New EU legislation for risk assessment of GM food: No scientific justification for mandatory animal feeding trials
Open accessAbstract
Summary: This commentary focuses on the potential added value of and need for (sub)‐chronic testing of whole genetically modified (GM) foods in rodents to assess their safety. Such routine testing should not be required since, due to apparent weaknesses in the approach, it does not add to current risk assessment of GM foods. Moreover, the demand for routine testing using animals is in conflict with the European Union (EU) Commission's efforts to reduce animal experimentation. Regulating agencies in the EU are invited to respect the sound scientific principles applied to the risk assessment of foods derived from GM plants and not to interfere in the risk assessment by introducing extra requirements based on pseudo‐scientific or political considerations.
AI snapshot
Written from the paper’s full text.
TL;DR
This commentary argues that mandatory routine 90-day rodent feeding trials for whole GM foods under new EU legislation lack scientific justification and add little to GM food safety assessment. It contends that EFSA’s case-by-case approach is more proportionate and that routine animal testing conflicts with EU animal-welfare policy.
Key findings
- The 2013 EU Commission Implementing Regulation requires a 90-day rodent feeding trial for every single transformation event and, in specific cases, for stacked events, whereas EFSA guidance recommends such studies only under certain conditions.
- EFSA estimated that a toxic substance produced by genetic modification in GM maize would need to be present at at least 4000 mg/kg in the animal diet to induce adverse effects under median toxic potency, meaning substances at lower levels or lower potency would not be detected.
- No animal feeding trials with whole GM foods/feed performed according to generally agreed quality standards have identified adverse effects, and the Seralini et al. (2012) NK603 maize study is criticized for design flaws including use of a rat strain with spontaneous mammary tumours, small group sizes, lack of reference controls, lack of compositional/phenotypic data, unconventional statistics, and no power analysis.
- The author concludes there is no need for additional requirements such as routine (sub)-chronic testing of GM foods/feed, and that such testing conflicts with EU Directive 2010/63/EU efforts to replace, refine, and reduce animal experiments.
Methods
- Commentary/opinion piece; no new experimental data are generated.
- It synthesizes EFSA guidance (2011a, 2011b), EU Regulation 503/2013, EFSA’s 2008 review on animal feeding trials, the Seralini et al. (2012) study, and reviews by Snell et al. (2012), Ricroch (2013), and Herman and Price (2013).
- Main analysis is a critical regulatory and toxicological argument comparing EFSA’s case-by-case approach with the EU’s mandatory 90-day testing requirement.
Limitations
- The paper states that whole-food animal feeding trials are difficult to perform, have low power to detect adverse effects, carry matrix effects, are limited by how much test food can be incorporated into the diet, and may create nutritional imbalances.
- The paper states that compositional analysis cannot provide complete assurance because of bias in compound selection, differences in extraction efficiency, detection sensitivity, and limited resolution for some compounds.
- Evident from the text: this is a commentary without primary data or a systematic review, so its conclusions reflect the author’s interpretation of existing guidance and studies rather than new empirical findings.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 26 cited sources checked · 0 supported · 0 flagged
- Findingcitation
To date, no animal feeding trials performed according to generally agreed quality standards with whole foods/feed derived from GM plants have been able to identify any adverse effects.
“To date, no animal feeding trials (both short term and long term) performed according to generally agreed quality standards with whole foods/feed derived from GM plants have been able to identify any adverse effects.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites EFSA, 2008
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- cites Snell et al., 2012
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- cites Ricroch, 2013
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- Findingcitation
The concentration of a toxic substance produced as a consequence of genetic modification in GM maize needs to be at least 4000 mg/kg in the animal diet to induce adverse effects, assuming a median toxic potency.
“It was estimated that the concentration of a toxic substance produced as a consequence of the genetic modification, in GM maize for example, needs to be at least 4000 mg/kg in the animal diet in order to induce adverse effects, assuming a median toxic potency.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA, 2008
Not checked in the free run.
- The authors state this as an assumption: A median toxic potency for the toxic substance.
- Findingcitation
In a majority of cases, adverse non-tumour effects seen in 2-year rodent tests with pesticides, pharmaceuticals, and contaminants were also observed in 3-month subchronic studies.
