Panel members at the time of adoption
This Guidance is applicable for applications submitted as of 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.