Regulatory Shifts in U.S. and Europe: What Biological Innovators Must Know
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By Adriana Puralewski, PhD; Jim Damico; Garth Drury
For ag-tech companies, 2025 is not just about developing innovative solutions, it is also about getting ahead. Regulatory shifts in the U.S. and EU are changing the rules for biostimulants, biopesticides, and microbial products. While complex, these changes create opportunities for companies that prepare early and think strategically.
The U.S. is making long-awaited progress toward clearer guidelines for biologicals, while the EU is aiming to improve consistency through regulatory updates, even as challenges remain.
U.S.: Toward a Clearer Path
2025 marks a turning point for U.S. regulation of biological inputs. While federal agencies are working toward greater consistency, emerging state-level policies are creating new compliance demands that require careful navigation and strategic planning.
Plant Biostimulant Act ReintroducedA bipartisan bill reintroduced in 2025 proposes a federal definition for plant biostimulants and directs the U.S. Environmental Protection Agency (EPA) and United States Department of Agriculture (USDA) to establish a consistent regulatory framework. Currently, biochemical, microbial, and seaweed-based inputs exist in a regulatory gray area—sometimes classified as fertilizers, soil amendments, or foliar amendments at the state level, and at other times as pesticides or plant growth regulators by both federal and state agencies. This ambiguity has led to inconsistent review standards. The proposed bill aims to eliminate confusion and streamline the approval process for biostimulant products. |
EPA Guidance Update on BiostimulantsThe EPA recently released updated draft guidance that clarifies which ingredients and label claims fall under FIFRA regulation. This guidance is helping companies determine early on whether their products require registration as plant growth regulators or qualify under fertilizer laws. It has become a key resource during early-stage product development. However, even with this updated federal clarity, many states are intensifying their scrutiny of biostimulant products. Some are now requiring registrants to petition the EPA for non-FIFRA determinations before state-level registration. |
EPA Guidance Update on BiostimulantsThe EPA recently released updated draft guidance that clarifies which ingredients and label claims fall under FIFRA regulation. This guidance is helping companies determine early on whether their products require registration as plant growth regulators or qualify under fertilizer laws. It has become a key resource during early-stage product development. However, even with this updated federal clarity, many states are intensifying their scrutiny of biostimulant products. Some are now requiring registrants to petition the EPA for non-FIFRA determinations before state-level registration. |
PRIA 5 and State-Level RequirementsUpdates under PRIA 5 have introduced higher fees, new review categories, and adjusted federal registration timelines. At the same time, states such as California and New York are implementing requirements that exceed EPA standards, including full disclosure and toxicity data for inert ingredients and adjuvants. These additional layers of regulation are making coordinated national product rollouts more challenging and costly. |
EU: Easier Entry and Higher Expectations
The European Union has outlined plans to support biological innovation, but its current regulatory framework still mirrors that of synthetic products—creating delays for biological approvals. While policymakers are beginning to explore more tailored regulatory pathways, progress will take time. For now, the EU remains a complex, high-barrier market where success depends on robust data, proven efficacy, and the ability to navigate regulatory hurdles. 
Regulation (EU) 2022/1438: Updated Microbial Approval ProcessThis 2022 regulation, now fully in effect, amends Annex II of Regulation (EC) No. 1107/2009 to refine approval criteria for microbial active substances. Although not new, it remains highly relevant in 2025 as more companies rely on it to simplify dossier requirements and accelerate market entry. While it may be too early to see measurable results from initial approvals under the updated criteria, the regulation is expected to improve consistency across member states and enhance predictability for applicants—reinforcing its continued importance. |
After SUR: National Plans Move ForwardFollowing the European Parliament’s rejection of the Sustainable Use Regulation (SUR) in 2023, EU policy has shifted focus from reduction targets to priorities such as food security and agricultural resilience. In 2025, several member states are advancing national strategies that promote integrated pest management (IPM), as well as organic and mechanical alternatives. For companies seeking product approvals, collaboration with regional field development and regulatory experts is key to overcoming market complexities and capturing value in this high-potential region. • |
Sources:
- S. EPA, Draft Guidance on Plant Regulators and Biostimulants, 2025
- S. House of Representatives, Plant Biostimulant Act Reintroduction, 2025
- New AG International, Biostimulants Market Update, 2025
- EUR-Lex, Regulation (EU) 2022/1438
- USDA Foreign Agricultural Service, Transparency Regulation Overview, 2025
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