Genetic engineering has already produced impressive results in biological research. The gene transfer and cloning methods are changing biotechnology into an innovative activity with potentially great impact on health care, on chemical, pharmaceutical and food industries, on the agricultural and the natural environment. It has thus attracted a great deal of attention from the public and regulatory authorities. There is a need to reconcile technological progress with safety assurance and civic acceptance. Technologies are regulated according to the inherent risk evaluated, through criteria based upon existing scientific evidence, new rigorous information, and/or records of safe applications and good performances. This should also apply to biotechnology. The title Scientific-Technical Backgrounds for Biotechnology Regulation is only intended to indicate that regulatory provisions for biotechnological activities should be in agreement and not in open contradiction with scientific knowledge and established technological experience.

The detection of genetically modified organisms (GMOs) is becoming very complex, with new GMOs, approved and unapproved, constantly entering world markets. Traceability and labelling of GMOs is defined in regulations worldwide, demanding accurate and reliable testing to support the requirements of legislation.

ThisBrief provides the current state-of-the-art on all key topics involved in GMO testing and is a source of detailed practical information for laboratories. Special focus is given to qualitative and quantitative real-time PCR analysis relevant to all areas where detection and identification rely on nucleic acid-based methods. The following topics, important for testing laboratories, are also discussed: organization of the laboratory, focusing on aspects of the quality system and methods for testing, validation and verification of methods, and measurement uncertainty. The Brief also discusses the new challenges of GMOs and novel modified organisms, using new technologies, and the possible solutions for GMO detection, including bioinformatics tools. Finally, legislation on GMOs and sources of information on GMOs are provided, which are relevant not only to testing laboratories, but to anyone interested in GMOs.

The authors of this Brief have many years of experience in GMO testing, development of real-time PCR methods, implementation of quality system requirements, validations and verification of methods, and measurement uncertainty. The National Institute of Biology is a highly qualified research laboratory and a National Reference Laboratory, which also performs routine analyses of food, feed and seed. The Institute for Health and Consumer Protection of the European Union Joint Research Centre has extensive knowledge and experience of GMO detection. It hosts the European Union Reference Laboratory for GM Food and Feed in addition to chairing the European Network of GMO Laboratories.

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