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On 16 June 2025, Ukraine officially notified the World Trade Organization (WTO) of a draft resolution of the titled "On Approval of the Rules for Joint Submission of Information in Applications for State Registration of Identical Chemical Substance”, which was issed by the Cabinet of Ministers. The draft resolution, developed by the Ministry of Environmental Protection and Natural Resources, outlines procedural requirements for joint submissions under Ukraine’s chemical registration framework, UA-REACH.  

Who Will Be Affected 

The proposed rules apply to all business entities involved in registering identical chemical substances. The rules cover substances, mixtures, and explosive or pyrotechnic articles classified under HS codes 28–38, (excluding Chapter 30 – Pharmaceuticals), and are closely aligned with the structure and principles of the EU REACH Regulation (EC) No. 1907/2006.   

Key Requirements of the Draft Rules 

To jointly submit information for the registration of an identical chemical substance, registrants must: 

• Form or join a data-sharing consortium (Information Exchange Consortium). 

• Designate a lead registrant, authorized to act on behalf of all participants.  

• Submit a joint notification to the Ministry of Environmental Protection and Natural Resources regarding the establishment of the consortium. 

What Is a Joint Notification 

A joint notification is a formal submission made by the lead registrant. It must include:   

• Contact details of all registrants and the lead registrant. 

• The chemical name and identifiers of the substance. 

The joint notification must be submitted within 10 working days of the consortium’s formation and may be submit in paper or electronic format via Ukraine’s Unified State Web Portal of Electronic Services or integrated government systems (including the EcoSystem digital platform) using a Qualified Electronic Signature or Seal, based on a qualified public key certificate, in compliance with national law. 

Supporting Documentation Required 

Each joint notification must be accompanied by documents that comply with the requirements set out in the Technical Regulation on the Safety of Chemical Products (UA-REACH), specifically:  

• Hazard classification data for the substance. 

• Summaries of hazard studies, including objectives, methods, results, and conclusions. 

• A chemical safety report or exposure information (where full assessment is not required). 

• Proposals for new tests, where necessary to complete the safety assessment. 

If any of the submitted information changes, the lead registrant must provide updated documentation within 10 calendar days.  

Legislative Context 

This draft regulation complements and operationalizes provisions of the following Ukrainian legal acts:   

• The Law of Ukraine “On Ensuring Chemical Safety and Management of Chemical Products”. 

• The Technical Regulation on Hazard Classification, Labelling and Packaging of Chemical Products (Cabinet Resolution No. 539 of 10 May 2024). 

• The Technical Regulation on the Safety of Chemical Products (Cabinet Resolution No. 847, 23 July 2024). 

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WTO Notification and International Alignment 

By notifying the WTO, Ukraine demonstrates its commitment to transparency and to aligning its chemical safety regulations with international best practices. This draft is an important step towards aligning national legislation with the EU REACH framework, in line with Ukraine’s WTO obligations and its Association Agreement with the EU. 

Implementation Timeline and Comment Period  

The adoption date of the Resolution is yet to be determined. The regulation will enter into force upon its official publication. Stakeholders have 60 days from the notification date to review the draft and provide feedback to the Ministry of Economy of Ukraine. 

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.