EFSA: Uncertainties Remain on Safety of Smoke Flavoring Product

New data on Zesti Smoke Code 10, still result in an insufficient margin of safety and EFSA concluded its use is of safety concern at the proposed uses and use levels.

Jul 28 2011 --- Following the evaluation of new data, the European Food Safety Authority (EFSA) has updated its opinion on the safety of two smoke flavourings used in the European Union. On the basis of the new information provided, EFSA’s experts say that at the proposed use and use levels Fumokomp is not of safety concern. New data on Zesti Smoke Code 10, however, still result in an insufficient margin of safety and EFSA concluded its use is of safety concern at the proposed uses and use levels. EFSA’s advice will help inform decision-makers in preparing a list of smoke flavourings authorised for use in the EU.

For a given smoke flavouring, the margin of safety is the ratio of the No-Observed-Adverse-Effect Level (NOAEL) typically identified through a 90-day toxicological study in animals, to the anticipated exposure of consumers to this substance through the diet. The expert evaluation of the accepted margin of safety takes into account evidence that the smoke flavouring is not genotoxic (i.e. does not damage DNA, the genetic material of cells) and applies uncertainty factors for variations between animals and humans and between population groups (e.g. infants, children, elderly...).

In 2009, experts on EFSA’s CEF Panel found that the margins of safety for Zesti Smoke Code 10 were too low when considering the uses and use levels specified by manufacturers. On the basis of a new 90-day toxicity study in animals and newly proposed upper use levels, the Panel concludes in its updated Scientific Opinion that there are still safety concerns about this smoke flavouring despite some increase in the margin of safety.

Previously, the CEF Panel was not able to assess the safety of Fumokomp due to a lack of adequate available data. Based on the results of a complete 90-day animal toxicity study that was unavailable in 2009, experts now confirm that this smoke flavouring is not of safety concern for consumers at normal and upper levels of the proposed uses.

Smoke flavourings are products which can be added to certain foods – including meat, fish or cheese – to give them a “smoked” flavour, as an alternative to traditional smoking. They can also be used as flavourings in other foods such as soups, sauces and ready-to-eat savoury products.

To assess the safety of smoke flavourings, the CEF Panel asks manufacturers for data on the composition and toxicity of their products as well as details on their intended uses and use levels. Based on this information, the Panel determines the highest intake level at which each product was shown not to cause adverse health effects in animals. This level is then compared to estimated intake levels for humans in order to determine “margins of safety”* for each product.

The safety of these smoke flavourings as a replacement for smoking in traditionally smoked products falls outside the scope of these evaluations.