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logicals are evaluated using frameworks 
originally designed for chemicals, which 
can result in long timelines, high fees and 
uncertainty, especially for new microbial 
technologies or gene-edited strains. 
“The absence of specific pathways for 
biologicals creates delays and complex­
ity,” Bäsel explains. 
This is further compounded by 
competitive market conditions and 
lingering grower skepticism fueled by 
inconsistent performance of early-
generation products.
On the technical side, Pronk stresses 
the difficulty of maintaining product 
efficacy throughout the seed’s shelf life. 
Biologicals must survive formulation, seed 
application, storage and downstream 
handling while still performing in the field. 
Compatibility inside increasingly complex 
seed treatment stacks is equally critical.
From a regulatory standpoint, Hazel 
highlights the dual challenge of stability 
and data requirements. For biopesticides, 
regulatory pathways are somewhat more 
aligned globally but still heavily data-
driven. Biostimulants and biofertilizers, 
however, operate in a more complex 
and evolving regulatory space, with 
requirements varying widely by country. 
Meanwhile, a lack of harmonized stand­
ards continues to slow commercialization.
Gaffney underscores that product 
consistency is essential for rebuilding 
grower trust. Extensive pre-commercial 
testing ensures seed safety, environ­
mental safety, compatibility with other 
treatments and performance across 
geographies and seed treatment pro­
cesses. The industry is rising to meet 
these expectations, but the bar is high.
Why Global Regulatory 
Harmonization Matters for 
Biological Seed Treatments
Given this fragmented global landscape, 
clearer guidance and shared terminology 
have become essential. Gaffney sees the 
ISF Guide for Biologicals as a practical 
step forward. By aligning definitions and 
product classifications, the guide sup­
ports advocacy for science-based and 
risk-proportionate regulation. It also helps 
facilitate trade and enables companies to 
build internal compliance systems around 
common principles.
For Bäsel, the guide’s value lies in cre­
ating a shared language. When regulators 
and industry speak consistently about 
biologicals, what they are, what they 
do and how they should be evaluated, 
communication improves across borders. 
Understanding the regulatory landscape 
in other regions, he notes, is critical for 
companies operating globally, and the 
guide provides a structured way to do 
exactly that.
What Drives Farmer Adoption of 
Biological Seed Treatments?
Farmer adoption ultimately depends on 
trust, and trust depends on results. Pronk 
believes that setting realistic expectations 
is fundamental. Biologicals are powerful 
tools, but growers must understand and 
use them appropriately to succeed.
Performance and return on invest­
Christine Hazel is the global 
regulatory lead – Seed Applied 
Technology at Corteva Agriscience.
Rob Pronk, global marketing 
manager and global regulatory 
manager at Incotec.
certain cases replace them altogether, 
highlighting how biologicals are diversify­
ing the role of seed-applied technologies 
across crops and regions.
Challenges and Barriers in 
Developing and Commercializing 
Biologicals
Despite their promise, biological seed 
treatments face a demanding road to 
market. The biological innovation cycle is 
fast, and Bäsel notes that this dynamism 
makes it difficult for large companies to 
align pipeline development with short- 
and mid-term portfolio needs. Bayer 
has responded with an open innovation 
model that relies on partnerships with 
smaller innovators and technology lead­
ers to keep pace with market demand.
Regulation remains the biggest struc­
tural barrier. Across many regions, bio­
Rob Gaffney is the director global 
marketing seed treatments – global 
key accounts at BASF.
Steve Bäsel, senior regulatory policy 
manager at Bayer.

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