Editing Substantial equivalence (section)

==Origin==
The concept of comparing genetically modified foods to traditional foods as a basis for safety assessment was first introduced as a recommendation during the 1990 Joint FAO/WHO Expert Consultation on biotechnology and food safety (a scientific conference of officials and industry), although the term ''substantial equivalence'' was not used.<ref name="faowho1996">{{cite web |url=ftp://ftp.fao.org/es/esn/food/biotechnology.pdf |title=Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety |publisher=FAO/WHO |date=October 1990 |archive-url=https://web.archive.org/web/20170518130948/ftp://ftp.fao.org/es/esn/food/biotechnology.pdf |archive-date=2017-05-18 |url-status=dead |access-date=16 February 2016}} "Joint FAO/WHO Consultation on the Assessment of Biotechnology in Food Production and Processing as Related to Food Safety" (1990)<br />"When molecular, microbial, genetic and chemical data establish that the food or food ingredient is sufficiently similar to its conventional counterpart, only minimal toxicological testing will generally be required." - Section 6.3.1, "Strategies for Assessing the Safety of Foods Produced by Biotechnology", report of a Joint FAO/WHO Consultation, World Health Organization, Geneva, 1991</ref><ref name="millstone">{{cite journal |title=Beyond 'substantial equivalence' |last1=Millstone |first1=Erik |last2=Brunner |first2=Eric |last3=Mayer |first3=Sue |journal=Nature |volume=401 |date=October 1999 |issue=6753 |pages=525–526|doi=10.1038/44006 |pmid = 10524614|bibcode=1999Natur.401..525M |s2cid=4307069 }}</ref> Adopting the term, ''substantial equivalence'' was formulated as a food safety policy by the OECD, first described in their 1993 report, "Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles.<ref name="agbiotechnet"/> 

The term was borrowed from the FDA's 1976 substantial equivalence definition for new [[medical devices]]—under [[Federal Food, Drug, and Cosmetic Act#Medical devices|Premarket Notification 510(k)]], a new [[Medical device#United States|Class II]] device that is essentially similar to an existing device can be cleared for release without further testing.<ref name="agbiotechnet" /><ref name="fda510k">{{cite web |url=https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ |archive-url=https://web.archive.org/web/20151009122013/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ |url-status=dead |archive-date=October 9, 2015 |title=Premarket Notification 510(k) |publisher=US Food and Drug Administration (FDA) |date=16 Sep 2015 |access-date=5 February 2016}}<br />"A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device ... that is not subject to PMS [Premarket Approval]. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims."</ref> 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.<ref name="agbiotechnet" />

In June 1999, [[G7|G8]] leaders requested the OECD to “undertake a study on the implications of biotechnology and other aspects of food safety.” In 2000, the OECD Edinburgh Conference on Scientific and Health Aspects of Genetically Modified Foods was held. Following those discussions, the OECD published an opinion that substantial equivalence is an important tool in analyzing the safety of novel foods, including GM foods. The document noted that substantial equivalence serves as a framework for approaching food safety assessment, rather than functioning as a quantitative standard or measure.<ref name=":0">{{Cite web |title=Pocket K No. 56: Substantial Equivalence of GM and Non-GM Crops |url=https://www.isaaa.org/resources/publications/pocketk/56/default.asp |access-date=Oct 13, 2024 |website=[[International Service for the Acquisition of Agri-biotech Applications]]}}</ref>