Ukraine Introduces Draft Law for State Registration of Chemical and Biological Hazardous Factors

On 19 October 2023, the Ministry of Health of Ukraine introduced an important draft law aimed at regulating and supervising the state registration of hazardous factors, with a particular focus on chemical and biological elements. The draft law, entitled the “On Approval of the Procedure for State Registration of Hazardous Factors”, outlines a comprehensive procedure for the state registration of these potentially harmful elements. The draft law was notified to the World Trade Organization (WTO) on 3 November 2023. The WTO is accepting comments for 60 days from the date of notification.

Details of the draft law

The main focus of the draft law is to establish a structured process for the state registration of chemical and biological hazardous factors. All individual chemicals, substances of biological origin as well as those present in mixed products are subject to registration. This is the case regardless of whether the substances are produced, used within Ukraine's borders, or imported into the country. The full text can be found here in Ukrainian.

Scope of registration: All individual chemical and biological hazardous factors, either as single substances or as part of mixed products, are subject to state registration in Ukraine. A hazardous factor that is part of a product or mixed product is subject to registration under the following conditions:

• Intentional release during use of the product or mixed product

• The concentration of the hazardous factor that is part of the product or mixed product is 0.1 % or more

• Impurities formed during the process of production or use of a substance are registered as individual substances.

Application and registration procedure: Applications for state registration of a hazardous factor may be submitted to the Ministry of Health, either in writing or electronically. In addition, if several manufacturers and importers are involved in the production or import of a particular hazardous factor, a joint application for registration is required.

Confirmation of registration: The registration of a hazardous factor is confirmed when the registration is recorded in the State Register of Hazardous Factors. Subsequently, the Ministry of Health issues a certificate confirming the registration.

State Register of Hazardous Factors: The following information on the substances is entered into the State Register:

• Name of the substance

• Source of origin (production

• Data on the purpose of the substance

• Characteristics of the biological action of the substance

• Hazard class

• Nature of action of the substance in the environment

• Methods of indication

• State medical and health standards established for the substance

• State medical and health rules for use (if necessary)

Hazard classification: The hazard classification of chemicals and chemical products follows the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The procedure for classification and labelling of chemicals and chemical products is established by the technical regulations approved by the Cabinet of Ministers of Ukraine.

Timeline: The proposed date of entry into force is 1 January 2024.