Regulatory Insight
Fixing Europe’s Regulatory Bottlenecks to Enable Coexistence, Innovation, and Timely Market Access
by Dr. José Carvalho, Europe Regulatory Lead for Certis Biologicals
“We need to move on. Europe created much of its current regulatory dilemma years ago… sustaining sterile debates about ‘chemical versus biological’ solutions.”
Geopolitical uncertainty has reached levels not seen in decades, creating a world where regulatory unpredictability feels almost predictable by comparison. In this environment, Europe’s regulatory framework—specifically the Plant Protection Products Regulation (Reg. 1107/2009)—continues to struggle with outdated discussions that are detached from scientific reality and global practice.
The Chemistry vs. Biology Divide
In Europe, data requirements for chemical products have reached levels that make registering new molecules nearly impossible. Meanwhile, biological products face their own barriers: chief among them are procedural delays, excessive timelines, and data requirements ill-suited for their nature. We are currently applying the same complex and costly processes to biologicals regardless of their market scale.
The Need for Coexistence
What we need is coexistence; chemistry and biology both have a place in modern agriculture. Emergency authorizations and confusing workarounds are signs of a cracked process. Fixing the core procedural issues would give growers faster access to the safe tools they need while reducing confusion across the market.
The Omnibus Simplification Package
The proposed simplification package, known as the “Omnibus,” is crucial as it focuses on improving implementation procedures without changing risk assessment or safety standards. Key benefits include:
- Selectivity Recognition: Ensuring current regulatory processes reflect the specific nature of biocontrol products.
- Enforced Timelines: Ensuring the 120-day timeline for mutual recognition is enforced to stop applications from dragging on for years.
- Maintaining Standards: Safety requirements remain strictly unchanged, but the system becomes more workable for innovation.
A Call to Action
Europe often acts only when it is almost too late. Industry and growers must seize this moment to demand fair market access and advocate for simpler, faster procedures that encourage innovation. If we do not act now, we risk reaching a cliff’s edge where we are forced to fix damage after it has already occurred.
Dr. José Carvalho is the Europe Regulatory Lead for Certis Biologicals, Chair of the IBMA Microbial Professional Group, and a member of the IBMA Council.
Certis Biologicals – Regulatory Perspective 2026
Advancing sustainable agriculture through regulatory reform and scientific excellence.
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