GMO Regulations, Testing & Pre-Market Review, Approval, & Labelling In Different Countries

Different countries have different requirements & processes when it comes to the assessment of GM crops and foods (both before becoming a crop, and before getting into the food supply or hitting the commercial market).

Some have specific regulations, whilst others don’t, and there can be different requirements during the testing and pre-market review, approval, and labelling phases.

In this guide, we’ve outlined some requirements, and some differences between countries.

We’ve also identified what might be some criticisms of the assessment processes and requirements in general.


*Note – this guide is intended as a basic introductory guide, and not an expert analysis.


Summary – GMO Regulations, Test & Pre-Market Review, Approval & Labelling


What is very clear about the assessment of GM crops and foods before they become crops, or before they get to the commercial market (and enter the food supply), is that that assessment process differs from country to country

Some countries have specific regulations and regulatory framework in place for GMOs, whilst others don’t

Some countries have more restrictive requirements and processes for testing and pre-market review, approvals, and labelling, whilst other countries have less restrictive requirements

The different States or Provinces within a country can even differ on their stance on GM crops and foods from other States & Provinces. In some countries or regions, States can alter or disapprove national level decisions on GM crops and foods

The US is an example of a country that might be less restrictive on GM crops and foods, and as a result, grow a greater range of GM crops than many other countries

Comparatively, other regions like the European Union appear far more restrictive (although, there are other places around the world that are similarly restrictive on what GM crops they allow to be grown)

How different countries and region assess GM crops and foods may differ too mentions that ‘While EU regulations focus on the technique used to modify the crop, other systems, like the Canadian system, focus on the characteristics of the crop produced … [and] In other regions, including many countries in Africa, biosafety regulation is still being developed’

Intended use of the GM product may matter too mentions that ‘Regulation varies in a given country depending on the intended use of the products of the genetic engineering. For example, a crop not intended for food use is generally not reviewed by authorities responsible for food safety’


In The United States

The US currently has no specific law that regulates GM foods

Instead, if a company wants to bring a crop or food to market, there’s a voluntary consultation process in place, in which responsible agencies like the FDA have the authority to make requests (of tests and data for example) of the party making the submission

Although some groups claim that a voluntary consultation is an inadequate protection measure in various ways (such as for testing food safety factors like allergenicity, digestibility and toxicity), companies making submissions point out that in practice, the safety assessment doesn’t end up being voluntary because they end up submitting a range of tests and data for new GM foods and crop products anyway. Additionally, the FDA is there is as a responsible third party with authority over the party making the submission.

Some biotech companies, or groups supporting GM crops/food use, reinforce this point by explaining that the average GM seed takes hundreds off millions of dollars and over a decade to bring to market – this involves a lot of research and testing on GM agricultural products.

The US has three agency bodies who assess GM crops and food, both before they become crops, and before they enter the food supply

These agencies are the FDA, USDA and EPA

Each one of these bodies has the responsibility to perform an assessment for a different and specific purpose in relation to the GM product in question

Overall, the regulation of GMOs in the US when it comes to testing is based on the principle of ‘substantial equivalence’

A very simplified explanation of this is that like drugs that alter or cause change in the human body, only GMOs designed to impact human health should be tested

GMOs designed to be equivalent to their non GE counterparts are not required to be tested

Allergenicity and animal feeding studies can be done to test whether an introduced protein or nutritional profile designed to cause a change to human health presents a risk – one criticism of this approach is that there is some questioning over the long term effects of GMOs when it comes to clinical tests and studies available


In Europe

Europe appears to have a far more restrictive GM crops and food policy and procedure than the US

One illustration of this is that GM foods can be banned even after approval in Europe (based on the latest regulatory framework)

As a result of these heavier restrictions, Europe tends to cultivate less GM crops and foods than the US (but Europe does approve more GMOs for importing and processing compared to what they approve for cultivation) 

GM foods are evaluated on a case by case basis in Europe

In Europe, there’s a central decision making making board, but also independent member States who have the responsibility for assessment and implementation of GM crops

Currently, independent member States have the final say on implementation over the central decision making group


In The UK

In the UK, GM crops can’t be grown with approval from the appropriate regulatory agency – DFRA plays a role here

There is also regulation on the movement of GM crops between the UK and other countries


In Australia

In Australia, there are Standards and Codes used to assess GM food safety, and it’s done on a case by case basis.

