Global Regulatory Compendium for Agricultural Biological Products – Biopesticides, Biofertilizers, and Biostimulants: Frameworks, Registration Pathways, and Oversight Worldwide

Abstract

The use of biological products in agriculture, including biofertilizers, biostimulants, and biopesticides, has moved from niche use into mainstream practice over the past decade. Global investment in the sector continues to rise, and market demand is projected to triple over the next ten years. The regulatory infrastructure governing these products, however, has not kept pace. In most jurisdictions, biologicals are still assessed under frameworks designed for synthetic chemistries with single, well-defined modes of action. Those frameworks were not built with the variability and multifunctional nature of products derived from living organisms in mind, and they often struggle to accommodate them. The result is a regulatory landscape that varies considerably across countries, sometimes within them, and at times sits uneasily with the underlying science of the products it is meant to govern.

The Agriculture & Food Systems Institute’s work in this area includes convening conferences and regional workshops, supporting expert dialogue on problem formulation and efficacy evaluation, and producing accessible resources that lower the barrier to understanding the regulatory landscape. The Global Regulatory Compendium for Agricultural Biological Products is one such resource, and an important one for the biologicals program. The Compendium consolidates, in a single reference, an overview of the laws, agencies, and registration pathways that govern biologicals across major jurisdictions. It is not intended as a recommendation for what regulation should look like, and it is not a substitute for direct engagement with national authorities. Its purpose is more practical. It is meant to help readers locate the relevant framework, identify the responsible agencies, and find the primary sources needed to plan, register, and steward products responsibly. The standardized structure of each chapter is intended to allow regulators, developers, consultants, and capacity-building partners to compare systems, anticipate data expectations, and engage more effectively with the authorities they work with.