Biocontrol: Navigating the EU Regulation for Natural Substances & Semiochemicals

Biocontrol products based on botanicals, natural substances and semiochemicals are often perceived as simple, yet in practice, they are among the most challenging to position within the EU regulatory framework, the course will help you navigate the regulation for these complex substances.

OverviewProgrammeVenuePrices & Services

Overview

From borderline classifications and low-risk criteria to complex substance identity and variable composition, these products require careful justification at every step. This training explores the key regulatory grey areas, including specification challenges, read-across strategies and the use of literature in place of standard data packages.

With a strong focus on applicable knowledge, the course equips you to navigate ambiguity, address common pitfalls, and build defensible IUCLID submissions for complex and often unconventional substances.

Deliverables:

  • Step-by-step understanding of EU regulatory procedures for biocontrol
  • Actionable guidance on data generation and dossier compilation
  • Expert tips to streamline approvals and reduce regulatory delays

Who should attend this meeting?

Sectors that should take part:

  • Chemical industry
  • Biopesticide and biocontrol developers and producers
  • Startups and small and medium-sized enterprises developing biocontrol products
  • Regulatory affairs

Professional groups:

  • Academic Researchers aiming to translate lab findings into regulatory submissions
  • Industry Experts transitioning to or supporting biocontrol solutions
  • Regulatory Affairs Specialist and consultants expanding into the biocontrol space

Picture credit © Auuu – iStock (Modified with AI)

 

Programme

PLEASE NOTE: The indicated times refer to Central European Time CET.

For further time zones, please view here.



Thursday, 12 November 2026


09:00 – 13:00 | CET
1. General introduction to regulatory affairs for plant protection products
Active substance approval and productauthorisation in EU
  • Involved authorities
  • Time lines
  • Data requirements for a.s. and products in general
  • Renewal
  • Low risk/Biocontrol (Omnibus proposal)
  • Risk assessment
2. Botanicals, Natural Substances & Semiochemicals – Navigating Complexity and Classification
Regulatory classification & borderline issues
  • Active substance vs basic substance vs biostimulant
  • Low-risk criteria and where they fail in practice
Substance identity and composition challenges
  • Common challenges of specification determination, batch analysis and lead component
Specific data requirements
  • Read-across, literature use, and waiving strategies
Risk assessment considerations
  • Human health and exposure assumptions
  • Environmental fate of complex mixtures
Guidance landscape and regulatory grey areas
Dossier preparation in practice
  • IUCLID challenges for complex substances
  • Common pitfalls in dRRs

Venue

Online Training
This training is going to be held online.
You can reach us directly at:
Phone : +49 231 75896-50
Email: info@akademie-fresenius.de
www.akademie-fresenius.de

Prices & Services

Participation Fee: € 645.00 plus VAT.

The registration fee includes the following benefits:

  • Participation in the Online Event
  • Certificate of participation
  • Training documentation (available after the training via download from our website)

Representatives of an authority or a public university are therefore eligible for a reduced fee of € 495.00 plus VAT per person (please provide evidence). The reduced fee cannot be combined with other rebates.

Group Reductions
For joint bookings received from one company we grant a 15% discount from the third participant onwards.

Terms of Cancellation / Book without Risk
You can cancel your participation in our online events free of charge and without giving reasons in writing up to 1 week before the start of the event. In the case of later cancellations and non-login to the online event, no participation fees can be refunded.
In this case, however, you will receive access to the documentation after the event.
You can name a substitute participant free of charge at any time.

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoeller@akademie-fresenius.de

Anne Möller

Your Contact

Anne Möller
Programme and conceptual design

+49 231 75896-84
amoeller@akademie-fresenius.de

Jennifer Zerth

Your Contact

Jennifer Zerth
Organisation and participant management

+49 231 75896-79
jzerth@akademie-fresenius.de

Jennifer Zerth

Your Contact

Jennifer Zerth
Organisation and participant management

+49 231 75896-79
jzerth@akademie-fresenius.de

Additional Dates for this Event:

23.07.2026,  Online Training

Display / Supplement

Present your Company at the Event.

You can personally present your products and services directly to your specified target group. We are happy to provide you with further information on our range of available options – from displaying company information at the reception counter to presenting your company with an exhibition stand.

We would be pleased to assist you personally:

Monika Stratmann

Monika Stratmann
Phone: +49 231 75896-48
info@akademie-fresenius.de

Press Contact

We offer journalists and editors a platform where they can get in touch with the experts.

If you are the editor of a specialist publication and interested in a press pass or media partnership, please contact us well in advance. We are happy to advise you.


Please contact us:

Katharina Geraridis

Katharina Geraridis
Phone: +49 231 75896-67
presse@akademie-fresenius.de