substantial equivalence
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food safety Food safety (or food hygiene) is used as a scientific method/discipline describing handling, preparation, and storage of food in ways that prevent food-borne illness. The occurrence of two or more cases of a similar illness resulting from t ...
, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been
genetically modified Genetic engineering, also called genetic modification or genetic manipulation, is the modification and manipulation of an organism's genes using technology. It is a set of Genetic engineering techniques, technologies used to change the gene ...
(GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time.Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles
OECD (1993)
It was first formulated as a food safety policy in 1993, by the
Organisation for Economic Co-operation and Development The Organisation for Economic Co-operation and Development (OECD; french: Organisation de coopération et de développement économiques, ''OCDE'') is an intergovernmental organization, intergovernmental organisation with 38 member countries ...
(OECD). As part of a food safety testing process, substantial equivalence is the initial step, establishing
toxicological Toxicology is a scientific discipline, overlapping with biology, chemistry, pharmacology, and medicine, that involves the study of the adverse effects of chemical substances on living organisms and the practice of diagnosing and treating expos ...
and
nutrition Nutrition is the biochemical and physiological process by which an organism uses food to support its life. It provides organisms with nutrients, which can be metabolized to create energy and chemical structures. Failure to obtain sufficient n ...
al 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. Substantial equivalence is the underlying principle in GM food safety assessment for a number of national and international agencies, including the
Canadian Food Inspection Agency The Canadian Food Inspection Agency (CFIA; french: Agence canadienne d'inspection des aliments) is a regulatory agency that is dedicated to the safeguarding of food, plants, and animals (FPA) in Canada, thus enhancing the health and well-being o ...
(CFIA), Japan's
Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...
(MHLW), the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), and the
United Nations The United Nations (UN) is an intergovernmental organization whose stated purposes are to maintain international peace and international security, security, develop friendly relations among nations, achieve international cooperation, and be ...
'
Food and Agriculture Organization The Food and Agriculture Organization of the United Nations (FAO)french: link=no, Organisation des Nations unies pour l'alimentation et l'agriculture; it, Organizzazione delle Nazioni Unite per l'Alimentazione e l'Agricoltura is an intern ...
(FAO) and
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
. ()
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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. "Joint FAO/WHO Consultation on the Assessment of Biotechnology in Food Production and Processing as Related to Food Safety" (1990)
"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
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. The term was borrowed from the FDA's 1976 substantial equivalence definition for new
medical devices A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
—under Premarket Notification 510(k), a new Class II device that is essentially similar to an existing device can be cleared for release without further testing.
"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 remarket Approval Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims."
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.


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 Antinutrients are natural or synthetic compounds that interfere with the absorption of nutrients. Nutrition studies focus on antinutrients commonly found in food sources and beverages. Antinutrients may take the form of drugs, chemicals that natura ...
)—such as the
glycoalkaloid Glycoalkaloids are a family of chemical compounds derived from alkaloids to which sugar groups are appended. Several are potentially toxic, most notably the poisons commonly found in the plant species ''Solanum dulcamara'' (bittersweet nightshade) ...
s
solanine Solanine is a glycoalkaloid poison found in species of the nightshade family within the genus ''Solanum'', such as the potato (''Solanum tuberosum''), the tomato (''Solanum lycopersicum''), and the eggplant (''Solanum melongena''). It can occu ...
in potatoes and alpha-tomatine in tomatoes—which do not affect their safety when prepared and eaten in traditional ways.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>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, 200

/ref> () 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. Further, the relative precision of biotech methods should allow assessment to be focused on the most likely problem areas. 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 consumer population.


