Kenya has no standalone biostimulant regulation. Products are regulated as biological agricultural inputs under the Fertilizers and Animal Foodstuffs Act (CAP 345) and the KEPHIS/KSTCIE biological product framework. Products containing GMO-derived material additionally require prior clearance from the National Biosafety Authority (NBA) under the Biosafety Act No. 2 of 2009.

All biostimulants must be approved by KEPHIS before being placed on the Kenyan market. KEPHIS acts as secretariat to the Kenya Standing Technical Committee on Imports and Exports (KSTCIE), which takes the final decision.

The completed biostimulant application form must be filed online via the KEPHIS Plant Import & Quarantine Regulatory System (PIQRS) and four hard-copy dossiers must be sent to KEPHIS HQ (Karen, Nairobi) with a cover letter to the Managing Director. Non-resident companies must appoint a Kenya-resident local agent.

The KEPHIS BIOSTIMULANT APPLICATION FORM asks for the following information:

- General information. Applicant, local agent, and manufacturer details; purpose and sector of use; trial import quantity.

- Organic source. Scientific name (genus, species, strain) of the organic source; biology supported by peer-reviewed publications; contaminants and relationship to known pathogens.

- Product identity & use. Trade name; full formulation (type, active agents, purity, concentration); registration certificates from country of manufacture and other countries; GLP-certified certificate of analysis; production method and QC reports; shelf-life data; mode of action; dosage and application details; efficacy trial reports; market label from country of origin.

- Safety data. Acute toxicity (rat oral/dermal/inhalation LD50), skin/eye irritation, WHO classification, and ecotoxicology for bees, aquatic organisms, birds, soil micro-organisms and non-target plants. All studies must be from a GLP-certified laboratory.

If the biostimulant contains or is derived from a genetically modified organism, NBA approval must be obtained before the KEPHIS application is submitted. The NBA dossier must include the GMO's identity and biosafety classification, intended use, quantity, and safe handling methods. The NBA publishes a public notice (30-day comment period), conducts a risk assessment, and must issue a decision within 90–150 days. Placing a GMO-derived product on the market without NBA approval carries a penalty of up to KSh 20 million and/or 10 years' imprisonment (Biosafety Act, s. 52).

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