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. 2010 Jun 23;8(6):1623. doi: 10.2903/j.efsa.2010.1623

Guidance on the data required for the risk assessment of flavourings to be used in or on foods

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids
PMCID: PMC13085161  PMID: 42006970

Abstract

This Opinion follows a request from the European Commission for the data required for the risk assessment of flavourings.

The Panel considered that the elaboration of a proposal concerning the data required for the risk assessment of new flavouring substances should build upon the experience gained in the course of the evaluation of flavouring substances included in the Union list.

A general principle of this Opinion is that new flavouring substances that can be assigned to one of the existing Flavouring Group Evaluations (FGEs) on the basis of structural and metabolic similarities should be evaluated according to the scientific principles and to the group‐based approach underlying the former evaluation programme.

In addition, the proposal provides a Procedure for the evaluation of flavouring substances which cannot be assigned to one of the existing FGEs. This should allow an individual evaluation of the new flavouring substance.

The proposal also covers flavourings other than flavouring substances for which an evaluation and an approval is required according to Article 9 (b) – (f) of the Regulation (EC) No 1334/2008.

In general, information on the following issues has to be provided: Identity of the source materials, manufacturing process, specifications, assessment of dietary exposure and toxicological data. Requirements covering aspects specific for the risk assessment of the different flavouring categories have been compiled.

Keywords: Flavourings, Guidelines, risk assessment, dietary exposure

Supporting information

This guidance document is applicable for applications submitted until 26 March 2021.

EFS2-8-1623-s001.pdf (202KB, pdf)

EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids ; Draft Guidance on the data required for the risk assessment of flavourings. EFSA Journal 2010;8(6):1623. [38pp.]. doi: 10.2903/j.efsa.2010.1623

Panel members: Arturo Anadon, Mona‐Lise Binderup, Wilfried Bursch, Laurence Castle, Riccardo Crebelli, Karl‐Heinz Engel, Roland Franz, Nathalie Gontard, Thomas Haertle, Trine Husøy, Klaus‐Dieter Jany, Catherine Leclercq, Jean Claude Lhuguenot, Wim Mennes, Maria Rosaria Milana, Karla Pfaff, Kettil Svensson, Fidel Toldra, Rosemary Waring, Detlef Wölfle

Acknowledgement: EFSA wishes to thank the members of the Working Groups on Flavourings for the preparation of this Scientific Opinion: Vibe Beltoft, Wilfried Bursch, Angelo Carere, Riccardo Crebelli, Karl‐Heinz Engel, Rainer Gürtler, Trine Husøy, John Christian Larsen, Catherine Leclercq, Pia Lund, Wim Mennes, Gerard Mulder, Karin Nørby, Gerard Pascal, Gerrit Speijers, the DG SANCO staff member Sirkku Heinimaa and the EFSA's staff members Alexandre Feigenbaum and Kim Rygaard Nielsen for the support provided to this EFSA scientific output.

Adoption date: 20 May 2010

Published date: 23 June 2010

Question number: EFSA‐Q‐2009‐00004

On request from: European Commission

Amended: 16 March 2021

This guidance is superseded by the 2022 Guidance on flavourings: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7673, which is applicable for applications submitted after 22 December 2022. The 2010 Guidance remains applicable for applications submitted from 27 March 2021 until 22 December 2022. Its former version, available under the Supporting information section, is applicable for applications submitted before 27 March 2021.

This guidance document is obsolete. See EFSA guidance webpage for latest info.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

This guidance document is applicable for applications submitted until 26 March 2021.

EFS2-8-1623-s001.pdf (202KB, pdf)

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