Smoking is traditionally used to help preserve certain foods such as fish, meat and dairy products and the smoking process also changes the flavour of foods. Smoke flavourings are produced by thermal degradation of wood. As an alternative to traditional smoking, they can be added to a range of different foods to give a “smoked” flavour. They can also be added to foods which are not traditionally smoked (such as soups, sauces or confectionery).
Since July 2008, the risk assessment of smoke flavouring is carried out by EFSA’s Panel on food contact materials, enzymes, flavourings and processing aids (CEF). Previously the task was performed by the former Panel on food additives, flavourings, processing aids and materials in contact with food (AFC).
In June 2007, EFSA’s former AFC Panel published an opinion on a smoke flavouring which had raised particular concerns and which the Panel found to be genotoxic in animals. This product was subsequently withdrawn from the market.
EFSA’s CEF Panel adopted a series of opinions on 11 further smoke flavourings in 2009.
In 2011, the CEF Panel updated its previous safety evaluation of the smoke flavourings Fumokomp and Zesti Smoke Code 10. On the basis of new information provided by the manufacturers, EFSA’s experts say at the proposed use and use levels Fumokomp is not of safety concern. New data on Zesti Smoke Code 10, however, still resulted in an insufficient Margin of Safety and EFSA concluded its use is of safety concern for the proposed uses and at the proposed use levels.
Glossary: Margin of Safety
For a given smoke flavouring, the Margin of Safety (MOS) 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 MOS 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...).
EFSA assesses the safety of smoke flavourings which are used or intended for use in the European Union (EU). EFSA carries out this work on the basis of applications submitted by companies for market authorisation. Guidance on the submission of applications was published in 2004 and sets out the types of information that industry should provide to enable EFSA to carry out the safety assessments, including the administrative and technical data and the toxicological tests required.
Smoke flavourings are regulated separately from other flavourings as they consist of complex mixtures of substances derived from specific processes to obtain this type of taste, which give rise to different safety issues. They are covered by Regulation EU 2065/2003 which establishes procedures for their assessment and authorisation for use within the EU. Regulation EU 1321/2013 established the official EU list of authorised smoke flavourings.
- Regulation EU 2065/2003 on smoke flavourings – EUR-Lex
- Regulation EU 1321/2013 on the Union list of authorised smoke flavourings – EUR-Lex
EFSA’s advice helps inform decision-makers to decide whether or not to include a specific smoke flavouring product on the EU list.