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 a wood-burning process called “pyrolysis”. As an alternative to traditional smoking, producers add them 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).
Smoke flavourings are regulated separately from other flavourings as they consist of complex mixtures including unidentified substances, which give rise to different safety issues.
In February 2021 EFSA published updated guidance on the scientific data applicants need to include in their dossiers for the authorisation of a new smoke flavouring, as well as for the renewal or modification of existing authorisations.
The guidance document builds on EFSA’s past experience of assessing smoke flavourings from 2005 to 2012 and takes into account scientific and technical developments since then as well as comments raised during the public consultation held at the end of 2020.
EFSA publishes updated scientific guidance for the preparation of applications on smoke flavouring primary products.
EFSA holds a public consultation on new draft scientific guidance for the preparation of applications on smoke flavourings primary products.
The European Commission asks EFSA to prepare an updated consolidated guidance for the submission of applications on smoke flavouring primary products.
EFSA meets industry representatives to explain new requirements for the assessment of chemical mixtures, focusing on the evaluation of genotoxicity.
February and July
Three smoke flavourings – SmokEz C – 10, SmokEz Enviro 23 and AM 01 – are all found to be of safety concern for the proposed uses and use levels.
New data clear the smoke flavouring Fumokomp but not Zesti Smoke Code 10, which EFSA concludes is of safety concern.
EFSA’s experts complete a series of opinions on 11 further smoke flavourings.
EFSA’s risk assessment of the smoke flavouring FF-B raises health concerns and the product is subsequently withdrawn from the market.
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 first published in 2005 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. EFSA is updating this guidance in expectation of applications for the renewal of authorisations which expire after 10 years.
Glossary: Margin of Safety
For a given smoke flavouring, our experts calculate its margin of safety (MOS) for consumers. The MOS is the ratio of the No-Observed-Adverse-Effect Level typically identified through a 90-day toxicological study in animals, to the estimated dietary exposure of consumers to the substance. Experts take into account evidence that the smoke flavouring is not genotoxic (i.e. does not damage DNA, the genetic material of cells) and apply safety factors for variations between animals and humans and between population groups (e.g. infants, children, elderly).
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 EC 627/2006 provides technical information need for analytical methods for smoke flavourings data collection. Regulation EU 1321/2013 established the official EU list of authorised smoke flavourings.
- Regulation EU 2065/2003 on smoke flavourings – EUR-Lex
- Regulation EC 627/2006 on quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products – 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, or update how it can be used in different food types.