Ukraine Notifies Draft Resolution on Hazardous Factors to WTO

On 16 September 2024, Ukraine notified the World Trade Organization (WTO) of its draft Regulation on the "Procedure for State Registration of Hazardous Factors". This regulation, issued by the Ministry of Health, outlines the procedure for the registration of chemicals, substances of biological origin and mixtures containing hazardous factors. The proposed regulation is intended to ensure that such substances are systematically controlled when they are produced, used or imported into Ukraine.

Scope and Applicability

The registration procedure applies to all individual chemical and biological hazardous factors, including those present in mixed products. Any hazardous factor intentionally released during the use of a product or constituting 10% or more of a mixed product must be registered. The notification emphasises the importance of this process for the protection of public health and the environment.

The draft Regulation applies to individual chemicals, substances of biological origin and mixed products used in all sectors, and includes provisions for substances generated during production or use as additives. These additives, even if produced as by-products, are subject to individual registration.

Registration Process

The process for registering 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". The application for registration may be submitted either electronically though the online system of the State Register or in written form, depending on technical availability.

Main information required for registration:

1. Full and abbreviated name of the applicant.

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 and chemical names 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.

In cases where several producers or importers are involved with a particular hazardous factor, a joint application for registration may be submitted. The application is then reviewed by the Committee, which reviews the materials on a contractual basis and issues an opinion within 30 calendar days. Based on the conclusion of the Committee, the Ministry of Health decides on the registration of the hazardous factor within 15 calendar days.

Decision Process and Validity of Registration

After receiving the expert evaluation, the Ministry of Health approves or rejects the state registration of the hazardous factor. The decision is made within 15 calendar days on the basis of the expert’s findings. 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.

Operation of the State Register of Hazardous Factors

The State Register, which will become operational on 1 January 2025, is intended to serve as a central database providing electronic services for the collection, accumulation, and processing of data related to hazardous factors. It will facilitate the rights and obligations of applicants by ensuring easy access to information on registered hazardous factors. The online system will streamline the registration process and maintain a record of all hazardous substances registered in Ukraine.

Alignment with International Standards

The classification of hazardous chemicals and products follows the guidelines of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), ensuring that Ukraine's regulations are in line with international chemical safety practices. This alignment will help to harmonise Ukraine's regulatory framework with international best practices and promote safer handling and use of hazardous substances.

Objective and Justification

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 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.

Timeline and Comment Period

The date of adoption of the proposed Regulation is yet to be determined and the Regulation is expected to enter, into force on 1 January 2025  with the registration system becoming fully operational on the same date. The final deadline for comments on the draft Regulation is 60 days from the date of notification, giving stakeholders ample time to review the proposal and provide input.