“Studies with different and specific substances (pesticides, pharmaceuticals, contaminants) in 3-month subchronic and 24-month studies in rodents indicated that in a majority of cases, the appearance of adverse (non-tumour) effects seen in the 2-year tests were also observed in the 3-month studies.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA, 2008
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- Findingcitation
Variations in composition resulting from traditionally bred crops under different environmental conditions were much larger than alterations resulting from transgenesis.
“Moreover, variations in composition resulting from traditionally bred crops under different environmental conditions were much larger than alterations resulting from transgenesis.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Herman and Price, 2013
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- Findingcitation
Data generated on comparative compositional analyses of GM plants and derived food/feed submitted under EU regulation have not indicated that genetic modification of plants results in significant unintended alterations that would impact on safety.
“Over the years, data generated on comparative compositional analyses of GM plants and derived food/feed and submitted in the framework of the EU regulation on GMOs have not indicated that the genetic modification of plants results in significant unintended alterations that would impact on safety (EFSA GMO Opinions, www.efsa.europa.eu/en/panels/gmo.htm).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA GMO Opinions
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- Findingcitation
Variation in crop composition is caused by genetic background, breeding technique, growing environment, genotype-environment interactions, and crop cultural practices.
“It has been well demonstrated that such variation is caused, for example, by genetic background, breeding technique used, growing environment (site, season), genotype-environment interactions and crop cultural practices (Barros et al., 2010;Davies et al., 2010;Kok et al., 2008;Ricroch, 2013).”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Barros et al., 2010
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- cites Davies et al., 2010
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- cites Kok et al., 2008
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- Findingreasoning
Many differences observed in published studies between animals exposed to GM test material and controls could not be interpreted or associated with the GM test material due to deficiencies in experimental design.
“In some published studies, differences have been observed in test parameters measured in animals exposed to GM test material or exposed to control material, but many of these differences could not be interpreted or associated with the GM test material, due to deficiencies in the experimental design.”
Quote in the paperSubstantial claim - Findingcitation
A recent review of data on compositional analyses of GM plants compared to traditionally bred plants, including cases evaluated by US FDA and Japanese authorities, indicates compositional equivalence.
“Similarly, a recent review of data on compositional analyses of GM plants compared to traditionally bred plants, which includes cases evaluated by the US FDA and Japanese authorities, indicates compositional equivalence (Herman and Price, 2013).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites Herman and Price, 2013
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- Findingcitation
Maize NK603 was assessed by the EFSA GMO Panel in 2003 and 2007 and found to be compositionally and agronomically equivalent to appropriate non-GM maize varieties, except for the presence of newly expressed proteins CP4 EPSPS and CP4 EPSPS L214P.
“These assessments indicated that maize NK603 was (with the exception of the presence of the newly expressed proteins CP4 EPSPS and CP4 EPSPS L214P) compositionally and agronomically equivalent both to an appropriate non-GM maize variety (with a comparable genetic background) and to other conventional maize varieties.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA GMO Opinions
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- Premisecitation
EFSA guidance recommends 90-day feeding trials with whole GM food/feed only under certain conditions.
“EFSA guidance recommends this type of experimentation only under certain conditions.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA, 2011a
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- Interpretationcitation
The capacity of a 90-day rodent test to evaluate the safety of whole food/feed is relatively low.
“Thus, the capacity of a 90-day rodent test to evaluate the safety of whole food/feed is relatively low.”
Quote in the paperSubstantial claim - Interpretationreasoning
Routine (sub)-chronic testing of whole GM foods in rodents does not add to current risk assessment of GM foods because of weaknesses in the approach.
“Such routine testing should not be required since, due to apparent weaknesses in the approach, it does not add to current risk assessment of GM foods.”
Quote in the paperSubstantial claim- Rests on an assumption: Animal feeding trials with whole (GM) foods are difficult to perform, have low power to detect adverse effects, carry inherent risks of matrix effects, and contribute little to safety evaluation.
- Premisecitation
The demand for routine animal testing of GM foods conflicts with EU Commission efforts to reduce animal experimentation.
“Moreover, the demand for routine testing using animals is in conflict with the EU Commission's efforts to reduce animal experimentation (European Directive 2010).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites European Directive 2010
Not checked in the free run.
