Revised Guidance on the Detection of Genetically Modified Rice Originating from China Using Real-Time PCR for the detection of P-35S, T-nos and Cry1Ab/Ac

In support to the Commission Implementing Decision 2013/287/EU , amending Decision 2011/884/EU , the European Union Reference Laboratory for Genetically Modified Food and Feed (EU-RL GMFF) prepared a revision of the previously published guidance document. This document provides further guidance on the correct use of the methods indicated in the Decision, including measures aimed at improving the specificity of the detection approach. This revised guidance, as its previous version, is exclusively meant for the implementation of Decision 2013/287/EU and should not be used for other screening activities. Laboratories should apply it only in conjunction with good standard practices for testing for the presence of GMOs (e.g. use of appropriate controls).JRC.I.3-Molecular Biology and Genomic

Report on the Verification of the Performance of MS8, RF3 and GT73 Event-specific PCR-based Methods Applied to DNA Extracted from GM Stack MS8xRF3xGT73 Oilseed Rape

A joint application was submitted by Bayer CropScience AG and Monsanto Company to request the authorisation of genetically modified stack (GM stack) MS8xRF3xGT73 oilseed rape (tolerant to glufosinate ammonium and glyphosate) and all sub-combinations of the individual events as present in the segregating progeny, for food and feed uses, and import and processing, in accordance with articles 5 and 17 of Regulation (EC) NoN° 1829/2003 on GM Food and GM Feed. The unique identifier assigned to GM stack MS8xRF3xGT73 oilseed rape is ACS-BNØØ5-8xACS-BNØØ3-6xMON-ØØØ73-7. The GM stack MS8xRF3xGT73 oilseed rape has been obtained by conventional crossing between three genetically modified oilseed rape events: MS8, RF3 and GT73, without any new genetic modification. The EU-RL GMFF has previously validated individually, and declared fit for purpose, the detection methods for the single events MS8, RF3 and GT73 (see http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx). In line with the approach defined by the ENGL (http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf) the EU-RL GMFF has carried out only an in-house verification of the performance of each validated method when applied to genomic DNA extracted from GM stack MS8xRF3xGT73 oilseed rape. The results of the in-house verification led to the conclusion that the individual methods meet the ENGL performance criteria also when applied to genomic DNA extracted from the GM stack MS8xRF3xGT73 oilseed rape.JRC.I.3-Molecular Biology and Genomic

Report on the use of EU Reference Methods and JRC decision tools for GMO analysis

To ensure harmonised scientific and technical approaches for GMO detection the European Union Reference Laboratory for GM Food and Feed (EURL GMFF) at the Joint Research Centre (JRC) has developed a freely accessible database, called “GMOMETHODS" providing a state-of-the-art catalogue of EU reference methods for GMO analysis. The EURL GMFF launched in 2015 a survey to assess the use of these EU reference methods by the official GMO control laboratories in the EU and to collect information on non-EU reference methods possibly employed for the same purpose. The survey aimed also to verify if, and to which extent, laboratories use two decision supporting tools, the JRC GMO-Matrix and Event-Finder which are available on the web site of the EURL GMFF. The survey was also directed to verify the types and frequencies of modifications possibly implemented in the protocols of the validated methods used by the official control laboratories. Results from the survey indicate that almost all official control laboratories (98 %) are using event-specific EU reference methods for quantifying GMOs while a lower number of laboratories is using EU reference methods for qualitative analyses (55 % for element-specific methods and 40 % for construct-specific methods). The use of qualitative non-EU reference methods for screening purposes may reflect the laboratory needs when facing rapid alert emergencies of quickly implementing analytical strategies for detecting non-authorised GM events. Indeed genetically modified crops have continued to increase globally, both in terms of approval status and event/trait diversification. In those cases methods validated in collaborative studies and having the status of EU-reference methods are generally not yet available. In the survey close to half of the respondents (41 %-47 %) declared also to employ to different extents the two JRC decision supporting tools, GMO-Matrix and Event-Finder. Interestingly the survey shows that almost half of the protocols of the reference methods used by the laboratories are somewhat adapted to laboratory specific conditions, mainly with respect to the master mix and the reaction volume of the polymerase chain reactions (PCR) while the primers and probes are never modified. In all cases, the impact of these modifications had been verified by the control laboratory to ensure the equivalence between the adapted and the original protocols. Without such proof, the laboratory would lose its mandatory accreditation. Moreover, participants in Comparative Testing schemes have achieve generally high score performance using those adapted methods suggesting that the modifications implemented do not affect analytical sensitivity, trueness and precision of the original protocols. The outcome of the 2015 survey reveals therefore that the combined efforts of the EURL GMFF and ENGL have been successful for enhancing harmonisation in quantitative GMO analysis by the adoption of scientific and technical approaches. This achievement allows the consistency of results for GM labelling and an equal-level playing field in the EU Member States.JRC.F.5-Food and Feed Complianc

