GMO Method Validation
The European Union has taken a cautious approach regarding the acceptance of GM crops and products derived from GMOs. Before GMO-based products can be commercialised in the European Union, they need to go through an authorisation process which is well defined by EU GMO legislation. Biotech companies who whish to bring their product on the market, need to submit an application for each GM event. Part of the application dossier includes a very specific method of detection for that particular GMO. Such method needs to be assessed for its general performance (fit-for-purpose). The Institute for Health and Consumer Protection (IHCP) takes account of this task through the validation of the submitted methods.
Moreover, many new GMO-based products are coming onto the market worldwide. Not all of them may be authorised for marketing in the European Union. The efficient detection of GMOs, authorised and non-authorised, is therefore becoming ever more important.
The placement of GM food and feed on the European market requires that a well defined authorisation process is followed. The different steps in this process are briefly outlined below.
Important steps in the GMO authorisation procedure
The Institute for Health and Consumer Protection (IHCP) is host to the European Reference Laboratory for GM Food and Feed (EURL-GMFF) which is a key part of this European authorisation procedure. It works closely with national reference laboratories (NRLs) in the EU Member States and carries out the scientific assessment and validation of a detection method for a particular GM event. A comprehensive overview of the EU GMO legislation, including answers to practical questions, can be found at DG SANCO's website dedicated to GMOs. A list of authorised GMOs in the European Union can be found as well.
The European Reference Laboratory for GM Food and Feed (EURL-GMFF)
The European Reference Laboratory for GM Food and Feed (EURL-GMFF) is the body responsible for the scientific assessment and validation of GMO detection methods for food, animal feed or seeds in the EU’s authorisation process. It became operational in 2004 with clear duties and tasks defined by the European legislation on GMOs.
Duties and tasks of the EURL-GMFF
The EURL-GMFF is assisted by the European Network of GMO Laboratories (ENGL). This network comprises over 70 national reference laboratories from the 27 Member States of the EU, as well as Norway and Switzerland (see ENGL membership list ). Other countries such as Turkey and China can attend the various meetings as observers.
This network of GMO laboratories strives to harmonise and standardise across Europe the methods for the sampling, detection, identification and quantification of GMOs.
The ENGL primarily will help the EURL-GMFF with the validation of the proposed methods of detection through participation in collaborative trials for assessing the performance of the particular method. In addition, during regularly organised meetings and working groups with its members, the ENGL will discuss technical issues for GMO analysis such as the detection of unauthorised GMOs, appropriate statistical analysis of data, problematics of sampling and measurement of content, etc. Various guidelines for the biotech companies are prepared and regularly updated, e.g. for the performance requirements of analytical methods. These guidelines can be retrieved from the EURL-GMFFs' website.
Emergency measures can be taken in the EU when unauthorised GMOs are detected on the market. These measures imply that the European Commission may impose a requirement for certificates on particular shipments arriving in the EU, assuring that they are free of a particular unauthorised GMO. Also, the European Commission can demand the testing of market products for a specific unauthorised GMO, and this in all Member States through the EU national reference laboratories.
Since 2005 there have been 3 such cases of EU unauthorised GMOs: maize Bt10, rice Bt63 and rice LL601. Other unauthorised GMOs have been detected (maize E32, flax FP967) though did not lead to emergency measures because of effective actions taken by the exporting country (sampling and confinement of suspect shipments). In all cases, the EURL-GMFF provided a quick response through the verification of a specific detection method for the GMO in question and publication of the method on its website.
The detection of unauthorised GMOs on the EU market is reported by the EU national reference laboratories and the Member States via DG SANCO's Rapid Alert System for Feed and Food (RASFF). Through an online searchable database, information on unauthorised GMOs in the EU can be retrieved by event name, date of reporting, location of the detection.
Useful documents and links