The EU Legislation on GMOs - An Overview

Genetic modification, also known as "genetic engineering¿ or ¿recombinant-DNA technology¿ was first applied in the 1970¿s. As an application of modern biotechnology, this technique allows selected individual genes to be transferred from one organism into another, also between non-related species. It is therefore one of the methods to introduce novel traits or characteristics into micro-organisms, plants and animals. The products obtained from this technology are commonly called "Genetically Modified Organisms (GMOs). Genetically modified organisms (GMOs) are officially defined in the EU legislation as "organisms in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination". The most common types of GMOs that have been developed and commercialised so far are genetically modified crop plant species, such as genetically modified maize, soybean, oilseed rape and cotton varieties. Such varieties have, in the main, been genetically modified to provide resistance to certain insect pests and/or tolerance to herbicides. The application of this technology is strictly regulated and the European Union has established an extensive legal framework on GMOs since the early 1990s. This specific legislation has two main objectives: - To protect health and the environment : a genetically modified organism (GMO) or a food product derived from a GMO can only be put on the market in the EU after it has been authorised on the basis of a detailed EU procedure based on a scientific assessment of the risks to health and the environment. - To ensure the free movement of safe and healthy genetically modified products in the European Union: once authorised on the basis of the strict EU GMO authorisation procedure, genetically modified products can be placed on the whole EU market. The entire corpus of European GMO legislation has been amended between 2000 and 2003, leading to the creation of a whole updated EU legal framework on GMOs as of 2003.JRC.DG.I.4-Molecular biology and genomic

Event-specific Method for the Quantification of Soybean CV127 using Real-time PCR

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out a validation study to assess the performance of a quantitative event-specific method on the soybean event CV127 (unique identifier BPS-CV127-9). The collaborative trial was conducted according to internationally accepted guidelines. In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, BASF Plant Science provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at unknown GM percentages (DNA/DNA)].The results of the international collaborative trial met the European Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm). The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.JRC.I.3-Molecular Biology and Genomic

Event-specific Method for the Quantification of Maize MON87460 Using Real-time PCR: Validation Report and Validated Method

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, in collaboration with the European Network of GMO Laboratories (ENGL), has carried out a collaborative study to assess the performance of a quantitative event-specific method to detect and quantify the MON 87460 transformation event in maize DNA (unique identifier MON-8746Ø-4). The collaborative study was conducted according to internationally accepted guidelines (1, 2). In accordance with Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and with Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Monsanto Company provided the detection method and the samples (genomic DNA extracted from homogenised seeds containing the transformation event and from conventional homogenised seeds). The EU-RL GMFF prepared the validation samples (calibration samples and blind samples at defined GM percentages [DNA/DNA], unknown to laboratories participating to the collaborative study). The collaborative trial involved twelve laboratories from ten European countries. The results of the international collaborative study met the ENGL performance requirements. The method is, therefore, considered applicable to the control samples provided, in accordance with the requirements of Annex I-2.C.2 to Commission Regulation (EC) No 641/2004. The results of the collaborative study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.JRC.I.3-Molecular Biology and Genomic

Verification Report on the extraction and analysis of GM pollen DNA in honey

Following the judgment of 06 September 2011 on GM honey by the European Court of Justice (legal case C-442-09), the European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF) established by Regulation (EC) No 1829/2003, performed an in-house study to test the extraction and PCR analysis of genomic DNA from genetically modified pollen in honey. The present report documents on an extraction method for isolation and analysis of pollen DNA present in honey, including the isolation and analysis of isolated genomic pollen DNA using real-time PCR on commercial honey samples and honey samples spiked with various levels of GM MON 810 pollen.JRC.I.3-Molecular Biology and Genomic

Event-specific Method for the Quantification of Soybean MON 87701 Using Real-time PCR

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out a validation study to assess the performance of a quantitative event-specific method on the soybean event MON 87701 (unique identifier MON-877Ø1-2). The collaborative trial was conducted according to internationally accepted guidelines. In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Monsanto Company provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at unknown GM percentages (DNA/DNA)]. The results of the international collaborative trial met the European Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm). The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.JRC.I.3-Molecular Biology and Genomic

Event-specific Method for the Quantification of Maize 98140 by Real-time PCR

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out a validation study to assess the performance of a quantitative event-specific method on the maize event 98140 (unique identifier DP-098140-6). The collaborative trial was conducted according to internationally accepted guidelines. In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Pioneer Overseas Corporation provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at unknown GM percentages(DNA/DNA)]. The results of the international collaborative trial met the European Network of GMO Laboratories (ENGL) method performance requirements (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm). The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.JRC.I.3-Molecular Biology and Genomic

