Panel members at the time of adoption
This guidance is superseded by the 2022 Guidance on flavourings: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7673, which is applicable for applications submitted after 22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.
Amended: 16 March 2021
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.