EU regulations on the traceability and detection of GMOs: difficulties in interpretation, implementation and compliance

Europe has probably the strictest GMO regulation in the world. Its objectives are to give maximum protection of public health and the environment, while at the same time providing a sciencebased regulatory structure where biotechnology can flourish. In contrast to the situation in the USA, European opinion on the health and environmental biosafety of GMOs has been highly polarized, with the result that the public has expressed the desire of having an informed choice in what they are eating. Consequently, the European Union has introduced legislation on the traceability and detection of GMOs, including labelling of food and feed containing GMOs, or derived products thereof, above a defined threshold of fortuitous presence. This review article summarizes EC regulations, directives and recommendations on traceability and labelling, and discusses the practical problems involved in their implementation. These include the definition of the labelling threshold and the units of measure, sampling of large cargos, mixtures of GMOs, stacked genes, unauthorized GMOs, unknown GMOs and asynchronous approval. The ways in which the EC integrated project Co-Extra is contributing to the resolution of these problems are also discussed.

[1]  P. Corbisier,et al.  Toward metrological traceability for DNA fragment ratios in GM quantification. 3. Suitability of DNA calibrants studied with a MON 810 corn model. , 2007, Journal of agricultural and food chemistry.

[2]  Knut G Berdal,et al.  The modular analytical procedure and validation approach and the units of measurement for genetically modified materials in foods and feeds. , 2004, Journal of AOAC International.

[3]  C. N. Gundry,et al.  Real-time multiplex PCR assays. , 2001, Methods.

[4]  Arne Holst-Jensen,et al.  Design of a DNA chip for detection of unknown genetically modified organisms (GMOs) , 2005, Bioinform..

[5]  D. J. Perry,et al.  Adventitious presence of GMOs: Scientific overview for Canadian grains , 2006 .

[6]  Monica Ermolli,et al.  First application of a microsphere-based immunoassay to the detection of genetically modified organisms (GMOs): quantification of Cry1Ab protein in genetically modified maize. , 2007, Journal of agricultural and food chemistry.

[7]  G. Gruère An Analysis of Trade Related International Regulations of Genetically Modified Food and Their Effects on Developing Countries , 2006 .

[8]  José Luis La Paz,et al.  A new PCR‐CGE (size and color) method for simultaneous detection of genetically modified maize events , 2006, Electrophoresis.

[9]  Maddalena Querci,et al.  Development and applications of real-time PCR standards for GMO quantification based on tandem-marker plasmids , 2005 .

[10]  Yann Devos,et al.  Risk assessment of GM stacked events obtained from crosses between GM events , 2007 .

[11]  Kristina Gruden,et al.  Accreditation of GMO detection laboratories: Improving the reliability of GMO detection , 2006 .

[12]  Bu-Young Yi,et al.  Detection methods for biotech cotton MON 15985 and MON 88913 by PCR. , 2007, Journal of agricultural and food chemistry.

[13]  Roy Macarthur,et al.  Model for tuning GMO detection in seed and grain , 2007, Nature Biotechnology.

[14]  Massimiliano Marini,et al.  Food safety: screening tests used to detect and quantify GMO proteins , 2006 .

[15]  Markus Lipp,et al.  Polymerase chain reaction technology as analytical tool in agricultural biotechnology. , 2005, Journal of AOAC International.

[16]  Wallace E. Huffman,et al.  Production, Identity Preservation, and Labeling in a Marketplace with Genetically Modified and Non-Genetically Modified Foods1 , 2004, Plant Physiology.

[17]  Neville Craddock Flies in the soup—European GM labeling legislation , 2004, Nature Biotechnology.

[18]  K. Bradford,et al.  Identity Preservation of Agricultural Commodities , 2002 .

[19]  Arne Holst-Jensen,et al.  Coherence between legal requirements and approaches for detection of genetically modified organisms (GMOs) and their derived products. , 2006, Journal of agricultural and food chemistry.

[20]  Carlo Brera,et al.  Kernel lot distribution assessment (KeLDA): a study on the distribution of GMO in large soybean shipments , 2006 .

