Release Of Genetically Modified Organisms Research Articles

Is the Covid‐19 Pandemic a Game Changer in GMO Regulation?

SummaryThe Covid‐19 pandemic has the potential to act as a much‐needed trigger for changes to the European Union regulations around genetically modified organisms (GMOs). There are two main reasons for this potential development. Firstly, the majority of vaccines under development would fall under Directive 2001/18 on the release of GMOs into the environment. The European Parliament and Council agreed that, in Recital 17 of Regulation 2020/1043, the current approval procedure for GMOs is not well‐suited to improving public health. This was driven in particular by the need for vaccine approval in the context of the Covid‐19 pandemic; and a more appropriate approval procedure would be applied. Secondly, several studies have shown that the Covid‐19 crisis reduces the purchasing power of households and increases their vulnerability in the case of food shortages; and consequent increases in food prices further exacerbate the nutritional problems of vulnerable groups. Modern plant breeding has the potential to provide less expensive solutions to support vulnerable groups. As the Covid‐19 crisis drains government budgets, views around GMOs in the EU may change in the light of positive experiences from the approval of Covid‐19 vaccines.

Food/Feed and Environmental Risk Assessment of Insect Resistant Genetically Modified Maize 1507 for Cultivation, Import, Processing, Food and Feed Uses under Directive 2001/18/EC and Regulation (EC) No 1829/2003 (C/ES/01/01, C/NL/00/10, EFSA/GMO/NL/2004/02)

Food/Feed and Environmental Risk Assessment of Insect Resistant Genetically Modified Maize 1507 for Cultivation, Import, Processing, Food and Feed Uses under Directive 2001/18/EC and Regulation (EC) No 1829/2003 (C/ES/01/01, C/NL/00/10, EFSA/GMO/NL/2004/02)

The EU regulatory framework on genetically modified organisms (GMOs).

The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.

Gene drives as a new quality in GMO releases-a comparative technology characterization.

Compared to previous releases of genetically modified organisms (GMOs) which were primarily plants, gene drives represent a paradigm shift in the handling of GMOs: Current regulation of the release of GMOs assumes that for specific periods of time a certain amount of GMOs will be released in a particular region. However, now a type of genetic technology arises whose innermost principle lies in exceeding these limits—the transformation or even eradication of wild populations. The invasive character of gene drives demands a thorough analysis of their functionalities, reliability and potential impact. But such investigations are hindered by the fact that an experimental field test would hardly be reversible. Therefore, an appropriate prospective assessment is of utmost importance for an estimation of the risk potential associated with the application of gene drives. This work is meant to support the inevitable characterization of gene drives by a comparative approach of prospective technology assessment with a focus on potential sources of risk. Therein, the hazard and exposure potential as well as uncertainties with regard to the performance of synthetic gene drives are addressed. Moreover, a quantitative analysis of their invasiveness should enable a differentiated evaluation of their power to transform wild populations.

A novel governance framework for GMO: A tiered, more flexible regulation for GMOs would help to stimulate innovation and public debate.

EMBO Reports (2019) e47812 New breeding techniques, in particular gene editing technologies such as CRISPR, have great potential to transform agri‐ and aquaculture. However, realising this potential depends in large part on the regulation of genetically engineered products. Given the rapid technological progress in molecular biology, and the widely diverging interests of stakeholders, there is an urgent need for novel approaches regarding the governance of genetically engineered crops and animals along with a restart of the public dialogue. Importantly, regulation should stimulate technological development while simultaneously maintaining governmental oversight and control; however, the EU's current regulatory regime for genetically modified organisms (GMOs) is not necessarily conducive for stimulating development of new products. We therefore propose a differentiated regulatory framework that would considerably lower the regulatory hurdles for certain uses of genetic engineering, and stimulate innovation and development to the benefit of society, while allowing flexibility in terms of risk assessment. We further call upon relevant authorities and governments to advance policy development and facilitate a goal‐oriented and inclusive public dialogue. The aim is to harness the potential of gene technologies in a safe, beneficial, sustainable and ethically justifiable manner while maintaining public trust. ### The Current Situation In July 2018, after years of regulatory uncertainty in the EU, the European Court of Justice decided that all gene‐edited organisms are subject to the approval requirements that currently apply to the deliberate release of GMO under EU Directive 2001/18/EC [1]. The court's decision has been criticised by many European scientists [2], [3], [4], [5], who assert that it jeopardises the future of agriculture and food‐related research and development in the EU. In particular, many critics highlight that the current regulatory landscape will prevent the use of gene editing to rapidly develop novel agricultural products to deal …

Next-generation sequencing as a tool for the molecular characterisation and risk assessment of genetically modified plants: Added value or not?

