Scientific Opinion
Smoke flavourings
Smoking is a method traditionally used to help preserve certain foods such as fish, meat, and dairy products. The smoking process also changes the flavour of foods.
As an alternative to traditional smoking, smoke flavourings may be added to foods to give them a smoky flavour. They can also be added to foods which are not traditionally smoked (such as soups, sauces, or confectionery). Smoke flavourings are produced by a wood-burning process called pyrolysis.
Latest
In November 2023 EFSA published scientific advice on the safety of eight smoke flavourings on the EU market, the authorisation of which was due for renewal, according to the applicable legislation.
Based on the available scientific evidence, experts could not rule out concerns regarding genotoxicity When a substance is capable of damaging the DNA in cells. for any of the eight smoke flavourings.
Milestones
2021
March
EFSA publishes updated guidance on the scientific data applicants need to include in their dossiers for the authorization of new smoke flavourings, or for the renewal or modification of existing authorisations.
The guidance document builds on EFSA’s experience of assessing smoke flavourings from 2005 to 2012, recent scientific and technical developments as well as comments raised during a public consultation.
2020
October-November
EFSA holds a public consultation on draft scientific guidance for the preparation of applications on smoke flavourings.
2019
June
EFSA meets industry representatives to explain new requirements for the assessment of chemical mixtures, focusing on the evaluation of genotoxicity.
2007-2012
EFSA completes the risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of 11 smoke flavourings used in the EU and found safety concerns for the proposed uses and use levels.
2005
April
EFSA publishes guidance on how to submit applications for the safety evaluation of smoke flavourings.
EFSA's role
EFSA assesses the safety of smoke flavourings which are used or intended for use in the European Union (EU). Our experts carry out this work based on applications submitted by companies for market authorisation.
Our risk assessments help decision-makers to decide whether to include a new smoke flavouring on the EU list, to renew currently authorized smoke flavourings or update how they can be used in different food types.
We also provide guidance to applicants on the information needed for our experts to carry out the safety assessments, including the administrative and technical data and the toxicological tests required.
EU framework
Smoke flavourings are regulated separately from other flavourings in the EU as they consist of complex mixtures of substances, which give rise to different safety issues.
- Regulation EU 1321/2013 on the Union list of authorised smoke flavourings – establishes the Union list of authorised smoke flavourings for use as such in or on foods and/or for the production of derived smoke flavourings.
- Regulation EU No 2065/2003 – establishes a procedure for the evaluation and authorisation of smoke flavorings for use within the EU.
- Regulation EC 627/2006 on quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke products – provides technical information needed for analytical methods for collecting data on smoke flavourings.