Flavourings
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, 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.
EFSA's ongoing work and published scientific advice
EFSA's role
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, the European Commission will establish a list of flavouring substances which can continue to 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) No 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.
EU framework
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
EFSA's 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’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.