BackgroundLegislations and international organizations provide a framework to ensure proper risk assessment of Genetically Modified Organisms (GMO). With regard to the deliberate release of GMO as food or feed, applications for Genetically Modified Plants (GMP) typically contain data for the molecular characterisation at the nucleic acid level based on Southern blot and polymerase chain reaction analysis in combination with Sanger sequencing. Along with the diverse range of applications of next-generation sequencing (NGS) in genomic research, some recent research projects and product developers explored the use of NGS as an alternative tool for meeting the data requirements for the molecular characterisation of GMPs in view of their risk assessment. Scope and approachBy means of a literature survey and information collected through the organisation of an international workshop, we investigated whether NGS can replace and/or complement the currently used techniques for molecular characterisation of GMP taking into account the possibilities and current bottlenecks of NGS technologies and recent developments in molecular breeding. Key findings and conclusionsWe conclude that although NGS might present clear advantages for product developers, NGS currently does not always offer a significant added value with respect to the risk assessment of GMPs. However, the approaches used so far may soon be further challenged by the fast evolution in NGS technologies and also by the recent developments in molecular breeding of plants. We postulate that setting up a common workflow for the generation of relevant and interpretable data by NGS would facilitate a scientifically sound assessment of GMPs.

Schizophrenic Stakes of GMO Regulation in the European Union

EU legislation on genetically modified organisms (GMOs) is the most stringent legislation governing the matter in the world, laying down strict conditions relating to labelling, traceability, threshold and release on the market. In light of a recent Commission proposal to amend Directive 2001/18, which currently regulates the release of GMOs on the European market, this article asks whether and on what basis such stringency is justified. This is done through an in depth analysis of the EU regulatory framework for GMOs while at the same time highlighting the multiple interests at stake (environmental, scientific, industrial, political, national and European).This article argues that the European institutions should proceed to amend Directive 2001/18 on the basis of a detailed examination of the benefits as well as the risks that GMOs present. This article, however, raises concern that the European regulatory framework will focus exclusively on the risks or on political concerns relating to GMOs instead, for it is a fear of GMOs that seems to permeate the system from top to bottom.

The structuring of GMO release and evaluation in EU law

Genetically modified organisms (GMOs) and their behavior in the environment are complex and can only be assessed if the different components are distinguished. This article examines, how by EU law the real causation processes from the GMO release to various endpoints are dissected, individually analysed and then again viewed in their entirety. In addition, the articles includes, how the intellectual process of assessment is divided into the steps of tiered generation, shared submission and structured evaluation of relevant knowledge. The framework proposed for such an examination allows to identify strengths and weaknesses of GMO risk assessment in the EU.

Risk assessment of genetically modified organisms (GMOs)

Risk assessment is a procedure normally carried out prior to decision-making on the release of genetically modified organisms (GMOs) into the environment. Most countries dealing with the release of GMOs have appropriate guidelines. The objectives of this paper are to critically examine the risk assessment provisions of the Malaysian Biosafety Act (2007), and to compare it with several risk assessment provisions in the Cartagena Protocol, as well as regulations in developed countries. There are inadequacies in the risk assessment provisions of the Malaysian Biosafety Act (2007 Act), compared to those of the Cartagena Protocol, as well as those found in European Commission Directives. Although the central objective of the 2007 Act was similar to the Cartagena Protocol, the Act was found to be very basic with only a brief provision on risk assessment and there is no specific coverage on the socio-economic and ethical aspects as well as the precautionary approach. It is hoped that these inadequacies will be improved upon, in order to bring the Malaysian Biosafety Act closer to the level seen in the biosafety laws of more developed countries and to ensure adequate level of protection for the Malaysian people against any adverse effects of GMOs and products. Key words: Risk assessment, biosafety, Malaysian Biosafety Act 2007, genetically modified organisms (GMOs).

