Microorganisms are crucial to Europe’s bioeconomy, driving innovation across industries. However, outdated EU regulations hinder their potential. A modernized framework is essential to fully harness these tiny powerhouses for a sustainable future.
Lucie McMurtry is the Senior Manager of Industrial Biotechnology at EuropaBio.
What are microorganisms?
On 17 September 1683, Antonie van Leeuwenhoek first described a microorganism in a letter to the Royal Society of London. This is why 17 September is International Microorganism Day – a day dedicated to celebrating the microscopic organisms that surround us and of which we are completely unaware, for the most part. Microorganisms, a large group comprising bacteria, yeasts, microalgae, viruses, and protozoa, are invisible to the naked eye and occupy every surface around you – from the screen you’re reading this article on to your skin, the air you breathe, the soil in your garden, and even the food you eat.
While this may sound alarming, only about 5% of bacteria are pathogenic (disease-causing). The rest are completely benign, going about their day ignoring you as much as you are unaware of them, or they are beneficial. For instance, probiotic bacteria like Lactobacillus and Bifidobacterium, found in fermented foods like yoghurt, sauerkraut, and kimchi, support good gut health.
Microorganisms are genetically and metabolically flexible – think of how yeast turns sugar into alcohol when making beer. That same pathway can be repurposed: if you give a microorganism the genetic instructions for building a particular target molecule, it will turn sugar into that molecule, instead of alcohol (in our yeast example). This discovery sparked the modern biotechnology industry in the 1980s by producing human insulin (the human hormone that regulates blood sugar) in a yeast cell. This improved treatment for diabetic patients who were until then dependent on insulin extracted from animal pancreases.
Since then, microorganisms have been used as tiny factories to biomanufacture molecules for use in a variety of sectors, including food & feed, detergents, cosmetics, and biomaterials. For example, 80% of cheese today is made using enzymes produced by microorganisms, instead of extracting rennet from calf stomachs. Flavourings like vanillin are synthesized more efficiently and sustainably through biomanufacturing. 75% of laundry detergents and 95% of dishwashing detergents contain enzymes, which increase the efficiency of detergents and reduce needed concentration of other ingredients, with corresponding consumer and sustainability benefits in terms of improved water and energy use and reduced GHG emissions and pollution. Vitamins and other bio-based chemicals can be biomanufactured from renewable feedstocks, moving away from fossil-based chemical synthesis. Finally, novel biomaterials like spider silk can be used in applications ranging from cosmetics to healthcare to textiles.
Beyond working as factories to biomanufacture ingredients and products, microorganisms can also be used directly as products in a wide variety of sectors, including food, feed, healthcare, and agriculture. Probiotic applications in food and feed can support human and animal health. Beer yeasts have been modified to produce the flavour compounds from hops, so that fewer hops are used while maintaining characteristic flavours. Agricultural applications have the potential to complement and reduce synthetic fertilizer and pesticide use, through plant-growth promoting bacteria or biocontrol. For example, some types of microorganisms can turn abundant atmospheric nitrogen into a form that plants can use and uptake, with positive results in terms of reduced greenhouse gas emissions, reduced nitrate pollution, and increased yields.
Why are microorganisms genetically modified?
In most cases microorganisms that are used as factories are genetically modified: they are provided with the genetic instruction to make a particular molecule (e.g. the gene for human insulin) or their metabolic pathways are modified to increase yields of a target molecule for more efficient production. Genetically modified microorganisms (GMMs) used in this way are considered processing aids as they are not present in the final products, such as food ingredients or feed additives, which are then regulated under relevant product-specific legislation. Microorganisms used directly as products can also be improved through genetic modification for safety, efficiency, and sustainability benefits. Advances in biotechnology, including new genomic techniques (NGTs), allow for increasing precision and efficiency.
It is important to note that genetic modification techniques are not considered hazardous by risk assessment agencies worldwide. The technique used to develop a product should not be the focus of a risk assessment, but instead the outcomes and product characteristics should be assessed. This is considered a product-based approach. However, the EU GM framework is process-based, assessing products based on techniques used. The framework was developed in the 1990s and does not reflect scientific advances. GMMs that are used directly as products, like the biofertilizer example above, are regulated under this framework, and thus far no GMMs have ever been submitted for approval. The 2021 EU Commission Study on NGTs recognized the GM framework as outdated and not fit for purpose, and as a result a targeted policy framework for plants developed using NGTs is currently under discussion. For microorganisms, the Commission mandated EFSA to produce a scientific opinion on new developments in biotechnology applied to microorganisms. The EFSA opinion, published in July, notes that NGTs do not pose novel hazards compared to established techniques while NGTs can also provide higher efficiency, specificity and predictability of genomic changes. EFSA recommends a consistent product-based risk assessment approach for microorganisms, regardless of the techniques used to produce them.
Microorganisms and the EU
The incredible potential of microorganisms is slowly being recognized in the EU, with recent legislative developments including new implementing regulations for microbial biocontrol or a new annex for microbial cleaning products in the revision of the Detergents Regulation. However, many applications involving microorganisms are still not able to reach the market due to the GM framework, meaning the EU is missing out on innovative and sustainable solutions. Microorganisms urgently need to be considered separately through a fit-for-purpose, product-based regulatory approach.
The European Commission’s Biotechnology & Biomanufacturing Initiative and future Biotech Act can support the broader implementation of biotechnology across the EU, including by paving the way for wider use of microorganism products. Just as microchips are the backbone of the digital transition, microorganisms should be recognized as the microchips of the bioeconomy.
Microorganisms are vital to Europe’s sustainable future. To learn more about how these tiny powerhouses transform industries and to meet Max the Microorganism, visit our dedicated microorganism page.