Ukraine Strengthens Genetic Engineering Activities in Closed Systems

Ukraine has adopted new risk assessment criteria for genetic engineering activities in closed systems, covering genetically modified crops and bioengineered organisms in closed systems.

Ukraine’s New Risk Assessment Criteria for Genetic Engineering Activities in Closed Systems

Ukraine has established a structured risk assessment framework for genetic engineering activities in closed systems, including genetically modified crops and bioengineered organisms. The criteria classify risk levels and mandate protective measures based on the potential impact on human health and the environment^{1, 2}.

1. Legal Framework and Objectives

The new criteria are introduced under the Draft Resolution of the Cabinet of Ministers of Ukraine “On Approval of Criteria for Assessing the Level of Risk in Conducting Genetic Engineering Activities in a Closed System”, developed pursuant to:

• Law of Ukraine No. 3339-IX of 23 August 2023 “On State Regulation of Genetic Engineering Activities and State Control over Placing GMOs and Genetically Modified Products on the Market”².
• Cartagena Protocol on Biosafety (ratified by Ukraine)².

Objective: To ensure responsible and controlled use of GMOs in closed systems while aligning with EU standards, focusing on:

• Protection of human health and safety.
• Environmental safeguarding².

The Resolution will enter into force on 16 September 2026, simultaneously with Law No. 3339-IX².

2. Key Definitions

The criteria define critical terms to standardize risk assessment:

• Hazard: Biological agents with pathogenic characteristics capable of harming humans or animals¹.
• Risk: A combination of the probability of harm occurring and the severity of that harm¹.
• Risk assessment: The process of gathering, evaluating, and using information to inform risk control measures¹.
• Safety system: Measures ensuring compliance with biosafety rules during genetic engineering activities¹.
• Biosafety system: Organizational, technical, and procedural measures to control risks and prevent adverse effects on health and the environment¹.

3. Risk Assessment Procedure

Genetic engineering operators must conduct a pre-activity risk assessment and repeat it if conditions change¹. The procedure includes:

1. Information Collection and Analysis¹:
   • Biological properties of the GMO (toxicity, allergenicity, pathogenicity).
   • Source of genetic material and type of modification.
   • Intended use and conditions of the closed system (e.g., temperature, humidity, isolation measures).

1. Hazard Identification¹:
   • Potential pathways of impact on human health and the environment.
   • Assessment of unintended release risks (immediate or delayed effects).

1. Risk Probability and Severity Evaluation¹:
   • Likelihood of negative consequences.
   • Severity of potential harm, considering GMO properties and system characteristics.

1. Risk Level Determination¹:
   • Classification into one of four risk levels (see Section 4).

1. Safety and Biosafety Measures¹:
   • Implementation of controls proportional to the assessed risk level.
   • Consideration of environmental impact, biodiversity, and operational characteristics (e.g., aerosol generation risks).

1. Documentation¹:
   • Results must be documented in a conclusion prepared by the Commission on Biological and Genetic Safety, as required by Article 15(2) of Law No. 3339-IX.

Annual Reassessment: Operators must conduct an annual risk review and update assessments if any of the following change¹:

• Genetic construct of the GMO.
• Intended use or conditions of use.
• Operational scale or methods.
• Personnel or safety protocols.

4. Risk Level Criteria

The criteria classify activities into four risk levels, using qualitative terms (low, moderate, high probability) rather than numerical values¹:

5. Responsibilities of Operators

• Primary Responsibility: The genetic engineering operator (or a designated authorized person) is accountable for compliance with the criteria¹.
• Protective Measures: Operators must implement safety and biosafety measures tailored to the risk level, scope of activity, and technical capabilities, regardless of legal form¹.
• Emergency Preparedness:
  • Develop an action plan for unintended GMO release, including containment, neutralization, and remediation measures¹.
  • Ensure personnel training on safety procedures and emergency response¹.
  • Maintain continuous monitoring of the closed system for biosafety compliance, including incident analysis¹.

6. Regulation Analysis

7. Public Consultation and Notification

• The draft Resolution was notified to the WTO Committee on Technical Barriers to Trade under notifications G/TBT/N/UKR/343, G/TBT/N/UKR/188/Add.1, and G/TBT/N/UKR/188/Add.2².
• Public comments were accepted until 2 May 2026².
• Responsible Agency: Ministry of Health of Ukraine (primary) and Secretariat of the Cabinet of Ministers (for comments)².

Summary Answer

Ukraine’s new risk assessment criteria for genetic engineering activities in closed systems, introduced under the Draft Resolution of the Cabinet of Ministers, establish a four-tier risk classification (Levels 1–4) based on potential hazards to human health and the environment^{1, 2}. Operators must conduct pre-activity and annual risk assessments, implement proportional safety measures, and document results in compliance with Law No. 3339-IX¹. The framework aligns with EU standards and the Cartagena Protocol, emphasizing biosafety, emergency preparedness, and continuous monitoring². The Resolution enters into force on 16 September 2026, replacing prior temporary criteria^{1, 2}. For enforcement, operators are held accountable for adherence to risk-based protocols, with oversight from the Ministry of Health and Cabinet of Ministers^{1, 2}.

Sources

1. ↩ members.wto.org — final measure / 26 03003 00 x https://members.wto.org/crnattachments/2026/TBT/UKR/final_measure/26_03003_00_x.pdf
2. ↩ Draft Resolution of the Cabinet of Ministers of Ukraine “On Approval of Criteria for Assessing the Level of Risk in Conducting of Genetic Engineering Activities in a Closed System” https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=Q:/G/TBTN25/UKR343R1.pdf&Open=True