Safety of smoke flavour Primary Product - Fumokomp

Abstract

This Opinion concerns the safety of the smoke flavouring Primary Product Fumokomp. 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. The product has been tested in in vitro and in vivo genotoxicity studies and in a 90-day feeding study in rats. While a positive result was obtained in one out of three in vitro genotoxicity tests, two in vivo genotoxicity tests were negative and sufficient to eliminate the concerns over the in vitro genotoxicity. The 90-day study was conducted before the advent of GLP, and only a summary report was available. In addition the identity of the material tested in this study is unknown. Therefore the Panel was not able to confirm the validity of the study and concluded that the toxicological data do not enable the safety of Fumokomp to be established.