Ukraine Notifies WTO of New Regulation on Hazardous Chemical and Biological Factors

On 28 May 2025, Ukraine officially notified the World Trade Organization (WTO) of the adoption of Cabinet of Ministers Resolution No. 588, titled “On Approval of the Procedure for State Registration of Hazardous Factors”, dated 21 May 2025. This important legislative act establishes a clear and structured process for the registration of chemical and biological hazardous factors, including both standalone substances and those contained within chemical products, that are manufactured, used, or imported into Ukraine.

What Does the Regulation Cover?

The Resolution defines the procedure for:

• Registration of chemical substances and biological agents classified as hazardous factors.

• Hazardous components within chemical products if intentionally released during use or present at concentrations of 10% or more.

• Substances manufactured, used, or imported into Ukraine, except those excluded under Part 4, Article 47 of the Law of Ukraine "On the Public Health System".

Key Elements of the Registration Procedure

1. Application Submission

Manufacturers, importers, or their authorized representatives may submit applications in person, by mail, or electronically.

2. Required Documentation

Applications must include:

2. • Identification data (IUPAC name, CAS number, EINECS).

   • Intended use and hazard classification.

   • A Safety Data Sheet (SDS) in Ukrainian.

   • List of confidential business information (if applicable).

3. Expert Review

Expert institutions have 30 calendar days to evaluate the submitted materials. An official contract between the applicant and the expert institution sets the evaluation fee, which is standardized for all applicants.

4. Decision and Entry into the Register

Based on the expert's recommendation, the Ministry of Health (MOH) will issue a registration decision within 10 calendar days and record the hazardous factor in the State Register. If approved, the entry must be made within 5 days of the decision.

Registration Characteristics

• Cost and Validity: Registration is free of charge and valid indefinitely, except in cases of temporary registration. It may be revoked if new hazardous properties are identified that pose risks to human health or the environment.

• Digital Access: The State Register of Hazardous Factors, an electronic information and communication system, will officially begin operation on 1 July 2025. 

• Transparency: The State Register will be maintained by the Ministry of Health and administered technically by the state enterprise “Electronic Health”.

WTO Notification and International Alignment

Ukraine’s notification to the WTO demonstrates its commitment to transparent regulatory practices and compliance with international trade obligations under the Technical Barriers to Trade (TBT) Agreement. This step aligns with Ukraine’s broader objectives under the EU-Ukraine Association Agreement, which aim to harmonize Ukrainian legislation with EU standards and promote trade integration with the European Single Market.

Implications for Businesses

Businesses handling chemical substances and products in Ukraine should:

• Comply with the new registration requirements.

• Update internal compliance processes to support electronic submissions.

• Prepare for mandatory expert reviews and possible requests for additional data.

Legal Framework

The Resolution was published and came into force on 28 May 2025 and will remain effective until 1 March 2030.