Scientific Opinion on Safety of smoke flavour - Primary Product – AM 01

This opinion concerns the safety of the smoke flavouring Primary Product AM 01. The Panel noted the shortcomings in the provided analytical data for the characterisation. The product has been tested toxicologically in in vitro and in vivo genotoxicity studies and in a 90-day feeding study in rats. A positive result was obtained in one of three in vitro genotoxicity tests, and another test was inconclusive. In vivo, no indication of DNA damage was obtained in a Comet assay of limited validity. In the light of the reduction of WBC in both sexes and a reduction of lung weight in male at the highest dose level of 500 mg/kg bw/day, the Panel concluded that the NOAEL in the 90-day study was 250 mg/kg bw/day. Given the limitations in the data set, the Panel concluded that the genotoxic potential in vivo of the Primary Product AM 01 can not be ruled out. Furthermore, the Panel noted that there were low margins of safety based on the NOAEL in the 90-day study. Therefore, the use of the substance at the intended uses and use levels would be of safety concern.