Subject: European Competitiveness in Biotech
From: "Thomas Schmidt" <[email-masked]>
To: "info - MKM" <[email-masked]>
Date: Mon, 6 Oct 2025 18:39:18 +0300

Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.

Dear Marie Allikmaa,

It was a privilege to meet you at the High-Level Summit for Biosolutions
in Copenhagen this July. I am grateful for the opportunity to present
21st.BIO’s work, and to highlight why Europe must act decisively now to
safeguard and expand its global leadership in biotech and in particular
within precision fermentation.

Precision Fermentation is a European Invention
Precision fermentation uses microbes in fermentation tanks to produce
specific proteins and peptides. With a carbon source such as sugar, these
microbes create high-quality proteins for human nutrition. This technology
was invented and developed in Europe. For over four decades, it has
delivered life-changing products: insulin, enzymes, food ingredients, and
more. It is efficient and sustainable. For example, it requires only 10%
of the land compared to conventional agriculture to produce high-quality
protein and offers a sharply reduced environmental footprint.

A Strategic Technology for Europe
Precision fermentation has the potential to:

*         Close the global protein gap – Europe is unfortunately a net
importer of protein,

*         Strengthen Europe’s food security and self-sufficiency,

*         Secure supply chain predictability and prices,

*         Deliver sustainable nutrition to citizens, and

*         Secure Europe’s role as a global leader in biotechnology.

The United States and China have already prioritized precision
fermentation as a strategic technology, backed by fast-track approvals and
predictable supportive investment frameworks. Europe risks losing ground:
our technologies are invented here, but they are being scaled outside
Europe. The result is that we risk seeing factories, jobs, technology
development, and supply chains moving abroad.

21st.BIO is a Clear Example
At 21st.BIO, we produce technology for production of high-value milk
proteins through precision fermentation. In the United States, approval
for our protein was granted within one year. In Europe, the same clean,
animal-identical protein faces a regulatory process expected to take more
than five years. This mismatch drives investments, industrial facilities,
and innovation out of Europe.

Europe Must Lead, Not Follow
We cannot allow a strategic field of biotechnology to slip away. Europe
has the foundation to lead – not only in innovation, but in industrial
scale-up. What is needed now is the ambition and policy framework to turn
potential into competitive advantage.

Recommendations

1.       Adopt an EU-wide ambition, vision, and strategy for leadership in
industrial biotechnology.

2.       Introduce fast-track approvals for well-characterized,
animal-identical proteins.

3.       Modernize EFSA’s procedures to ensure global competitiveness,
focusing on:

o    Speed: approvals in 1-2 years, not 5+ years,

o    Predictability: alignment and pre-application support,

o    Focus: assessment of the product, not the process.

4.       Launch competitive funding schemes for European protein
‘mega-factories’, with direct government backing – similar to what can be
envisioned with AI mega-factories.

5.       Establish EU and national strategies for protein self-sufficiency
and bio-based value chains, from raw materials (e.g., sugar) to industrial
production and market adoption.

Conclusion
Europe invented precision fermentation. With decisive action, we can also
own its future. By accelerating regulation, aligning strategy, and backing
industrial scale-up, Europe can retain global leadership in biotechnology,
build resilient supply chains, and create sustainable growth for decades
to come.

We at 21st.BIO are ready to support your efforts to strengthen Europe’s
bioeconomy, sovereignty, and technology leadership. We hope the
forthcoming EU Biotech Act will seize this opportunity. For that we need a
broad and bold Biotech Act.

That is why we urge you to come together and make it clear, that precision
fermentation and other biotechnologies are the next industries not to lose
to the US and China. We must act now to capture the full potential for
Europe’s economic development, its ability to be self-sufficient, and its
technology leadership in biotechnology.

With respect,

Thomas Schmidt
CEO & Co-founder, 21st.BIO

Thomas G. Schmidt
Founder & CEO
+45 40 19 44 00

Delivering Innovative Biology
Sydmarken 42, DK-2860 Søborg/Copenhagen
www.21st.bio <http://www.21st.bio/>