Report on the Verification of the Performance of a MON810 Event-specific Method on Maize Line MON810 Using Real-time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF) (see Regulation EC No 1829/2003), has carried out an in-house verification study to assess the performance of the MON810 method to detect and quantify the MON810 transformation event in maize DNA (unique identifier MON-¿¿810-6). The method has previously undergone a full validation on samples represented by certified reference material. The present verification was conducted in order to verify the performance of the validated method on the control samples provided by the applicant as requested by Annex I.2.C.2 to Regulation (EC) No 641/2004 stating that ¿The method shall be applicable to samples of the food or feed, to the control samples and to the reference material, which is referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003.¿ The study was conducted according to internationally accepted guidelines (1,2). In accordance with Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, the CRL-GMFF carried out a verification of the event-specific detection method previously validated by the Federal Institute for Risk Assessment (BfR) in collaboration with the American Association of Cereal Chemists (AACC), Joint Research Centre (JRC) of the European Commission (EC), Institute for Reference Material and Measurement (IRMM), the Institute for Health and Consumer Protection (IHCP) and GeneScan, Berlin; Monsanto Company provided the control samples (MON810 maize seeds and conventional maize seeds) used in the verification. The JRC prepared the in-house verification samples (calibration samples and blind samples at different GM percentages). The results of the in-house verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to the results of the full validation (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of CRL-GMFF in-house verification study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm).JRC.DDG.I.4-Molecular biology and genomic

Fuzzy-logic based procedures for GMO Analysis

A monitoring system for GMOs (Genetically Modified Organisms) and GMO-derived products in the food and feed chains has been established in the European Union (EU) - . In previous letters to your journal - , challenges were highlighted to implement EU regulations for labeling of products containing GMOs. Test methods for monitoring GMOs are based mainly on the Polymerase Chain Reaction (PCR).JRC.I.3-Molecular Biology and Genomic

In-house validation of an Event-specific Method for the Quantification of Oliseed Rape MS1 using Real-time PCR

The European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF), established by Regulation (EC) No 1829/2003, has carried out an in-house validation study to assess the performance of a quantitative event-specific method on the oilseed rape event MS1 (unique identifier ACS-BN004-7). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Syngenta Crop Protection AG) provided the detection method and the control samples. The EU-RL GMFF prepared the validation samples [calibration samples and blind samples at different GM percentages (DNA/DNA)]. The results of the in-house validation were evaluated with respect to method acceptance criteria and method performance requirements recommended by the European Network of GMO Laboratories (ENGL) (http://gmocrl.jrc.ec.europa.eu/guidancedocs.htm) and to its applicability in different real-time PCR instruments. The results obtained indicate that the method complies with the ENGL criteria. The method is therefore considered applicable to the control samples provided, in accordance with the requirements of Annex I – 2.C.2 to Regulation (EC) No 641/2004.JRC.I.3-Molecular Biology and Genomic

Report on the Verification of the Performance of MON89034 and NK603 Event-specific Methods on the Maize Event MON89034 x NK603 Using Real-Time PCR

The JRC as Community Reference Laboratory for GM Food and Feed (CRL-GMFF), established by Regulation (EC) No 1829/2003, has carried out a verification study to assess the performance of two quantitative event-specific methods on the maize event MON89034 x NK603 (unique identifier MON 89Ø34-3 x MON-ØØ6Ø3-6) which combines the MON89034 and NK603 transformation events. The two methods have been validated individually on single-trait events, to detect and quantify each event in maize samples. This study was conducted according to internationally accepted guidelines (1, 2). In accordance to Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed and to Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003, Monsanto Company provided the detection methods and the control samples: genomic DNA extracted from seeds of MON89034 x NK603 maize (lot GLP-0701-17954-S), genomic DNA extracted from seeds of non-GM maize (lot GLP-0612-17871-S). The JRC prepared the verification samples (calibration samples and blind samples at different GM percentages). The results of the verification study were evaluated with reference to ENGL method performance requirements (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and to the validation results on the individual parental events (http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). The results of this study are made publicly available at http://gmo-crl.jrc.ec.europa.eu/.JRC.DDG.I.4-Molecular biology and genomic