Report on the In-house Validation of a DNA Extraction Method from Oilseed rape Grains and Validated Method

In accordance with relevant EU legislation , Pioneer Overseas Corporation provided to the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF) a DNA extraction method for oilseed rape grains and the relevant samples (ground oilseed rape grains). In line with its mandate , the EU RL GMFF has conducted an in-house validation of this DNA extraction method. To this end it tested the DNA extraction method on the samples provided and evaluated its performance in terms of DNA yield, integrity and quality. The in-house validation study confirmed that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL , and that it satisfies the provisions of Annex I-2.C.2 to Regulation (EC) No 641/2004. The method is therefore fit for the purpose of producing rapeseed DNA of suitable quantity and quality for subsequent PCR-based analysis. This report is published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.htm.JRC.I.3-Molecular Biology and Genomic

Report on the Single-laboratory Validation of a PCR-based Detection Method for Identification of Florigene™ 26407 GM Carnation

Suntory Holdings Ltd has submitted an application for marketing (C/NL/09/02) of a genetically modified carnation line 26407 (Unique identifier: IFD-26407-2). In this context, the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF) was asked to carry out a singlelaboratory validation of the performance of a polymerase chain reaction (PCR)-based method for detecting and identifying the carnation GM line 26407, developed by the applicant. This report describes the results of this validation, carried out by the EU-RL GMFF with control samples provided by the applicant. The method is a duplex end-point PCR, where a carnation (taxon) target and a transgenic sequence are detected simultaneously. The limit of detection (LOD) of the method has been established to be at least 10 copies for the taxon-specific target and between 50 and 10 copies for the GM target, based on haploid genome copy number. The event-specificity of the method was assessed by the applicant as being sufficient. The EU-RL could verify that the taxon-specific primers correctly detect the endogenous gene target in genomic DNA of a conventional carnation line (negative control) and in the genomic DNA of the GM carnation line, while the GM target is detected by the GM specific primers only in genomic DNA of 26407 GM line (positive control).JRC.I.3-Molecular Biology and Genomic

Report on the In-house Validation of a DNA Extraction Method from Soybean Grains and Validated Method

In accordance with relevant EU legislation , Dow AgroSciences LLC provided to the European Union Reference Laboratory for GM Food and Feed (EU-RL GMFF) a DNA extraction method for soybean grains and the relevant samples (ground soybean grains). In line with its mandate , the EU RL GMFF has conducted an in-house validation of this DNA extraction method. To this end it tested the DNA extraction method on the samples provided and evaluated its performance in terms of DNA yield, integrity and quality. The in-house validation study confirmed that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL , and that it satisfies the provisions of Annex I-2.C.2 to Regulation (EC) No 641/2004. The method is therefore fit for the purpose of producing soybean DNA of suitable quantity and quality for subsequent PCR-based analysis.JRC.I.3-Molecular Biology and Genomic

60 years of science for society: 1957-2017: An artist's view

The Joint Research Centre, the European Commission's science and knowledge service, turned sixty in 2017. Established in 1957 as part of the European Atomic Energy Community (Euratom) with the initial name Joint (Nuclear) Research Centre it was created as a collaboration with the original six Member States to do research on the development of nuclear technology for civilian purposes. After its foundation the JRC established its first four sites (Ispra/Italy, Karlsruhe/Germany, Petten/The Netherlands, and Geel/Belgium). From the exclusive focus on nuclear research, over the years the JRC expanded into many non-nuclear research fields and today its mission is to support EU policies with relevant scientific evidence through knowledge management. In the booklet three main periods of the JRC's history are reflected: the early years from 1957 to 1967 when the sites and international teams of young brilliant scientists were set up; the phase from 1968 to 1986, a period of transition and redefinition of priorities beyond nuclear research; and the period from 1987 until present during which the fifth JRC site in Seville (1994) was established and in 2016 the DG JRC developed its actual mission and strategy.The "JRC's Strategy 2030" defined the JRC as the science and knowledge service of the Commission, supporting EU policies with independent scientific evidence throughout the whole policy cycle. Having the life of the citizen at its core, the JRC contributes as a knowledge producer and knowledge manager with its activities dedicated to secure energy supplies, economy and finance, a healthy and safe environment, sustainable mobility and consumer health and safety providing its expertise to the policy making process. This booklet attempts to tell the story of the JRC with a new science-based artistic visualisation of information and data contained in 60 years of archived documents. On the basis of an initial body of documents the JRC's history is depicted as a visual experiment with keywords and their relations over time. The interplay of science, ICT and art becomes a journey through JRC's history.JRC.A.3-Inter-institutional, International Relations and Outreac

