Substantial Equivalence

Substantial equivalence is a concept used in novel food assessment where the applicant demonstrates that the novel food is compositionally, nutritionally, and toxicologically equivalent to an existing food or food ingredient with a history of safe use. If substantial equivalence can be established, a reduced data package may be acceptable for certain sections of the dossier.

Under Regulation (EU) 2015/2283, substantial equivalence is not a separate regulatory pathway but a scientific argument that may influence the scope and depth of the required safety assessment. An applicant claiming substantial equivalence must provide detailed comparative analytical data showing that the novel food does not differ from its conventional counterpart in any safety-relevant aspect.

EFSA assesses substantial equivalence claims critically. The comparison must be made against a well-characterised reference food with known safe use. Key parameters for comparison include nutritional composition, contaminant profile, anti-nutritional factors, and any bioactive or potentially toxic constituents. Differences in the production process — even when the final product appears compositionally similar — may preclude a finding of substantial equivalence if the process could introduce novel risks.

A successful substantial equivalence argument can reduce the toxicological data requirements, but it does not eliminate the need for characterisation, compositional data, or stability studies.