Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

Udenrigsministeriet
Asiatisk Plads 2, 1448 København K Tlf.: +45 3392 0000 Fax: +45 32 54 05 33
E-mail: um@um.dk Web: UM.dk 1/1
Medlemmerne af Folketingets Europaudvalg Dato
12-06-2025
Bilag
2
Sag/ID Nr.
25/01475
Enhed
EUKOOR
NOTAT OG HØRINGSSVAR
Biotech Act
Til underretning for Folketingets Europaudvalg vedlægges Erhvervsministeriets ori-
enteringsnotat samt dansk høringssvar vedrørende EU-Kommissionens høring til
konsekvensvurderingen af det kommende forslag til en forordning om bioteknologi
(Biotech Act).
Marie Bjerre
Offentligt
EUU Alm.del - Bilag 538
Europaudvalget 2024-25


12. juni 2025
2025 - 6214
davchi
NOTAT
Regeringens høringssvar på EU-Kommissionens høring til konse-
kvensvurderingen af det kommende forslag til en forordning om bio-
teknologi (Biotech Act)
EU-Kommissionen har lanceret en høring, der anmoder om bidrag til EU-
Kommissionens arbejde med konsekvensvurderingen af det kommende
forslag til en forordning om bioteknologi (Biotech Act). Biotech Act skal,
ifølge EU-Kommissionen, foreslå en række tiltag for at fremskynde over-
gangen af bioteknologiprodukter fra laboratorium til fabrik og til markedet,
samtidig med at de højeste sikkerhedsstandarder opretholdes for beskyt-
telse af befolkningen og miljøet. Konsekvensvurderingen vil fokusere på
følgende områder: 1) hastighed og strømlining, 2) finansiering, 3) skala, 4)
færdigheder, og 5) anvendelse af data og kunstig intelligens inden for bio-
teknologi.
Regeringen støtter i høringssvaret stærkt op om formålet med Biotech Act,
da der er behov for en sammenhængende og langsigtet lovgivning på bio-
teknologiområdet, der kan gøre styrke EU’s konkurrenceevne, bæredygtig-
hed, resiliens og økonomiske sikkerhed. Det vil være centralt for, at EU
kan indfri sine grønne målsætninger og opnå strategisk uafhængighed på
bl.a. fødevare- og sundhedsområdet i fremtiden.
I høringssvaret opfordrer regeringen bl.a. EU-Kommissionen til at:
- Forenkle og accelerere godkendelsesprocedurer.
- Gøre større brug af regulatoriske sandkasser, one-stop shops og struk-
tureret vejledning til ansøgere.
- Vurdere muligheden for og effekten af at indføre fast-track-mekanis-
mer for bæredygtige bioteknologiske løsninger f.eks. ved at differenti-
ere datakrav og godkendelsestidslinjer for henholdsvis konventionelle
(f.eks. kemiske) og bioteknologiske løsninger.
- Fremme risikovurderingsprocedurer, der lægger vægt på slutprodukter
frem for processer.
- Revidere reguleringsrammer for praktisk anvendelse af avancerede bio-
teknologiske innovationer.
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Europaudvalget 2024-25
2/2
- Støtte udvikling af fælles storskala demonstrations- og bioproduktions-
faciliteter, inklusive fermenterings- og rensningsfaciliteter for SMV'er
og start-ups.
- Undersøge modeller til støtte for etablering af de første storskala pro-
duktionsanlæg.
- Sikre en opdateret oversigt over relevante europæiske faciliteter og tek-
nologier for optimal anvendelse og undgåelse af overlappende nyetab-
leringer.
- Yde støtte til bioteknologiske klynger og videns centre gennem målret-
tede EU-investeringer og politisk koordinering.
- Bidrage til bæredygtig forsyning og anvendelse af biomasse ved at
fremme kaskadeprincipper og fokusere på betaling for økosystemtjene-
ster.
- Integrere bioteknologi i de bredere industrielle økosystemer, såsom
bioøkonomien og grønne forsyningskæder.
EU-Kommissionens forslag er planlagt til tredje kvartal 2026. Processen
for konsekvensanalysen vil blive igangsat i andet kvartal 2025. Analysen
informeres af høring af interessenter i forbindelse med indeværende høring
og en mere struktureret offentlig høring i september 2025.


Danish feedback to the call for evidence for the
forthcoming EU Biotech Act
This document responds to the European Commission’s Call for Evidence
regarding the forthcoming EU Biotech Act, which is scheduled for presen-
tation in Q3 2026. The input reflects feedback from the Danish Govern-
ment across the five objectives outlined by the Commission in the Call for
Evidence. We welcome the Commission’s evidence-based approach and
call for a thorough impact assessment.
