National Biotechnology Development Policy, 2006, Biosafety Act CAP 320, Biosafety (Contained Use) Regulations 2011, Biosafety (Environmental Release) Regulations 2011, Biosafety (Import, Export and Transit) Regulations 2011, Biosafety (Labelling) Regulations 2012, Genome Editing Guidelines, Food Safety Assessment Guidelines, Environmental Risk Assessment Guidelines, Socio-economic Consideration Guidelines, Institutional Biosafety Committees Guidelines, Biosafety Labelling Guidelines, Transportation and packaging of GMOs, Simplified Procedure for assessment of GMOs, Post Release Monitoring Guidelines, Guidelines on LLP (Low Level Presence) and AP (Adventitious Presence).

Kenya signed the Cartagena Protocol on Biosafety in 2000 and ratified it in 2003. Following the approval of the National Biotechnology Development Policy in 2006 and enactment of the Biosafety Act CAP 320 in 2009, the National Biosafety Authority was established in 2010 as the National Competent Authority on biosafety matters in Kenya. Since then, four Biosafety Regulations have been published to support the implementation of Biosafety Act. These include (i) The Biosafety (Contained use) Regulations, 2011, (ii) The Biosafety (Environmental Release) Regulations, 2011 (iii) The Biosafety (Import, Export and Transit) Regulations, 2011 (iv) The Biosafety (Labelling) Regulations, 2012. The Authority currently has 51 staff, 22 of whom are Biosafety Officers directly dealing with biosafety matters. The Authority is established as a State Corporation under the Ministry responsible for Science and Technology and gets annual budgetary allocation from the National Government. However, the budgetary allocations are inadequate for the full achievement and operation of the implementation of Article 2. The nation is at an enhanced stage to integrate biosafety matters in national, sectoral and cross-sectoral strategies, action plans and programmes. There is need for enhanced biosafety considerations in the National Biodiversity Action Plans and corresponding budgetary allocations to assist the Competent Authority to effectively implement provisions of Cartagena Protocol on Biosafety at national level. Kenya has actively participated in COP-MOP meetings and other international forums.

Section 3(2) of Biosafety Act exempts pharmaceuticals for human use from the scope of regulation. All pharmaceuticals for human use are governed by the Poisons and Pharmacy Board, Ministry of Health under the framework of WHO. However, this exemption only applies to pharmaceuticals that have been approved at all levels for human use. Pharmaceuticals that are still under research and involve GMOs are regulated under the Biosafety Act CAP 320.

Kenya regulates both transit and contained use of GMOs. This is through the implementing Regulations namely, Biosafety (Import, Export and Transit) Regulations, 2011 and Biosafety (Contained use) Regulations, 2011. The Biosafety (Contained use) Regulations cover research of GMOs from laboratory experiments to Confined Field Trials (CFTs). Some of the contained use projects in Kenya are undertaken in partnership with other collaborators that necessitates import of experimental transgenic plant, animal, microorganisms and pharmaceuticals for research. Where the purpose of import of LMO is for contained use research, the applicable regulations in this case are the Biosafety (Contained use), Regulations, 2011.

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Regarding AIA, Kenya has placed the responsibility to reach out to the relevant Parties on the applicant. Where risk assessment is required before approval to import is granted, acknowledgement is given to the applicant within 30 days and a decision made within 150 days but in some instances, due to the existing conservatory orders by the court, 2 decisions on import and placement of LMOs have been extended beyond the prescribed timeline of 150 days and applicants notified.

Use of GMOs as FFP is governed by the Biosafety (Environmental release) Regulations. Import, export, and transit of GMOs are regulated through the Biosafety (Import, Export and Transit) Regulations, 2011. These apply to import, export or transit of GMOs for all purposes except for research. For GMOs requiring risk assessment, acknowledgement is given to the applicant within 30 days, and a decision is made within 150 days. These regulations provide guidance on handling, transportation, and storage of GM inputs and outputs of direct food, feed, and processed products. Where sufficient safety data and experience exist Section 28 of the Biosafety Act CAP 320 on non-assessment of risks applies and a simplified risk assessment is conducted with a decision being given within 30 days. Kenya approved Bt cotton MON 15985 in January 2020 for cultivation, food, feed and for processing. Decisions for GMOs as food, feed and processing have been extended/delayed due to court conservatory orders.

