Chile has taken inspiration from the European legislative framework and established a detailed regulatory framework for biostimulants through Law Nº 21.349, its Regulation (Decreto Nº 61/2023), and a series of SAG (Agricultural and Livestock Service) resolutions.

Below are the main points with reference to the relevant legislation.

For starters, biostimulants are defined as “_substances, mixtures, or microorganisms applied to seeds, plants, or the rhizosphere to stimulate natural processes, improving nutrient use efficiency, stress tolerance, quality attributes, or nutrient availability in soil or the rhizosphere._” (Ley N.º 21.349, Decree 61/2022).

Distinction is made between microbial ((biofertilizers), such as nitrogen-fixing bacteria, mycorrhizal fungi, phosphorus-solubilizing fungi, and other nutrient-enhancing or bioactive-producing microorganisms) and non-microbial biostimulants, which then have different and specific requirements. For instance, for microbial biostimulants the genus, species, strain, and content of microorganisms (in CFU, spores, or propagules) must be indicated on the label.

Some imports, such as laboratory samples, personal use quantities (≤5 kg or litres), and certain control samples, may be exempt from sampling, but must still meet labelling and registration requirements. Microbial biostimulants are generally not exempt due to phytosanitary risks.

Quality and Safety Standards apply to both types of plant biostimulants: minimum nutrient contents and maximum contaminant levels, which must be declared on product labels or leaflets. Parameters include heavy metals, pathogens, and other hazardous substances.

Each product must be registered with detailed information on composition, intended use, quality parameters, and evidence of efficacy and safety and all actors (manufacturers, importers, distributors, etc.) must register in the _Registro Único Nacional_ managed by SAG (Servicio Agrícola y Ganadero - the Agricultural and Livestock Service).

Labels must be in Spanish, clear, permanent, and legible, with a white background and black text (minimum 8-point font).

Required label information includes:

- Product identification (name, batch number, origin, manufacturer/importer)

- Composition (bioactive substances, microorganisms, contaminants)

- Physical-chemical parameters (pH, solubility, density, etc.)

- Usage instructions and storage conditions

- Suitability for organic agriculture, if applicable

- Prohibitions: No misleading claims, no pesticidal or unsubstantiated environmental claims

SAG conducts sampling and analysis at any stage (import, production, sale) to verify compliance. Non-compliance can result in corrective actions (relabelling, reformulation, re-export, disposal) and sanctions.

Imported biostimulants must comply with Chilean standards and may be sampled and analysed upon entry. Exported products can adapt labels to destination country requirements.

All claims made on the label regarding the function of the biostimulant must be supported by scientific documentation or technical publications.

Biostimulants for organic farming must also comply with Law 20.089 on organic certification.

Existing companies and products have a transition period (up to three years) to comply with new requirements.

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The sciBASICS Team.