GMO Testing & Analysis

A Genetically Modified Organism (GMO) refers to an organism that has undergone genetic material alterations using genetic engineering techniques. Common examples of GMOs include soybean and maize. Numerous countries worldwide have implemented laws to regulate the presence of GMOs in food products.

In the mid-90s, the agricultural industry introduced GMOs on a large scale, primarily cultivating genetically modified (GM) crops such as soybean, maize, cotton, and oilseed rape. These GM crops possess novel characteristics not typically found in nature, such as resistance to certain pathogens or tolerance to herbicides (e.g., Round-up Ready crops resistant to glyphosate). By 2016, the global acreage dedicated to these crops amounted to 185 million hectares (Ketler et al., 2018).

Various sectors, including food, agriculture, zootechnics, and medicine (e.g., production of human insulin, recombinant vaccines, etc.), now extensively utilize GMOs.

Regulations on GMOs

Directive no. 2001/18/EC regulates the release of GMOs into the environment in Europe and also provides the definition of GMOs. According to this directive, a GMO is an organism with genetically altered material not naturally occurring through mating or natural recombination.

Regulations no. 1829/2003 and no. 1830/2003 officially introduced the term “GMO” for food and feed in 2003. These regulations govern GMO labeling, traceability, and market placement.

GM food and feed either contain GMOs (e.g., GMO soybean biscuit), are composed of GMOs, or are derived from GMOs. The latter refers to GMO-derived foods or ingredients without transgenic DNA or proteins (e.g., soy oil).

In Europe, there are numerous authorized and commonly marketed GMOs. They all originate from plants (maize, soybean, rapeseed, beet, cotton). However, only certain Member States (including Portugal and Spain) permit restricted cultivation, such as MON 810 maize. This results in highly limited cultivation of these crops.

Although most European countries do not cultivate GMOs, this does not imply that they are GMO-free. GMOs that receive specific authorization and registration according to relevant procedures can still be marketed. They consequently find their way into food, feed, and other products.

For instance, genetically modified soy constitutes a significant portion of the global supply. It is then reasonable to assume that a substantial amount ends up in food or feed. In Europe, feed manufacturers utilize GM soy for approximately 90% of their feed production. 87% of Italian compound feed is GM due to the high percentage of imported soybean and soybean meal from countries characterized by extensive biotech crop cultivation (Agricultural Biotechnology Annual, 2017), such as the USA, Brazil, and Canada (ISAAA, Global Status of Biotech/GM crops: 2017).

GMO Food & Feed Labelling

The labeling of genetically modified food and feed must clearly indicate the presence of GMOs when they exceed 0.9%. However, a negative analytical GMO testing does not automatically demonstrate that the product is GMO-free. Food business operators are responsible for tracing GMOs and products derived from GMOs throughout all stages of production and distribution. If GMOs are below 0.9%, there is no need to indicate their presence on the label, provided that their presence is accidental or unavoidable. In such cases, food operators must demonstrate to the competent authorities that they have taken all appropriate measures to prevent their presence.

The same tolerance level applies to organic food products. However, authorities do not tolerate certain GMOs, including specific varieties of GM oilseed rape and the products derived from them. The market has withdrawn these GMOs, and they require monitoring as per Commission Implementing Decision (EU) no. 2016/2268.

In the case of seeds, with limited GMO cultivation throughout the European Union, many GMO varieties cannot be cultivated or present in seeds unless explicitly specified.

GMO-Free?

Many food products available on the market claim to be GMO-free, but at the EU level, there is no actual regulation on these types of claims. This leaves Member States with the autonomy to legislate on the topic by proposing guidelines or regulatory provisions for GMO-free labelling. Certain Member States, like Belgium and Sweden, have chosen to prohibit this type of labeling.

The tolerance levels for the accidental and technically unavoidable presence of GMOs vary depending on the country of origin and whether legislation, guidelines, or voluntary systems are in place. These voluntary systems propose protocols for non-GMO certification with specific limits for food, feed, and seeds.

The Italian Government does not have an official position on GMO-free labeling. However, many companies and organizations have developed their own voluntary rules for GMO-free labelling, specifying certain limits for food and feed.

GMO Testing

A GMO is an organism whose genome has been modified by the introduction of a foreign DNA sequence, typically known as a transgene (or gene). To detect GMOs, the most appropriate technique involves testing for the presence of specific DNA sequences, also referred to as “events.” Unlike proteins, PCR (polymerase chain reaction) allows the isolation and amplification of DNA (a relatively stable molecule) from highly processed goods

Currently, Real-Time PCR is the preferred technique for GMO analysis. It enables qualitative and quantitative analysis of DNA using specific oligonucleotides and fluorescent probes designed for one or more GMOs.

PCR assays allow for the utilization of:

Screening tests, which target common DNA sequences known as “gene elements” (e.g., 35S promoter, NOS terminator) shared by groups of GMOs.
Event-specific tests that can identify the DNA of specific GMO events.

It is important to employ both screening and event-specific approaches when testing for GMOs. Screening tests improve analysis reliability with multiple markers, but cannot detect specific GMO events. These events require specific reactions tailored to the sample composition.

The Joint Research Center (JRC) serves as the reference body for GMO analysis in Europe. It has approved several reference methods for the analysis of numerous GMO events in crops.

Our Services Dedicated to GMO Analysis

Mérieux NutriSciences offers comprehensive GMO analytical services for the food and feed sectors. We provide extensive GMO screening for various crops, including soybean, maize, rapeseed, rice, cotton, sugar-beet, wheat, and even salmon. Salmon became the first genetically modified animal approved for the food market.

Our services include accredited GMO screening, as well as specific identification and quantification of GMO events using quantitative Real-Time PCR in a wide range of food and feed matrices.

We follow official methods from JRC and ISO, ensuring compliance with Minimum Performance Requirements. Additionally, our laboratories are certified with ISO 17025:2017 and ISO 9001:2015 standards.

To maintain the highest quality standards, we actively participate in two FAPAS Proficiency Tests per year for each accredited analytical method used for GMO analysis.