In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time. It was first formulated as a food safety policy in 1993, by the Organisation for Economic Co-operation and Development (OECD).
As part of a food safety testing process, substantial equivalence is the initial step, establishing toxicological and nutritional 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 (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.
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. 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—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. 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.
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 glycoalkaloids solanine in potatoes and alpha-tomatine in tomatoes—which do not affect their safety when prepared and eaten in traditional ways.[note 1]
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.[note 2]
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
There has been discussion about applying new biochemical concepts and methods in evaluating substantial equivalence, such as metabolic profiling and protein profiling. 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.[better source needed]
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. 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.
To establish substantial equivalence, the modified product is tested by the manufacturer for unexpected changes to a targeted set of components such as toxins, nutrients, or allergens, 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.
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There have been criticisms of the effectiveness of substantial equivalence.
- GRAS - Generally Recognized As Safe, an FDA designation
- Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts and Principles OECD (1993)
- Schauzu, Marianna (Apr 2000). "The concept of substantial equivalence in safety assessment of foods derived from genetically modified organisms" (PDF). AgBiotechNet. 2.
- Kok EJ, Kuiper HA (October 2003). "Comparative safety assessment for biotech crops" (PDF). Trends Biotechnol. 21 (10): 439–44. doi:10.1016/j.tibtech.2003.08.003. PMID 14512230. Archived (PDF) from the original on 2016-02-14. ()
- "Substantial Equivalence in Food Safety Assessment" (PDF). Council for Biotechnology Information. March 2001. Archived (PDF) from the original on 7 February 2016. Retrieved 6 February 2016. () (Page archive)
- "Joint FAO/WHO Expert Consultation on Biotechnology and Food Safety" (PDF). FAO/WHO. October 1990. Retrieved 16 February 2016. "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
- Millstone, Erik; Brunner, Eric; Mayer, Sue (October 1999). "Beyond 'substantial equivalence'". Nature. 401 (401): 525–526. doi:10.1038/44006. PMID 10524614.
- "Premarket Notification 510(k)". US Food and Drug Administration (FDA). 16 Sep 2015. Retrieved 5 February 2016.
"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."
- 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
- 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 
- "GM food safety assessment: tools for trainers" (PDF). Food and Agriculture Organization (FAO). 2009. Archived (PDF) from the original on 24 February 2016. Retrieved 8 February 2016. ()
- Joint FAO/WHO Expert Consultation on Foods Derived from Biotechnology (June 2000). "Safety aspects of genetically modified foods of plant origin" (PDF). World Health Organization (WHO). 4. Approaches to the Nutritional and Food Safety Evaluation of Genetically Modified Foods. Archived (PDF) from the original on 16 February 2016. Retrieved 12 February 2016.
- "Restrictions on Genetically Modified Organisms". Library of Congress. 9 Jun 2015. Retrieved 9 February 2016.
- "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)
- "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)