The European Commission (EC) recently published a legislative proposal that hints at a science-based approach to the regulation of genome-editing applications in crops in the EU. This would be in line with legislation in an increasing number of countries worldwide, but further science-based advice on implementation will be essential.

A large variety of fermentation products are used in food and feed production, but also in other industries, and many of these products are produced with genetically modified microorganisms (GMMs). In food and feed production, prominent examples are amino acids, vitamins, food and feed enzymes, colorants, non-caloric sweeteners, human milk oligosaccharides, or vegan alternatives of dairy, egg and meat products. From a regulatory perspective, fermentation products are typically produced under containment. This means that premises, equipment and work processes need to be designed to prevent or at least minimize release of GMMs into the environment. The fermentation products themselves should not contain any live cells of the GMM. Over the past years, there have been concerning developments, particularly in the European Union, stipulating that also absence of recombinant DNA might be interpreted as a regulatory requirement for fermentation products produced with GMMs. In this paper, we (i) attempt to place these developments into the historical context, (ii) sketch the potential negative repercussions for the food and feed industries, (iii) elaborate on the safety of recombinant DNA, and (iv) postulate that recombinant DNA should remain an integral part of the safety assessment of fermentation products but should not be misconstrued as a criterion for regulatory classification of products of biotechnology.

Facing unprecedented global declines in the extent and integrity of ecosystems, the 15th UN Biodiversity Conference (COP-15) in Kunming, China, presents an opportunity for transformative change. However, a lack of consensus on two key issues – resource mobilization and Access and Benefit Sharing (ABS) associated with Digital Sequence Information (DSI) – risks stalling negotiations for an ambitious ‘Post-2020 Global Biodiversity Framework’ as the next 10-year strategic plan under the Convention on Biological Diversity. We highlight systemic misconceptions concerning the financing of biodiversity and the burden this places on the ABS system. In the context of DSI, we caution that conflating ABS with resource mobilization risks disrupting modern science policy built on open access, with potentially severe ramifications for scientific research and innovation. To resolve these tensions, we call for a recalibration of discussions on ABS in order to maximize the value delivered by biodiversity for all of society, including indigenous peoples and local communities.

The upcoming UN Biodiversity Conference should address shortfalls of Access and Benefit Sharing systems inspired by the Nagoya Protocol to help improve sustainable use of biodiversity and equitable benefit sharing.

The upcoming UN Biodiversity Conference should address shortfalls of Access and Benefit Sharing systems inspired by the Nagoya Protocol to help improve sustainable use of biodiversity and equitable benefit sharing.

Here, we discuss options to reform the EU genetically modified organism (GMO) regulatory framework, to make risk assessment and decision-making more consistent with scientific principles, and to lay the groundwork for international coherence. We discussed the scope and definitions in a previous article and, thus, here we focus on the procedures for risk assessment and risk management.

We discuss options to reform the EU genetically modified organisms (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. The first in a threepart series, this article focuses on reform options related to the scope of the legislation and the GMO definition.

Debates about the source of antibodies and their use are confusing two different issues. A ban on life immunization would have no repercussions on the quality of antibodies.

We discuss options to reform the EU genetically modified organism (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. In this third of three articles, we focus on labeling and coexistence as well as discuss the political reality and potential ways forward.

The ability to successfully exploit genome edited organisms for the benefit of food security and the environment will essentially be determined by the extent to which these organisms fall under specific regulatory provisions. In many jurisdictions the answer to this question is considered to depend on the genetic characteristics of the edited organism, and whether the changes introduced in its genome do (or do not) occur naturally. We provide here a number of key considerations to assist with this evaluation as well as a guide of concrete examples of genetic alterations with an assessment of their natural occurrence. These examples support the conclusion that for many of the common types of alterations introduced by means of genome editing, the resulting organisms would not be subject to specific biosafety regulatory provisions whenever novelty of the genetic combination is a crucial determinant.

Governments all over the world are struggling with the regulatory status of gene-edited organisms. Are they regulated? Should they be regulated? In the present paper, the main focus is on the regulatory status of gene-edited organisms within the European regulatory framework. A stepwise analysis is performed that comes to the conclusion that gene-edited agricultural products that carry edits that can also occur naturally by mating and/or natural recombination are not a genetically modified organism. On the question whether they should be regulated, it is argued that it is difficult to require regulatory oversight that would go beyond what we now require for conventional products that can carry the same types of alterations. A regulatory approach is pleaded for that abides to fundamental principles of law making, and which allows for gene editing to develop responsibly.

