Study might prepare for rapid revision of EU GMO law

The European Commission (EC), headed by Christian Democrat Ursula von der Leyen, is taking action to overhaul the current EU GMO legislation in order to exempt new breeding technologies (NBT) from the current testing, labelling, and approval requirements. The industry-friendly move to overcome European consumer rejection of food products made by genetic engineering techniques was prepared long beforehand by the former Agriculture Commissioner Phil Hogan. Following the European Court of Justice’s 2018 ruling (C-528/16) that all crops, which were modified by biotechnological, targeted mutagenesis techniques, fall under the strict legal regulations for genetically modified organisms (GMOs), Hogan requested a new study on NBTs to prove the benefits of NBTs versus classical breeding. The study is now underway, confirmed Health Commissioner Stella Kyriakides in December. Previously, the European Council, under leadership of the Netherlands, demanded that such a study be carried out (see European Biotechnology, Winter edition 2019). Kyriakides said its results will be published by Spring 2021 under Portuguese EC presidency and will form the basis for a political solution. However, Kyriakides left open why the Commission does not want to utilise the results from an already existing study published by the EU Joint Research Centre (JRC) in Ispra in 2011 and ordered by the EC to lay the scientific foundation for a political decision on NBTs. Insiders told European Biotechnology that a study published after the ECJ ruling would be more convincing.

Greens party representatives, however, fuelled rumours that the Commission intends to follow a lobbying push by agri-biotech proponents – EU researchers, who depend on funds for their agri-biotech research and multinational ag-companies – to remove the process-orientated, precautionary labelling and testing regime applied to GMOs when it comes to products obtained by new, mutational techniques.

Greens mounting the barricades

Martin Häusling, agricultural policy spokesman for the Green Group in the European Parliament called for EU-wide, strict regulation of breeding technologies using targeted mutagenesis. “The organic sector must become unmistakably loud here, because if we don’t have very clear regulation, we will be at the mercy of the industry,” suggested Häusling at BioFach (17 – 20 February 2020), the world’s leading trade fair for organic food in Nuremberg, Germany. He warned against replacing the precautionary principle with the innovation principle in Brussels. Risk assessment, traceability, labelling, and safety monitoring must be guaranteed, because the new genetic engineering comes with risks, he claimed. For the organic sector, a dilution of the strict labelling and traceability requirements currently applied under EU rules to NBTs would put their holistic “100% natural and GMO-free” approach at risk, as producers wouldn’t be able to track if a field planted with NBT-modified crops neighbours a field with organically produced products. According to Häussling, the organic sector would be faced with an enormous task, if this happened. “We are the form of agriculture that has a future,” claimed Häussling, pointing to the sustainability ambitions of the EU’s bioeconomy strategy.

EU on the path to innovation

Kyriakides said innovation, in all its forms, is essential “particularly if we want to reduce the current dependence on chemical pesticides,” as announced in the Commission’s recent green deal communication, whose financial promises haves come under doubt after failed EU budget negotiations (see page 5)
between the European Council and the Commission. “I have always made clear that we need to have a broad and open debate whether and, if so, how biotechnologies could help make our food system more sustainable, both for citizens and the environment,” she added.

What can be expected specifically from this latest approach of the Commission to overcome public resistance against genetic engineering in food production is written down in a position paper (translated from German: “Genome Modification in Plants: Opportunities for Sustainable and Resource-Conserving Agriculture”) published by von der Leyen’s Christian Democratic party last December.

Creating public acceptance?

