Flavourings are substances used to impart taste and/or smell to food. Flavourings have a long history of safe use in a wide variety of foods, from confectionery and soft drinks to cereals, cakes and yoghurts. They are used in comparatively small amounts so that consumer exposure is relatively low. European Union (EU) legislation defines different types of flavourings, such as natural flavourings and smoke flavourings.
The risk assessment of flavouring substances is currently carried out by EFSA’s Panel on Food Additives and Flavourings (FAF).
EFSA’s work on smoke flavourings, which are regulated separately from other flavourings, are detailed in a separate topic.
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 asked manufacturers to provide further data on around 400 substances. EFSA re-assesses those substances once the required data are received. A complete evaluation is needed for the substances to be included on the EU 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.
- Database of flavouring substances - European Commission, DG Health and Consumers
- EFSA opinions on flavourings group evaluations
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 Additive (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.
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.
EFSA has two main functions in relation to flavouring substances:
- Evaluating currently marketed flavouring substances
- Assessing applications for the authorisation of new flavourings.
As required by EU legislation, EFSA has divided all currently marketed substances into chemical groups and is assessing each group separately, looking at the safety of individual compounds for human health. Based on EFSA's work, in October 2012 the European Commission established a list of flavouring substances which can be used in the EU.
EFSA has developed guidelines which specify the data industry should submit for the safety evaluation of new flavourings. The guidelines were finalised following a public consultation and a workshop with stakeholders. They consist of two parts:
- Part A outlines the data required for the risk assessment of flavouring substances (chemically defined substances with flavouring properties)
- &Part B outlines the data required for the risk assessment of other flavourings (flavouring preparations, flavouring precursors, thermal process flavourings and other flavourings) for which an evaluation is required according to Regulation EC 1334/2008.
Applicants are required to submit information on the identity of the source materials, the manufacturing process, an assessment of dietary exposure and toxicological data.
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.
- EU legislation on food flavourings – European Commission, DG Health and Consumers
Regulation 2232/96 set out the main rules on the use of flavourings in foods in the EU and launched a procedure to establish an EU list of flavourings which governs the flavourings that may be added to foods. Flavourings are added to the EU list following a comprehensive safety evaluation programme by EFSA. Member States notified the European Commission of over 2,000 substances authorised at national level for inclusion in the programme. Among them are many substances which occur naturally.
- Regulation 2232/96 on the procedure for flavourings – EUR-Lex
- Evaluation Programme for food flavourings – European Commission, DG Health and Consumers
In December 2008, Regulation 1331/2008 introduced a common approval procedure for additives, enzymes and flavourings used in food, based on scientific opinions from EFSA. This became fully applicable in 2011. Regulation 1334/2008 on flavourings established an EU list of authorised flavouring substances.
- Regulation 1331/2008 on a common authorisation for food additives, enzymes and flavourings – EUR-Lex
- Regulation 1334/2008 on flavourings and certain food ingredients with flavouring properties – EUR-Lex
In October 2012, the Commission adopted two new regulations on food flavourings to harmonise and clarify the rules for the use of these substances in the EU. Regulation EU 872/2012 contains the EU list of flavouring substances authorised for use in food. It enters into force on 22 October 2012 and applies as of 22 April 2013. Flavouring substances not on the list will be banned after an 18-months phasing-out period. Regulation EU 873/2012 introduces transitional measures for other flavourings (e.g. those made from non-food sources) to be evaluated and authorised at a later date. This regulation enters into force on 22 October 2012 with immediate effect.
- EU list of authorised flavouring substances – European Commission
Separate legislation sets out EU labelling rules on food flavourings.
- EU legislation on food labelling – European Commission, DG Health and Consumers