Editing Substantial equivalence (section)

==Adoption==
Approaches to GM food regulation vary by country, while substantial equivalence is generally the underlying principle of GM food safety assessment. This is the case for national and international agencies that include the [[Canadian Food Inspection Agency]] (CFIA), Japan's [[Ministry of Health, Labour and Welfare]] (MHLW), the US [[Food and Drug Administration]] (FDA), and the [[United Nations]]' [[Food and Agriculture Organization]] (FAO) and  [[World Health Organization]].<ref name="faotools"/><ref name="loc">{{cite web | url=https://www.loc.gov/law/help/restrictions-on-gmos/index.php | title=Restrictions on Genetically Modified Organisms | publisher=Library of Congress | date=9 Jun 2015 | access-date=9 February 2016}}</ref><ref name="councilforbiotechinfo"/> In 1997, the [[European Union]] established a [[novel food]] assessment procedure whereby, once the producer has confirmed substantial equivalence with an existing food, government notification, with accompanying scientific evidence, is the only requirement for commercial release, however, foods containing genetically modified organisms (GMOs) are excluded and require mandatory authorization.<ref name="agbiotechnet"/>

To establish substantial equivalence, the modified product is tested by the manufacturer for unexpected changes to a targeted set of components such as [[toxin]]s, [[nutrient]]s, or [[allergen]]s, that are present in a similar unmodified food.  The manufacturer's data is then assessed by a regulatory agency. 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. However, if the product has no natural equivalent, or shows significant differences from the unmodified food, or for other reasons that regulators may have (for instance, if a [[gene]] produces a protein that has not been a food component before), further safety testing may be required.<ref name="oecd"/>