Report on the Verification of the Performance of 1507, 59122, MON 810 and NK603 Event-specific PCR-based Methods applied to DNA extracted from Stack Maize 1507 x 59122 x MON 810 x NK603

An application was submitted by Pioneer Overseas Corporation to request the authorization of the genetically modified maize stack 1507 x 59122 x MON 810 x NK603, resistant against certain lepidopteran pests, protected against corn rootworm larvae, and glufosinate-ammonium and glyphosate tolerant, and all sub-combinations of the individual events as present in the segregating progeny, for food and feed uses, and import and processing, in accordance with articles 5 and 17 of Regulation (EC) N° 1829/2003 GM Food and GM Feed. The unique identifier assigned to 1507 x 59122 x MON 810 x NK603 maize is DAS-Ø15Ø7-1xDAS-59122-7xMON-ØØ81Ø-6xMON-ØØ6Ø3-6. The genetically modified maize line 1507 x 59122 x MON 810 x NK603 has been obtained by conventional crossing of four genetically modified single maize events: 1507, 59122, MON 810 and NK603 without any new genetic modification. The EU-RL GMFF has previously validated, and declared fit for purpose, the detection methods for the single events 1507, 59122, MON 810 and NK603 (see: http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm). In line with the approach defined by the ENGL (http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf) the EU-RL GMFF therefore has carried out only an in-house verification of the performance of each validated method when applied to DNA extracted from 1507 x 59122 x MON 810 x NK603. The herewith reported in-house verification study lead to the conclusion that the individual methods meet the ENGL performance criteria also when applied to DNA extracted from the GM maize stack 1507 x 59122 x MON 810 x NK603.JRC.I.3-Molecular Biology and Genomic

Report on the Verification of the Performance of Bt11, MIR162, 1507 and GA21 Event-specific Methods on the Bt11 x MIR162 x 1507 x GA21 Maize Using Real-time PCR

An application was submitted by Syngenta Crop Protection AG to request the authorisation of genetically modified Bt11 x MIR162 x 1507 x GA21 maize (tolerant to herbicides containing glufosinate ammonium and glyphosate and resistant to important lepidoptera maize pests) and all sub-combinations of the individual events as present in the segregating progeny, for food and feed uses, and import and processing, in accordance with articles 5 and 17 of Regulation (EC) N° 1829/2003 GM Food and GM Feed (1). The unique identifier assigned to Bt11 x MIR162 x 1507 x GA21 maize is SYN-BTØ11-1 x SYN-IR162-4 x DAS-Ø15Ø7-1 x MON-ØØØ21-9. Bt11 x MIR162 x 1507 x GA21 maize has been obtained by conventional crossing between four genetically modified maize events: Bt11, MIR162, 1507 and GA21. No new genetic modification was used for the development of Bt11 x MIR162 x 1507 x GA21 maize. The EU-RL GMFF has previously validated individually, and declared fit for purpose, the detection methods for the single events Bt11, MIR162, 1507, GA21 and has published the corresponding reports http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx; therefore, in line with the approach defined by the ENGL (Annex 1, http://gmo-crl.jrc.ec.europa.eu/doc/Min_Perf_Requirements_Analytical_methods.pdf) the EU-RL GMFF has carried out only an in-house verification of the performance of each validated method when applied to DNA extracted from Bt11 x MIR162 x 1507 x GA21. The results of the in-house verification study were evaluated with reference to ENGL requirements and to the validation results on the individual events; as a result, the EU-RL GMFF concludes that the individual methods meet the ENGL criteria and can also be applied to Bt11 x MIR162 x 1507 x GA21 maize. This report is published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx.JRC.I.3-Molecular Biology and Genomic

Event-specific Method for the Quantification of Soybean DAS-68416-4 Using Real-time PCR: Validation report

In line with its mandate the European Union Reference Laboratory for GM Food and Feed (EU RL GMFF), in collaboration with the European Network of GMO Laboratories (ENGL), has validated an event-specific polymerase chain reaction (PCR) method for detecting and quantifying soybean event DAS-68416-4 (unique identifier DAS-68416-4). The validation study was conducted according to the EU-RL GMFF validation procedure (http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm) and internationally accepted guidelines. In accordance with current EU legislation , Dow AgroSciences LLC provided the detection method and the positive and negative control samples (genomic DNA extracted from soybean kernels harbouring the DAS-68416-4 event as positive control DNA, genomic DNA extracted from conventional soybean kernels as negative control DNA). The EU-RL GMFF prepared the validation samples (calibration samples and blind samples at different GM percentage [DNA/DNA]), organised an international collaborative study and analysed the results. The study confirms that the method meets the method performance requirements as established by the EU-RL GMFF and the ENGL and according to Annex I-2.C.2 to Regulation (EC) No 641/2004 and it fulfils the analytical requirements of Regulation (EU) No 619/2011JRC.I.3-Molecular Biology and Genomic