Cultivation of GMO in Germany: support of monitoring and coexistence issues by WebGIS technology

BackgroundIn Germany, apart from the Amflora potato licensed for cultivation since March 2010, Bt-maize MON810 is the only genetically modified organisms (GMO) licensed for commercial cultivation (about 3,000 ha in 2008). Concerns have been raised about potential adverse environmental impacts of the GMO and about potential implications on the coexistence between conventional and genetically modified production. These issues should be considered on a regional base. The objective of this article is to describe how GMO monitoring that is required after risk assessment and GMO release can be complemented by a Web-based geoinformation system (WebGIS). Secondly, it is also described how WebGIS techniques might support coexistence issues with regard to Bt-maize cultivation and conservation areas. Accordingly, on the one hand, the WebGIS should enable access to relevant geodata describing the receiving environment, including information on cultivation patterns and conservation areas containing protected species and habitats. On the other hand, metadata on already established environmental monitoring networks should be provided as well as measurement data of the intended GMO monitoring. Based on this information and based on the functionality provided by the WebGIS, the application helps in detecting possible environmental GMO impacts and in avoiding or identifying coexistence problems.ResultsThe WebGIS applies Web mapping techniques to generate maps via internet requests and offers additional functionality for analysis, processing and publication of selected geodata. It is based on open source software solely. The developments rely on a combination of the University of Minnesota (UMN ) MapServer with the Apache HTTP server, the open source database management systems MySQL and PostgreSQL and the graphical user interface provided by Mapbender. Important information on the number and the location of Bt-maize fields were derived from the GMO location register of BVL. The "WebGIS GMO Monitoring" provides different tools allowing for the application of basic GIS techniques as, for instance, automatic or interactive zooming, distance measurements or querying attribute information from selected GIS layers. More sophisticated GIS tools were implemented additionally, e.g. a buffer function which enables generating buffers around selected geo-objects like Bt-maize fields. Finally, a function for intersection of different maps was developed. The WebGIS comprises information on the location of all Bt-maize fields in Germany according to the official GMO location register of the Federal Office of Consumer Protection and Food Safety between 2005 and 2008. It facilitates, amongst others, access to geodata of GMO fields and their surroundings and can relate them with additional environmental data on climate, soil, and agricultural patterns. Furthermore, spatial data on the location of flora-fauna-habitats and environmental monitoring sites in the federal state of Brandenburg were integrated.The WebGIS GMO monitoring was implemented according to the concept for an "Information System for Monitoring GMO" (ISMO) which was designed on behalf of the German Federal Agency for Nature Conservation. ISMO includes hypotheses-based ecological effects of GMO cultivation and suggests checkpoints for GMO monitoring to test whether impacts may be observed in the receiving environment.In contrast to the public GMO register, the WebGIS GMO monitoring enables mapping of GMO fields and provides relevant geodata describing environmental and agricultural conditions in their neighbourhood of the cultivation sites as well as information derived from monitoring sites. On this basis, spatial analyses should be enabled and supported, respectively. Further, the WebGIS GMO monitoring supplements PortalU which, in Germany, is the technical realisation of the Infrastructure for Spatial Information in Europe directive (Directive 2007/2/EC) released by the EU in 2007.ConclusionsThe article should have shown how to support and complement GMO monitoring with the help of the WebGIS application. It facilitates co-operation and data access across spatial scales for different users since it is based on internet technologies. The WebGIS improves storage, analysis, management and presentation of spatial data. Apart from the improved flow of information, it supports future long-term GMO monitoring and modelling of the dispersal of transgenic pollen, for instance. Additional information (e.g. data on wind conditions or soil observation sites) provided by the WebGIS will be helpful to determine representative monitoring sites for detecting potential GMO impacts by means of monitoring or modelling. Thus, the WebGIS can also serve as part of an early warning system. In the near future, the integration of locations of all Bt-maize fields in Germany into the WebGIS as a continuous task should be automatised. Additionally, a methodology should be developed to detect maize fields by means of remote sensing data to manage coexistence problems on the basis of actual field patterns.