There is also a Regulator that identifies the risk and assesses the safety of a GM organism against its conventional counterpart

Both the national government and State government play a role in decision making on what can and can’t be grown. But, the individual States ultimately having the final say on what they allow and ban


Food Labeling

When looking specifically at the labeling stage, the US and Australia are examples of countries with different labeling requirements

In Australia, whilst imported GM ingredients are unlikely to be labeled, other foods containing GM material can be

In the US, labelling of GMO products … is not required and no distinction between marketed GMO and non-GMO foods is recognized by the US FDA


Support For The Current Regulations

Some scientists say that GMOs are adequately regulated and tested for what they are, so their positive impact on humans and human health is nothing to worry about (


Potential Criticisms Of The Regulation Of GM Foods & Crops

A subjective summary of some of the criticisms or things people might disagree with about the regulation of GM foods and crops might be:

– In the US, some might argue there should be a compulsory consultation instead of a voluntary consultation for companies submitting testing and data to the FDA 

– In the US, some might argue that the ‘substantial equivalence’ principle is not adequate, and that all GM products should be tested, whether they cause a change or not

– Some might argue that not having long term effect testing results or studies on some GM products is a safety concern

– Some might argue that labelling requirements in the US need to change to better communicate which food products contain what specific GM ingredients 

– Some argue that there could be a conflict of interest in how seemingly closely aligned the FDA might be to GMO and biotech companies making submissions to get new GM crops or foods to market


Other Notes

Note that this information may change over time as GM regulatory processes are updated or change.

Make sure to cross check accuracy of data at the time of reading this guide.


Firstly, What Are GM Crops & Foods?

In this guide, we outline what GM crops and foods are, their potential uses, their engineered traits, give examples of them, and more.


Regulation Of GM Food & Crops In The United States

The US has what seems like less strict regulation of GM crops and foods compared to most other countries and region around the world, with the European Union being one example.


Bodies Who Regulate GM Crops & Foods

A crop might be assessed before it enters the environment, and a food might be assessed before it enters the food supply. outlines that ‘[Only once FDA, USDA and EPA assessments have been done on a GM crop] do foods from those crops enter [the] food supply in the US’ mentions thought that ‘Most developed genetically modified plants are reviewed by at least two of the agencies, with many subject to all three … [and] Final approval can still be denied by individual counties within each state [and in 2004, California did this]

More information on what those agencies do is:


– The Department of Agriculture (USDA)

The USDA regulates field testing of GM crops for research i.e. they assess a crop’s potential impacts on the environment and agriculture

They might also evaluates a plant’s potential to become a weed.


– The Environmental Protection Agency (EPA)

The EPA regulates plants with pest-resistant (essentially engineered pesticide) properties

Per ‘… the EPA assesses the environmental and food safety of the new substance produced by the plant that provides the pest resistance trait’


– The Food and Drug Administration (FDA)

The FDA has the responsibility of assessing the safety any GM crops that are eaten by humans as food, or animals (as animal feed)

Said another way, the FDA reviews plants that could enter or alter the food supply


Read more here about what the US Department Of Agriculture, Food & Drug Administration, and Environmental Protection Agency each individually do in the GM food and crop regulatory process in the US in the guide listed


There’s No Laws That Specifically Regulate A GM Crop’s Pre-Market Review

There’s no specific law that regulates genetically modified foods [or that requires specific testing from companies]

Instead [there’s] a voluntary “consultation” process for companies that want to sell new GM crops.

The companies conduct a safety assessment [themselves, on the risks of novel genetic traits, which vox lists, and] FDA scientists can ask for additional tests and data as needed.

Biotech companies [might comment that the safety assessment isn’t actually] “voluntary” in practice … [because] They end up carrying out a large number of tests and give the FDA whatever data the agency asks for.

… the FDA [ultimately has] the authority to require pre-market review for any substances not generally recognized as safe



More Information On The Pre Market Process For GM Crops & Foods

Before they reach the market, crops from genetically modified seeds are studied extensively to make sure they are safe for people, animals and the environment.  

Today’s genetically modified products are the most researched and tested agricultural products in history.

In fact, genetically modified seeds take an average of $130 million and 13 years to bring to market [and] more than 75 different tests are performed to ensure that GMOs are safe for people, animals and the environment.

Unlike new varieties of crops produced by other methods (e.g., mutagenesis, cross-species breeding), GMOs on the market today are tested for food safety, including for allergenicity, digestibility and toxicity.  

[Only once FDA, USDA and EPA assessments have been done on a GM crop] do foods from those crops enter our food supply.



What Principle Are Regulations Of GMOs Are Based On, & Why

The regulation of GMOs is based on the principle of “substantial equivalence”, meaning that the nutritional content of the GE crop and the non-GE crop that it originated from is the same.

What remains to be demonstrated is that the [new] protein introduced poses no greater risk to human health than non-GE crops, which is why studies on allergenicity and animal feeding studies are performed.

