GMO testing and analysis

A Genetically Modified Organism (GMO) is an organism whose genetic material has been altered using genetic engineering techniques. These commonly include soybean and maize. Many countries around the world have enacted laws to restrict the levels of GMOs in food products.

GMOs were commercially introduced on a large-scale in the mid-90s, with the cultivation of genetically modified (GM) crops –such as soybean, maize, cotton and oilseed rape– that were genetically modified to confer novel characteristics that are normally absent in nature, such as resistance to certain pathogens or tolerance to herbicides (e.g. Round-up Ready crops resistant to glyphosate). As of 2016, the acreage of these crops worldwide amounted to 185 million hectares (Ketler et al, 2018).

GMOs are now widely used in many fields such as the food, agricultural, zootechnical and medical sector (e.g. production of human insulin, recombinant vaccines, etc.).

In Europe, GMO release into the environment is regulated by Directive no. 2001/18/EC, where also the definition of GMOs can be found. A genetically modified organism (GMO) is defined as an organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination, and with the techniques specified in Annex I.

It is only in 2003 that the GMO term applies to food and feed, with Regulations no. 1829/2003 and no. 1830/2003 governing GMO labeling, traceability and placement on the market.

Genetically modified food and feed are defined as those containing GMOs (e.g. GMO soybean biscuit), made up of GMOs or produced from GMOs (meaning foods or ingredients obtained from GMOs, in which neither transgenic DNA nor proteins are found, e.g. soy oil).

In Europe, there are many authorized and commonly marketed GMOs and they all come from plants: maize, soybean, rapeseed, beet and cotton. On the other hand, their cultivation is extremely limited, with only some Member States (including Portugal and Spain) allowing a limited cultivation (MON 810 maize).

Even though most European countries do not grow GMOs, it does not mean that they are GMO-free, as GMOs that can be marketed (after a specific authorization and registration according to relevant procedures) and therefore end up in food, feed and other types of products.

For example, genetically modified soy is a significant portion of the global supply and it is plausible to think that much of it ends up in food or feed. In Europe, around 90% of the soy used as feed is genetically modified; 87% of Italian compound feed is genetically modified, due to 85%-90% of imported soybean and soybean meal from the countries characterized by the highest percentage of biotech crops on their surface (Agricultural Biotechnology Annual, 2017), such as USA, Brazil and Canada (ISAAA, Global Status of Biotech/GM crops: 2017).

GMO food and feed labeling

The label of genetically modified food and feed must clearly indicate the presence of GMOs when they exceed 0.9%.
A negative analytical testing though, does not automatically demonstrate that the product is GMO-free food business operators must trace GMOs and products derived from GMOs during all the phases of the production and distribution chain. When GMOs are below 0,9% there is no need to indicate their presence on the label, provided that this presence is accidental or technically unavoidable; in this case the food operators must demonstrate the competent authorities that they have taken all the appropriate measures to avoid their presence.
The same tolerance applies to organic food products.
Some GMOs are not tolerated (as occurs for some varieties of oilseeds rape GMOs and derived products), they have been withdrawn from the market and need to be monitored according to Commission Implementing Decision (EU) no. 2016/2268.
In seeds, where GMO cultivation is limited as it is throughout the European Union, many GMO varieties cannot be cultivated and therefore be present in seeds, unless differently specified.


Many food products on the market claim to be GMO-free, but this type of claim is actually not regulated at EU level. That leaves much room left to Member States that can legislate autonomously on the topic, by proposing guidelines or regulatory provisions governing GMO-free labeling. Some Member States such as Belgium and Sweden have decided to prohibit this type of labeling.

The levels of tolerance for the random and technically unavoidable presence of GMOs differs depending on the country of origin whether or not legislation exists, on guidelines and voluntary systems, which propose voluntary protocols for non-GMO certification with specific limits for food, feed and seeds.
Italian Government does not have a position on GMO-free labeling; many companies and organizations have developed their own voluntary rules for GMO-free labeling by claiming specific limits to be applied to food and feed.

