxicity studies were negative at doses up to 7,000 or 10,234 mg/kg-body weight/day in micronucleus and transgenic rodent assays, respectively, much higher than typical limit doses. Whole mixture reproductive/developmental screening and subchronic 90-day testing data were also negative. The lowest NOAELs were the highest doses tested in the subchronic studies (785-1,367 mg/kg-body weight/day). Human exposure was conservatively assessed using multiple approaches; the most refined exposure estimates assuming typical SFPP use levels were derived using EFSA’s DietEx model adjusted for market share (0.29-0.42 mg/kg-body weight/day). The resulting margins of safety (2,000-4,700) between the health benchmark and exposure estimates exceed EFSA’s target of 300 for each SFPP, thus supporting continued use of these SFPPs as safe alternatives to conventional smoking of food. • EFSA’s updated guidance for evaluating the safety of SFPPs requesting re-authorization includes substantial additional requirements for analytical characterization, dietary exposure and safety assessment. • The most notable change pertained to genotoxicity, in which the presence of a single constituent with possible or known in vivo genotoxicity at an estimated dietary exposure greater than the TTC could bring the entire safety assessment to a premature end. • Whole mixture in vivo genotoxicity, sub-chronic, and screening reproductive toxicity studies for all three SFPPs were negative • The margin of safety was greater than EFSA’s target of 300 based on the lowest NOAELs and the most reliable dietary exposure estimate derived using EFSA’s DietEx model and adjusted for market share, indicating safety of these SFPPs under conditions of intended use.
Source: Food and Chemical Toxicology
Institution: ToxStrategies LLC (United States)
Language: English
Subfield: Food Science
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,670
Funder: European Commission
OpenAlex ID: W4410022413