- Interpretationreasoning
The 2-year and 3-month studies are not strictly comparable because they were carried out in different laboratories and at different times.
“However, these studies are not strictly comparable because they were carried out in different laboratories and at different times.”
Quote in the paperSubstantial claim - Interpretationreasoning
Testing chemicals in a 90-day trial with rodents is generally of sufficient duration to detect adverse effects.
“Thus, the testing of chemicals in a 90-day trial with rodents is generally of sufficient duration to detect adverse effects.”
Quote in the paperSubstantial claim - Premisecitation
The extensive array of compounds analysed in targeted compositional analyses, representing many relevant metabolic pathways, enables the risk assessor to identify with confidence the possible occurrence of unintended effects.
“The extensive array of compounds analysed, which represent many relevant metabolic pathways, enables the risk assessor to identify with confidence the possible occurrence of unintended effects.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites OECD Consensus Documents
Not checked in the free run.
- Rests on an assumption: Perturbations in a plant's physiology and biochemistry will likely be detected by phenotypic, agronomic or targeted compositional analyses.
- Interpretationreasoning
There is no scientific rationale for chronic testing of whole food/feed derived from GM plants.
“Furthermore, in the light of current discussions on chronic testing of whole food/feed derived from GM plants, it should be emphasized that there is no scientific rationale for these types of study.”
Quote in the paperSubstantial claim - Interpretationreasoning
The deficiencies in the Seralini et al. (2012) study render any claims of the authors regarding long-term adverse effects of GM maize NK603 highly disputable and scientifically unfounded.
“The deficiencies noted in this study render any claims of the authors regarding long-term adverse effects of GM maize NK603 highly disputable and scientifically unfounded.”
Quote in the paperSubstantial claim - Interpretationreasoning
It is unlikely that animal feeding trials can provide any extra information in the case of whole GM food/feed.
“It is therefore unlikely that animal feeding trials can provide any extra information in the case of whole GM food/feed.”
Quote in the paperSubstantial claim - Interpretationreasoning
There is no need for additional requirements, that is, routine (sub)-chronic testing of foods/feed derived from GM plants.
“Thus, there is no need for additional requirements, that is, routine (sub)-chronic testing of foods/feed derived from GM plants.”
Quote in the paperSubstantial claim - Interpretationreasoning
Complete assurance of detecting unintended effects cannot be provided due to bias in compound selection, differences in extraction efficiency, availability and sensitivity of detection methods, and lack of resolution power for some compounds.
“However, it is clear that complete assurance cannot be provided due, for example, to bias in the selection of compounds, to differences in the efficiency of extraction methods and availability and sensitivity of detection methods and to the lack of resolution power for some of the compounds assayed (for example the quantification of total proteins rather than proteome analysis).”
Quote in the paperNot a substantial claim - Interpretationreasoning
Current approaches for the safety and nutritional assessment of foods/feed derived from GM plants as developed by national and international bodies like OECD, FAO/WHO, and EFSA have proven to be proportionate and fit for purpose.
“In conclusion, current approaches for the safety and nutritional assessment of foods/feed derived from GM plants as developed by national and international bodies like OECD, FAO/WHO, and EFSA, have proven to be proportionate and fit for purpose.”
Quote in the paperSubstantial claim- Rests on an assumption: The guidelines for risk assessment of GM crops are robust and guarantee a high level of safety once a positive evaluation has been completed.
- Premisecitation
The potential for unintended effects is not confined to GM crops but applies to all breeding technologies including conventional crossing.
“The potential for unintended effects is not confined to GM crops but will apply to all breeding technologies including conventional crossing.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Cellini et al., 2004
Not checked in the free run.
- Classified as probably not a substantial claim. 1
- May combine two claims. 8
Probably not a substantial claim: may not pass S3 (load-bearing).
FindingcitationIn some studies, new findings were observed in the 2-year tests.
“In some studies, new findings were observed in the 2-year tests.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites EFSA, 2008
Not checked in the free run.
May combine two claims.
FindingcitationThe Seralini et al. (2012) long-term toxicity study of GM maize NK603 had key limitations including use of a rat strain with spontaneous mammary tumours, small group sizes, lack of reference controls, lack of compositional data, unconventional statistics, and lack of power analysis.