The EU regulation on organic farming does not allow the use of genetically modified organisms (GMOs) which are subject to Directive 2001/18/EC. Mutagenesis using irradiation or chemicals is genetic modification, but the organisms obtained through these techniques are not subject to the provisions of the GMO directive. Such mutants can therefore be used in organic agriculture. Derived from its basic principles, organic farming can only use natural substances to control disease and crops should be resilient, which, in the case of disease resistance, means that durable (horizontal) resistance is preferred to vertical (single gene) resistance. Cisgenesis can achieve such a durable resistance by introducing multiple resistance genes in one step. These multiple-resistant plants only contain natural genes that can also be introduced by breeding. In case cisgenic plants are not subject to the provisions of the GMO legislation, they can even be legally used in organic agriculture. In case they are not exempted from the GMO regulation, the question is: why obstruct a cisgenic potato crop that can hardly be distinguished from a potato crop that is the result of conventional breeding? Among the reasons why organic agriculture does not allow the use of GMOs it is mentioned that genetic engineering is unpredictable, it causes genome disruption and it is unnatural. However, our knowledge of plant genome evolution and breeding has increased dramatically. We now know that breeding is more unpredictable and causes more genome disruption than genetic engineering. Recent field trials have shown the efficacy of cisgenic late blight–resistant potatoes carrying multiple resistance genes. Large-scale growing of such durably resistant potatoes would not only be environmentally beneficial by it would strongly reducing the need for fungicide sprays in conventional potato cultivation and it would also reduce the disease pressure in organic potato cultivation.

for GM plants with single transformation events, the controversy continues.This is due to the fact that in 2016 the European Commission will have to review this particular provision in the legislation (ibid, Article 12), and because of questions raised by long-term feeding studies with GM maize.In response to this controversy, the European Commission-funded project GRACE (GMO Risk Assessment and Communication of Evidence, www.grace-fp7.eu)conducted four 90-day feeding trials as well as a 1-year feeding trial with the GM maize MON810 and investigated the scientific value of animal studies for GMO risk assessment in comparison with alternative studies, i.e. those not being performed in animals.In recent years, animal feeding trials conducted with whole food/feed have been a focal issue in the controversy on the safety assessment of genetically modified (GM) plants and derived food/feed.Within the scientific community and among stakeholders, quite different views have been expressed on how these studies should be conducted, analysed and interpreted, what they might add in terms of information relevant to safety and whether 90-day rodent feeding trials should be mandatory.Despite the fact that the Commission Implementing Regulation (EU) No. 503/2013 (specifying the requirements for the risk assessment of GM food/feed) requests mandatory 90-day feeding trials

Biotechnology can greatly improve the efficiency of forest tree breeding for the production of biomass, energy, and materials. However, EU regulations impede the market introduction of genetically modified (GM) trees so their socioeconomic and environmental benefits are not realized. European policy makers should concentrate on a science-based regulatory process.

Late blight, caused by Phytophthora infestans, remains the most devastating disease in potato resulting in economic costs that sum up 5.2 billion euros, globally. The use of resistant varieties is a powerful, viable and environmentally friendly alternative or supplement for the current, commonly deployed chemical control strategies. In this study, we set out to improve the susceptible potato variety Desiree by transformation with single or multiple late blight (R) resistance genes. Rpi-sto1, Rpi-vnt1.1 and a stack of Rpi-sto1:Rpi-vnt1.1:Rpi-blb3, were transformed and eight, eight, and ten independent transformants (events) respectively, were selected because of absence of vector backbone, low T-DNA copy number, responsiveness to the cognate Avr effectors, P. infestans resistance in detached leaf assays (DLAs) and preliminary field experiments. The performance of the selected events was studied under field conditions in The Netherlands and Belgium, after P. infestans inoculation and/or to natural late blight infection during two consecutive growing seasons. All selected events were more resistant than the non-transformed susceptible reference clone. The different individual R genes, however, contributed to different levels of resistance. The selected events were also compared to conventionally bred late blight resistant varieties with (partially) known R gene content. Generally, it was found that plants with single R genes showed a lower level of resistance than plants with R gene stacks. Only the events harbouring three late blight R genes remained unaffected until the end of the growing season, in both locations and in both growing seasons. (C) 2015 Elsevier Ltd. All rights reserved.

