Risk assessment of the synthetic antioxidant butylhydroxytoluene (BHT)
Report no: 2019:14
The Norwegian Scientific Committee for Food and Environment (VKM) concludes that BHT exposure is unlikely to cause adverse health effects in adults.
Butylated hydroxytoluene (BHT, E321) is a synthetic antioxidant authorised for use as a food additive. In addition, BHT is used in e.g. cosmetics, in animal feed and in food contact materials.
BHT is characterised by extensive use and multiple exposure sources and routes. Therefore, it is important that these sources and routes are included in the estimations to arrive at the most accurate picture of the population's exposure. To our knowledge, risk assessments including exposure estimates for BHT from multiple sources and exposure pathways have not been performed.
An acceptable daily BHT intake (ADI) of 0.25 mg/kg bodyweight (bw) per day was established by EFSA based on effects on the litter size and pup body weight in two 2-generation studies. The ADI was based on the no observed adverse effect level (NOAEL) of 25 mg/kg bw per day in these two studies and an uncertainty factor of 100. The ADI was used as reference point for BHT toxicity in this risk assessment.
The exposure was estimated for «realistic» and «high» scenarios. Data considered most realistic for the Norwegian exposure were used for «realistic» exposure estimation, whereas the «high» exposure scenario was a worst-case estimation representing a risk assessment for potentially high consumers.
The estimated «realistic» exposure was below the ADI for both women and men. The 50 percentile of the estimated «high» exposure (the worst-case estimation representing a risk assessment for potentially high consumers) was below the ADI, whereas the 95 percentile was above the ADI. Thus, a small fraction of the population may exceed the ADI and be at risk for negative effects on reproductive health.
The Panel concludes that BHT exposure is unlikely to cause adverse health effects in adults.
VKM’s Panel on Food Additives, Flavourings, Processing Aids, Materials in Contact with Food, and Cosmetics is responsible for the risk assessment.