Detectability and traceability of GMO products

A number of GM plants are authorised in the EU as food and feed. Authorised GMOs are imported in significant quantities from third countries, mainly for use as feed. Imports into the EU containing GMOs must be labelled accordingly. Regulatory controls include both documentation checks and laboratory controls. In addition, the controls for GMOs also include deliveries that are declared as conventional or organic. Standardised detection methods are used by the competent bodies of the Member States, the national reference laboratories, to be able to detect GMOs qualitatively and quantitatively in the samples taken during controls. The latter is of importance because in the area of authorised GMOs, a labelling limit of 0.9% applies, provided that these traces are adventitious or technically unavoidable (Regulation (EC) No 1830/2003). For non-authorised GMOs, zero tolerance applies and no such GMOs must be detectable in analytical controls.

These event-specific detection methods must be made available in the EU by the applicant as part of the authorisation applications for GMO market authorisation. The methods are then validated by the European Reference Laboratory in cooperation with the national reference laboratories of the Member States and thus checked for their quality. A detection method validated in this way constitutes a requirement for authorisation. These requirements also apply to GMOs authorised for cultivation in the EU.

In addition, controls are also carried out in the EU for GMOs that are not authorised in the EU. Here, too, detection methods have been developed by various institutions and working groups, e.g. the working group "Development of methods for the identification of foodstuffs produced with the aid of genetic engineering processes" in accordance with §64 of the German Food and Feed Code. Detection methods were developed here primarily for those GMOs that had already been found in the supply chains or whose presence was suspected. These methods are based on publicly available information regarding the GMOs in question and are mostly based on the detection of so-called screening elements. Event-specific detection methods can only be developed if the relevant (sequence) information is available. It is important to note in this context that there is as yet no internationally uniform procedure for the development and publication of detection methods that support the detection of GMOs that are not authorised in the EU.

The problem of the lack of uniform or sometimes non-existent detection methods for non-authorised GMOs is exacerbated by the development of GMOs produced using new genetic engineering methods (e.g. by means of genome editing). This is because products modified in this way are not legally classified as GMOs in many countries – necessary information from official approval procedures is therefore often not available. In addition, genome editing makes it possible to create very small changes in the genome. Although these changes can be detected analytically, the challenge is to prove that the corresponding mutation was produced by means of genetic engineering and was not produced conventionally or arose naturally. This circumstance led to discussions at EU level regarding a possible adaptation of the genetic engineering legislation for plants that were produced with cisgenesis or targeted mutagenesis. The process initiated by the EC is currently underway and also includes the issue of traceability and labelling.

However, in addition to technical evidence, the traceability of a product (i.e. the documentation of a GMO through the entire supply chain) is a possible complementary basis for control and labelling. When importing GMOs into the EU, feed (raw materials) are of particular importance. Many different stakeholders are involved along the supply chain, from seeds in the country of origin to the use of the final product by consumers. Currently, the traceability of feed supplies is particularly important for ensuring GM-free and organic products. This traceability is also supported by laboratory controls. However, the current practice of traceability is primarily based on the quality of the product and specific information with regard to potentially contained GMOs (e.g. the contained varieties according to the catalogue) is partly not available.

Against the background of the above-mentioned problem, the aim of the project is to support both the analytical detection and the traceability of products that may contain GMOs.