[2] As part of a food safety testing process, substantial equivalence is the initial step, establishing toxicological and nutritional differences in the new food compared to a conventional counterpart—differences are analyzed and evaluated, and further testing may be conducted, leading to a final safety assessment.
[2][7] The underlying approach of comparing a new product or technique to an existing one has long been used in various fields of science and technology.
The document noted that substantial equivalence serves as a framework for approaching food safety assessment, rather than functioning as a quantitative standard or measure.
These concepts refer, respectively, to the complete measured biochemical spectrum (total fingerprint) of compounds (metabolites) or of proteins present in a food or crop.
[2] To establish substantial equivalence, the modified product is tested by the manufacturer for unexpected changes to a targeted set of components such as toxins, nutrients, or allergens, that are present in a similar unmodified food.
If regulators determine that there is no significant difference between the modified and unmodified products, then there will generally be no further requirement for food safety testing.