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Substantial equivalence
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==Description== The OECD bases the substantial equivalence principle on a definition of food safety where we can assume that a food is safe for consumption if it has been eaten over time without evident harm. It recognizes that traditional foods may naturally contain toxic components (usually called [[antinutrients]])—such as the [[glycoalkaloid]]s [[solanine]] in potatoes and [[Tomatine|alpha-tomatine]] in tomatoes—which do not affect their safety when prepared and eaten in traditional ways.<ref name="biotech-info.net">[http://www.biotech-info.net/antinutrients.html Substantial equivalence of antinutrients and inherent plant toxins in genetically modified novel foods, Novak, W. K.; Haslberger, A. G.,Food and Chemical Toxicology Volume 38 (6) p.473-483, 2000]</ref><ref name="OECD2000">Organisation for Economic Co-operation and Development. Report of the Task Force for the Safety of Novel Foods and Feeds C(2000)86/ADD1. May 17, 2000 [http://www.biosafety.be/ARGMO/Documents/report_taskforce.pdf] {{Webarchive|url=https://web.archive.org/web/20160311114405/http://www.biosafety.be/ARGMO/Documents/report_taskforce.pdf|date=2016-03-11}}</ref><ref name="faotools">{{cite web | url=http://www.fao.org/3/a-i0110e.pdf | title=GM food safety assessment: tools for trainers | publisher=Food and Agriculture Organization (FAO) | date=2009 | access-date=8 February 2016 | url-status=live | archive-url=https://web.archive.org/web/20160224193755/http://www.fao.org/3/a-i0110e.pdf | archive-date=24 February 2016 }} ()</ref>{{refn|group=note|"The safety of food for human consumption is based on the concept that there should be a reasonable certainty that no harm will result from intended uses under the anticipated conditions of consumption. Historically, foods prepared and used in traditional ways have been considered to be safe on the basis of long-term experience, even though they may have contained natural toxicants or anti-nutritional substances. In principle, food has been presumed to be safe unless a significant hazard was identified." (OECD, 1993)<ref name="oecd"/>}} The report proposes that, while biotechnology broadens the scope of food modification, it does not inherently introduce additional risk, and therefore, GM products may be assessed in the same way as conventionally bred products.<ref name="oecd"/> Further, the relative precision of biotech methods should allow assessment to be focused on the most likely problem areas.<ref name="oecd"/> The concept of substantial equivalence is then described as a comparison between a GM food and a similar conventional food, taking into account food processing, and how the food is normally consumed, including quantity, dietary patterns, and the characteristics of the consuming population.{{refn|group=note|"For foods and food components from organisms developed by the application of modern biotechnology, the most practical approach to the determination of safety is to consider whether they are ''substantially equivalent'' to analogous conventional food products, if such exist. Account should be taken of the processing that the food may undergo, as well as the intended use and the exposure. ''Exposure'' includes such parameters as the amount of food or food component(s) in the diet, the pattern of dietary consumption, and the characteristics of the consuming population(s). The approach provides a basis for an evaluation of food safety and nutritional quality." (OECD, 1993)<ref name="oecd"/>}} <!--A quote from FAO, one of the agencies that developed the concept, is useful for defining it: "Substantial equivalence embodies the concept that 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 (i.e., the food or food component can be concluded to be as safe as the conventional food or food component)".<ref>Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety. Rome, Italy, 30 September to 4 October 1996 [https://web.archive.org/web/20170518130948/ftp://ftp.fao.org/es/esn/food/biotechnology.pdf] p. 4</ref>-->
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