GMO analysis (molecular characterisation of the GM insert, development of detection methods, quantification of the GMO content) is an integral component in the development of new GM plants, in breeding, seed production and verification programmes. It is also essential for product authenticity and traceability, in the export and import of agricultural products, for labelling and for ascertaining regulatory compliance of GMOs in different countries.
The Institute for Health and Consumer Protection (IHCP), through its European Reference Laboratory for GM Food and Feed (EURL-GMFF), is engaged in the validation of the detection methods which are provided by the applicant companies. Other GMO-related topics that are studied include:
- molecular characterisation of GMO events
- development of GMO detection methods
- investigation of various technical approaches for the molecular analysis of GM inserts and reference systems
- formulation of GMO sampling plans
- statistical analysis of GMO derived data.
The Institute also provides scientific and technical support to EU policy makers and the European Food Safety Authority (EFSA) on issues related to GMO sampling, detection, and quantification. This is important in the context of regulating not only authorised but also unauthorised GMOs on the European market which may give rise to the need for new or revised legislation.
Research into new avenues of detection and analysis
The Institute is actively researching new analytical approaches for identifying and quantifying GMOs as well as to understand their molecular characteristics.
In recent years, the development of tools to detect several GMOs simultaneously has received increasing attention. The Institute has recently developed a system for the simultaneous detection of 39 GMOs, both authorised and non-authorised in the EU. This system (commonly known as pre-spotted plates) is based on already validated event-specific methods of GMO detection. Parallel research has led to the development of screening systems, based on the presence of well defined elements in the GM inserts (such as 35S promoter, nos terminator, …). Integration of such screening systems with software programmes will allow an efficient interpretation of the data.
Molecular characterisation and stability studies have been carried out. Further investigations are ongoing into technologies for the detailed analysis of the genetically modified make-up of GM crops and relevant reference genes.
In past years, softwares for statistical analysis of GMO methods derived data were developed. Currently, application of fuzzy logic to interpretation of GMO methods data is being investigated.
Ad hoc scientific and technical support to customer Directorate Generals and the European Food Safety Agency
On request of DG SANCO and/or DG ENV, the institute provides advice and reports on GMO related topics which can lead to new and/or modified pieces of GMO legislation.
The institute was involved in 2003 with the drafting of the regulation on GM food and feed and derived regulations. In 2000, a significant input for sampling plans was furnished, leading to a sampling recommendation. When unauthorised GMOs in the EU were discovered the institute co-drafted with DG SANCO emergency regulations and was also involved in the repealing of emergency measures. Technical advice is furnished for issues such as the definition and applicability of the Unit of Measurement for GMOs and solutions for establishing a low level presence tolerance of unauthorised GMOs. Currently, a revision of the existing GMO legislation is ongoing to which the institute is contributing.
Scientific assistance is also provided to EFSA when so requested. This may involve advice with the bio-informatics analysis on GMO derived DNA sequences, or wet lab experiments to analyse specific scientific questions.
The key to identifying genetically modified organisms (GMOs) is through analysis of their DNA sequence. Such investigation can be carried out with wet-lab experiments but equally important are the in silico analyses of respective DNA sequences.
The GMO application dossiers submitted in the context of seeking EU approval for the specific GM event.
, which is hosted by the Institute for Health and Consumer Protection (IHCP), contains the non-publicly available DNA sequences of genetically modified organisms together with related information. All data has been primarily obtained from The DNA sequence records are available to EFSA for GMO assessments and made accessible on request (restricted user-access). Common bioinformatics applications (BLAST, ClustalW, EMBOSS package etc.) allow immediate bioinformatics analyses to be undertaken.
The database on the notifications for GMO experimental releases into the environment and for commercial purposes (GMOINFO) contains data about the field trials for GMOs and about GMOs which have been authorised for sale on the European market.
The database contains a summary of the notifications (known as SNIFs) which are fed into the system by the national authorities. The information in the database includes: organism, type of genetic modification, period of release, purpose of the release, and additional data as required by the current legislation.