EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

Europaudvalget 2024-25
EUU Alm.del Bilag 538
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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

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

supports efforts to simplify and accelerate approval procedures, without

compromising safety standards.

The Danish Government urges the Commission to explore the wider use

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.

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

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 EU

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-

Andreas Haaf & Vera Sale, Measuring the Economic Footprint of the Biotechnology Indus-

try in the European Union, WifOR Institute, March 2025, EuropaBio.

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

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)

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,

“Toward sustainable food systems”- Reflections by HOAs September 2023.

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

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

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

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

EUU, Alm.del - 2024-25 - Bilag 538: Notat samt høringssvar vedr. forordning om bioteknologi (Biotech Act)

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.