Scientific Opinion on safety of smoke flavour Primary Product – TRADISMOKE™ A MAX

This opinion concerns the safety of the smoke flavouring Primary Product TRADISMOKETM A MAX. The Panel considered the technical and analytical data provided acceptable to characterise the Primary Product and to demonstrate its batch-to-batch variability and stability. Two in vivo genotoxicity tests were negative and sufficient to eliminate the concerns over the in vitro genotoxicity. The Panel derived a NOAEL of 1000 mg/kg bw/day from a 90-day study in rats. Based on this NOAEL and on the intake data calculated with the use levels of the Primary Product TRADISMOKETM A MAX provided by the applicant for the 18 food categories, the margins of safety would amount to 30 and 61 for the intake estimates based on the upper use levels, and to 139 and 294 when normal use levels are considered. When assuming the use in traditionally smoked products only, the margins of safety would amount to 83 and 120 for the intake estimates based on the upper use levels, and to 417 and 588 when normal use levels are considered.

The fact that these margins of safety based on a 90-day toxicity study are inadequate, and in addition, that data on reproduction and developmental toxicity and long term studies are absent, it is concluded that the uses and use levels for the Primary Product in a wide range of product categories would require a larger margin of safety. The Panel concludes that the margins of safety are insufficient and that the use of Primary Product TRADISMOKETM A at the proposed uses and use levels is of safety concern.