“The key limitations of the study include (i) the use of a rat strain with a well-known spontaneous occurrence of mammary tumours in female rats, (ii) the small number of animals used in the various test groups, (iii) the lack of reference controls or data on natural variations of test parameters,”
- Also stated in: § Risk assessment approach for the safety evaluation of GM foods · plain
“(iv) the lack of data on the agronomic, compositional and phenotypic characteristics of the test and control materials, (v) the use of unconventional statistical methods and (vi) the lack of power analysis prior to the start of the study.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites EFSA, 2012 source
Not checked in the free run.
- Also stated in: § Risk assessment approach for the safety evaluation of GM foods · plain
May combine two claims.
FindingcitationOmics technologies provide wide coverage of genes, proteins and metabolites, and a growing number of examples indicate that such profiling approaches are useful in identifying sources and extents of variation in crop composition, including unintended effects of breeding techniques.
“Indeed, 'omics' technologies in general provide wide coverage of genes (transcriptomics), proteins (proteomics) and metabolites (metabolomics) and a growing number of examples indicate that such profiling approaches are useful in identifying sources and extents of variation in the composition of crops, including unintended effects of breeding techniques.”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites Barros et al., 2010
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- cites Davies et al., 2010
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- cites Kok et al., 2008
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May combine two claims.
FindingcitationGenetic modification induces minor changes in plant gene expression and composition, whilst environmental factors have a much greater impact.
“A number of studies indicate that the genetic modification induces minor changes in plant gene expression and composition, whilst environmental factors have a much greater impact.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites Barros et al., 2010
Not checked in the free run.
- cites Davies et al., 2010
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- cites Kok et al., 2008
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May combine two claims.
InterpretationcitationSubstances present in smaller amounts or with lower toxic potency than the 4000 mg/kg threshold will not be detected in 90-day feeding experiments, whereas most analytical detection methods have greater sensitivity.
“Substances present in smaller amounts or with a lower toxic potency will therefore not be detected in this type of feeding experiment, whereas most analytical detection methods have a much greater sensitivity with respect to detection and quantification.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationThe new EU regulation demands a 90-day feeding trial in rodents for every single transformation event and, in specific cases, for plants containing transformation events stacked by conventional crossing.
“However, unlike EFSA guidance, the new regulation demands a 90-day feeding trial in rodents for every single transformation event and, in specific cases, the same trial for plants containing transformation events stacked by conventional crossing.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites European Commission, 2013
Not checked in the free run.
May combine two claims.
InterpretationcitationRoutine animal testing will lead to an unnecessary waste of animals, which is contradictory to EU Commission policies to stimulate the RRR principles.
“Of particular concern is that routine animal testing will lead to an unnecessary waste of animals, which is contradictory to EU Commission policies to stimulate the RRR principles, that is, replacing of animal tests by alternative methods, refine methods to reduce pain and distress of animals and to reduce the number of animals wherever possible (European Directive 2010).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites European Directive 2010
Not checked in the free run.
May combine two claims.
PremisereasoningTraditional or conventional breeding produces intended or unintended mutations, deletions, insertions and rearrangements in the genome, but the history of safe use of products developed with these approaches tells us that few toxicological hazards have arisen.
“So called 'traditional' or 'conventional' breeding will produce intended or unintended mutations, deletions, insertions and rearrangements in the genome, but the history of safe use of products developed with these approaches tells us that few toxicologically hazards (e.g.enhancement of levels of natural toxins) have arisen.”
Quote in the paperSubstantial claimMay combine two claims.
InterpretationreasoningThe new EU requirement for routine testing of food/feed derived from GM plants in 90-day studies is not based on sound science but rather satisfies political agendas of some regulatory agencies.
“The new EU requirement for routine testing of food/feed derived from GM plants in 90-day studies is not based on sound science but rather satisfies political agendas of some regulatory agencies which are of the view that issues, other than scientific ones, need to be taken into account (e.g.socio-economic).”
Quote in the paperNot a substantial claim
The authors state this as an assumption.
Traditionally cultivated crops have a history of safe use for consumers and/or domesticated animals.
“The underlying assumption of this comparative approach is that traditionally cultivated crops have gained a history of safe use for consumers and/or domesticated animals.”