The Biosafety Act provides for the review of decisions made by the Competent Authority (Section 33). Those aggrieved by decisions of the Competent Authority can also appeal to the Biosafety Appeals Tribunal, which is operational (Section 35 of the Biosafety Act). No review of the decision has been made on the transboundary movement of GMOs during the reporting period.

Kenya has developed guidance for non-assessment of risks as per Section 28 of the Biosafety Act CAP 320. This guides the process requirements such as aspects of data transportability and history of safe use, to assess adequacy for decision making. Kenya has considered 1 application for a simplified procedure on the cultivation of Bt maize, which has been previously approved in the country.

Kenya has ratified a Mutual Recognition Agreement (MRA) with Uganda for trade in select cereals, including maize, sorghum, beans, and rice (both GM and Non-GM). To support this, a multi-agency service level agreement (SLA) has been signed for the management of air and sea cargo.

Bilaterally, Kenya has signed an MRA with Uganda to facilitate trade in cereals. This agreement has mapped players in each country and accepts competent authorities’ regulatory manifests as sufficient for trade. Multi-Agency SLAs involving the National Biosafety Authority (NBA) and the Kenya Revenue Authority (KRA) were signed in August 2025 to enhance the efficiency of sea cargo clearance, as stipulated by the World Trade Organization (WTO). It defines timelines and roles for biosafety-related cargo, especially GMOs. There have been discussions on harmonizing risk assessments at the regional level, namely the East African Community (EAC) and COMESA. However, there have not been formal agreements between these countries, as discussions have not been finalized.

For all GMO applications, whether Research, Environmental release or used for FFP, risk assessment is conducted prior to approval. After GMOs are approved for environmental release, Kenya conducts Post release monitoring for 20 years. Kenya has a post-release monitoring manual that guides this process. There is a need for continuous capacity strengthening on detection, Identification, Risk Assessment, risk management, and monitoring.

Kenya is not aware of any unintentional transboundary movements of LMOs within its borders. This is ensured by Border Control and Management, which have Biosafety Officers who frequently monitor and inspect land and sea cargo. There is a need for continuous collaboration with neighbouring countries to maintain monitoring at points of entry.

Kenya has limited capacity for LMO detection, with only 2 national molecular laboratories certified for this. At points of entry, Biosafety Inspectors conduct rapid detection, though there are often delays in testing. The Biosafety (Labelling) Regulations, published in 2012, and their supporting guidelines prescribe a GM and GM-Free labelling system with a unique identifier for each GMO. Kenya has in place packaging and transportation guidelines as well as registration requirements for GMO handlers, operators, and facilities. Certificate of Origin and approval documents from agencies other than the Competent Authority, such as Plant Import Permit, are part of the other documentation not specific to LMOs. The trained officers at the border are the Biosafety officers. They are trained in detection but not identification. Therefore, there is a need to strengthen capacity and improve infrastructure by establishing additional testing laboratories nationwide.

The National Biosafety Authority was established in 2009 under the Biosafety Act CAP 320 and designated as the Competent Authority to the Cartagena Protocol on Biosafety. A CPB and BCH Focal points as well as Contact person for Emergency measures have also been appointed and information made available in the BCH. . In performing its functions, the competent authority collaborates with other national regulatory agencies.

Summaries of risk assessments continue to be uploaded in the central portal of BCH notwithstanding the challenges of registering new LMOs for issuance of unique identifier by the CBD Secretariat. All decisions made by the Authority are posted in the National BCH. In some applications, decisions have been made but due to existing court orders, the decision has not been published on the BCH. The choices do not reflect the situation in the country, they were limiting hence the need for introducing a ‘Not Applicable’ option.

