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The European Union’s Shift in GMO Regulations and its Impact on Market and Innovation

The European Union's Shift in GMO Regulations and its Impact on Market and Innovation

Historically, Europe has been known for its stringent stance on the use of Genetically Modified Organisms (GMOs), with regulatory measures against GMOs implemented since 2001. The cornerstone legislation includes Directive 2001/18/EC, addressing the intentional introduction of GMOs into the environment, and Regulation (EC) No 1829/2003, pertaining to genetically modified food and feed. These laws establish a system for GMO approval based on risk assessments for environmental and human health impacts, mandates traceability and labeling, and sets up a framework for monitoring GMOs in the market.

However, in 2021, the commission suggested a revision of these regulations, considering them outdated in the face of new gene-editing technologies gaining traction globally. The proposed changes involve a bifurcation of GMOs into two categories: (1) those originating from ‘naturally occurring techniques,’ akin to traditional plant breeding methods, which will be exempt from the current process, and (2) New Gene Editing Techniques similar to GMOs, which would still need to comply with existing protocols.

Over the past year, the commission has aimed to promote a more sustainable economy with decreased pesticide use. With this announcement, the European Commission commented, “Today’s proposals will also boost innovation and sustainability by enabling the safe use of technical progress in new genomic techniques, to enable developing climate-resilient crops and reducing the use of chemical pesticides, and by ensuring more sustainable, high-quality and diverse seeds and reproductive material for plants and forests.” This initiative forms part of the European Green Deal, an extensive program committing to enhanced sustainability across the region.

Possible Ramifications for the Region & Market

Recognizing the significant impact of its tight regulations on market development, the European Commission referenced a recent study stating, “NGTs and their products have developed rapidly in the last two decades in many parts of the world, with some applications already on the market and more applications in different sectors expected in the coming years. This study confirms considerable interest in research on new genomic techniques in the EU, but most of the development is happening outside the EU. Which affected both private and public research and market development.”

“New genomic techniques can, in many ways, yield the same outcomes as conventional and natural selection or targeted crossbreeding, but with much more speed, precision, and efficiency,” said European Commission Vice President Frans Timmermans on ABC on the European Union’s shift in GMO stance.

The proposed regulation relaxation presents a substantial market that many companies have avoided in the past two decades. According to Business Market Insights, the Genome Editing technologies market was estimated at about $1Bn in 2021 and was projected to grow at an 18% CAGR prior to the regulatory easing proposal. This proposal could catalyze market growth, with some analysts predicting it could hit $15Bn by 2027.

New technologies like CRISPR-Cas9 will find it easier to introduce new products to the market.

The proposal, as per the Vice President of the European Commission, will facilitate market access and provide farmers with new tools to combat climate change effects, including droughts and new pests.

Cibus US LLC has claimed that this proposal holds significant implications and could greatly influence international policy alignment. Tony Moran, Senior Vice President of International Development and Government Affairs at Cibus, believes that this legislative change will encourage innovation in plant science, particularly within academia and SMEs, leading to a more sustainable EU agri-food system driven by NGTs.

Conversely, Greenpeace activists and other consumer protection NGOs caution that these regulations must maintain safety standards to prevent any undesired effects on the population. Politico reported that green lawmakers, environmental advocacy groups, organic and small farmers, and over 400,000 EU citizens have signed a petition opposing the deregulation of what they term “new GMOs.”

Photo by Melissa Askew on Unsplash 

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