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Flavourings

Flavourings are substances used to impart taste and/or smell to food. Food manufacturers have been using flavouring substances for many years in a wide variety of foods, from confectionary and soft drinks to cereals, cakes and yoghurts. EU legislation defines different types of flavourings, such as natural, natural-identical (chemically identical to natural substances but obtained by chemical processes) and artificial flavourings, as well as flavourings of plant or animal origin and smoke flavourings.

EU framework

Flavourings have a long history of safe use and are utilised in comparatively small amounts so that consumer exposure is relatively low. Member States have taken different regulatory approaches in the past, mainly opting not to regulate the use of flavourings. The regulatory framework is now harmonised through EU legislation on food flavourings. EFSA’s risk assessment work supports this regulatory environment.

Regulation (EC) N° 2232/96 set out the main rules on the use of flavourings in foods in the EU. Based on this legislation a procedure was launched to establish an EU positive list of flavourings which will govern the flavourings that may be added to foods. The positive list is to be set up after a comprehensive safety evaluation programme is completed. Member States have notified the Commission of around 2,800 substances authorised at national level to be included in the programme. Among them are many substances which occur naturally.

Regulation (EC) 1331/2008 on a common authorisation procedure for food additives, food enzymes and food flavourings upgraded existing EU rules in this area, including a simplified common approval procedure for these substances based on scientific opinions from EFSA. It entered into force in 2009.

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 (EC) 2065/2003 which establishes Community procedures for their assessment and authorisation.

Separate EU legislation on food labelling sets out the Community labelling rules which cover flavourings added to foods.

EFSA’s role and activities

Since July 2008, the risk assessment of Flavouring substances 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).

EFSA is completing the evaluation programme of flavouring substances, which will allow European Commission to establish a positive list of flavourings in the EU in 2010. EFSA intends to complete the programme in 2009. As the legislation requires, EFSA has divided the 2,800 substances into 48 chemical groups and is assessing each group separately, looking at the safety of individual compounds for human health. 

In October 2009, CEF Panel launched a public consultation on a draft guidance document that specifies which data industry should submit to EFSA for the safety evaluation of new flavourings. The guidelines are due to be finalised in early 2010.

Flavouring group evaluations

EFSA regularly adopts opinions on each chemical group, known as flavouring group evaluations. To assess safety, EFSA scientists look at intake levels, absorption, metabolism and toxicity of individual substances. Where EFSA identifies data gaps – for instance on toxicity or exposure – it notifies the need for further data to the applicant and to the European Commission. In the course of its work EFSA has identified data gaps for around 300 substances. Applicants need to supply full data for EFSA to complete its evaluation. A complete evaluation is needed for the substances to be included on the EU positive list.

The European Commission maintains a register of flavourings notified by Member States as present on the EU market. It may remove substances during the evaluation programme, particularly when EFSA identifies safety concerns.

Some flavouring substances evaluated by EFSA have already been assessed by other risk assessment bodies such as the Joint FAO/WHO Expert Committee on Food Additives (JECFA). EFSA always takes account of any relevant conclusions available when it assesses flavouring substances. EFSA's assessments put more emphasis on the potential genotoxicity of flavouring substances, which is not prioritised to the same degree in the evaluations carried out by other risk assessment bodies such as JECFA.

The CEF Panel has developed a   Genotoxicity Test Strategy   for flavourings in Flavouring Group Evaluation 19, to ensure applicants supply the relevant study data needed to assess potential genotoxicity. The Panel will apply this to substances for which it has identified data gaps during the evaluation process. A list of flavouring substances considered to be representative of all of the substances in Flavouring Group Evaluation 19 has also been developed. The list was adopted in November 2008 and updated in March 2009.

Smoke flavourings

Smoking is traditionally used to help preserve certain foods such as fish, meat and dairy products. Over time, changes to the flavour of foods brought about by smoking have become more important than its preservative function. Smoke flavourings are liquids produced by thermal degradation of wood. They are added to a range of different foods, including those which are not traditionally smoked.

The European Commission asked EFSA to assess the safety of the smoke flavourings which are used or intended for use in the EU. EFSA does this on the basis of applications from companies for market authorisation. Based on EFSA’s opinions, the European Commission is to establish a list of smoke flavouring products authorised for use in foods. By the end of 2009, EFSA’s CEF Panel is due to adopt opinions on eleven different smoke flavourings which are currently on the market.

If the Panel identifies any safety concerns when assessing individual smoke flavourings, it highlights these in its opinions. So far the Panel has expressed safety concerns over the uses and use levels of the flavouring products Zesti Smoke Code 10, Unismoke, Scansmoke PB1110, SmokEz C-10, and SmokEz Enviro 23 due to limited toxicological data. The Panel could not establish the safety of the flavouring primary product Fumokomp because toxicological data submitted to EFSA for evaluation were incomplete. The Panel also found that the use of Smoke Concentrate 809045 and Scansmoke SEF7525 was not of safety concern. These conclusions are based on a further opinion which gives exposure estimates for all eleven smoke flavourings which EFSA has been asked to assess, using several different calculation methods.

The Guidance on submission of applications published in 2004 lays down the types of information that companies should provide to enable EFSA to carry out the safety assessments, including the administrative and technical data and the toxicological tests required.

Other flavouring substances

In addition to the flavouring group evaluation programme, EFSA assesses the safety of individual flavouring substances in response to requests from the European Commission and other risk managers. It has issued opinions for instance on camphor and coumarin.

For more information

Food flavouring – European Commission, DG Health and Consumers
Database of flavouring substances - European Commission, DG Health and Consumers