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). Because primary products are produced from smoke which is subjected to fractionation (a process that uses heat to separate a substance into its components) and purification processes, the use of smoke flavourings is generally considered to be of less health concern than the use of smoke that is made by burning wood or by heating saw dust or small wood chips. 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.
Regulation (EC) No 2065/2003 (OJ L 309, p1, 26.11.2003) of the European Parliament and of the Council of 10 November 2003 on smoke flavourings used or intended for use in or on foods
Regulation (EU) 2019/1243 (OJ L 198, p241, 25.07.2019) of the European Parliament and of the Council of 20 June 2019 adapting a number of legal acts providing for the use of the regulatory procedure with scrutiny to Articles 290 and 291 of the Treaty on the Functioning of the European Union
Regulation (EU) 2019/1381 (OJ L 231, p1, 06.09.2019) of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain
Consolidated version of Regulation (EC) No 2065/2003 (as at 23rd March 2021)
Commission Regulation (EC) No 627/2006 (OJ L 109, p3, 22.04.2006) of 21 April 2006 implementing Regulation (EC) No 2065/2003 of the European Parliament and of the Council as regards quality criteria for validated analytical methods for sampling, identification and characterisation of primary smoke product.
Authorised smoke flavouring primary products
Commission Implementing Regulation (EU) No 1321/2013 (OJ L 333, p54, 12.12.2013) of 10 December 2013 establishing the Union list of authorised smoke flavouring primary products for use as such in or on foods and/or for the production of derived smoke flavourings. This regulation entered into force on the 1 January 2014.
This Regulation lists the 10 authorised smoke flavouring primary products and their conditions of use.
The production of smoke flavourings starts with the condensation of smoke. The condensed smoke is normally separated by physical processes into a water-based primary smoke condensate, a water-insoluble high-density tar phase and water-insoluble oily phase. The water-insoluble oily phase is a by-product and unsuitable for the production of smoke flavourings. The primary smoke condensates and fractions of the water-insoluble high-density tar phase, the ‘primary tar fractions’, are purified to remove components of smoke which are most harmful to human health. They may then be suitable for use as such in or on foods or for the production of derived smoke flavourings made by further appropriate physical processing such as extraction procedures, distillation, concentration by evaporation, absorption or membrane separation and the addition of food ingredients, other flavourings, food additives or solvents, without prejudice to more specific EU legislation.
Regulation (EC) No 2065/2003 applies to:
1. smoke flavourings used or intended for use in or on foods;
2. source materials for the production of smoke flavourings;
3. the conditions under which smoke flavourings are prepared;
4. foods in or on which smoke flavourings are present.
The Regulation provides for the scientific evaluation of primary smoke condensates and primary tar fractions, i.e. ‘primary products’, in terms of the safety of their use as such and/or for the production of derived smoke flavourings intended for use in or on foods.
The European Food Safety Authority (EFSA) assesses the safety of smoke flavourings which are used or intended for use in the EU. This task is carried out on the basis of applications submitted by companies for market authorisation. Guidance on the submission of applications as required under Regulation (EC) No 2065/2003 was first published by EFSA in 2004. EFSA issued a new guidance on the genotoxicity assessment of chemical mixtures in January 2019. According to these new rules, all smoke flavourings in the EU market should be reassessed and further characterisation of these products will now be required. As a result, EFSA developed updated scientific guidance to assist applicants in the preparation of applications on smoke flavouring primary products. The guidance describes the scientific data to be included with all applications for the authorisation of new smoke flavouring primary products, as well as for the modification or renewal of the existing ten authorisations, submitted under Articles 7, 11 and 12 of Regulation (EC) No 2065/2003. Information to be provided in all applications relates to: the characterisation of the primary product, including the description of the source materials, the manufacturing process, chemical composition, specifications and stability; the proposed uses and use levels and the assessment of the dietary exposure; toxicological and safety data and information on the safety for the environment. This guidance is currently open for public consultation on the EFSA website.
The current authorisations for the smoke flavourings listed in Commission Implementing Regulation (EU) No 1321/2013 is due to expire in 2023. As a result, all smoke flavourings will need to be re-assessed before this expiry date and data will need to be submitted to EFSA 18 months in advance of this in order for the EFSA to complete their assessment before the expiry date.
Labelling of smoke flavourings
In accordance with Regulation (EU) No. 1169/2011, labelling of a food should not mislead consumers as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings.
Annex VII Part D of Regulation (EU) No. 1169/2011 specifies that the designation ‘smoke flavouring(s)’, or ‘smoke flavouring(s) produced from “food(s) or food category or source(s)” (e.g. smoke flavouring produced from beech), may only be used if the flavouring component contains flavourings as defined in Article 3(2)(f) of Regulation (EC) No 1334/2008 and imparts a smoky flavour to the food. Regulation (EC) No 1334/2008 defines ‘smoke flavouring’ in Article 3(2)(f) as meaning a product obtained by fractionation and purification of a condensed smoke yielding primary smoke condensates, primary tar fractions and/or derived smoke flavourings as defined in points (1), (2) and (4) of Article 3 of Regulation (EC) No 2065/2003.
1. A smoke flavouring added to a meat product which imparts a smoky flavour to the food should be designated as:
‘smoke flavouring produced from beech’
Note: In accordance with Regulation (EU) 1169/2011, the labelling should not confuse the consumer as to whether the product is smoked conventionally with fresh smoke or treated with smoke flavourings.