Substantial equivalence

Substantial equivalence is a regulatory concept used in the risk assessment of genetically modified organisms (GMOs). It posits that a novel food (in this case, a food product produced through genetic modification) should be considered the same as a conventional food product if it demonstrates the same characteristics and composition as the conventional food. This concept is pivotal in the biotechnology and food safety sectors, guiding the evaluation process for the introduction of GMOs into the market.

Overview

The principle of substantial equivalence was introduced by the Organization for Economic Co-operation and Development (OECD) in the early 1990s. It serves as a starting point for the safety assessment of genetically modified foods. According to this principle, if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety. However, if differences are identified, further safety assessment is required.

Application

The application of substantial equivalence involves a comparative analysis between the GMO and a conventional counterpart that has a history of safe use. The comparison typically focuses on attributes such as nutritional value, composition, allergenicity, toxicants, and any other unintended effects that may arise from the genetic modification process.