A world already shaped by chemical consequences
To understand why this new technology was met with such caution, it is worth remembering what the world had just experienced.
The 1970s and 1980s were decades during which the environmental and human costs of industrialization were becoming increasingly visible. For the first time, societies were confronting the unintended consequences of large-scale chemical use across ecosystems and populations.
In the 1970s and 1980s, the widespread use of pesticides like DDT was beginning to raise serious concerns.
Issues such as air and water pollution had gained global prominence. Acid rain was damaging forests and lakes across regions. The widespread use of pesticides like DDT had raised serious concerns about long-term environmental and health impacts. By the mid-1980s, the discovery of the ozone hole showed that everyday chemicals — used in products like refrigerators and air conditioners — could affect the planet’s atmospheric systems in ways no one had anticipated.
Alongside these developments were major industrial accidents — including Love Canal in the United States, where toxic waste contaminated a residential area, and the Bhopal and Seveso disasters, both major chemical plant accidents in India and Italy, respectively, with severe human and environmental impacts — that made it clear how serious the consequences of poorly managed chemical use could be.
Taken together, these events revealed a clear pattern. Technologies that were introduced with confidence and clear benefits could, over time, produce consequences that were neither anticipated nor fully understood.
This was the backdrop against which biotechnology began to take shape in public consciousness.
So when a new technology emerged, it wasn't viewed in isolation — it was viewed through the lens of recent experience with chemicals.
And that experience had taught the world a useful lesson: innovation can sometimes move faster than our understanding of its risks — which is exactly why building careful oversight in from the start matters.
From breakthrough to framework
In just over a decade, from 1972, when Paul Berg first demonstrated the new technology to the mid-1980s, the field evolved rapidly. What began as a laboratory breakthrough did not remain confined to research settings for long. The new technology began moving into industrial use, becoming part of manufacturing processes in sectors such as pharmaceuticals and food production.
Some of the earliest applications emerged during this period, including the production of human insulin in 1982, followed by enzymes used in products like detergents and bread. Over time, its use expanded across industries — from healthcare and agriculture to food processing and consumer goods — laying the foundation for many of the applications we see today.
By the 1980s, recombinant DNA technology had moved from the laboratory into industrial use, including the production of human insulin
As the technology matured and moved from controlled experiments into real-world use, it understandably drew attention. Across countries and regions, regulatory agencies began to step in. The question was no longer whether biotechnology could work, but how it should be regulated and governed.
By the mid-1980s, this shift had begun to take shape. In 1986, Denmark enacted the Gene Technology Act, the world’s first national law specifically regulating biotechnology. Just weeks later, the United States introduced its Coordinated Framework for the Regulation of Biotechnology, outlining how existing regulatory agencies would oversee the field. Soon after, the European Union followed through with directives that set the conditions under which biotechnology could move beyond the laboratory and into wider use.
Different countries took different routes. Some chose to adapt existing regulatory systems, while others developed new frameworks tailored to the emerging technology. And yet, despite these differences, there was a common thread. Their primary aim was to ensure safety, manage risk, and prevent unintended consequences.
This emphasis is understandable: These laws did not emerge in isolation, but in a world that had recently learned, through hard experience, the importance of getting oversight right — particularly around chemicals.
By the time biotechnology entered the scene, societies had developed a structured way of thinking about risk: how to test new substances, control their use, limit exposure, and respond when something went wrong. In this context, caution was not merely a preference, but a learned response.
So when faced with biotechnology, policymakers drew on this experience, applying the same rigor — risk assessment, control, and careful oversight — that had come to define responsible regulation more broadly. It was a sign of how seriously the field was being taken from the outset.
Why this matters now for biosolutions
The story we have traced so far does not end in the past. It continues to shape what happens to biotechnology today, how it is regulated, the steps it must go through from discovery to application, and how quickly its benefits reach society.
Over the past few decades, biotechnology has steadily moved beyond laboratories and into industrial settings, finding applications across sectors ranging from pharmaceuticals and agriculture to materials and manufacturing.
What we now describe as biosolutions is a continuation of the biotechnology journey. In many cases, they work through biological processes that enable a more circular use of resources, reducing waste, and making better use of what already exists. Here, biology is not just studied, but used deliberately to produce everyday products, improve processes, and reduce our reliance on resource-intensive and fossil fuel-based materials.
