Options to Reform the European Union Legislation on GMOs: Scope and Definitions

Eriksson, Dennis; Custers, René; Björnberg, Karin Edvardsson; Hansson, Sven Ove; Purnhagen, Kai P.; Qaim, Matin; Romeis, Jörg; Schiemann, Joachim; Schleissing, Stephan; Tosun, Jale; Visser, R.G.F.

doi:10.1016/j.tibtech.2019.12.002

Cited by 51 publications

(34 citation statements)

References 19 publications

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“…There is currently discussion whether genome-edited organisms could be exempted from the EU GMO regulation and whether it should be revised to focus on the product, rather than the process used to generate them [186]. One argument for the exemption of certain genome-edited organisms includes considerations of whether the changes induced by SDN-1 (or even SDN-2) are similar to those that might arise spontaneously and naturally or through conventional breeding or traditional mutagenesis (i.e.…”

Section: Risk Assessment For Organisms Developed Through Genome Editimentioning

confidence: 99%

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Kawall¹,

Cotter²,

Then³

2020

Environ Sci Eur

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Genome editing techniques, especially the CRISPR/Cas technology, increase the possibilities and the speed of altering genetic material in organisms. So-called genome editing is increasingly being used to achieve agriculturally relevant novel traits and/or genetic combinations in both plants and animals, although predominantly as proof of concept studies, with commercial growing or rearing so far limited to the U.S. and Canada. However, there are numerous reports of unintended effects such as off-target effects, unintended on-target effects and other unintended consequences arising from genome editing, summarised under the term genomic irregularities. Despite this, the searching for genomic irregularities is far from routine in these studies and protocols vary widely, particularly for off-target effects, leading to differences in the efficacy of detection of off-target effects. Here, we describe the range of specific unintended effects associated with genome editing. We examine the considerable possibilities to change the genome of plants and animals with SDN-1 and SDN-2 genome editing (i.e. without the insertion of genes conferring the novel trait) and show that genome editing techniques are able to produce a broad spectrum of novel traits that, thus far, were not possible to be obtained using conventional breeding techniques. We consider that the current EU risk assessment guidance for GMOs requires revision and broadening to capture all potential genomic irregularities arising from genome editing and suggest additional tools to assist the risk assessment of genome-edited plants and animals for the environment and food/animal feed in the EU.

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Section: Risk Assessment For Organisms Developed Through Genome Editimentioning

confidence: 99%

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Kawall¹,

Cotter²,

Then³

2020

Environ Sci Eur

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“…The EU process-based regulatory system has resulted in a regulatory burden on African and other developing countries, regarding the commercialization of GM crops, which appears to be set to extend into the coming decade, given the CJEU 2018 ruling. Gene-edited crops hold significant potential for increase food security and adjusting the changing climates and an efficient regulatory system within the EU would facilitate adoption of these technologies in other countries ( Eriksson et al, 2020 ; Zaidi et al, 2019 ). Clearly, the EU regulatory system needs to transition to a product-based system to ensure that regulatory burdens are reduced in countries that are far less food secure than Europe.…”

Section: Effects Of Regulatory Burdensmentioning

confidence: 99%

Regulatory barriers to improving global food security

Smyth

2020

Global Food Security

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Crop agriculture and food production constantly face climactic challenges to the supply of safe, nutritious food. These challenges highlight the importance of innovation resulting in improved crop technologies, capable of providing consistently increasing yields in the face of abiotic and biotic stresses. This article addresses the challenge that regulatory barriers are, and can, have on the adoption of innovative crop and food technologies that improve food security. Evidence of increased crop yield and the potential for increased yields, are presented from innovative plant breeding technologies, especially gene editing. Recent advances from the use of gene editing in the pharmaceutical field may offer opportunities to reduce regulatory burdens.

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“…In the end, we are actually all consumers and expect safe food. Legislation is seeing a lot of issues related to allergens, organics, and package labeling [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

“…The food industry is a key branch in the global economy. As a consequence, many authors highlighted its relevance for employment and economic output [9,11,14].…”

Section: Introductionmentioning

confidence: 99%

Introductory Chapter: A Global Presentation on Trends in Food Processing

Marc¹

2020

Food Processing

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Options to Reform the European Union Legislation on GMOs: Scope and Definitions

Cited by 51 publications

References 19 publications

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Broadening the GMO risk assessment in the EU for genome editing technologies in agriculture

Regulatory barriers to improving global food security

Introductory Chapter: A Global Presentation on Trends in Food Processing

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