GMO analysis

A GMO is an organism whose genome was modified by introducing a foreign DNA sequence, a gene or better a transgene. For this reason, the most appropriate technique for GMO detection tests the presence of the DNA sequence of a given GMO (called "event"). Moreover, in contrast to proteins, DNA is a relatively stable molecule that can be isolated from highly processed goods and amplified by PCR.
To date, the technique of choice for GMO analysis is Real-Time PCR, which allows qualitative and quantitative DNA analysis, by means of oligonucleotides and fluorescent probes specific for one or more GMOs.

By PCR assays it is possible to carry out:

  • a screening test, by targeting DNA sequences, the so-called gene elements (eg. 35S promoter, NOS terminator, etc.), which are common to groups of GMOs
  • event-specific tests that can identify the DNA of specific GMO events.

When testing for GMOs, it is important to combine both the screening and event-specific approach. While performing a screening test, the more are the markers used, the more reliable the analysis is, but there is also a number of specific GMO events that cannot be screened like that and have to be addressed through specific reactions, depending on the sample composition.

The reference body for GMO analysis in Europe is JRC (Joint Research Center), which approved several reference methods for the analysis of numerous GMO events in maize, soy, cotton, rice, rapeseed, potato and beet.

Mérieux NutriSciences service on GMOs

Mérieux NutriSciences provides complete GMO analytical service for the food and feed sectors, with a large screening of GMOs coming from soybean, maize, rapeseed, rice, cotton, sugar-beet, wheat and also salmon (the first GM animal approved on the food market).
We offer accredited GMO screening and specific identification/quantification of GMO events by means of quantitative Real-Time PCR in a variety of food and feed matrices.

Our methods are based on official JRC and ISO methods, and guarantee Minimum Performance Requirements according to JRC (the European Reference laboratory for GMO testing).
Our laboratories are ISO 17025:2017 and ISO 9001:2015 certified.

We participate to 2 FAPAS Proficiency Test per year, for every accredited analytical method on GMOs.


Sector-specific GMO analysis: what do you need?


Food business operators have to trace GMOs and derived products during all the phases of the food production and distribution chains. Mérieux NutriSciences identifies and quantifies GMOs in food products: tofu, soybean oil, beverages, hamburgers, meat substitutes, cream ice creams, gummy sweets, fruit jellies that are all soy-based products; grains, corn oil and flour, snacks, corn syrup that can contain maize; snack or baked products that can contain rapeseed oil or cotton oil, etc.

Among other things, organic food must not contain GMOs, nor it has to be made with ingredients containing/derived from GMOs. Mérieux NutriSciences identifies GMOs in organic products according to legislation and voluntary certifications.

European legislation is silent on the use of GMO ingredients in baby food and single Member States apply their laws. Italy for example, prohibits GMO use in baby food production, while French manufacturers have self-disciplined themselves not to use them.
Mérieux NutriSciences identifies and quantifies GMOs in baby food products including infant and follow-on formulas.

All GMOs authorized in the European Union can be used for feed production. Mérieux NutriSciences analyzes GMOs in feed products and ingredients and provides a full service for the entire sector, including QS accreditation and GMP+ certification.

GMOs authorized in the European Union can be used in the production of pet food. Pet food marketing is focused on the ‘free-from’ concept, with “GMO-free” claims dominating the scene, in particular among European consumers.
Mérieux NutriSciences provides full GMO analysis in petfood.

In 2017 the first transgenic animal - the salmon by the American company AquaBounty Technologies’s – was authorized for human consumption on the American and Canadian market by FDA, with an unprecedented regulatory decision.
The AquAdvantage GM salmon, which reaches commercial size in half time with less food, looks the same as ordinary salmon, but it doesn’t have to show on the label that it is a GMO.
This has raised much concern over product traceability in the European market where the GM AquAdvantage salmon is not approved.
Mérieux NutriSciences can detect the presence of the GM salmon AquAdvantage and can therefore provide a valuable tool to analytically confirm that imported products meet the specific requirements.

GMOs cultivation is very limited throughout Europe. Many GMO varieties are authorized for marketing but cannot be grown, depending on Countries and GMO varieties. Mérieux NutriSciences provides GMO testing in seeds.

Mérieux NutriSciences analyzes specific GMO sets from different plants:

  • GMOs from soybean
  • GMOs from maize
  • GMOs from rapeseed
  • GMOs from rice
  • GMOs from potato
  • GMOs from cotton
  • GMOs from sugar-beet

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