In simple terms, biosolutions are just biotechnology applied at large scale in real-world settings. It's often at this exact stage — when a technology is ready to be deployed widely — that progress can slow. This is usually driven less by the robustness of regulatory systems and more by how well they are coordinated with one another.
Biotechnology has steadily moved beyond laboratories and into industrial settings. But it is often at this stage that progress slows down due to regulatory, political, or societal barriers.
Bringing a new biosolution from the laboratory to the real world is rarely a straightforward journey. It involves navigating multiple layers of assessment, different regulatory authorities, and requirements that vary across sectors and countries. Even when the underlying science is well understood, the pathway itself can be long, complex, and, at times, difficult to predict.
The European Biosolutions Coalition, for instance, points to regulatory complexity, limited coordination, and differing rules across member states — creating what it describes as a patchwork of regulations7. Approval processes can be lengthy, and administrative procedures are not always easy to navigate. What is often missing isn't safeguards but simplification and coordination across the system.
In practice, this means that the journey from idea to application is not a single, coordinated pathway. A solution may move through multiple stages, each governed by different requirements and authorities. Processes do not always align seamlessly, and scientific breakthroughs can take considerably longer to reach people than the underlying science alone would suggest. The result is that valuable innovations — including biosolutions that play a key role in sectors like manufacturing, energy security, and food production — can take longer than necessary to reach those who would benefit from them.
This broader pattern becomes even clearer when you look at how specific technologies move through the system. An analysis by the OECD highlights similar structural challenges — overlapping frameworks, regulatory fragmentation, limited flexibility, and lengthy approval timelines8.
In some cases, these challenges have very visible consequences for access to innovations that have the potential to address some of the most pressing political and societal priorities.
For instance, in the case of animal feed enzymes and probiotics, estimates suggest that approval in South Korea can take around two months, compared to the EU where the process may take up to 15 times longer, or 2.5 years. For dietary supplements, estimates indicate that regulatory approval takes approximately 11 months in Brazil, whereas in China the process can take up to around 42 months, or 3.5 years.
What this reveals isn't that some systems are too cautious and others too lax — it's that different parts of the global system move at different speeds, with limited coordination between them. A product may be considered acceptable in one context, yet face a much longer pathway in another. So, the challenge is not just whether a solution works. It is how easily it can move through a system that wasn't always designed with today's pace of biological innovation in mind.
When familiar biology meets a system built for caution
Many biosolutions today are built on biological processes that are not new. Fermentation, enzymatic reactions, and microbial activity have been used safely for decades, in some cases for much longer. What is new is not always the biology itself, but how it is applied, scaled, and integrated into modern industrial systems.
The regulatory pathways they must navigate do not always reflect that track record yet — which is why the conversation around regulation is beginning to shift.
Across Europe, there is growing recognition that existing frameworks, while built on sound principles, may need to evolve to better support the role biotechnology is now expected to play. The European Biosolutions Coalition, together with counterpart organizations in Brazil and North America, calls for faster and more coordinated approval pathways, clearer and time-bound processes, and a move towards evaluating technologies based not only on their risks, but also on their potential benefits. It also highlights the need for improved incentives for scaling and infrastructure, along with greater investment in research, innovation, and public awareness.
These are not calls to weaken regulation. They are calls to make it more responsive to how biotechnology, and biosolutions in particular, are developing today.
Seen in this light, the underlying question becomes clearer: Not whether protection is needed — it clearly is and should remain non-negotiable — but whether the systems delivering that protection have kept pace with how the technology itself has developed.
If biosolutions are to move from promise to practice, the systems that govern them can evolve to become more coordinated and efficient, without compromising their protective purpose. Businesses have an opportunity to help shape that evolution, working together with policymakers and regulators to build regulation that is fit-for-future and not based on the past.
But regulation is only part of the story. Because even the most forward-looking policy cannot, by itself, create public trust, shift old habits, or make a new way of producing feel natural and desirable. For that, something deeper must also change: How society understands biology, how innovation is communicated, and how unfamiliar ideas become accepted over time. We’ll dive more into that in our third article in this series.
