On July 23, 2024, the Government of Ukraine approved the technical regulation “Safety of Chemical Products”, known as “Ukraine REACH” (UA REACH). This is an important step that brings Ukraine’s chemicals management system closer to European standards and reflects the requirements of the EU’s REACH regulation. Six months after approval, Ukraine’s REACH will enter into force on 26 January 2025.
Technical regulations on the safety of chemical products: https://zakon.rada.gov.ua/laws/show/847-2024-%D0%BF#Text
Obligations for manufacturers and importers of chemicals
Ukraine REACH introduces a system for the registration, evaluation, authorisation and restriction of chemicals in Ukraine. All companies that manufacture or import substances (both individually and in mixtures) with a volume of 1 ton per year or more are required to pre-register and register these substances with the Ministry of Environmental Protection and Natural Resources of Ukraine (MFDPR).
Foreign manufacturers or formulators exporting chemicals to Ukraine can simplify compliance by appointing a “single representative” in Ukraine. This representative assumes responsibility for REACH for all importers, allowing them to consider them as end-users. Alternatively, importers can comply with their obligations under REACH individually.
Pre-registration of chemicals
The pre-registration of chemicals is an important step for companies that manufacture, import or supply chemicals to the Ukrainian market. Under REACH, pre-registration allows businesses to continue using certain chemicals once they are already on the market and prepare for full registration.
Pre-registration allows companies to register substances that they manufacture or import in large quantities and are used on the market. This is a simplified process that helps maintain market access by allowing the substance to be used until it is fully registered.
Registration of chemicals
The registration process involves the preparation of a technical dossier that includes the identification of the substance, physicochemical, toxicological and ecotoxicological characteristics, as well as risk management proposals. This file is submitted to the Ministry of Environmental Protection of Ukraine, which assesses the compliance of the above data with legislative requirements.
Key terms:
The regulation will enter into force on 26 January 2025 and the provisional registration will last until 26 January 2026. After that, the registration will have to be completed within the following deadlines, depending on the volume and hazard of the substance:
- before 1 October 2026: substances above 1 000 t/year, CMR substances 1A and 1B (carcinogenic, mutagenic, toxic to reproduction) with a volume of ≥1 t/year, substances very toxic to aquatic life with a volume of more than 100 t/year.
- before 1 June 2028: substances with a volume of 100-1 000 tonnes/year.
- before 1 March 2030: substances with a volume of 1-100 tonnes/year.
In addition, Ukraine’s REACH obliges companies to develop safety data sheets (SDS) in Ukrainian for hazardous substances and mixtures that must be accessible to end users.
Who needs to register chemicals in Ukraine?
In Ukraine, all companies that manufacture or import chemicals in quantities from 1 tonne per year must register chemicals. This obligation also applies to companies working with new chemicals or mixtures that may pose a risk to health and the environment. The registration process involves submitting a technical file to the relevant authorities, such as the Ministry of Environmental Protection.
Authorised representative
An authorized representative ( уповноважений представник) is a natural or legal person who officially represents a foreign manufacturer on the territory of Ukraine and fulfils obligations related to registration and interaction with regulatory authorities.
In the case of the appointment of an authorised representative, the foreign manufacturer is obliged to notify all importers of such chemical products of the appointment.
The main duties of an authorised representative:
- submits an application for state registration on behalf of a foreign manufacturer
- It keeps accessible and up-to-date information on chemical imports, consumers, products, industrial safety, registration data, etc.
- represents the interests of the foreign producer in the consortium for the exchange of information
- communicates with the Ministry of the Environment on relevant issues
- is controlled by state supervisory authorities
An authorized representative is needed for foreign manufacturers exporting chemicals to Ukraine without a local authority or for manufacturers who want to simplify the registration and compliance process.
Notification
Notification is the procedure for officially informing regulators about the presence of certain chemicals in products or their import into Ukraine. A key step within UA REACH to ensure compliance with the law.
All companies that import or produce chemicals in Ukraine in the amount of 1 ton per year must be informed. The notification is necessary to control the use of potentially hazardous substances and ensure the availability of information on chemicals on the Ukrainian market.
An authorized representative and proper notification are critical aspects for UA REACH compliance. They help minimise the risks of administrative fines and blocking access to the Ukrainian market.
Support of the EKOTOX CENTER UKRAINE
EKOTOX CENTER UKRAINE provides comprehensive support in accordance with the requirements of REACH in Ukraine. Our services include representing you as the only representative, ensuring full compliance on your behalf, or assisting with the pre-registration, registration, authorization, classification and labelling of your substances. For more information, contact the Ukrainian Ekotox at ekotox@ekotox.com.ua.
CLP in Ukraine: https://ekotox.eu/clp-in-ukraine/
Registration of biocides in Ukraine: https://ekotox.eu/biocides-in-ukraine/
Safety data sheet in Ukraine: https://ekotox.eu/sds-in-ukraine/