Inadequate safety assessment
of GE foods


It has been scientifically establised that genetic engineering can cause the appearance of unexpected harmful substances. Therefore, a very careful procedure is necessary for detecting them in GE foods. Yet such a procedure is not used.

In spite of this, an approval procedure is being used worldwide that may let through outright dangerous GE foods. It is based on the principle of "substantial equivalence" (SE). It states that the only requirement for approval is that the GE food should be "grossly similar" to its natural counterpart. It is based on the scientifically invalid assumption that such similarity grants safety.

Every molecular biologist can confirm that this assumption is fundamentally wrong. In reality, a GE food may even not only be grossly similar, but almost completely identical with its natural counterpart (far more than required by the SE principle) and yet contain an unexpected harmful substance.

Therefore, foods approved on the basis of "substantial equivalence" are not safe. This includes all GE foods on the market in the world, becasue they have all been approved on the basis of "substantial equivalence".

Therefore, it is our conclusion that every GE-food must be withdrawn from the market.

Scientifically invalid

The the principle of "substantial equivalence" for GE food approval is unscientific, being based on incorrect assumptions about the effects of genetic engineering.

The assumption is that if it is established that the genetically engineered organism is similar to its natural counterpart, "substantially equivalent", then there is no reason to believe that it is hazardous.

To decide if a GE food is substantially equivalent, only a limited set of characteristics (selected by the manufacturer) needs to be compared according to this principle. If this superficial testing procedure reveals no significant difference between the GE food and its natural counterpart, then it is assumed that no further food safety testing is required.

So the approval procedure is based on the assumption that GE foods are safe if they are "substantially equivalent". This assumption would have been justified only if genetic engineering had been a safe technology that never could give rise to unexpected substances. However the opposite is the case:

Molecular biological theory has predicted and experimental findings have confirmed that unexpected substances may be created through genetic engineering. This includes carcinogenic (cancer-generating), mutagenic (mutation-generating), poisonous and allergenic substances, see "Genetic Engineering Possesses Inherent Unpredictability" [EL] and "The safety of GE foods. Reasons to expect hazards and the risk for their appearance". [ML]  [Partly EL]. This is especially problematic as it may be very difficult to detect such hazardous substances. Some poisons are harmful even in very small concentrations.

Unexpected substances may appear however "equivalent" the GE variety is. This means that a GE food may be hazardous even if it is not just substantially equivalent but completely equivalent with the natural counterpart but for one unexpected harmful substance that runs a considerable risk of being undiscovered unless very rigorous food safety testing is done. This was the case in the Showa Denko disaster, see the box below.

Examples of failure of the present approval procedure

  • A dreadful example demonstrating that approval based on "substantial equivalence" is not only useless but also dangerous is the "Showa Denko" tryptophan disaster that killed 37 and permanently disabled 1.500 persons, see "An example of fatal substantial equivalence".

  • Monsanto's genetically engineered Soy, is approved as human food, being "substantially equivalent" with natural soy. When hamsters were fed on it in three generations, they developed slower growth and high mortality among the pups. Fertility was less in the second generation and in the third generation many were sterile.

    This result is in accord with the results of a number of other research studies reporting decreased fertility in GMO-fed animals, indicating that at least in this respect the harmful effect was due to genetic engineering, see "Genetically modified soy linked to sterility, infant mortality". Another study likewise found a high litter mortality and stunted growth in mice who ate Monsantos GMO soy (see "Most offspring died when mother rats ate genetically engineered soy").

  • A variety of GE maize, declared to be "substantially equivalent" was found to have 67 significant differences from natural Maize. The difference could indicate toxicity according to Professor Gilles-Eric Seralini, a leading biotechnology expert. More.

  • Genetically engineered Roundup Ready Soy of Monsanto, has been declared to be "substantially equivalent" and therefore approved as human food. Liver, pancreas and testicular changes were detected in mice eating it. This soy is widely used as human soy. For more, see "Liver changes from GE food".

The approval procedure has been rejected by important bodies of scientists

Thie approval procedure based on "substantial equivalence" has been critisized and rejected by important bodies of scientists. This includes a/o the US National Academy of Science; its Canadian counterpart, the Royal society and the The UK Medical Research Council. It has also recently been revealed that the US Food and Drug Administation (FDA), suppressed serious concerns about the safety of GE foods expressed by its own experts. Below just one example:

The Royal Society of Canada:
SE is not a scientific safety standard

"...substantial equivalence does not function as a scientific basis for the application of a safety standard, but rather as a decision procedure for facilitating the passage of new products, GE and non-GE, through the regulatory process, " -

The Royal Society of Canada (see footnote) (2001) Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada, Ottawa, p.182 (April 2001).

