Flavourings are products added to food to give them a different or stronger taste and/or smell.
They can be produced in different ways such as by extraction from plants or from other material of vegetable, animal or microbiological origin. Flavourings can also be synthesised or obtained through a variety of different processes.
European Union (EU) legislation defines different types of flavourings such as flavouring substances (substances with flavouring properties), flavouring preparations (orange oil or vanilla extract, for example) and smoke flavourings.
Smoke flavourings are regulated separately from other types of flavourings and they are detailed under a separate topic.
EFSA provides scientific advice to support the authorisation process of food flavourings by the European Commission.
Upon request from the Commission, our experts carry out risk assessments of food flavourings. These assessments take into account the data submitted by applicants on the flavouring’s chemical properties, potential toxicity and metabolism as well as dietary exposure estimates.
Our expert Panel on Food Additives and Flavourings (FAF) reviews these data and concludes whether or not a food flavouring presents risks for the consumer under the proposed conditions of use.
EFSA has two main tasks in relation to food flavourings:
- Evaluating new flavourings or proposed modifications to already authorised flavourings, submitted by applicants under Regulation (EC) No 1331/2008.
- Evaluating additional data submitted by industry to finalise the assessment of currently marketed flavourings, in accordance with Regulation (EC) No 1565/2000.
New flavourings or new uses
EFSA developed new guidance in December 2022 on the data required for the risk assessment of flavourings to be used in or on foods. The guidance applies to all applications submitted since 22 December 2022. Applications submitted before this date are subject to the previous guidance and explanatory notes.
Data requirements relate to:
- the characterisation of the flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability, and reaction and fate in foods;
- the proposed uses and use levels and the assessment of the dietary exposure;
- the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity, and information on the safety for the environment.
Finalisation of the assessment of some substances in the Union list
Chemically defined flavouring substances that have structural and metabolic similarities have been evaluated together in “Flavouring Group Evaluations” (FGEs) opinions, using a group-based approach, as provided for in Commission Regulation (EC) No 1565/2000.
EFSA has assessed approximately 2000 flavouring substances in this way, which were included in the first version of the Union list of flavourings published in 2012.
For a number of these substances, marked with a footnote in the Union list, we required additional data to conclude on their safety. EFSA is in the process of assessing these additional data.
- Regulation (EC) No 1334/2008 lays down general requirements for safe use of flavourings in the EU and provides definitions for different types of flavourings. The Regulation sets out substances for which an evaluation and approval is required.
Authorised flavourings are included in the EU list of permitted food flavourings laid down in Annex I of Regulation (EC) No 1334/2008, which also specifies their conditions of use.
- Regulation (EC) No 1331/2008 describes a common authorisation procedure for food additives, food enzymes and food flavourings.
Other legislation (partially applicable):
The following Regulations remain applicable to substances in the Union list of flavourings that are marked with a footnote, for which EFSA is finalising the assessment of additional data:
- European Parliament and Council Regulation (EC) No 2232/96 of 28 October 1996 laying down a Community procedure for flavouring substances used or intended for use in or on foodstuffs.
- Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation programme in application of the European Parliament and of the Council Regulation (EC) No 2232/96.