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

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DOI
https://doi.org/10.2903/j.efsa.2022.7673
Keywords
Food flavourings, flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings, source materials
On request from
European Commission
Question Number
EFSA‐Q‐2021‐00289
Panels
Food Additives and Flavourings
Panel members at the time of adoption
Maged Younes, Gabriele Aquilina, Laurence Castle, Gisela Degen Karl‐Heinz Engel, Paul J Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Ursula Gundert‐Remy, Rainer Gürtler, Trine Husøy, Melania Manco, Wim Mennes, Peter Moldeus, Sabina Passamonti, Romina Shah, Ine Waalkens‐Berendsen, Detlef Wölfle and Matthew Wright.

This guidance supersedes the previous 2010 Guidance on flavourings: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2010.1623. It is applicable for applications submitted after 22 December 2022.

Abstract

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.

This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7669/full

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