EFSA completes first safety assessments of smoke flavourings
8 January 2010
The European Food Safety Authority (EFSA) has completed the first ever review of the safety of 11 smoke flavourings used in the European Union. Based on EFSA’s work, the European Commission will establish a list of smoke flavouring products authorised for use in foods.
Klaus-Dieter Jany, the chair of EFSA’s expert Panel on flavourings (CEF Panel) said: “The Panel based its conclusions on the limited data which are currently available as well as conservative – or cautious – intake estimates. The Panel expressed safety concerns for several smoke flavourings where intake levels could be relatively close to the levels which may cause negative health effects. However, this does not necessarily mean that people consuming these products will be at risk as, in order to be on the safe side, the consumption estimates deliberately over-estimate intake levels.”
To assess the safety of these smoke flavourings, the CEF Panel asked 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 determined the highest intake level at which each product was shown not to cause adverse health effects in animals. This level was then compared to estimated intake levels for humans in order to determine “margins of safety” for each product.
Out of the 11 smoke flavourings evaluated by the Panel, experts found that the margins of safety for two of the products were large enough not to give rise to safety concerns when considering the uses and use levels specified by the manufacturers. For eight others, the smaller margins of safety did give rise to safety concerns and for one of those smoke flavourings the Panel could not rule out concerns regarding possible genotoxicity (damage to the genetic material of cells) given the available data. The Panel could not assess the safety of one further smoke flavouring due to the lack of adequate data available.
Smoke flavourings are products which can be added to certain foods – including meat, fish or cheeses – 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, drinks and confectionery. All of the smoke flavourings which have now been assessed by EFSA are currently, or have previously been, on the market in the EU.
Notes to editors:
The Panel also issued a separate statement on how the margins of safety should be interpreted for these smoke flavouring products. It says that what constitutes an “acceptable” margin of safety varies in each case and depends on several factors including the chemical properties of the product in question and the toxicological data which are available.
- Scientific Opinion on safety of smoke flavour Primary Product – TRADISMOKE™ A MAX
- Scientific Opinion on Safety of smoke flavour - Primary Product – AM 01
- Scientific Opinion on the safety of smoke flavour Primary Product Scansmoke R909
- Statement on the Safety Evaluation of Smoke Flavourings Primary Products: Interpretation of the Margin of Safety
 In several cases, no adverse effects were reported in animals at the highest levels tested. The margins of safety were calculated using these levels as no data were available on possible effects at higher levels. In other cases, certain products were found to affect the kidneys, blood biochemistry or body weight in animals at certain levels of intake.
 Scansmoke SEF7525 and Smoke Concentrate 809045
 TRADISMOKE A MAX, Scansmoke R909, Scansmoke PB 1110, SmokEz C-10, SmokEz Enviro 23, Unismoke, Zesti Smoke Code 10.
 AM 01