Op Ed: Dr Anastasia Krivoruchko, CEO of Melt & Marble, on Why Reformation of Food Regulations is Imperative

Dr. Anastasia Krivoruchko is an entrepreneurial scientist with a strong research background in molecular biology, microbial metabolic engineering, and synthetic biology. With over ten years of experience in precision fermentation, Anastasia has made significant contributions to the field.

As a project leader at Chalmers University of Technology, she led cutting-edge microbial engineering projects, resulting in publications in top journals and multiple patents. Co-founding Melt&Marble, Anastasia focuses on precision fermentation to produce fats for animal-free foods.

Reforming Food Regulation for a Greener Tomorrow

By Anastasia Krivoruchko

Recently, Nature Climate Change published a study concluding that emissions from the food system alone pose a substantial threat to world climate targets. Addressing unsustainable foods like meat and dairy becomes paramount. In this pursuit, innovative technologies like precision fermentation emerge as game-changers, steering us towards a more sustainable food future. By harnessing precision fermentation, we unlock the ability to produce animal-identical proteins and fats from simple sugars or other sources, offering consumers animal-free alternatives without sacrificing taste.

Moreover, fermentation-based production transcends weather, climate, and geographical limitations, rendering it a promising solution to global food security concerns in the face of rising temperatures. The road to a greener and more secure food system lies in embracing precision fermentation.

Melt & Marble with salmon steak
© Melt & Marble

Why Europe presents challenges

The good news is the landscape is brimming with innovation – precision-fermented products, like Impossible Foods’ burger infused with precision-fermented heme, have already made their mark, and countless others are in the pipeline, many poised to delight consumers in the coming year. However, to facilitate this transition, we must ensure that regulatory approval frameworks adopt a pragmatic outlook when evaluating novel food options. Presently, navigating these approvals remains a challenge, particularly in Europe.

In the EU, most precision-fermented products are defined as Novel Foods, necessitating pre-market authorization before introduction to the European market. This process involves validation, risk assessment, risk management, and eventual approval, spanning around three years. Such prolonged approval timelines prove particularly challenging for startups racing to enter the market swiftly. Moreover, ambiguity over the requirements and lack of pre-submission consultations contribute to a backlog of applications and further delays. The rigidity of the process in Europe poses additional challenges, offering limited options to modify the production strain or process after submission. For precision-fermentation companies, this can be problematic, as they may continue improving their production processes well beyond the initial market launch.

Melt & Marble meatball
Image courtesy Melt & Marble

The GMO dilemma further adds complexity to the equation. Products falling into the “genetically modified” category, even if they contain only trace amounts of the host’s DNA, are subject to rigorous GMO regulations in Europe. While these regulations are largely driven by political and perception factors rather than scientifically-based safety concerns, they can pose challenges for some precision-fermented products. Take Impossible Foods’ leghemoglobin product, for instance – available in the US and other markets for years, it has been stuck in the European regulatory process since 2019 due to the presence of the host’s DNA and proteins in the final product. The impact of Europe’s GMO regulations on individual companies depends on their product purification process, as some may require additional steps to ensure the absence of DNA, leading to higher production costs. Regrettably, this could mean that certain product types may never find their way to European grocery shelves. 

The burden of restraints

The burden of these regulatory constraints compels numerous forward-thinking European precision fermentation companies to launch their products elsewhere. As a consequence, European consumers are deprived of access to the most innovative, delicious, and sustainable products. Furthermore, investors may exhibit hesitancy towards supporting startups targeting the EU market, given the considerable regulatory obstacles they must navigate, alongside the inherent risks involved in developing and scaling novel solutions. 

Beef fat, Melt & Marble
Image courtesy Melt & Marble

So, what’s the path forward? European regulatory bodies hold the key to progress by adopting a more pragmatic stance. Valuable insights can be gleaned from jurisdictions like Singapore, where the significance of novel food technologies for food security is acknowledged, and proactive measures are taken to support companies launching products in the region. By reducing ambiguity around safety requirements, conducting pre-market consultations with regulatory bodies, and allocating additional funding to EFSA (the European Food Safety Authority) to expedite application processing, we can significantly shorten the time to market without compromising product safety.

It’s also time to challenge assumptions about genetically-modified materials. Each product’s safety profile should be individually evaluated, breaking free from the blanket notion that all genetic modifications are inherently detrimental. Embracing a science-based and open-minded approach will foster an environment where innovation can flourish, benefitting both consumers and the alternative protein industry as a whole.

“To achieve a sustainable and resilient future, our food system requires significant reform”

It will be interesting to watch the UK, where the current Novel Foods approval process closely mirrors that of the EU. The FSA, the authoritative body overseeing Novel Foods in the UK, has taken an encouraging step forward by initiating a comprehensive review of its approval process. This much-needed review has unveiled potential revisions aimed at enhancing efficiency and staying abreast of innovation. Although complete reform may still be a couple of years away, there’s hope for progress as the first steps towards a more streamlined approval system are anticipated to be implemented this year. 

The urgency of the climate change crisis and the ambitions of the European Green Deal demand a swift and efficient response from our food systems. To achieve a sustainable and resilient future, our food system requires significant reform. Unfortunately, the current Novel Foods framework’s complexity and inefficiency seem out of sync with this pressing need for transformation. In the face of environmental catastrophe, we must ensure that regulatory approval processes keep pace with innovation in order to accelerate the green transition, rather than hindering it. In the meantime, as a new generation of foods emerges beyond European borders, Europe risks falling behind.

About Melt&Marble

Melt&Marble is a pioneering company dedicated to advancing the animal-free food industry by revolutionizing the production of fats for a tastier and more sustainable future. Harnessing their expertise in microbial engineering and precision fermentation, Melt&Marble recreates the best characteristics of animal fats without the need for animals. The results are ingredients that make sustainable animal-free foods highly palatable, and that are better for people and the planet.

At the core of their technology lies precision fermentation, where yeast metabolism is rewired to convert sugars into fats, allowing for the replication of existing fats and the creation of new ones with tailored properties. This revolutionary process is underpinned by an extensive technology platform that has been developed using research spanning over a decade.

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