During the original safety assessment of the flavorings that took place between 2009 and 2012, EFSA identified safety concerns for most of the products due to their insufficient margin of safety at the proposed levels of use. Therefore, the applicant was required to revise the proposed levels of use before the products were approved for the EU market.

For the most recent safety assessment of the eight flavorings, based on the available scientific evidence, EFSA could not rule out concerns regarding genotoxicity for any of the eight smoke flavorings. Genotoxicity is the ability of a chemical to damage the genetic material of cells, which may increase the risk of developing conditions like cancer and inherited diseases. It is not possible to define a safe level for genotoxicity.

In the recent safety assessment, EFSA used an updated methodology, which was not available at the time of the first assessment, to assess the new data submitted by applicants. The methodology recommends that if a single component of a complex mixture (i.e., smoke flavorings) is confirmed as genotoxic, then the whole mixture is to be considered as genotoxic.  

EFSA concluded that six of the assessed smoke flavorings contain genotoxic substances and therefore raise safety concerns, while safety concerns for the remaining two flavorings could not be ruled out due to a lack of data.

Although there may be an elevated risk of harmful effects when consuming genotoxic substances, EFSA emphasized that the likelihood of such effects emerging depends on various factors, including an individual’s genetics and dietary habits. The chance that such harmful effects would occur as a result of consumption of foods containing smoke flavorings has not been investigated by EFSA, however, the agency noted that it takes a conservative approach to its assessments, meaning that it considers worst-case scenarios to estimate hazards and risks.