Kenya periodically updates summaries of risk assessments in the central portal of BCH, notwithstanding the challenges of litigation and court orders. Decisions made by the Authority on confined field trials and environmental releases are posted on the central BCH. The available information that has not been posted on the BCH is for reasons such as: Pending court cases with standing orders over the LMO application(s)

Section 25 of the biosafety Act CAP 320 allows an applicant to identify information to be treated as confidential with justification for claims on confidentiality to be provided upon request. The authority assesses the request and decides whether to accept or reject it, with reasons, and provides an opportunity for consultation.

Kenya has shared experience with several countries on biosafety matters. Kenya has received financial and technical support from several development partners to strengthen the country's biosafety framework. Capacity needs assessments have been carried out at the national level, and priority areas have been identified. The Competent Authority has a department dedicated to capacity building on biosafety matters in the country. Accessing the GEF funds has not been easy. Also, the allocated funds are not enough for the proposed activities.

Modalities have been put in place for public participation in contained use and decision-making for environmental release. This includes the Competent National Authority (CNA) appointing biosafety champions to devolved units to respond to issues at the grassroots. The country is revising the national biotechnology policy, which enhances public participation, and organizes an annual national biosafety conference to include wider stakeholders for public awareness (farmers and indigenous). Educational materials in the form of brochures, public notices, advertisements, supplements, FAQs, and policy briefs have been developed to aid in public awareness. The IEC materials are available to the public during conferences, seminars, shows, trade fairs, and at the CNA premises and the website.

Kenya has engaged in transboundary movements of GM material with non-Parties. This has especially happened with the exchange of GM material to be used for research. In all cases the procedures of moving into, or out of, Kenya of GMOs have been consistent with the objective of Cartagena Protocol.

Section 52 of the Biosafety Act, CAP 320, has provided for offences and penalties for any person who makes contained use of, releases into the environment, places on the market, imports, or exports a GMO without the approval of the Authority, or does not adhere to the conditions of approval.

Kenya has taken into account socio-economic considerations in decision-making for environmental release and market placement of GMOs. During the reporting period, the country made decisions on two applications that required socio-economic considerations; however, the full implementation of Article 26 remains limited. There is a need for more local studies to evaluate the impact of socio-economic considerations. For instance, recent research estimated a Ksh. 20 billion loss over five years due to postponing of LMO adoption (Kovak et al., 2024) https://allianceforscience.org/wp-content/uploads/2024/11/Genetically-modified-crops-in-Kenya_the-cost-of-delay_241126-final.docx.pdf Despite these challenges, socio-economic evaluations have supported key decisions such as the adoption of Bt cotton and have enhanced consumer choice through GMO labelling regulations, demonstrating progress while underscoring the need for strengthened and timely socio-economic considerations

Kenya has an established National Multi-Sectoral Implementation Committee to support the Competent Authority in implementing the Cartagena Protocol and other biosafety-related matters at the national level. This Committee comprises relevant stakeholders from different sectors. The country has cooperated with other parties and non-parties in exchange for information, including socio-economic information, particularly information published in the BCH for decision-making, capacity building, and the implementation of the protocol.

Kenya is not yet a Party to the Supplementary Protocol but has laws that provide for compensation in case of damages to any person for any injury to the person or property

The Multi-Sectoral Committee on Implementation of the Cartagena Protocol has developed a country position paper regarding accession to the Supplementary Protocol. The position paper is currently under consideration by the relevant Government Ministries and Departments. The government generally provides, within the national budget cycle, mechanisms for financial security against claims and court awards. The Biosafety Act Section 17 provides for liability accruable to NBA in case of injury caused as a result of its decision. The Act also provides mechanisms where the Authority can order for a restoration of the environment to a state in which it was before release of a GMO. In certain cases, the Authority has powers to revoke a licence and order recall of released GM products. To-date, there has not been any legal case or ruling involving damage of any GMO.