[21]  M. Feinberg,et al.  Quantitation of 35S promoter in maize DNA extracts from genetically modified organisms using real-time polymerase chain reaction, part 2: interlaboratory study. , 2005, Journal of AOAC International.

[22]  A. Holst-Jensen Chapter 8 – Sampling, detection, identification and quantification of genetically modified organisms (GMOs) , 2007 .

[23]  Claudia Paoletti,et al.  Simulating Kernel Lot Sampling: the Effect of Heterogeneity on the Detection of GMO Contaminations , 2003 .

[24]  H Schimmel,et al.  Detection and traceability of genetically modified organisms in the food production chain. , 2004, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[25]  Jean-Louis Laffont,et al.  Testing for adventitious presence of transgenic material in conventional seed or grain lots using quantitative laboratory methods: statistical procedures and their implementation , 2005, Seed Science Research.

[26]  Yukihiro Goda,et al.  Novel reference molecules for quantitation of genetically modified maize and soybean. , 2002, Journal of AOAC International.

[27]  I. Arvanitoyannis,et al.  Presentation and comments on EU legislation related to food industries–environment interactions: sustainable development, and protection of nature and biodiversity – genetically modified organisms , 2006 .

[28]  Markus Lipp,et al.  Immunoassay as an analytical tool in agricultural biotechnology. , 2006, Journal of AOAC International.

[29]  Marc De Loose,et al.  Event-specific plasmid standards and real-time PCR methods for transgenic Bt11, Bt176, and GA21 maize and transgenic GT73 canola. , 2005, Journal of agricultural and food chemistry.

[30]  Ioannis S. Arvanitoyannis,et al.  An update of EU legislation (Directives and Regulations) on food‐related issues (Safety, Hygiene, Packaging, Technology, GMOs, Additives, Radiation, Labelling): presentation and comments , 2005 .

[31]  D. Kershen Adventitious Presence: Inadvertent Commingling and Coexistence Among Farming Methods , 2005 .

[32]  Yves Bertheau,et al.  Trends in analytical methodology in food safety and quality: monitoring microorganisms and genetically modified organisms , 2007 .

[33]  Kaoru Wakabayashi,et al.  Quantitative detection system for maize sample containing combined-trait genetically modified maize. , 2005, Analytical chemistry.

[34]  H. Akiyama,et al.  Quantification of Genetically Modified Soybeans Using a Combination of a Capillary-Type Real-Time PCR System and a Plasmid Reference Standard , 2006, Bioscience, biotechnology, and biochemistry.

[35]  Marc Loose,et al.  Cloned plasmid DNA fragments as calibrators for controlling GMOs: different real-time duplex quantitative PCR methods , 2004, Analytical and bioanalytical chemistry.

[36]  T. Pan,et al.  Event-specific real-time detection and quantification of genetically modified Roundup Ready soybean. , 2005, Journal of agricultural and food chemistry.

[37]  Florian Weighardt European GMO labeling thresholds impractical and unscientific , 2006, Nature Biotechnology.

[38]  T. Pan,et al.  Detection of genetically modified maize MON810 and NK603 by multiplex and real-time polymerase chain reaction methods. , 2004, Journal of agricultural and food chemistry.

[39]  Marta Hernández,et al.  Development and comparison of four real-time polymerase chain reaction systems for specific detection and quantification of Zea mays L. , 2004, Journal of agricultural and food chemistry.

[40]  M. Feinberg,et al.  Quantification of the 35S promoter in DNA extracts from genetically modified organisms using real-time polymerase chain reaction and specificity assessment on various genetically modified organisms, part I: operating procedure. , 2005, Journal of AOAC International.

[41]  Yves Bertheau,et al.  Detection methods and performance criteria for genetically modified organisms. , 2002, Journal of AOAC International.

[42]  A. Kobilinsky,et al.  Minimum cost acceptance sampling plans for grain control, with application to GMO detection , 2005 .

[43]  G. Moschini,et al.  Identity Preservation and Labeling of Genetically Modified Products: System Design and Enforcement Issues , 2004 .

[44]  Claire Halpin,et al.  Gene stacking in transgenic plants--the challenge for 21st century plant biotechnology. , 2005, Plant biotechnology journal.