Regulating Agricultural Innovation: Biosafety, Seed Certification and Agrochemical Rules for Kenyan Agri-Tech

Agricultural technology regulation in Kenya is a multi-regulator problem that agri-tech founders often underestimate until it delays a launch. A new agricultural product can touch the National Biosafety Authority if it involves genetically modified material, the Pest Control Products Board if it is applied to crops to control pests, and seed and plant health rules administered through the Kenya Plant Health Inspectorate Service. A business assuming that one approval covers all of these has usually assumed wrong. This article covers the statutes we could verify and the court decisions that have changed the position in the last two years.

Genetically modified organisms: the courts are still deciding

The Biosafety Act (Cap. 320, Act No. 2 of 2009) regulates activities in genetically modified organisms and establishes the National Biosafety Authority. Among its powers, the Authority can issue a cessation order for an approved activity, or require additional risk management measures, where it determines in consultation with the relevant regulatory agency that there is an imminent danger to biological diversity or human health (section 42). The Authority remains the competent body for GMO approvals however the litigation resolves.

The legal status of GM crops and food has been unsettled since the Cabinet dispatch of 3 October 2022 lifting the earlier restriction. In the Court of Appeal’s ruling of 7 March 2025 in Kenya Peasants League v Attorney General & 19 others (Civil Application E004 of 2025), [2025] KECA 448, the Court was asked for an injunction pending appeal against a High Court ruling of 7 November 2024. It issued a limited conservatory order. The order restrains specified respondents, including the Attorney General, two Cabinet Secretaries, the National Biosafety Authority and the Cabinet, from taking further action aimed at allowing the importation of GMO crops and food or advancing the Cabinet dispatch. The Court certified the appeal as urgent and directed that it be listed for hearing in the second term of 2025.

We searched Kenya Law for a Court of Appeal judgment disposing of that appeal and did not find one at the time of writing. Do not treat the March 2025 order as the final word. Any business considering GM cultivation, importation or trade should confirm the current position with the National Biosafety Authority and obtain up-to-date legal advice before committing capital.

Seed law: a 2025 constitutional ruling

Seed businesses should note a High Court judgment of 27 November 2025 in Wathome & 14 others v Kenya Plant Health Inspectorate Service & another (Petition 11 of 2022), [2025] KEHC 18166, delivered at Machakos by Rutto J. The Court allowed the petition and declared several provisions of the Seed and Plant Varieties Act unconstitutional, namely section 3D(1), section 8(1), section 8A, parts of section 10(4), section 20(1) and section 20(1E). It also declared rules 6, 16, 19 and 21(1) to (5) of the Seed and Plant Varieties (Seeds) Regulations, 2016 unconstitutional. The Court observed that the respondent had not argued for suspension of the declaration of invalidity, and it made no order on costs against any party.

We have not reviewed the content of each provision in the judgment, and we have not checked whether the decision has been appealed or whether Parliament has responded. A seed company, distributor or breeder that relies on these provisions or rules for licensing, registration or enforcement should obtain a current legal view before relying on them. The same caution applies to any compliance programme that was designed around the 2016 Regulations.

Pest control products and biopesticides

The Pest Control Products Act (Cap. 346) regulates the importation, exportation, manufacture, distribution and use of products used for the control of pests. Section 3 provides that no person may manufacture, package, store, display, distribute, use or advertise a pest control product except in accordance with conditions prescribed by regulations, and that labelling and advertising must not be false, misleading or deceptive. Section 4(1) provides that no person may import into, or sell in, Kenya any pest control product unless it has been registered, packaged and labelled in accordance with the regulations and conforms to the prescribed standards.

The penalties are meaningful. A contravention of section 3 or 4 is punishable by imprisonment of up to two years or a fine of not less than KES 250,000, or both (section 12(1)). Adulterating or counterfeiting pest control products, or possessing counterfeit products, labels or packages, attracts a fine of between KES 250,000 and KES 1,000,000, imprisonment of up to two years, or both (section 4A). An employer can be liable for the acts of an employee or agent unless it shows the offence was committed without its knowledge or consent and that it exercised all due diligence (section 12(3)).

A product marketed as natural or biological is not safe from this regime simply because of how it is described. Whether a particular biological product falls within the Act depends on the statutory definition of a pest control product and the regulations, so check that definition before assuming an exemption. We have not verified the separate permit process for importing trial or research quantities, so confirm it with the Pest Control Products Board before shipping samples.

Data and agricultural technology regulation in Kenya

Much agri-tech activity involves data rather than biological products, such as satellite or drone crop monitoring, mobile advisory services and platforms that collect farmer data to underwrite credit or insurance. These businesses are not mainly regulated by the bodies above, but they process personal data, including location and financial information, and must comply with the Data Protection Act, 2019. Build the lawful basis for processing and any registration duties into the product design from the start, and confirm current registration requirements with the Office of the Data Protection Commissioner.

Protecting the innovation

Agri-tech businesses often invest more in regulatory approvals than in protecting the innovation itself, whether a formulation, a data model or a breeding technique. A genuine technical invention may justify a patent, as discussed in our guide to patent prosecution at KIPI. A process the business prefers not to disclose may be better protected as a trade secret, and our overview of IP protection tools for founders compares the options.

Frequently asked questions

This article is general information on Kenyan law as at its publication date, not legal advice. Reading it does not create an advocate and client relationship.