Implications of GMO cultivation and monitoring-series

Genetic engineering is a technological approach that allows for the application of new genetic material across species borders. It is assumed to yield specific benefits, e.g., increased food production, decreased use of pesticides and herbicides, and improved food quality. However, after more than a decade of commercial experience in some countries outside Europe, it seems apparent that several initial expectations could not be met, for example, the overall reduction in pesticide use. Unlike chemicals that degrade by time, genetically modified organisms (GMO) as well as their decomposition products have the potential to proliferate and persist in the environment, eventually without the possibility of removing them once they have been released. Thus, concerns have been raised about potential adverse environmental impacts of the GMO and about potential implications on the coexistence between conventional and genetically modified production. This makes risk assessment as well as monitoring highly challenging tasks towards minimising the risk of adverse effects. Ecological, agricultural and economic implications resulting from the cultivation of GMO at large spatial scales are currently discussed in science, administration and in the context of agricultural practice. A challenging task in this context is how to assess large-scale and long-term effects of GMO release in the approval procedure, in the planning of coexistence measures and in post-market monitoring regarding environmental as well as food monitoring. The international conference ‘Implications of GM Crop Cultivation at Large Spatial Scales’ (GMLS) was held at the University of Bremen first in April 2008. In March 2010, a second edition of the conference (GMLS II) was initiated. Presenters from 11 European and overseas nations contributed new scientific findings on risk analysis of GMO and largescale assessments of environmental effects. As it was for the first GMLS conference in 2008, the results were documented on the website http://www.gmls.eu. Topics include empirical work concerning findings on GM traits, dispersal of GMO, and possible effects on nontarget organisms as well as risk assessment, theoretical concepts and methodological aspects such as modelling and data analysis facing large spatial and temporal dimensions. Strategic implications for good governance and approaches for unknown effects have been discussed from a social-ecological perspective. GMLS is part of the studies on systemic risks funded by the BMBF in the call on Social Ecological research. In this context, scientific findings are linked to social considerations on how nature and the human society mutually influence each other. This interdisciplinary approach aims at a deeper understanding of the following mutual response: How do social actions shape the environment, and, vice versa, how do environmental processes impact the success of social activities–agriculture as well as other natural resource uses. This special series publishes some key contributions presented at the GMLS II conference. The articles describe different aspects of large-scale cultivation of GMOs: Overview of the series, thematically oriented:

State of exception in the regulation of genetically modified organisms in Brazil

The regulation of genetically modified organisms (GMOs) in Brazil has involved intense disputes between the three branches of government (legislature, executive and judiciary). This process arose out of a class-action suit that overruled a decision authorizing the commercial release of GM soybeans by the regulatory body. After a seven-year legal ban, the disputes moved into the legislative and executive branches, as two successive federal governments have created ad hoc legal means to overcome the requirements for a precautionary approach to the commercial release of GMOs in Brazil. This paper intends to show that the evolution of the regulatory agency responsible for GMOs reveals a political practice which is not based on commonly agreed rules but rather on regimes of exception, in which the legal system has consistently been violated in the name of governability. Copyright , Beech Tree Publishing.

Anomalies at the precautionary kingdom: reflections on the GMO Panel's decision

The case before the WTO panel is a reflection of a wide-ranging social discontent. At the heart of this discontent lies the question of the risks genetically modified organisms (GMOs) pose to human health and the environment. A prominent feature of this discontent was the unrelenting anti-GMO campaign, which was led by several transnational environmental groups, such as Greenpeace and Friends of the Earth. The idea of precautionary action has played a key role in this campaign. It was invoked as a ground for imposing stricter regulatory controls on the release of GMOs to the environment and their placement on the market. The precautionary principle, entangled with the concept of risk, stands then at the core of this conflict, at both the social and legal levels. However, the notion of precaution is a contested and highly vague concept. Environmental groups have not succeeded in developing a coherent understanding of this notion, and neither, as I will argue below, has the Panel. This comment has two main goals. First, it offers a critique of the Panel's interpretation of the precautionary principle and its WTO version - Article 5.7 of the Agreement on the Application of Sanitary and Phytosanitary Measures, arguing that the Panel's view is incoherent. Second, it develops an alternative approach for interpreting the precautionary principle and incorporating it into the law of the WTO.

