The Brazilian legislation distinguishes fertilisers, biostimulants and soil conditioners.

To register a biostimulant prior to placing it on the market, a dossier needs to be prepared and submitted for evaluation. This dossier includes a toxicological and ecotoxicological dossier, especially for products containing living microorganisms. The physical-chemical characterization requires detailed studies of the product's physical state, pH, density, and miscibility, adhering to validated methodologies. It must provide documentation on the origin of raw materials, which includes stability studies and control of contaminants. These studies are crucial for ensuring safety and compliance with regulatory standards. Overall, the comprehensive information gathered and submitted will support the assessment of product safety and effectiveness.

However, there would be cases where biostimulants could be exempted from toxicological studies; this would be potentially in the following cases:

1: When they are used in traps or devices that do not apply the product to parts of the plant intended for consumption.

2: If the active ingredient is exclusively baculovirus.

3: When the formulation contains only substances authorized for use in organic agriculture.

Efficacy studies for biostimulants must also be submitted and they must demonstrate their effectiveness in stimulating physiological processes in plants, particularly in relation to stress response and growth enhancement. These studies should include data on the biostimulant's performance across various crops and conditions, as well as its impact on plant health and yield.

Additionally, the studies should consider the storage period of seeds when evaluating efficacy. Efficacy trials for microbiological products must be conducted in accordance with Good Laboratory Practices (GLP). This ensures that the studies are reliable, reproducible, and meet the regulatory standards required for approval.

By and large, if you plan to place a biostimulant on the brazilian market, you will have to set up a dossier that should include (unless exemption from some of the elements can be claimed):

1: A comprehensive characterization of the product, including its composition and the active ingredients.

2: Toxicological and ecotoxicological studies, demonstrating safety for human health and the environment.

3: Efficacy studies that provide evidence of the product's effectiveness in enhancing plant growth and stress response.

To request the registration of a microbiological product, the following documentation is required:

1: Identification of the microorganism isolate and its deposit collection.

2: A dossier containing toxicological, ecotoxicological, and efficacy studies, along with data on the origin of raw materials and stability studies.

3: A declaration of the qualitative and quantitative composition of the product, including minimum and maximum limits of active ingredients and other components.