Agriculture faces many challenges to maximize yields while it is required to operate in an environmentally sustainable manner. In the present study, we analyze the major agricultural challenges identified by European farmers (primarily related to biotic stresses) in 13 countries, namely Belgium, Bulgaria, the Czech Republic, France, Germany, Hungary, Italy, Portugal, Romania, Spain, Sweden, UK and Turkey, for nine major crops (barley, beet, grapevine, maize, oilseed rape, olive, potato, sunflower and wheat). Most biotic stresses (BSs) are related to fungi or insects, but viral diseases, bacterial diseases and even parasitic plants have an important impact on yield and harvest quality. We examine how these challenges have been addressed by public and private research sectors, using either conventional breeding, marker-assisted selection, transgenesis, cisgenesis, RNAi technology or mutagenesis. Both national surveys and scientific literature analysis followed by text mining were employed to evaluate genetic engineering (GE) and non-GE approaches. This is the first report of text mining of the scientific literature on plant breeding and agricultural biotechnology research. For the nine major crops in Europe, 128 BS challenges were identified with 40% of these addressed neither in the scientific literature nor in recent European public research programs. We found evidence that the private sector was addressing only a few of these neglected challenges. Consequently, there are considerable gaps between farmer's needs and current breeding and biotechnology research. We also provide evidence that the current political situation in certain European countries is an impediment to GE research in order to address these agricultural challenges in the future. This study should also contribute to the decision-making process on future pertinent international consortia to fill the identified research gaps.

Transgenic plants that are being developed for commercial cultivation must be tested under field conditions to monitor their effects on surrounding wildlife and conventional crops. Developers also use this opportunity to evaluate the performance of transgenic crops in a typical environment, although this is a matter of commercial necessity rather than regulatory compliance. Most countries have adapted existing regulations or developed new ones to deal specifically with transgenic crops and their commodities. The European Union (EU) is renowned, or perhaps notorious, for having the broadest and most stringent regulations governing such field trials in the world. This reflects its nominal adherence to the precautionary approach, which assumes all transgenic crops carry an inherent risk. Therefore, field trials in the EU need to demonstrate that the risk associated with deploying a transgenic crop has been reduced to the level where it is regarded as acceptable within the narrowly defined limits of the regulations developed and enforced (albeit inconsistently) by national and regional governments, that is, that there is no greater risk than growing an equivalent conventional crop. The involvement of national and regional competent authorities in the decision-making process can add multiple layers of bureaucracy to an already-intricate process. In this review, we use country-based case studies to show how the EU, national and regional regulations are implemented, and we propose strategies that could increase the efficiency of regulation without burdening developers with further unnecessary bureaucracy.

Background Global warming, environmental disasters, and increasing oil prices have catalyzed a worldwide trend to use plant biomass as a renewable source for liquid biofuels and bio-based materials. Plant biomass can be processed into fermentable sugars by enzymatic depolymerization of the cell wall polysaccharides, followed by fermentation. However, the presence of lignin in the cell wall constitutes a major recalcitrance factor because it limits the accessibility of polysaccharidases to the cellulose microfibrils. To overcome this hurdle, plant biomass is pretreated in a costly and energyrequiring process. One approach to overcome the recalcitrance problem is to engineer lignin amount or alter its composition to make lignin more susceptible to chemical degradation [1]. Cinnamoyl-CoA reductase (CCR), the enzyme that converts feruloyl-CoA into coniferaldehyde, is considered the first enzyme in the monolignol-specific branch of the phenylpropanoid pathway. Poplar trees down-regulated in CCR have been produced in the early nineties and planted in a field trial in France to produce sufficient wood for small scale chemical pulping tests [2]. These trees had 20% lower lignin levels and relatively more cellulose per gram of wood [2]. Given that lignin is one of the main limiting factors limiting the conversion of plant biomass into fermentable sugars, and that poplar is considered as a promising second generation biofuel crop, we have re-grown these trees in the greenhouse and in the field, and evaluated wood produced from these trees by saccharification experiments. Methods Cinnamoyl-CoA reductase (CCR) expression was downregulated in poplar by sense and antisense strategies [2]. Transgenic trees were evaluated for lignin amount and composition [2] and for sugar release by saccharification assays [3]. After obtaining permission from the regulatory authorities, two transgenic lines were planted in a field trial in Belgium and two in a field trial in France, both under short rotation coppice culture to maximize biomass production. Wood was saccharified with and without acid pretreatment.