Coexistence or Conflict? A European Perspective on GMOs and the Problem of Liability

In March 2004, the U.K. government announced its intention to grant limited authorization for the growing of commercial genetically modified (GM) crops. This article reviews the potential liabilities that may arise from GM cropping, for environmental damage and for economic losses claimed by non-GM producers. It considers the application of the European Community (EC) Environmental Liability Directive of 2004 to genetically modified organisms (GMO) releases, and the proposed statutory scheme for the coexistence of GM and non-GM agriculture in England and Wales. It also examines the application of the common law of nuisance to the release of GMOs and considers the relevant case law of the English courts. Although there will be a residual role for liability at common law following the establishment of a statutory coexistence scheme, the article highlights a number of formidable problems facing attempts to establish claims for liability arising from GMO releases at common law.

Awareness of and attitudes towards biotechnology and GMOs in Southwest Nigeria: a survey of people with access to information

In this paper, we examine awareness of biotechnology and the attitudes towards products and services derived from Genetically Modified Organisms (GMOs) in Southwest Nigeria. For this purpose, we surveyed 180 respondents across selected segments of the regional population. The paper demonstrates that while respondents have some awareness of biotechnology techniques, there is little awareness about specific GM crops that include Bt maize, Bt cotton and golden rice. Most of the respondents tend to be in favour of the introduction of GM crops and would eat GM foods if they are more nutritious than non-GM foods. The attitudes of the respondents towards GMOs suggest that though more people are in favour of the introduction of GM crops, they do not consider the current state of Nigeria's institutional preparedness satisfactory for the approval and release of GMOs.

Anomalies at the Precautionary Kingdom: Reflections on the GMO Panel's Decision

The case before the WTO panel is a reflection of a wide-ranging social discontent. At the heart of this discontent lies the question of the risks genetically modified organisms (GMOs) pose to human health and the environment. A prominent feature of this discontent was the unrelenting anti-GMO campaign, which was led by several transnational environmental groups, such as Greenpeace and Friends of the Earth. The idea of precautionary action has played a key role in this campaign. It was invoked as a ground for imposing stricter regulatory controls on the release of GMOs to the environment and their placement on the market. The precautionary principle, entangled with the concept of risk, stands then at the core of this conflict, at both the social and legal levels. However, the notion of precaution is a contested and highly vague concept. Environmental groups have not succeeded in developing a coherent understanding of this notion, and neither, as I will argue below, has the Panel. This comment has two main goals. First, it offers a critique of the Panel's interpretation of the precautionary principle and its WTO version - Article 5.7 of the Agreement on the Application of Sanitary and Phytosanitary Measures, arguing that the Panel's view is incoherent. Second, it develops an alternative approach for interpreting the precautionary principle and incorporating it into the law of the WTO.

Cisgenic plants are similar to traditionally bred plants

![][1] ![][2] ![][3] The testing and release of genetically modified organisms (GMOs)—in particular GM plants—is tightly regulated internationally to prevent any negative effects on the environment or human health. However, these regulations are based on transgenic organisms and do not discriminate between transgenic plants and cisgenic plants, although we believe that they are fundamentally different (see sidebarNow, cisgenic plants fall under regulations designed for transgenic organisms, possibly because there have not yet been any applications for the approval of the deliberate release of cisgenic plants into the environment. Definitions of key terms in relation to plants Cisgenesis is the genetic modification of a recipient plant with a natural gene from a crossable—sexually compatible—plant. Such a gene includes its introns and is flanked by its native promoter and terminator in the normalsense orientation.Cisgenic plants can harbour one or more cisgenes, but they do not contain any transgenes. Transgenesis is the genetic modification of a recipient plant with one or more genes from any non‐plant organism, or from a donor plant that is sexually incompatible with the recipient plant. This includes gene sequences of any origin in the anti‐sense orientation, any artificial combination of a coding sequence and a regulatory sequence, such as a promoter from another gene, or a synthetic gene. Traditional breeding encompasses all plant breeding methods that do not fall under current GMO regulations.As the European legal framework defines GMOs and specifies various breeding techniques that are excluded from the GMO regulations,we use this framework as a starting point, particularly the European Directive 2001/18/EC on the deliberate release of GMOs into the environment (European Parliament, 2001). Excluded from this GMO Directive are longstanding cross breeding, in vitro fertilization, polyploidy induction,mutagenesis and fusion of protoplasts from sexually compatible plants (European Parliament, 2001). Although transgenesis and cisgenesis both use the same genetic … [1]: /embed/graphic-1.gif [2]: /embed/graphic-2.gif [3]: /embed/graphic-3.gif

