In Venezuela, plant biostimulants, known as _bioestimulantes_ or “insumos agroecológicos u orgánicos,” are regulated by the National Institute of Comprehensive Agricultural Health (INSAI)

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The specific regulatory instrument is Administrative Provision INSAI No. 007/2023 (Gaceta Oficial No. 42.687, 8 Aug 2023), which defines product classifications, registration procedures through the National Single Registry of Comprehensive Agricultural Health (RUNSAI), and obligations for manufacturers, importers, and distributors. INSAI’s authority is derived from the Comprehensive Agricultural Health Law (Decreto N° 6.129, 2008).

Under INSAI, agroecological or organic inputs are divided into three main categories: biological inputs (bioinsumos), organic inputs, and mineral inputs.

Bioinsumos, which include plant biostimulants, are further classified into biofertilizers, biocontrol agents, and regulators & growth stimulants. Biofertilizers are subdivided into organic fertilizers, foliar fertilizers, and bioestimulants (foliar or vegetal). Functional classes relevant to biostimulant activity are therefore primarily regulators & growth stimulants, though biofertilizers and biocontrol agents may also contribute.

To place a biostimulant on the market, the responsible company must register in RUNSAI and obtain an operating authorization.

The product dossier, submitted to INSAI for the National Product Registry, typically includes a technical description, composition certificate, intended label artwork in Spanish, quality control data, efficacy and safety evidence, and environmental/biosecurity assessments if required. Imported products must also provide certificates of origin, free sale, and phytosanitary compliance.

INSAI evaluates the dossier and grants registration valid for two years, renewable for the same period, with non-transferable status. Only approved claims may appear on the label, and any GM or special technologies must be explicitly declared.

INSAI also enforces post-market inspections, reporting obligations, and can revoke registrations for non-compliance, in accordance with the Comprehensive Agricultural Health Law.

**References**:

- Providencia Administrativa INSAI No. 007/2023, Gaceta Oficial No. 42.687, 8 Aug 2023

- Ley de Salud Agrícola Integral, Decreto N° 6.129, 2008

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The sciBASICS Team.