General comments
The Danish Government strongly supports the European Commission’s
ambition to promote biotechnology as a key strategic technology for Eu-
rope’s competitiveness, sustainability, resilience and economic security.
Biotechnologies hold great transformative potential across multiple do-
mains. They can help decarbonise industrial processes, ensure access to
innovative life-saving medicine and treatment, help future-proof
healthcare systems, enhance sustainable food production, and support the
circular economy and a sustainable land-use. To fully realise these bene-
fits, Europe needs an ambitious, forward-looking, and cross-sectoral pol-
icy response. Without a coherent policy for the biotechnologies, Europe
will fall behind its global competitors and increase its strategic dependen-
cies.
The Danish Government calls on the Commission to ensure that the Bio-
tech Act reflects the horizontal relevance of biotechnology across sectors,
including industrial transformation, environmental sustainability, and
data-driven innovation. The regulatory, financial and infrastructural barri-
ers and the biomass availability gap, which are currently limiting the cross-
cutting potential of the technology, must be addressed comprehensively.
The Biotech Act must provide a coherent and enabling framework that
accelerates the journey from laboratory to market, increases harmoniza-
tion and coordination, ensures regulatory predictability, and strengthens
European leadership in biotech. In doing so, the Act should contribute to
the green transition of the EU and deliver on our climate and biodiversity
targets.
The messages in this paper are largely limited to non-pharmaceutical bio-
technology, however, it is obvious that a competitive biotechnology sec-
tor plays a vital role in the development of innovative medicine and treat-
ments.
1. Speed and Streamlining
Efficient and predictable regulatory pathways are critical for biotech com-
panies, particularly if start-ups and SMEs are to succeed in a highly com-
petitive and fast-moving global environment. The Danish Government
Offentligt
EUU Alm.del - Bilag 538
Europaudvalget 2024-25
supports efforts to simplify and accelerate approval procedures, without
compromising safety standards.
The Danish Government urges the Commission to explore the wider use
of regulatory sandboxes, one-stop shops, and structured pre-submission
guidance to reduce administrative complexity and approval timelines. Pre-
submission guidance to applicants on their data generation, testing strate-
gies and protocols, could increase the quality of the applications, and
thereby decrease the need for ‘clock stops’ and the overall time between
submission and approval.
Furthermore, the Danish Government invites the Commission to consider
the possibility and effects of introducing fast-track mechanisms for sus-
tainable biotechnological solutions. This could be in the form of differen-
tiated data requirements and approval timelines for conventional and bi-
otechnological solutions, respectively. This is in order to support the mar-
ket introduction of new and more sustainable biotechnological solutions.
Furthermore, risk assessment procedures should focus more on end prod-
ucts instead of process, while ensuring the proper balance when it comes
to safety and health. Especially when identical products are derived
through different biotechnological means. The concept of “Generally Rec-
ognised as Safe” (GRAS), as applied in other jurisdictions, may offer a
useful model for selected biotech applications.
At the same time, there is an urgent need to reduce unnecessary admin-
istrative burdens for the biotechnology sector in Europe to ensure inno-
vation-friendly regulation. Specifically, there is a need for a review of a
number of regulations. This is particularly important for EU chemicals
legislation, including REACH (Regulation (EC) 1907/2006), and for
Placing of Plant Protection Products on the Market (Regulation
1107/2009) as well as a number of regulations on agri-food.
In the following we would like to highlight some important legislations
within the agri-food sector that should be more tailored to the innovative
biotech products that the fast-developing industry is able to deliver:
 GMO legislation
While we welcome the NGT-proposal and wish the trilogues to come to a
swift and balanced conclusion, we note that the NGT-proposal only has a
limited scope and leaves many of the fundamental problems with the cur-
rent GMO legislative framework un-addressed. We would therefore wel-
come suggestions from the Commission on more substantial improve-
ments of the GMO legislative framework. A first step should be an initia-
tive on microorganisms developed by NGTs.
The scope of Regulation (EU) 1829/2003 on genetically modified food and
feed needs to be further clarified with regard to products from fermentation
in contained use by use of Genetically Modified Microorganisms. Double
authorisations of the same product (e.g. both under food additives legisla-
tion and GMO-legislation) should be avoided.
Data requirements for authorisation of genetically modified food and feed
products should be proportionate to the risks. Furthermore, the need for re-
authorisation requirement for genetically modified food and feed every ten
years should be re-considered.
