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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.

The Ministry of Environmental Protection and Natural Resources of Ukraine (MEPR) has officially released the pre-registration template for chemical substances under the Ukraine REACH Technical Regulation. This is a significant step in the implementation of the national REACH framework, enabling businesses to start pre-registering substances placed on the Ukrainian market.

Who Must Pre-Register?

As outlined in the transitional provisions of Ukraine REACH, the following actors must pre-register substances manufactured or imported at ≥1 tonne per year, unless they are specifically exempted:

• Manufacturers

• Importers

• Only Representatives (ORs) acting on behalf of non-Ukrainian entities.

Pre-registration is mandatory in order to benefit from the staggered registration deadlines and ensure continued access to the Ukrainian market.

Pre-Registration Timeline

• Start Date: 26 January 2025

• Deadline: 26 January 2026

Registration Deadlines

• 26 January 2026: CMR substances (Category 1A and 1B) above 1 tonne per year, and substances very toxic to aquatic organisms (acute or chronic) above100 tonnes per year.

• 1 October 2026: Substances above 1,000 tonnes per year.

• 1 June 2028: Substances from 100 to 1,000 tonnes per year.

• 1 March 2030: Substances from 1 to 100 tonnes per year.

Pre-Registration Template and Submission Instructions

To streamline the compliance process, the MEPR has introduced a standardized Excel-based pre-registration form, which is only available in Ukrainian.

The form must be:

• Completed per substance

• Filled out in Ukrainian

• Electronically signed using a Qualified Electronic Signature (QES)

• Submitted along with supporting documents, and (if applicable) an Only Representative appointment letter

Completed forms should be submitted to reach@mepr.gov.ua

The official template and instructions can be found on the MEPR website.