Scientific opinion on the safety of smoke flavour Primary Product Fumokomp - 2011 Update

The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product Fumokomp based on evaluation of a new 90-day dietary toxicity study. In 2009, EFSA concluded that the toxicological data then available did not enable the safety of Fumokomp to be established. The new chemical data provided, though limited, indicate that the composition of test material Fumokomp no. 6482 is comparable to that of the Primary Product and of the material previously evaluated by EFSA. From the new 90-day toxicity study in rats the Panel identified a NOAEL for Fumokomp of 400 mg/kg bw/day, since the changes in kidney and liver weight, urine volume and specific gravity in males receiving either 100 or 400 mg/kg bw/day, together with some changes in females receiving 400 mg/kg bw/day, and coupled with minor haematological and clinical chemistry changes were considered to be adaptive in nature and non-adverse. Based on the 2009 estimates and depending on the exposure assessment model used, dietary exposure (in mg/kg bw/day) is 0.13-0.20 (upper use levels) or 0.08-0.13 (normal use levels) from use of Fumokomp in all food sources (18 categories), and 0.05-0.09 (upper use levels) or 0.03-0.06 (normal use levels) from its use in traditionally smoked foods only. If Fumokomp is present in all food sources, the margins of safety as compared to the NOAEL of 400 mg/kg bw/day amount to 2,000-3,077 or 3,077- 5,000 for the intake estimates based on the upper or normal use levels, respectively. When assuming the use of Fumokomp in traditionally smoked products only, the margins of safety amount to 4,400-8,000 or 6,666-13,333 for the intake estimates based on the upper or normal use levels, respectively. Given the margin of safety of at least 2,000 and the fact that this margin of safety is based on a conservative exposure estimate and a NOAEL that is the highest dose level tested, the Panel concludes that the use of Primary Product Fumokomp at the proposed uses and use levels is not of safety concern.