Flavourings are substances used to impart taste and/or smell to food. Regulation (EC) No. 2232/96 sets out the main rules on the use of flavourings in foods in the EU and launched a procedure to establish an EU list of flavourings which governs the flavourings that may be added to foods.
Flavourings are added to the EU list following a comprehensive safety evaluation programme made by EFSA. (Link to Regulation)
All flavouring substances have been divided into 34 chemical groups (Flavouring Group Evaluations - FGEs). According to the EFSA Guidance on the data required for the risk assessment of flavourings to be used in or on foods, new flavouring substances can be assigned to one of the existing Flavouring Group Evaluations (FGEs) on the basis of structural and metabolic similarities according to the scientific principles and to the group-based approach. A proposal should be provided by the applicant.
For any new flavouring substance its genotoxic potential has to be assessed in the first step of the evaluation. This assessment should start with in vitro tests, covering all three genetic endpoints, i.e. gene mutations, structural and numerical chromosomal aberrations. Afterwards, if sufficient structural/metabolic similarity of the flavouring substance to flavouring substances in an existing FGE has been demonstrated, a group-based evaluation using the Procedure can be performed.
The Procedure is a stepwise approach that integrates information on intake from current uses, structure-activity relationships, metabolism and, when needed, toxicity (e.g., subchronic, developmental toxicity studies).
We can support you in the safety assessment of new flavouring substances with a range of solutions and services:
- Strategy definition for the hazard assessment of flavouring substances
- Analysis of existing information on the target substance
- Similarity analysis for the assignment of the target compound to one of the existing FGEs
- Definition of the workflow to characterise the safety profile of substance making the best use of non-testing methodologies
- Database search and expert review of experimental toxicological data
- TTC assessment
- (Q)SAR predictions for genotoxicity and other relevant endpoints
- Read-across predictions
- Grouping of chemicals
- Prediction of potential metabolites