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

Lookup NU author(s): Professor Matthew Wright



This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License (CC BY-ND 4.0).


Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) 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. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use.

Publication metadata

Author(s): Younes M, Aquilina G, Castle L, Degen G, Fowler PJ, Fernandez MJF, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Mennes W, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Boon P, Chipman K, De Knecht J, Nørby K, Arcella D, Barmaz S, Carfì M, Laganaro M, Martino C, Tard A, Vianello G, Engel K-H

Publication type: Article

Publication status: Published

Journal: EFSA Journal

Year: 2022

Volume: 20

Issue: 12

Online publication date: 23/12/2022

Acceptance date: 09/11/2022

Date deposited: 25/01/2024

ISSN (electronic): 1831-4732

Publisher: John Wiley & Sons Ltd


DOI: 10.2903/j.efsa.2010.1623

PubMed id: 36579172


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