Footnote: In British Commonwealth countries, the Royal society is a national body of distinguished scientists and scholars that promote learning and research. In other countries, the corresponding body is called "The National Academy of Science".

The rejection of Substantial Equivalence by these distinguished bodies of scientists becomes even more understandable if you study the table below that demonstrates important differences between the procedure based on substantial equivalence and rigorous scientific assessment.

We have been critisizing this approval procedure since several years and feel greatly satisfied to find that important bodies of scientists have joined us in rejecting it. It should be a matter of short time before the GE food approval regulations will be changed accordingly. This should inevitably lead to the withdrawal of all GE foods on the market as they were all approved on the basis of this flawed principle.

The paragraph above was written in year 2000 and yet this unscientific and dangerous approval procedure is still being used, although 10 years have passed, indicating that the governmental authorities dealing with approval are ignoring science in a seriously irresponsible way. This includes the FDA in the US, and the European Food Safety Agency, EFSA, of the European Union.

For more about the criticism by scientific bodies, see "Scientists and scientist organizations rejecting the principle of Substantial Equivalence". See also "How could this unreliable assessment method become established?" below.

See also

  • "Our recommendation" [EL] (in the end of this document) - Presently marketed GE foods should be withdrawn from the market as they have not been tested properly. New regulatory procedures for establishing food safety need to be established that effectively prevent political interventions and exclude the influence from biased scientists and industrial lobbyists.
  • The approval of Monsanto's genetically engineered Roundup Ready Soy as a food. [ML]
    A case illustrating the inadequacy of the principle of Substantial Equivalence as appliced in practice.

Table comparing substantial equivalence with a scientifically valid food assessment procedure

Safety assessment based on substantial equivalence as applied in practice (on the basis of the recommendations of the United Nation's organ FAO), is compared below with the kind of assessment required from a rigorously scientific and impartial standpoint.

 Assessment based on
substantial equivalence

 Assessment based on
scientific knowledge

Based on the unsubstantiated assumption that genetic engineering is not different from breeding. If there is no obvious difference between the assessed product and it's natural counterpart, regarding its appearance, taste, or selected chemical and nutritional properties, it is assumed to be equivalent and then no thorough testing is necessary.

Based on the scientific fact that there is a considerable difference between GE and breeding. Because of the insertion of a foreign gene, unpredictable metabolic changes may occur that may generate unexpected hazardous substances that require thorough testing to be detected.

Food that is substantially equivalent with regard to selected characteristics need only be tested as follows:

No food can be excluded from rigorous testing on the basis of comparing selected characteristics or for any other excuse. The GE organism may be identical with its mutual counterpart but for one harmful substance. Therefore the following tests are always necessary:

1. Short term assessment of the influence on growth rate and similar gross and superficial symptoms is sufficient to establish the safety of GMOs. No thorough laboratory analysis is required.

1. Short term animal testing with thorough laboratory analysis is necessary in every case for reliable detection of immediate harmful effects.

2. No long term animal testing is required to establish the safety of GMOs.

2. Rigorous long term animal testing is necessary in every case for reliable detection of slow acting harmful substances.

3. No human testing is required to establish the safety of GMOs. Animal testing is enough.

3. Rigorous human testing over several years, is necessary, as animal testing is not a fully reliable means for detecting harmfulness to humans in the case of slowly acting harmful substances like carcinogens.

 4. Biochemical allergen analysis and animal tests are accepted as sufficient for assessing allergenicity

 4. Biochemical analyses and animal tests are not reliable indicators of allergenicity. Human allergy testing, both short and long-term, is necessary for reliable assessment.

For more details about scientifcally required testing, see the right table column in: The approval of Monsanto's genetically engineered Roundup Ready Soy as a food. [ML]

Conclusions from the comparison above

It is obvious from this table that GE food "safety assessment" based on substantial equivalence has no scientific basis. This principle neglects well established scientific facts of crucial importance for food safety assessment. These facts invalidate it completely. The application of the principle of substantial equivalance carries with it a great risk that unexpected harmful substances will pass undetected.