Composting: A Potentially Safe Process for Disposal of Genetically Modified Organisms

ABSTRACTThe widespread use of genetically modified organisms (GMOs) may result in the release of GMOs into the environment. The potential risks regarding their use and implementation of disposal methods, especially the possibility of novel genes from GMOs being transferred to natural organisms, need to be evaluated and better understood. There is an increasingly accepted public view that GMO products introduced into the environment should be degradable and should disappear after a limited period of time. Due to the risk of possible horizontal gene transfer, disposal methods for GMOs need to address destruction of both the organism and the genetic material. During the last two decades, we have developed a greater understanding of the biochemical, microbiological and molecular concepts of the composting process, such that maximum decomposition may be achieved in the shortest time with minimal negative impacts to the environment. The conditions created in a properly managed composting process environment may help in destroying GMOs and their genes, thereby reducing the risk of the spread of genetic material. When considering composting as a potential method for the disposal of GMOs, the establishment of controlled conditions providing an essentially homogenous environment appears to be an important requirement. An evaluation of composting as a safe option for disposal of GMOs is provided in this review.

Capacity Building in Agricultural Biotechnology in Turkey

Turkey, situated at the junction of two continents, benefits both from its rich Asian legacy and its proximity to neighboring European countries. Although the level of socioeconomic development places the country clearly in the group of developing countries, Turkey has been a candidate country for admission to the European Union (EU) since 1999. As a result, the conditions for capacity building in agricultural biotechnology include elements from both the industrialized and developing countries. Because of its favorable climate and time‐tested farming traditions dating back to ancient Mesopotamia, the country possesses one of the richest floras in the world. This review attempts to illuminate the role and importance of local actors in introducing modern biotechnology to the Turkish agricultural system. Agricultural biotechnology, specifically plant biotechnology, has a high priority in the Turkish government's program. Public‐funded research and education in this field is given due priority, but research by the private sector is relatively poorly funded. The ongoing field trials with genetically modified seeds are conducted mostly by multinational companies whose aim it is to commercialize the genetically modified organisms (GMOs) as soon as legislation concerning biotechnology is implemented. The attitude of the big farm owners to genetically modified crops is positive because they expect economic advantages from these crops. On the other hand, public awareness about genetically modified food is quite low, and neither the consumer organizations nor the media represent a particular power in this area. Thus, the power centers in agricultural biotechnology are the government and the multinational biotech companies. The local industry, the consumers, and the media have relatively less input. Moreover, communication between groups is fairly poor, and this contributes to a growing gap between the strong and the weak actors. Turkey has already decided to implement the EU regulation in contained use and the deliberate release of GMOs, which has been shaped in the European sociopolitical environment where the consumers and their organizations represent a powerful force, and where the power constellation between the actors is quite different. Nevertheless, it can be argued, that this route might still be the right choice for Turkey during the phase of introducing this high‐tech method of production to its agriculture.

The division of powers between the EU and the Member States with regard to deliberate release of GMOs (the new Directive 2001/18)

The first directives regulating the use and trade of genetically modified organisms (GMOs) were adopted at the Community level in 1990. These acts formed a core of the Community gene technology legal regime and harmonised the authorisation procedures prior to both contained use and deliberate release of genetically modified organisms. Accordingly, no GMO may be placed on the European Union market without obtaining a written consent for it and only after an appropriate environmental risk assessment has been carried out. Under the old Deliberate Release Directive 90/220, 18 GM products were allowed to be placed on the Community market following either the Commission decisions or Member States consent and over 1000 were notified to the Member States authorities for experimental purposes.