Biologicals: Why the same product can fall into different categories across markets

Agrolatam
2026.08.15

Innovation in agricultural biologicals is accelerating in 2026, but the regulatory systems governing these products are not moving at the same pace or in the same direction. A technology classified as a biopesticide, biostimulant or biofertilizer in one market may face a different regulatory pathway in another, depending on its composition, mode of action and, critically, the claims made on its label. For developers seeking access to the United States and international markets, these differences can determine what studies are required, how a product can be marketed and how long it takes to reach farmers.

The issue begins well before a regulatory dossier is submitted. While agricultural biologicals are broadly associated with living organisms, naturally derived substances or biological processes, there is no single global regulatory definition covering the entire sector. A product promoted for improving plant nutrition can follow a very different pathway from one claiming to control disease or modify plant growth, even when their underlying technologies are similar. As a result, product positioning and label claims are increasingly becoming regulatory decisions made during the earliest stages of development.

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