Directive 2001/18/EC reflect that the GMO techniques were new to the
world at the time the directive was written and therefore it was built on the
Precautionary Principle. At that time, these techniques did not have a long
history of safe use. After more than 30 years of growing genetically mod-
ified crops outside the EU, the experience has shown, that the benefits of
growing genetically modified crops are large. That is both for the climate
and the environment, as well as for farmers’ economy and food security
(isaaa.org, info graphics). Many of the horror scenarios from back then,
have proven false. In the EU, only one genetically modified event has been
approved for cultivation – The MON810 approved for cultivation in Spain
and Portugal. Maybe it is time to have a closer look at the effect of the
precautionary principle – does the directive have the intended effect or
not? What societal benefits have EU missed due to the strict regulation of
GMO’s in Directive 2001/18/EC? It is striking, that the research report
from WifOR Institute finds, that pharmaceutical and industrial biotechnol-
ogy deliver a direct gross value added of €32.75 bn and €5.18 bn, respec-
tively, while agricultural biotechnology account for only €0.18 bn (0,47%)
in the EU1
.
If Directive 2001/18/EC is included in a Biotech Act, there are opportuni-
ties to simplify the rules of GMO legislation. As an example, the directive
state, that applicants need to prepare a 90-days feeding study as input to
the risk assessment. There is a general view, that this demand does not
make sense from a scientific point of view. It is therefore possible to relax
the demands to the risk assessment without putting food security and the
environment at danger. In addition, consent holders of approved GM crops
must prepare an annual ‘Post-Marketing Environmental Monitoring’
(PMEM) report. Many resources are used to prepare these reports, but it is
questionable, if they serve any purpose that benefit the food security or the
environment in the EU.
 Novel food legislation
Efforts are also needed in order to lower the European Food Safety Au-
thority’s (EFSA) workload related to novel foods. It is relevant that EFSA
always considers the need for data for their risk assessments on a need-to-
1
Andreas Haaf & Vera Sale, Measuring the Economic Footprint of the Biotechnology Indus-
try in the European Union, WifOR Institute, March 2025, EuropaBio.
know rather than nice-to-know approach. In addition, risk managers
should carefully consider how mandates to EFSA are drafted in order to
narrow the scope of EFSAs work to the necessary.
Denmark also finds it crucial to consider the reintroduction of the substan-
tial equivalence approach for novel foods and food ingredients that are
equivalent to existing food products independently of how they are manu-
factured. Also, the date of which foods are considered novel could be ad-
vanced until e.g. 2010.
Regarding Regulation 2015/2283 on novel foods, simplification of the im-
plementation could be considered with the purpose of reducing the number
of products falling under the scope of the regulation.
 Feed additives legislation
The feed additive regulation (EU Reg. 1831/2003/) is expected to be re-
vised soon. Efforts are also needed on this area to lower EFSAs work-load,
but also the workload of the Commission, the member states and others.
This can be done via reduction of regulatory burdens, preferably by intro-
ducing permanent feed additive approvals for safe and well-known sub-
stances. It would also help the field of biotechnology if the rules on claims
related to the effect of a feed additive are clarified and preferably expanded
to provide better legal possibilities for sustainability claims for the already
established functional groups of feed additives. An introduction of simpler
rules for the marketing of non-EU approved additives for export is also a
relevant change to consider.
 Other feed related initiatives
There is a need to look further into the possibilities to introduce circularity
on some very specific risk assessed safe Animal By-Products. This could
e.g. be the use of incinerated sludge for the production of very clean phos-
phorus for use as feed and fertilizer, due to a worldwide deficiency of nat-
urally occurring phosphorus.
There is a need to clarify the rules on environmental claims on feed mate-
rials. This e.g. to ensure access to feed materials for methane reduction.
Denmark would like to draw attention to the Heads of Agencies (HoA)2
sustainability catalogue from 2023. The Danish Veterinary and Food Ad-
ministration coordinated a working group among 10 EU member states to
recommend some principles and suggestions to deliver on the sustainabil-
ity agenda. The catalogue also delivers some considerations in relation to
biotech e.g. the use of fermented feed additives.
Relevant legislation in the health sector
In the area of health, it is important that the policy response creates added
value when it comes to biotechnology application and innovation uptake,
2
“Toward sustainable food systems”- Reflections by HOAs September 2023.
while balancing the need for patient safety and an evidence-based approach.
This could include looking at the framework for multi-country clinical trials
and the Medical Device Regulation and in vitro diagnostics to ensure their
compatibility with the rapidly changing landscape. The policy response
should focus on addressing overarching challenges that existing regulations
have not or cannot address. It is important that the act simplifies or facilitates
implementation of the existing ruleset rather than adding an additional layer
of complexity to an already highly regulated sector.
