On 23 January 2025, Ukraine notified the World Trade Organization (WTO) of its draft Regulation entitled "Procedure for State Registration of Hazardous Factors" (Rev. 2). This Regulation, issued by the Ministry of Health of Ukraine, provides a comprehensive framework for the registration of chemicals, biological substances, and mixtures containing hazardous factors. This initiative underscores Ukraine's commitment to ensuring systematic oversight of hazardous substances, whether they are produced, used, or imported into the country.
What’s New in Rev. 2?
Building on the earlier version notified in September 2024, Rev. 2 introduces several changes:
Enhanced Application Review Process: Aligned with the Law of Ukraine "On Administrative Procedure.
Joint Applications Removed: Producers and importers must now submit individual applications for hazardous factor registration.
Simplified Certification Requirements: Eliminating storage obligations for registration certificates details (number and validity period) in the State Register.
These changes reflect Ukraine's forward-thinking approach to enhancing regulatory clarity, transparency, and efficiency.
Scope of the Regulation
The Regulation governs the registration of all chemical and biological hazardous factors, including:
Individual substances of chemical or biological origin, produced, used, or imported into Ukraine.
A hazardous factor that is part of the product if it is intentionally released during use.
Mixed products containing hazardous factors in concentrations of 10% or more
Additives formed during production or use.
Registration Process
The process of registration of hazardous factors is managed by the Ministry of Health of Ukraine, with expert evaluations provided by the State Enterprise "Committee on Hygienic Regulation of the Ministry of Health of Ukraine".
Application Requirements:
1. Applicant’s full and abbreviated name.
2. Applicant’s address and contact information (telephone number, e-mail).
3. Information about the authorised person submitting the application on behalf of the applicant.
4. Trade name and chemical name of the hazardous factor (according to IUPAC nomenclature).
5. The Chemical Abstracts Service (CAS) number or the European Inventory of Existing Commercial Chemical Substances (EINECS) number.
6. Information on the scope of application of the hazardous factor.
7. Safety data sheet in Ukrainian.
8. Identification of the similarity of the hazardous factor.
9. Hazard classification and labelling data.
The application for registration shall be submitted to the Ministry of Health either electronically through the online system of the State Register or in written form, depending on technical availability.
Decision Process and Validity of Registration
The State Enterprise "Committee on Hygienic Regulation" examines the registration documents within 30 calendar days. The Ministry of Health then decides on registration or refusal within 10 calendar days, based on the Committee’s expert conclusion. If the hazardous factor is approved, it will be registered in the State Register of Hazardous Factors. The registration is valid indefinitely, except for cases specified in the regulation where certain conditions may justify a re-evaluation or cancellation of the registration.
State Register of Hazardous Factors
The State Register of Hazardous Factors, which will become operational upon the official publication of the resolution, is intended to provide electronic services to implement the rights and obligations of applicants for the collection, accumulation and processing of data on hazardous factors registered in Ukraine.
The State Register will contain:
Substance names and sources of origin.
Data on intended use, biological effects, and hazard classification.
Environmental impact and detection methods.
State medical and sanitary standards.
Alignment with International Standards
The regulation follows the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), aligning the Ukrainian framework with global best practices. This alignment ensures safer handling and use of hazardous substances while supporting international trade.
Objectives and Benefits
The primary objective of the draft Regulation is to protect human health and safety and the environment. By implementing a robust registration system for hazardous chemicals and biological substances, Ukraine aims to minimise the risks associated with exposure to harmful substances, both during production and use. This regulation will help to ensure that such hazardous factors are carefully managed, tracked and controlled.
Legislative Context
The draft aligns with key Ukrainian laws, including:
"On Public Health System"
"On Protection of Population Against Infectious Diseases"
"On Ensuring Chemical Safety and Management of Chemical Products"
Implementation Timeline and Comment Period
The date of adoption for the Regulation is yet to be determined. Stakeholders have 60 days from the notification date to review the draft and provide feedback.