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

2002 ◽  
Vol 3 (5) ◽  
Author(s):  
Patrycja Dabrowska
Keyword(s):  
Risk Assessment ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Gene Technology ◽  
The European Union ◽  
Legal Regime ◽  
Member States ◽  
Division Of Powers ◽  
Deliberate Release ◽  
The Eu

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.

Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

BioTech ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. 10
Author(s):  
Michael F. Eckerstorfer ◽  
Marcin Grabowski ◽  
Matteo Lener ◽  
Margret Engelhard ◽  
Samson Simon ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Genome Editing ◽  
Genetically Modified Organisms ◽  
Unintended Effects ◽  
The European Union ◽  
Gm Plants ◽  
European Court ◽  
Assessment Approach ◽  
Deliberate Release ◽  
Specific Assessment

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

scholarly journals National Food Safety Systems in the European Union: A Comparative Survey

2013 ◽  
Vol 2 (1) ◽  
Author(s):  
Andreas Hadjigeorgiou ◽  
Elpidoforos S. Soteriades ◽  
Anastasios Philalithis ◽  
Anna Psaroulaki ◽  
Yiannis Tselentis ◽  
...  
Keyword(s):  
Risk Assessment ◽  
European Union ◽  
Food Safety ◽  
The European Union ◽  
Member States ◽  
Eu Member States ◽  
Comparative Survey ◽  
Safety Systems ◽  
Central Level ◽  
The Eu

This paper is a comparative survey of the National Food Safety Systems (NFSS) of the European Union (EU) Member-States (MS) and the Central EU level. The main organizational structures of the NFSS, their legal frameworks, their responsibilities, their experiences, and challenges relating to food safety are discussed. Growing concerns about food safety have led the EU itself, its MS and non-EU countries, which are EU trade-partners, to review and modify their food safety systems. Our study suggests that the EU and 22 out of 27 Member States (MS) have reorganized their NFSS by establishing a single food safety authority or a similar organization on the national or central level. In addition, the study analyzes different approaches towards the establishment of such agencies. Areas where marked differences in approaches were seen included the division of responsibilities for risk assessment (RA), risk management (RM), and risk communication (RC). We found that in 12 Member States, all three areas of activity (RA, RM, and RC) are kept together, whereas in 10 Member States, risk management is functionally or institutionally separate from risk assessment and risk communication. No single ideal model for others to follow for the organization of a food safety authority was observed; however, revised NFSS, either in EU member states or at the EU central level, may be more effective from the previous arrangements, because they provide central supervision, give priority to food control programs, and maintain comprehensive risk analysis as part of their activities.

scholarly journals THE EUROPEAN UNION, THE UNITED STATES, AND THE GENETICALLY MODIFIED ORGANISMS (GMOs)

2020 ◽  
Vol 21 (1) ◽  
pp. 11-20
Author(s):  
Anisa ◽  
Chelsilya ◽  
Grace Yohana ◽  
Mucco Eva ◽  
Morry Zefanya ◽  
...  
Keyword(s):  
European Union ◽  
Genetically Modified Organisms ◽  
Human Life ◽  
Genetically Modified ◽  
The United States ◽  
Environmental Damage ◽  
The European Union ◽  
Technological Advances ◽  
The Us ◽  
The Eu

Current technological advances have been present in all aspects of human life, including technological advances in biotechnology. Biotechnology not only raises hope for science but also raises heated debates among scientists, especially between the European Union and the US. This debate arises because of differences in perspective between the EU and the US. The EU has stringent rules regarding the development efforts of genetically modified organisms (GMOs). At the same time, the US thinks that GMOs are part of agriculture, so there is no need for any special laws to regulate them. Various side effects also come hand in hand with the birth of GMOs. They are ranging from adverse effects on human health, the health of food products, and even environmental damage. The development of GMOs can damage the ecosystem of species that exist in the environment. Still, more complex problems arise due to GMOs like economic problems and monopolies.   Keywords: The  GMOs, The EU, The US.