In the paper, experts from the Federal Expert Committee on Education, Research, and Innovation of the Christian Democratic Party conclude: that the ECJ judgement makes the application of the new breeding methods in the EU practically impossible and, thus, prevents their beneficial use for biodiversity and sustainable agriculture; that the judgement is based on the Directive 2001/18/EG from 2001, the scientific basis of which, in turn, dates back to the 1980s and which has, so far, been exclusively focused on the regulation of classical genetic engineering, namely the introduction of foreign, transgenic DNA into organisms, which can be easily detected. In contrast, the genetic changes introduced into crops by NBT are often “no longer distinguishable from changes in plants obtained by conventional breeding or mutagenesis”; that this would mean “that organisms carrying one and the same genetic modification are regulated completely differently in the EU, depending on how the modification was produced”; that in this way, European genetic engineering law would not only inhibit research, development, and application of urgently needed improved crops to support sustainable agriculture. On the contrary, the time-consuming and cost-intensive approval procedure, which applies equally to classical, genetically modified organisms and genome-modified organisms, would also promote further monopolisation in the already highly concentrated seed and plant breeding markets. At the same time, European genetic engineering law threatens to uncouple the EU from international biotechnological and bioeconomic developments.

According to the paper, technologies improving food and feed quality and reducing the use of fertilisers and crop protection products could help support global problems, such as hunger, climate change, and supply of bio-based resources for industrial production within the framework of a bio-economy. As this progress could not be achieved in the short term with conventional breeding, “the procedural regulatory approach is not scientifically justifiable,” and updated EU GMO rules should allow deregulation of products generated using NBTs. For example, research on more resistant crops – part of the US$55.4bn global seed market – must be intensified, says the paper – particularly with field trials. At the heart of this U-turn in GMO regulation is a campaign to build consumer acceptance for genome-edited crops and products. This drive’s aim is “to drop positive labelling specific to genetic engineering” for all products that do not contain genes from alien organisms.

Silent start of campaigning

In contrast, researchers attached to the green lobby, such as Michael Antiniou from Kings College London, warn that existing on-target and off-target effects of NBTs, particularly those triggered by uncontrollable cellular DNA repair mechanisms, would be downplayed. However, as the Commission wants to actively implement consumers in the decision process to improve acceptance, consumers may have options to create a solution that goes beyond economic interests.

Furthermore, figures published by the ag-industry information broker and consultancy Phillips McDougal demystifies the claim that the “unduly slow and expensive EU-GMO rules” would present an important barrier for biotech SMEs to apply for EU product approval. According to the study, only 25% of the average $136m cost of bringing a GM trait to market between 2008 and 2012 is related to regulatory issues. The remaining 75% went towards research and development and licencing costs.

By mid-February, the “EU information campaign for consumers” took off with an announcement from Italy. Italian Agriculture Minister Teresa Bellanova said that Italy will continue to keep GMOs from the market while launching a collaboration that is set to foster next-gen biotech in Italy’s farming, namely “sustainable biotechnologies, such as cisgenesis and genome editing.” The deal between the farmer association Coldiretti and the Italian Society of Agricultural Genetics (SIGA) will focus on the application of latest-generation biotech to typical Italian varieties, representing a turning point in the troubled relationship between anti-GM farmers and pro-GM scientists. SIGA member Mario Pezzotti from the University of Verona announced that development of climate-change- and pathogen-resistant grape varieties with conserved oenological profile will be one goal of the collaboration, which would need a change in the current EU GMO law.

At the end of February, Sweden, which criticised the ECJ ruling, joined the PR club publishing a press release for Mistra Biotech, a research programme focusing on the use of biotechnology in crop and livestock breeding for sustainable and competitive agriculture led by Lund University. In a series of articles, agri-researchers discuss options for reforming EU GMO rules in order “to make risk assessments and decision-making more compatible with scientific principles, and to lay the foundations for international harmonization, which is a prerequisite for the feed and food chain to function globally.”

Opposition from France

At the beginning of February, France’s highest court, the Conseil d’Etat, ruled that organisms obtained by biotechnological mutagenesis techniques should be identified within six months and become subject to GMO rules. A big challenge for policymakers in their information campaign will be to differentiate between interest-group-led PR and serious scientific input.


This article was published in the European Biotechnology Magazine Spring Edition 2020.