Assessment process

Substantial equivalence is the starting point for GM food safety assessment. It can be applied at different points in the food chain, from unprocessed harvested crop to final ingredient or product, depending on the nature of the product and its intended use. For a GM plant, the overall evaluation process may be viewed in four phases: () #Substantial equivalence analysis
Considering introduced genes, newly expressed proteins, and new secondary metabolites #Toxicological and nutritional analysis of detected differences
Gene transfer, allergenicity, degradation characteristics, bioavailability, toxicity, and estimated intake levels #Toxicological and nutritional evaluation
If necessary, additional toxicity testing, possibly including whole foods (return to Phase 2). #Final safety assessment of GM plant


Technological developments

There has been discussion about applying new
biochemical Biochemistry or biological chemistry is the study of chemical processes within and relating to living organisms. A sub-discipline of both chemistry and biology, biochemistry may be divided into three fields: structural biology, enzymology an ...
concepts and methods in evaluating substantial equivalence, such as metabolic profiling and
protein profiling Proteins are large biomolecules and macromolecules that comprise one or more long chains of amino acid residue (biochemistry), residues. Proteins perform a vast array of functions within organisms, including Enzyme catalysis, catalysing metabo ...
. These concepts refer, respectively, to the complete measured biochemical spectrum (total fingerprint) of compounds (metabolites) or of proteins present in a food or crop. The goal would be to compare overall the biochemical profile of a new food to an existing food to see if the new food's profile falls within the range of natural variation already exhibited by the profile of existing foods or crops. However, these techniques are not considered sufficiently evaluated, and standards have not yet been developed, to apply them.


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 The Canadian Food Inspection Agency (CFIA; french: Agence canadienne d'inspection des aliments) is a regulatory agency that is dedicated to the safeguarding of food, plants, and animals (FPA) in Canada, thus enhancing the health and well-being o ...
(CFIA), Japan's
Ministry of Health, Labour and Welfare The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare. It was formed with the merger of the former Ministry of Health and Welfare or and the ...
(MHLW), the US
Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
(FDA), and the
United Nations The United Nations (UN) is an intergovernmental organization whose stated purposes are to maintain international peace and international security, security, develop friendly relations among nations, achieve international cooperation, and be ...
'
Food and Agriculture Organization The Food and Agriculture Organization of the United Nations (FAO)french: link=no, Organisation des Nations unies pour l'alimentation et l'agriculture; it, Organizzazione delle Nazioni Unite per l'Alimentazione e l'Agricoltura is an intern ...
(FAO) and
World Health Organization The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
. In 1997, the
European Union The European Union (EU) is a supranational political and economic union of member states that are located primarily in Europe. The union has a total area of and an estimated total population of about 447million. The EU has often been des ...
established a
novel food A novel food is a type of food that does not have a significant history of consumption or is produced by a method that has not previously been used for food. Designer food Designer food is a type of novel food that has not existed on any regional ...
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. To establish substantial equivalence, the modified product is tested by the manufacturer for unexpected changes to a targeted set of components such as
toxin A toxin is a naturally occurring organic poison produced by metabolic activities of living cells or organisms. Toxins occur especially as a protein or conjugated protein. The term toxin was first used by organic chemist Ludwig Brieger (1849– ...
s,
nutrient A nutrient is a substance used by an organism to survive, grow, and reproduce. The requirement for dietary nutrient intake applies to animals, plants, fungi, and protists. Nutrients can be incorporated into cells for metabolic purposes or excret ...
s, or
allergen An allergen is a type of antigen that produces an abnormally vigorous immune response in which the immune system fights off a perceived threat that would otherwise be harmless to the body. Such reactions are called allergies. In technical terms ...
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 In biology, the word gene (from , ; "...Wilhelm Johannsen coined the word gene to describe the Mendelian units of heredity..." meaning ''generation'' or ''birth'' or ''gender'') can have several different meanings. The Mendelian gene is a ba ...
produces a protein that has not been a food component before), further safety testing may be required.


Issues

There have been criticisms of the effectiveness of substantial equivalence.


See also

* GRAS - Generally Recognized As Safe, an FDA designation


References


Notes

{{Reflist, group=note, 2 Food safety Genetically modified organisms in agriculture Biotechnology