Flavourings

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.

New legislation on food additives, flavourings and enzymes has been adopted which
will upgrade existing EU rules in this area, including a simplified common approval procedure for these substances based on scientific opinions from EFSA. It will enter 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. 

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.

Genotoxicity text strategy

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.

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 also assesses smoke flavourings 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.