[The reason clinical trials aren’t done on GMOs the same way they are on drugs is that] Drugs are designed to cause a change in the human body … [whereas] … GMOs are designed to be equivalent to their non-GE counterparts: they aren’t drugs or nutritional supplements

[However] GE crops which ARE designed to impact human health, such as vitamin-A enriched rice, should be tested in humans to determine if the desired outcome is achieved

But such studies [and testing] are not the same as looking for unknown long-term effects. 



Regulation Of GM Food & Crops In Europe

Europe has more requirements and is much stricter than the US when it comes to GM crops and foods.


[In the European Union, regulatory policy means that] GM foods must be strictly evaluated on a case-by-case basis before they’re marketed.

… even after approval, individual EU countries can request to ban certain GM foods from their borders under a “safeguard” clause.

As a result, Europe tends to have far fewer genetically modified crops and foods [than some other countries]



The European Union differentiates between approval for cultivation within the EU and approval for import and processing. 

While only a few GMOs have been approved for cultivation in the EU, a number of GMOs have been approved for import and processing. 

The cultivation of GMOs has triggered a debate about the market for GMOs in Europe. 

Depending on the coexistence regulations, incentives for cultivation of GM crops differ.



All applications to develop a GM crop within the EU are assessed using the same regulatory system [and] This involves the European Food Safety Authority (EFSA), the regulatory authorities of independent member states and, finally, approval by the central European authorities in Brussels.

… final responsibility for local implementation [now rests with the] member states, who can now decide whether to opt out from cultivation of a GM crop that was authorized at the EU level.  

The assessment covers details supplied by the applicant, including the particular GM method used, information about the inserted DNA and characteristics of the plant, and results from animal feeding trials, where appropriate.

Applications also include an environmental assessment, which examines the possible interactions between the GM crop and factors like soil and other organisms in the ecosystem.  



Regulation Of GM Food & Crops In The UK

The UK has regulation on GM crops internally, and also between the UK and other countries.



GM crops cannot be grown, either for experiments or commercial farming, without approval by the appropriate regulatory agency, in the UK by DEFRA.

The movement of GM crops or food between countries is also regulated.

Details of this process vary from country to country but the same objectives underlie all regulation; that the novel GM crop is safe for human or animal health and the environment.


Regulation Of GM Food & Crops In Australia

Australia has Standards/Codes, and also a regulating body that looks at the risks of, assesses safety of, and assesses the labelling of GM organisms and GM products.


The resource explains regulation of GM crops and foods in Australia. Our paraphrased notes are:

GM crops are regulated by both the Commonwealth and state governments

[There is a Regulator who identifies the risk and assesses the safety of a GM organism against its conventional counterpart during experiments, growing, transporting, importing]

Australian and imported GM foods are assessed for their safety and labelling requirements … [with Standards/Codes] on a case by case basis

FSANZ look at risks that arise as a result of the altered genes, risks that come with the intended or unintended use of the product, and if any conditions of use are needed to enable the safe use of the food.

It must be shown to be as safe and nutritious as its conventional counterpart.

[Some States in Australia have a complete ban on the the growing of GM crops, some only allow some GM crops to be grown, and some allow a range of GM crops to be grown. These are listed in the resource]


GMO Food Labelling In The United States vs Other Countries

The US and Australia are examples of two countries with differences in labelling of GM foods at the commercial level.

The US seems has less strict requirements, and less requirements overall compared to Australia.


United States

… labelling of GMO products … is not required in the United States and no distinction between marketed GMO and non-GMO foods is recognized by the US FDA (




[Imported GM ingredients] are unlikely to be labelled as containing GM ingredients. 

By law, food that contains GM protein or ‘novel DNA’ must be labelled.

And GM foods that have an altered characteristic (e.g. soy beans with increased oleic acid content) compared to the non-GM counterpart must be labelled.

[However, there are exemptions, and lists these exemptions.]

[Two examples of exemptions are] meat, dairy and eggs from animals fed GM feedstock, … [and] unintentionally present GM ingredients of no more than 1%


Potential Way To Approach GM Crops & Foods Regulations In The Future has an idea for approaching the regulatory process of GMO’s in the future:

A reasonable balance between [the US and European] regulatory approaches is probably the most sensible way forward.

… Ideally, regulation should focus more on questions around the types of genetic modifications that we should allow in our crops than the way that they were introduced and where they came from.

… The primary priority for policymakers and regulators is to ensure crop safety.

Maintaining an open and transparent dialogue will be crucial so that the public can trust the decisions.

[For more information on’s proposal for potentially improving the way GM foods and crops are regulated, read the full resource at the provided link]


GMO Crops Grown In Different Countries 

This guide outlines the GMO crops that are grown in different countries around the world, as well as some of the countries that ban, partially ban or restrict GMOs in some way.














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