Regulation (EC) 1333/2008 sets the rules on food additives: definitions, conditions of use, labelling and procedures.
A tiered approach for their toxicological evaluation is proposed by EFSA, and it consists of 3 tiers. According to this tiered approach, a minimal dataset applicable to all compounds has been developed under Tier 1, while Tier 2 testing, generating more extensive data, will be required for compounds which are absorbed and/or demonstrate (geno)toxicity in Tier 1 tests. Tier 3 should be performed on a case-by-case basis taking into consideration all the available data, to elucidate specific endpoints needing further investigation of findings in Tier 2 tests.
Before embarking on any testing, it is recommended to consider other relevant knowledge on the substance, including (Q)SAR data, structural alerts and read-across of data between structurally-related substances, which are considered as valid supporting information. This information can also be important for interpretation of genotoxicity testing results and particularly relevant for the choice of any in vivo study.