Foods assessed this way are consequently not safe to eat. This goes for all GE foods on the market as they have all been approved on the basis of this principle.

How could this unreliable assessment method become established?

To be reliable, the testing demanded by food safety experts would have cost millions of dollar in each case. In addition, it would have delayed their approval for years as such testing takes long time. Billions of dollars had already been invested in the development GE foods and such demands and delays would have made the GE food projects unprofitable. So the Biothec firms were under pressure to find some way to get around these impediments.

A judicial hoax to facilitate rapid approval

The solution was "substantial equivalence" that was invented by legal advisors to facilitate rapid approval procedures for GE foods in USA without any demands on careful testing. It is thus a judicial hoax without any scientific basis.

US Governmental interference

Unfortunately it was succesfully established globally. This was achieved through strong pressure from the United States Government that made it a national and even a presidential issue to promote its Biotech Multinationals so that they could lead and dominate the biotech sector. The American Food and Drug Agency (FDA) played a key role in officially declaring (1994) that these foods were as safe as natural ones in spite of warnings by their own experts, who were gagged and findings indicating harmful effects of a GE food were suppressed, see FDA scientists indirectly rejected the principle.

Serious failure of food safety authorities

The international (FAO and Codex Alimentarius) and national food safety committees still support this approval procedure. Their approval of this non-scientific and unreliable assessment method represents an unacceptable failure of the procedures for developing food safety regulations and indicates a serious dysfunction of the national and international scientific expert committees that endorse it.

It is truly amazing that this useless and dangerous safety assessment procedure is still approved by the scientists in the international organizations, including FAO, Codex Alimentarius, European Food Safety Authority (EFSA) as well those in and national food safety authorities like the American FDA, the Danish Födevaredirektoratet, the Swedish Livsmedelsverket, the British Food Standard Authority, the German Bundesamt für Lebensmittelsicherheit etc. Are these scientists gravely incompetent or corrupted or what? In any case it is very evident that the scientists dealing with food safety in organs approving substantial equivalence are seriously irresponsible unless they have been gagged by their superiors, which has been the case at least in FDA.

This demonstrates the danger of political and corporate intervention into judgements and decisions that should be made completely impartially by independent scientists. See also "Towards a pseudoscientfic world order?"

For more details, see "Why were genetically engineered foods approved in spite of insuffient safety data?"

"The ubiquitous argument that "since there is no evidence that GM products make people sick, they are safe" is both illogical and false. There are, again, simply no data or even valid assays to support this contention. Without proper epidemiological studies, most types of harm will not be detected, and no such studies have been conducted."

David R. Schubert, professor and head of the Cellular Neurobiology Laboratory at the Salk Institute, La Jolla, California, “The Problem with Nutritionally Enhanced Plants”, Journal of Medicinal Food, Vol. 11, No. 4, 2008


Our recommendation

Foods that have been approved on the basis of the principle of Substantial Equivalence should be declared unsafe and be withdrawn from the market, see our Open letter to governments.

If it takes time to implement this, mandatory labeling is necessary for all GE foods and food containing GE components in order to facilitate early discovery of unexpected harmful effects.

Regulations for securing the safety of food should only be based on impartial scientific considerations. This has obviously not been the case in regulations applying the principle of substantial equivalence.

Measures need to be introduced in the regulatory procedures that prevent political interventions and exclude the influence from biased scientists and industrial lobbyists (see: A suggested procedure to ensure impartial safety assessment).

Without drastic improvements of the regulatory procedures, the health of the population of the Earth may be exposed to peril from insufficiently tested Novel foods that now are being developed and marketed.

Physicians and Scientists for Responsible Application
of Science and Technology

Published at Nov 3, 1998. Last updated May 6, 2010.

Scientists and scientist organizations rejecting the principle of Substantial Equivalence

This section has been moved to a separate document, Click here.

Related articles:

Physicians and Scientists for Responsible
Application of Science and Technology
- A Global Network -

"Genetically Engineered Food - Safety Problems"
Published by PSRAST

Siteguide   Starting points   Student section   Website search   Site Map   Home page   

News   Introductory articles   Health hazards    Environmental hazards   

Global issues   Safety issues   Alternatives to GE   FAQ   

About us   What You can do   Membership   E-mail   How to sponsor us