Genetically Modified Organisms

2019 ◽  
pp. 508-530
Author(s):  
Anne Saab
Keyword(s):  
United States ◽  
Risk Assessment ◽  
European Union ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
The United States ◽  
Legal Framework ◽  
The European Union ◽  
Gm Foods ◽  
Product Regulation

This chapter examines comparative approaches to risk assessment and regulation of genetically modified organisms (GMOs). It first provides a brief background on the emergence, increased use, and controversy surrounding GMOs as well as the important legal questions and complexities they raise before discussing the legal approaches used to assess and regulate risks associated with GM foods, labelling of GM foods, and the application of intellectual property rights (IPRs) to GMOs. In particular, it considers risk assessment in the United States and in the European Union, focusing on the precautionary approach versus the permissive approach. It also compares process regulation and product regulation for regulating the risks posed by GMOs in the United States and the European Union, along with risk assessment and regulation in Brazil, China, and Costa Rica. Finally, it analyses the legal framework for IPRs as they apply to GMOs and comparative approaches to patenting GMOs.

scholarly journals Characterization of Genetically Modified Maize in Weakly Contaminated Seed Batches and Identification of the Origin of the Adventitious Contamination

2007 ◽  
Vol 90 (4) ◽  
pp. 1098-1106 ◽  
Author(s):  
Laetitia Petit ◽  
Galle Pagny ◽  
Fabienne Baraige ◽  
Anne-Ccile Nignol ◽  
David Zhang ◽  
...  
Keyword(s):  
Ssr Markers ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
The European Union ◽  
Maize Seeds ◽  
Genetic Modifications ◽  
Polymerase Chain ◽  
The Individual ◽  
The Eu

Abstract So far, relatively few genetically modified plants (GMPs) have been planted in the European Union (EU). However, in France, seed batches weakly contaminated by unidentified GM materials have recently been detected among commercial maize seeds (14 seed batches positive out of 447 analyzed). We have developed a 3-step approach to precisely identify the genetic modifications detected in such maize seed batches. First, to isolate GMPs derived from the contaminated seed batches, 10 000 maize seeds of each batch were planted and screened by polymerase chain reaction (PCR) on 100-plant batches, then on 10-plant subbatches, and finally, plant by plant. In a second step, specific identification of the individual GMPs was performed. Finally, to determine the origin of the contamination, each individual GMP was analyzed by simple sequence repeat (SSR) markers. The results showed that all batches were contaminated by few GM seeds, having a GM content <0.1%. Finally, 12 individual GMPs have been isolated from 17 plant pools that were tested positive either for P35-S and/or T-Nos. MON810 and T25 transformation events approved for cultivation in the EU were detected in 7 individual GMPs. The other seed batches were contaminated by genetically modified organisms (GMOs) that are not approved in the EU, including GA21 or the stacking MON810/T25. Presumable identification of T14 was also achieved following sequencing of 1 individual GMP. The data also showed that most of the seed batches were contaminated by several transformation events. Finally, analysis of SSR markers indicated that the contaminations were essentially due to cross-pollination in the seed production process.

A precautionary approach to genetic modification

2002 ◽  
Vol 8 (3) ◽  
Author(s):  
Mark Lubbock ◽  
Andrew Coop
Keyword(s):  
Precautionary Principle ◽  
Genetic Modification ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Legal Regime ◽  
Precautionary Approach ◽  
The Precautionary Principle ◽  
Deliberate Release

Presents a study that discussed the development of a new legal regime for the deliberate release of genetically modified organisms (GMO) into the European environment, as of January 2002. Information on the Precautionary Principle requirement of the existing regime; Assessment of the possible effect of the Precautionary Principle on decisions about GMO releases; Implications for the expectations of consumers regarding genetically modified products.

