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Biosafety Law, Regulation, Guidelines and Agreements (LAW)
  |  
BCH-LAW-KE-283495-1   |   PDF   |   Print   |  
last updated: 20 Feb 2026
Amendment
No
General Information
Guidelines for the Environmental Risk Assessment of genetically modified crops
EN
Legislative details
Guidelines
These guidelines outline the requirements and procedures for conducting environmental risk assessment (ERA) of genetically modified (GM) crops intended for environmental release in Kenya. They provide direction to applicants, expert reviewers, risk assessors, and decision-makers on the data needed for GMO applications, including a structured stepwise approach for identifying potential hazards, assessing adverse environmental effects, and implementing appropriate risk mitigation measures. The guidelines also clarify the evaluation of stacked gene events proposed for commercialization. They apply to both imported and locally developed GM crops intended for cultivation or imported in viable form for food, feed, or processing where accidental environmental release could lead to establishment. However, they exclude non-viable GM products (such as processed derivatives), other GM organisms like microorganisms and animals, and GMOs for confined field trials. The environmental risk assessment is done on a case by case basis.
EN
01 Sep 2022
Document details
Relationship with other laws/regulations
  • BCH-LAW-KE-102981-5 Biosafety Law, Regulation, Guidelines and Agreements The Biosafety Act CAP 320
    All functions pursuant to the Cartagena Protocol on Biosafety
  • BCH-LAW-KE-102983-3 Biosafety Law, Regulation, Guidelines and Agreements The Biosafety (Import, Export and Transit) Regulations, 2011
    Competent National Authorities and National Focal Points, Confidential Information, Handling, transport, packaging and identification, Human and/or Animal Health, Illegal transboundary movements, Information Sharing, Intentional introduction into the environment (AIA), Liability and redress, LMOs for direct use as feed, LMOs for direct use as food, LMOs for processing, Public awareness and participation, Risk assessment and management, Simplified Procedure, Socio-economic considerations, Transboundary movement (import/export), Transit, Unintentional transboundary movements and emergency measures
  • BCH-LAW-KE-102984-2 Biosafety Law, Regulation, Guidelines and Agreements The Biosafety (Environmental Release) Regulations, 2011
    Competent National Authorities and National Focal Points, Confidential Information, Handling, transport, packaging and identification, Human and/or Animal Health, Illegal transboundary movements, Information Sharing, Intentional introduction into the environment (AIA), Liability and redress, LMOs for direct use as feed, LMOs for direct use as food, LMOs for processing, Public awareness and participation, Risk assessment and management, Simplified Procedure, Socio-economic considerations, Transboundary movement (import/export), Transit, Unintentional transboundary movements and emergency measures
This guideline developed by the National Biosafety Authority (NBA) provides guidance for the Environmental Risk Assessment (ERA) of genetically modified crops submitted within the framework of the Biosafety Act and Biosafety (Environmental release) Regulations, 2011. It also applies to imported viable grains.
EN
Regulatory contact information
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