2. Financing
Securing access to adequate, risk-tolerant capital across the innovation
chain remains a central challenge for the biotech sector in Europe. In par-
ticular, there is potential for increased access to late-stage venture capital
and scale-up funding to improve commercialisation of biotech solutions.
It is key that biotech startups can attract adequate capital on their full
growth journey – from the idea phase to large-scale production. In addi-
tion, it is also essential to ensure coherence between efforts to mobilise
biotech financing and broader EU objectives on decarbonisation, industrial
resilience and sustainable food systems.
The Danish Government supports an enhanced role for the Savings and
Investment Union and encourages the Commission to explore increased
use of de-risking instruments and blended financing models.
The long payback period and capital intensity of first-of-its-kind large-
scale biotech production facilities require tailored solutions, including sim-
plification of access to existing EU instruments.
The sector is in great need of more venture capital. Therefore, further stra-
tegic use of EU budget guarantees or venture equity instruments has to
be considered while at the same time creating incentives for increased in-
vestment of private venture capital. There is a need to explore opportuni-
ties to further enhance access to risk capital for life science companies
in order to support the private capital market through market-based efforts
and collaborations with private investors, for example, under the auspices
of the European Investment Bank (EIB).
While other initiatives seem more relevant for pursuing the above-men-
tioned goals – e.g. a future Competitiveness Fund, and the Savings and
Investment Union – the Biotech Act must also address the question of at-
tracting investments to the EU. This means addressing the elements cre-
ating uncertainty for investors, including acceleration of approval times,
developing technical screening criteria for biotechnological climate solu-
tions as enabling technologies in the EU taxonomy for sustainable activi-
ties, and overhaul outdated regulation as described in section 1.
3. Scale
Biotech solutions must be deployed at scale to realize their societal and
economic benefits. Yet companies often struggle to bridge the gap between
pilot-scale innovation and full industrial production. The scaling-process
for these solutions is typically very expensive, lengthy and uncertain.
Access to facilities for testing, demonstration and scaling of the production
is vital for biotech companies, but most of the fermentation capacity in
Europe is already in use and only a minor share is for large-scale demon-
stration, which is necessary to convince investors and future customers.
This lack of facilities can force European biotech companies out of the EU.
The Danish Government encourages the Commission to put forward initi-
atives that can support the development of shared open access large-scale
demonstration and biomanufacturing infrastructure — including fer-
mentation and purification facilities — accessible to SMEs and start-ups.
The Danish government also encourages the Commission to explore pos-
sible models for supporting the establishment of first-of-its-kind large-
scale production plants. Today, the EU supports new solutions for decar-
bonisation. However, there is a need to simplify the rules for applying for
EU funding so that the framework is in place for the establishment of first-
of-its-kind large-scale biotechnology plants in Europe..
To ensure optimal use of existing facilities and preventing overlap in new
establishments, it is also crucial to have an easy and up-to-date overview
of all relevant European facilities and technologies – e.g. based on the
existing Pilots4U platform.
We also encourage support to biotech clusters and centers of excellence.
A geographically balanced deployment of infrastructure can strengthen re-
gional innovation capacity and avoid duplication. Infrastructure develop-
ment should be complemented by simplified permitting procedures and a
supportive investment environment, ensuring integration into broader in-
dustrial ecosystems, such as bioeconomy strategies and net-zero supply
chains. In this regard, specific attention should be paid to environmental
and spatial planning procedures and their interaction with biotech scale-
up.
Scale-up will increase supply chain demand for biomass as feedstock to
the biotech sector and therefore lead to an increased pressure on natural
resources. A Biotech Act should therefore also contribute to a sustainable
supply and use of biomass. This should be done by promoting the princi-
ple of cascading use of biomass in the biotech sector through regulation
or other incentives and at the same time have a strong focus on payment
for ecosystems services throughout the value chain. Cascading use of bi-
omass contributes towards reducing the expected biomass availability gap
and can simultaneously reduce the dependency of fossil resources and in-
crease the responsible use of renewable biological resources within the
planetary boundaries.
4. Skills
To attract the necessary talent to the European biotech sector, Europe needs
to build on its strong research community and create European innovation
hubs where stakeholders can collaborate across sectors and disciplines.
5. Use of Data and AI
Artificial intelligence, real-world data and high-performance computing
are crucial enablers for the biotech sector. Whether in enzyme discovery,
molecular design or regulatory simulations, AI offers transformative
productivity and insight gains. However, biotech actors continue to face
challenges related to data access, and infrastructure availability.