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.

A Register of flavouring substances used in or on foods in the Member States was adopted by Commission Decision 1999/217/EC, as last amended by 2009/163/EC. All flavouring substances were divided into 34 chemical groups, containing substances with some metabolic and biological behaviour in common. These chemical groups are covered in 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).