Scientific Opinion on the Safety of smoke flavour Primary Product Zesti Smoke Code 10 - 2011 Update

The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product Zesti Smoke Code 10 based on evaluation of a new 90-day dietary rat toxicity study. In 2009, the Panel concluded that the margins of safety (range: 5-32) for this Primary Product were insufficient and that the proposed uses and use levels were of safety concern. In this new application, the petitioner proposed to reduce upper use levels and to avoid use in composite foods. The chemical data provided demonstrate that the material tested in the new 90-day study is representative of the Primary Product evaluated by EFSA in 2009. From the new 90-day study the Panel identified a NOAEL for Zesti Smoke of 664 mg/kg bw/day, based on the reduced weight gain and white blood cell changes in female rats elicited by a high dose level. The Panel considers that this NOAEL supersedes that of 134 mg/kg bw/day identified in an earlier 90-day study, since the new study’s experimental design permits a more accurate identification of the NOAEL. When use of Zesti Smoke based on upper use levels is considered in all food sources (18 categories), estimated dietary intake ranges from 6.7 to 8.4 mg/kg bw/day, depending on the exposure assessment model used. When use (upper use levels) is assumed in traditionally smoked food only, exposure is estimated to be 5.0-7.7 mg/kg bw/day. The margins of safety for this Primary Product, i.e. ratio between the NOAEL from the new 90-day study and the intake estimates, are either 79-99 (all food sources) or 86-133 (traditionally smoked sources only). The Panel considers that these margins of safety are insufficient, since they are based on a 90-day toxicity study, and data are lacking on reproductive, developmental and long-term toxicity. In line with its conclusions of 2009, the Panel concludes that the Primary Product Zesti Smoke Code 10 at the proposed uses and use levels is of safety concern.