Regulation (EU) 2015/2283 defines “Novel Foods” as any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, and that falls under at least one of the defined categories outlined in the Regulation, e.g. food with a new or intentionally modified molecular structure; food consisting of, isolated from or produced from microorganisms, fungi or algae; food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi or algae; etc.
Scientific and technical guidance for the preparation and presentation of applications for authorisation of novel foods has been developed by EFSA.
Based on the EFSA guidance, toxicological studies should be carried out with the novel food as intended to be marketed. All relevant knowledge on the novel food should be considered in order to make decisions on whether and which toxicity studies are necessary. Evaluations might include:
- available kinetic data
- available toxicological data on the novel food or its constituents
- available human studies
- available relevant information on non-food uses (e.g. cosmetics, chemicals, pharmaceuticals)
- toxicological data on structurally related substances (i.e., read-across)
- (quantitative) structure–activity relationship ((Q)SAR) data (in case of insufficient experimental data)
The tiered toxicity testing approach proposed for food additives should be considered as the default approach, which integrates the core areas of kinetics, genotoxicity, repeated dose toxicity testing (subchronic, chronic toxicity and carcinogenicity) and reproductive and developmental toxicity (EFSA ANS Panel, 2012).
Additional studies may be needed to examine specific biological processes, e.g. immunotoxicity, hypersensitivity and food intolerance, studies on neurotoxicity, endocrine activity and mode of action.