Deforming mirrors converting GMOs into smog

2016 ◽  
Vol 46 (5) ◽  
pp. 620-627
Author(s):  
Roberto Defez
Keyword(s):  
Economic Development ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Environmental Damage ◽  
Human Consumption ◽  
The European Union ◽  
Content Type ◽  
Gm Food ◽  
Gm Plants ◽  
The Eu

Purpose The debate around the use and study of genetically modified organisms (GMOs) is so complex that frequently people miss that the outcome of some political/social/economic decisions are taken in such a way that the legal/agricultural/medical coherence is lost. The purpose of this text is to underline the contradictions in the European approach to GMOs, when for the past 20 years the European Union (EU) has been using and importing GMOs but rejecting its study or cultivation. Design/methodology/approach The approach follows the distance among public declarations against GMOs from most of the political representatives, followed by decision on our health, nutrition and economic development going exactly in the opposite direction. The arrival of the new genome-edited plants cannot solve all requirements, as in many cases an entire new function should be added and, at present, this will be again a GMO irrespective to the technique used to add a new gene. The delay in taking these decisions are now posing a hazard on the cultural and economic development of the EU. Findings The laws (directives) on GMOs in the EU are far too restrictive and suffer from an over-regulation that prevent any attempt to come to a science-based approach on genetically modified (GM) plants. The basis for the definition and the restrictions is on the technology and not on the final product. However, on the other hand, the GMOs are the only product where the safety analysis is on the final product (which is not the case for organics productions). The paradox is that all restrictions are concentrated on GM plants to be cultivated in Europe, as if the main hazard would be on the environmental impact of local cultivation. Meanwhile, the EU has no concern if the same environmental damage happens abroad and EU is the final user of the technology as 68 different GMOs are imported and used even for human consumption in Europe. Originality/value Fighting against the EU over-regulation would appear to be a position supporting multinational seed companies (none of them based in the EU), described as polluters. The proposed approach is the opposite, asking for a more restrictive regulation to show to the consumers that: most local EU high quality food products are derived from GM-fed animals; GM cotton is potentially far more risky than any GM food; and reducing GM plants cultivated in Europe increases the pesticide sold by chemical companies (mostly based in the EU).

Legal and political hybridity of the European Union – genetically modified organisms’ case

2020 ◽  
pp. 125-144
Author(s):  
Monika Szkarłat
Keyword(s):  
Decision Making ◽  
European Union ◽  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Decision Making Process ◽  
The European Union ◽  
Gm Plants ◽  
Decision Making System ◽  
Modern Biotechnology ◽  
The Eu

The European Union can be described as a particular hybrid integration structure that combines features of a state and intergovernmental organisation. Its institutional framework, legal system and division of competences are examples of a supranational organisation or a transnational decision-making system. The decision-making process is an outcome of network interactions between multiple actors, whose relations are non-hierarchically ordered. Genetically modified organisms (GMO) as an example of modern biotechnology application is a highly polarising subject in the EU, as well as globally. Thus, the policy towards GMO is an exemplification of legal and political hybridity of the EU. The analysis of the EU’s legal and political hybridity will be narrowed down to the GM plants case and methodologically organised around the concept of decision-making analysis that is composed of five categories: decision-making situation, actors, decision-making process, decision, implementation of the decision

The Member States’ Long and Winding Road to Partial Regulatory Autonomy in Cultivating Genetically Modified Crops in the EU

2013 ◽  
Vol 4 (2) ◽  
pp. 143-157 ◽  
Author(s):  
Sara Poli
Keyword(s):  
Genetically Modified Organisms ◽  
Genetically Modified ◽  
Genetically Modified Crops ◽  
European Countries ◽  
Gm Crops ◽  
Member States ◽  
Gm Maize ◽  
The Eu ◽  
Gm Potato ◽  
Mon 810

Member States wishing to cultivate genetically modified organisms (GMOs) have always been a minority in the EU. Only eight out of twenty-seven have experienced transgenic agriculture. Throughout the years, the opposition to this form of farming has become a genuinely transnational phenomenon given that many regions of different European countries declared themselves GMO-free. Moreover, Member States such as Austria, Luxembourg, Greece, Poland and, most recently, Hungary officially banned transgenic agriculture within their borders altogether. France and Germany suspended the cultivation of GM maize MON 810, respectively in 2008 and 2009.In addition, the EU has previously authorized only two GM crops: GM maize MON 810 (authorization renewed in 2008) and GM potato EH92-527-1 (2010), known as the ‘Amflora potato.’ The cautious approach towards transgenic farming is also witnessed by the long and contested process of renewal of the permit to cultivate GM maize MON 810 and the issue of the authorization for the Amflora potato.

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