The number of genetically modified crops and the area cultivated with them are steadily increasing worldwide. In the EU, only one GM maize is currently cultivated but many other GMO crops are authorised for food and feed use. However, products derived from or containing GMOs are strictly controlled with a zero tolerance for unauthorised GMOs. Authorisation is depending on a thorough risk assessment and on the availability of a validated method for detecting, identifying, and quantifying the GMO in food or feed. Biotech companies, who wish to bring their product to the market, need to submit an application for each GM launch. Part of the application dossier includes a very specific method of detection of each particular GMO. The JRC is responsible for validating these methods through its European Union Reference Laboratory for GM Food and Feed hosted by the Institute for Health and Consumer Protection in Ispra, Italy. The currently used methods rely on certified reference materials (CRM) which are produced by the JRC's Institute for Reference Materials and Measurements in Geel, Belgium.
Genetically Modified Organisms (GMOs) are organism with genes that have been altered in a way not naturally occurring through breeding or mating. Typically their genome includes an "insert", a strand of DNA, often stemming from the genome of another species, which could not be crossed with the host species by natural breeding.
As part of its effort to ensure that the official control laboratories in all EU Member States have the same capacity to reliably detect, identify and quantify GMOs, the JRC not only validates, but also develops and optimises GMO testing methods, runs the European Network of GMO Laboratories (ENGL) and organises proficiency testing for control laboratories.
In its Institute for Prospective Technological Studies in Seville the JRC hosts two Bureaux, the European GMO Socio-Economics Bureau (ESEB) to define indicators and methodologies to produce socio-economic assessments on the implications of the cultivation and use of GMOs, and the European Coexistence Bureau (ECoB), producing guidelines for EU farming on technical segregation measures to achieve coexistence between GM, conventional and organic agriculture.
Directorate-General for Health and Food Safety – Genetically Modified Food and Feed
GMO method validation
Food and feed made from or containing GMOs can only be allowed on the EU market once the GMOs have received authorisation from the EU, following a procedure which includes a thorough risk assessment by the European Food Safety Agency (EFSA) based on a comprehensive authorisation dossier provided by the applicant, i.e. the GMO developer/owner.
The EU policy on GMO respects the consumer's right-to-know by ensuring clear labelling and traceability of GMOs. This requires reliable methods for their detection, identification and quantification (for authorised GMO) in food, feed, and the environment.
Reliability means that the methods must provide trustworthy data wherever and by whomever they are used.
The validation verifies that the method is "fit-for-purpose", i.e.
• For un-authorised GMOs the purpose of the method is to correctly and reliably detect and if possible identify GM material, without the need to quantify.
• For authorised GMOs, or GMOs authorised elsewhere and already undergoing the EU authorisation process, the purpose of the method includes quantification.
The EURL GMFF declares methods to be valid for the detection, identification and quantification only if they meet pre-defined method performance criteria which are established in close collaboration with the European Network of GMO Laboratories (ENGL).
It is the responsibility of the applicant to develop and include such a method in the application dossier and it is the responsibility of the JRC, through the EURL GMFF, to confirm that the method is valid, i.e. fit-for-purpose.
The validation of GMO methods is carried out by the EURL GMFF according to a five step procedure:
1. Completeness check: is the information provided by the GMO developer complete?
2. Dossier assessment: has the applicant correctly tested the method and are the test results OK?
3. In house verification: Does the method work well in the laboratory of the EURL GMFF on control samples provided by the GMO developer?
4. International validation trial: Does the method function adequately in 12 qualified laboratories, all receiving the same test samples?
5. Reporting: The results of the validation steps are summarised in a report that then is provided to EFSA, as part of its overall opinion on the GMO, published on the EURL GMFF website, and included into the GMO Methods database.
So far, the EURL GMFF has validated more than 80 GMO analysis methods that can detect, identify, and in most cases also quantify specific GM versions of soybean, cotton, maize, oilseed rape, potato, rice and sugar beet.
Many current GMOs include in their inserts so called "elements", shorter strings of DNA that are typical indicator for GMOs. If one or several of these elements are found in a food or feed product where they do not belong, a GMO is present. Methods targeting these elements are also validated by the EURL GMFF and can be found in the GMOmethods database. They are used by control laboratories for an initial screening of food or feed samples for the presence of any GMO and allow detecting unauthorised, i.e. illegal GMOs for which no specific method is available.
Thresholds and labelling
In case of unavoidable "contamination" of non GM material with authorised GMOs, the critical threshold is 0.9%, i.e. if 0.9% or more of the ingredient (e.g. all the maize material in a compound feed) is GMO, the product needs to be labelled as "containing GMO", allowing the customer to decide. GMOs that are authorised elsewhere and are in the EU authorisation process may be present in feed with up to 0.1% of the ingredient. The validation of the relevant specific method therefore needs to confirm that the method is reliably able not only to detect and identify a GMO but also to correctly quantify it.
Harmonised, reliable, cost-efficient, and fast GMO analysis is essential for implementing the EU policy on GMOs.
In the EU, GMO analysis is based on the detection of known DNA sequences (targets) that are characteristic for GMOs in raw materials (seed, plant tissue) or in food or feed products. To this end DNA is extracted from the sample to be tested for GMO presence and is run through a series of Polymerase Chain Reaction (PCR) experiments to determine if the target DNA sequences, i.e. the target that characterise the GM insert and the related species, are present or not. For authorised GMOs, quantification is then done by comparing the amount of the GM-specific targets to the amount of the related species specific targets that are found.
GMO identification and quantification
A GMO is an organism that has in its genome a string of DNA, an "insert" that is "foreign" to the original species genome and that gives the modified organism a trait, a characteristic that has not been there, without the insert.
Current state-of-the-art methods for GMO analysis verify if a target DNA-sequence that is known to characterise the insert/GMO is present or not. If this target spans the connection between the insert and the host genome, its presence identifies clearly the GMO; if it is somewhere in the insert, it could be found in a group of GMOs, and if it targets an element that is present in many GMOs, it can be used to confirm presence/absence of a GMO (detection) but not for identifying the GMO. However, if a group of elements is detected, the JRC GMOmatrix helps identifying all GMOs that carry that corresponding group of elements. Alternatively it helps to define which methods needs to be run if a certain range of GMOs are potentially present.
The quantification of GMOs is based on the comparison of the GM-fraction (%) of an ingredient with the total amount of that ingredient. This percentage is established by comparing the number of appearances of a DNA sequence that is present in both the GM and non-GM cells (reference gene) and the number of appearances of the GM-specific sequence.
GMO testing capacity building
Over the past decade the JRC has accumulated considerable expertise in GMO detection, identification and quantification. Since several years it is proactively spreading this knowledge to help build and harmonise global capacity for GMO detection. Training and capacity building activities help laboratories in third countries to apply the same methods for GMO detection, identification and quantification. Over the years a number of regional GMO laboratory networks have developed and cooperate with the JRC. This will allow GMO producing countries to control their exports with the same methods used in the EU for controlling imports.
The JRC runs several highly specialised databases and web-based tools facilitating work in bioinformatics analysis. At present, we apply Bioinformatics to genetic data, i.e. to DNA sequences, for the detection, identification and quantification of Genetically Modified Organisms (GMOs) in plants. However, our expertise and the underlying infrastructure may also be applied to genetic information in other research areas like food fraud, medical diagnostics and environment.
Certified Reference Materials for GMO analysis
For the implementation of the EU legislation that regulates the authorisation and the labelling of GMOs, the JRC develops, produces and distributes certified reference materials. These are used for the calibration or quality control of GMO quantification measurements.
Reference materials for GMO analysis