Male C3H mice fed a diet containing 0.5% or 0.05% BHT showed a significantly increased incidence of liver tumors compared to controls... It is concluded that the effect of BHT on tumor development depends on strain and target organ examined and possibly also on the chemical carcinogen used.
A peer-reviewed feeding study in the journal Toxicology found that male mice fed dietary BHT had a significantly increased incidence of liver tumors versus controls, with tumor-promoting effects varying by strain and target organ.
FDA is requesting information on the current uses and safety data for butylated hydroxytoluene (BHT) in human food and as a food contact substance as part of its systematic process for conducting post-market assessments of chemicals in food... FDA intends to use the information received to determine if BHT remains safe under its current conditions of use in food and as a food contact substance.
In May 2026 the U.S. FDA formally launched a post-market safety reassessment of BHT in food and food-contact materials, issuing a Federal Register Request for Information to determine whether BHT remains safe under its current conditions of use.
Based on the NOAEL of 25 mg/kg bw/day and an uncertainty factor of 100, the Panel derived an ADI of 0.25 mg/kg bw/day... it is also unlikely that this ADI is exceeded at the mean, but is exceeded for some European countries (Finland, The Netherlands) at the 95th percentile [for children].
EFSA's 2012 re-evaluation set an Acceptable Daily Intake for BHT of just 0.25 mg/kg body weight per day, and found that high-consuming children in some EU countries can exceed this ADI at the 95th percentile of exposure.