The authors state this as an assumption.
A median toxic potency for the toxic substance.
“assuming a median toxic potency.”
The paper relies on this without support.
Animal feeding trials with whole (GM) foods are difficult to perform, have low power to detect adverse effects, carry inherent risks of matrix effects, and contribute little to safety evaluation.
“There is general consensus amongst toxicologists that animal feeding trials with whole (GM) foods are difficult to perform, have a low power to detect adverse effects, carry inherent risks of matrix effects and contribute little, if anything, to the safety evaluation of whole foods.”
The paper relies on this without support.
The guidelines for risk assessment of GM crops are robust and guarantee a high level of safety once a positive evaluation has been completed.
“There is general agreement amongst producers, food safety experts, risk assessors and regulatory authorities that the guidelines for risk assessment of these crops are robust and guarantee a high level of safety of these products once a positive evaluation has been completed.”
The paper relies on this without support.
Perturbations in a plant's physiology and biochemistry will likely be detected by phenotypic, agronomic or targeted compositional analyses.
“It is generally accepted that perturbations in the plant's physiology and biochemistry will likely be detected by phenotypic, agronomic or targeted compositional analyses.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Many toxicologists concur that animal feeding trials of whole GE food have low power to detect adverse effects and contribute little to the safety assessment of whole foods.
“Many toxicologists concur that animal feeding trials of whole GE food have a low power to detect adverse effects and contribute little, if anything, to the safety assessment of whole foods (Kuiper et al., 2013).”
From Prevalence and impacts of genetically engineered feedstuffs on livestock populations1 (2014) · cites this paper as Kuiper et al., 2013
Despite a wealth of studies and literature to the contrary, these isolated and poorly designed studies have resulted in the promulgation of new regulations, including a mandatory 90-d rodent subchronic toxicity feeding study for all new GE approvals in the EU, and have generated a great deal of media attention.
“Despite a wealth of studies and literature to the contrary, these isolated and poorly designed studies have resulted in the promulgation of new regulations, including a mandatory 90-d rodent subchronic toxicity feeding study for all new GE approvals in the EU (Kuiper et al., 2013), and have generated a great deal of media attention (Arjó et al., 2013).”
From Prevalence and impacts of genetically engineered feedstuffs on livestock populations1 (2014) · cites this paper as Kuiper et al., 2013
Cites
1 retracted
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“The test materials used include whole food/feed derived from GM maize, potatoes, rice, soybeans, tomatoes, rapeseed, triticale etc. (see for review EFSA, 2008 (Table 2), Snell et al., 2012; Ricroch, 2013).”
RetractedOfficial Journal of the European Communities
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“The test materials used include whole food/feed derived from GM maize, potatoes, rice, soybeans, tomatoes, rapeseed, triticale etc. (see for review EFSA, 2008 (Table 2), Snell et al., 2012; Ricroch, 2013).”
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- Authors
- Kuiper, H. A., Kok, E. J., & Davies, H. V.
- Affiliations
- Wageningen University & Research (NL)
- James Hutton Institute (GB)
- Corresponding author
- Kuiper, Harry A.
- ORCID
- Kok, Esther J.
- Venue
- Plant Biotechnology Journal
- Publisher
- Wiley
- Published
- 2013-06-21
- Volume
- 11
- Issue
- 7
- Pages
- 781-784
- ISSN
- 1467-7644 (ISSN-L)
- 1467-7652
- OpenAlex
- W2012910743
- Cited by
- 38
- References
- 15
- Citations by year
- 2026: 1 · 2023: 1 · 2022: 2 · 2021: 1 · 2019: 2 · 2018: 5 · 2017: 3 · 2016: 1 · 2015: 9 · 2014: 10 · 2013: 2 · 2012: 1
- FWCI
- 8.86
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Plant Biotechnology Journal (publishedVersion)
- PubMed (publishedVersion)
- Socio-Environmental Systems Modeling (acceptedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Topics
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
- Keywords
- genetically modified foods, risk assessment, feeding experiments, animal testing reduction, EU food law, food safety
- MeSH terms
- Animals, Environmental Exposure, European Union, Legislation, Food, Risk Assessment, Food, Genetically Modified, Rats, Food Safety
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