Ukraine Regulatory News

On 15 November 2024, the Ukrainian Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products, adopted in May 2024, will enter into force. Certain provisions, ...

On 15 November 2024, the Ukrainian Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products, adopted in May 2024, will enter into force. Certain provisions, specifically Section 3 and clauses 130-133 of Section 6,  will enter into force on 1 January 2025.

Alignment with EU and UN Standards

With this regulation, Ukraine integrates the standards of the EU Regulation 1272/2008 on Classification, Labelling and Packaging of Chemicals and Mixtures (CLP Regulation), which incorporates the UN Globally Harmonized System (GHS) for Classification and Labeling of Chemicals.

The Technical Regulation establishes the procedure for the submission of hazard  classification data and hazard information by companies, and establishes the procedure for the approval of national hazard classifications and hazard information.

New Classification, Labeling and Packaging Requirements

The Technical Regulation in Ukraine introduces:

• European rules and criteria for the hazard classification of chemical substances and products – according to 33 hazard classes.

• Requirements for labeling and packaging  of chemical products.

Market Obligations for Compliance

This regulation increases the responsibility of market participants. Before placing chemical products on the market, manufacturers, importers, suppliers and other operators must gather all available information on the hazardous properties, assess the validity of this information and classify the chemical according to the technical regulation.

In addition, companies must ensure that:

• The chemical products they produce, import or place on the Ukrainian market are classified for hazard according to the criteria of the Globally Harmonized System (GHS).

• Such chemical products are appropriately packaged and labelled with hazard information.

Access to the Full Text

The full text of the Regulation, including Annex VIII which compares the provisions of the EU CLP Regulation and the Ukrainian Technical Regulation, is available here in Ukrainian.

The Cabinet of Ministers of Ukraine has adopted Decree No. 1068 on 17 September 2024, introducing amendments to Appendices 3 and 4 of the Technical Regulation on limiting the use of hazardous substanc...

The Cabinet of Ministers of Ukraine has adopted Decree No. 1068 on 17 September 2024, introducing amendments to Appendices 3 and 4 of the Technical Regulation on limiting the use of hazardous substances in electrical and electronic equipment. This regulation, originally issued on 10 March 2017, aims to align Ukraine’s safety standards with international practices, particularly regarding the use of substances such as mercury and cadmium.

Key Changes

- Cadmium: New restrictions apply to cadmium use in semiconductor nanocrystalline quantum dots for displays and projection devices, effective until 31 December 2027.

- Lead: Restrictions on lead and cadmium in plastic profiles containing recycled polyvinyl chloride (PVC) for windows and doors, with compliance required by 28 May 2026.

- Mercury: Extended exemptions for mercury in certain lamps and transducers, with deadlines determined by future Cabinet decisions.

Timeline

The Resolution was published on 24 September and notified to the World Trade Organization (WTO) on 25 September 2024. It will come into force on 24 March 2025, except for specific clauses that take effect immediately upon publication. The full text of the amendment can be found here.

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 Ministr...

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.

On 9 September 2024, Ukraine notified the WTO of the adoption of Order No. 661 entitled "On Approval of the Procedure for Labelling of Controlled Substances, Goods, and Equipment". The Order, issued b...

On 9 September 2024, Ukraine notified the WTO of the adoption of Order No. 661 entitled "On Approval of the Procedure for Labelling of Controlled Substances, Goods, and Equipment". The Order, issued by the Ministry of Environmental Protection and Natural Resources on 10 June 2024, will come into effect on 1 March 2025.

The Order outlines mandatory labelling requirements for ozone-depleting substances (ODS) and fluorinated greenhouse gases (F-GHG), as listed in Annexes 1 and 2 to the Law of Ukraine "On Regulation of Economic Activities with Ozone-Depleting Substances and Fluorinated Greenhouse Gases", as well as goods and equipment containing them.  It aims to increase transparency and compliance and ensure that consumers and authorities are informed about the environmental impact of these substances.

Alignment with EU Regulations

The procedure is based on the requirements of Article 12 of Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases, which repealed Regulation (EC) No 842/2006. It also follows Commission Implementing Regulation (EU) 2015/2068 of 17 November 2015, which sets out the format of labels for products and equipment containing fluorinated greenhouse gases. This alignment ensures that Ukrainian regulations are consistent with European standards, facilitating compliance for companies involved in international trade.

Scope and Application

The Order applies to companies involved in the import, export or marketing of products containing controlled substances. Items such as refrigeration equipment, air conditioning equipment, heat pumps, firefighting equipment, electrical switching equipment and aerosol sprays are subject to mandatory labelling.

Specific Labelling Requirements

Products containing controlled substances must be labelled with:

- Information confirming the presence of controlled substances.

- The industrial and chemical name of the substance.

- The quantity of the controlled substance in kilograms and its potential ozone depleting and global warming potential equivalents in tonnes.

For substances intended for special uses, such as military or semiconductor applications, additional text is required, including phrases such as "For disposal only" or "For use in military equipment only".

Packaging and Marking Guidelines

Labels must be durable, clearly legible and placed in visible locations on the product, i.e. near service ports used for filling or collecting of controlled substances or on the part of the product or equipment that contains the controlled substances. Recycled or regenerated substances shall be labelled "100% recycled". For products below 125 ml, this information may be included in the accompanying documentation in lieu of direct labelling.

Implementation and Supervision

The Order, which was registered with the Ministry of Justice on 7 August 2024, will come into force six months after its publication, on 1 March 2025, and its implementation will be overseen by the Department of Industrial Pollution Prevention and Climate Policy.

On 3 September 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine announced that it is set to launch a ground-breaking pilot project aimed at implementing Extended Produce...

On 3 September 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine announced that it is set to launch a ground-breaking pilot project aimed at implementing Extended Producer Responsibility (EPR) schemes in the country. The initiative, developed in collaboration with the business community and local authorities, was announced following a recent meeting with members of the European Business Association.

Purpose of the Project

According to Yevhenia Popovych, Director of the Department of Digital Transformation, E-Government Services and Waste Management at the Ministry, the pilot project is a crucial step on Ukraine’s path towards European integration. It aims to bring business processes in line with European standards by allowing companies to test extended producer responsibility models. This will provide essential experience for the development of future waste management legislation.

Scope of the Pilot

The EPR project will explore new approaches to waste management, including packaging, electronic and electrical equipment, batteries and other categories. The initiative requires producers to take responsibility for the collection, recycling and disposal of their products once they have been used by consumers. Initially, participation will be voluntary, allowing companies to test the new system and gain experience in line with European standards.

Business Community's Response

During the meeting, major Ukrainian companies expressed their willingness to adopt new environmental standards, including packaging collection and recycling schemes. They provided a number of suggestions and concerns to be taken into account in the implementation of the pilot project.

Next Steps

The European Business Association will consolidate the suggestions of the business community and submit them to the Ministry for further consideration in refining the Government Resolution on the pilot project. This resolution will cover different types of waste, including packaging, electronic and electrical equipment and batteries.

On 21 August 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine (MEPNR) announced that the Cabinet of Ministers of Ukraine has approved the procedure for maintaining the S...

On 21 August 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine (MEPNR) announced that the Cabinet of Ministers of Ukraine has approved the procedure for maintaining the State Register of Chemicals. This is an important step towards alignment with European Union standards. This register will contain detailed information on all chemical substances produced, imported or sold in Ukraine in quantities exceeding one tonne per year. It will cover not only industrial chemicals but also those used in everyday products such as detergents, paints, clothing, furniture and electronics.

Database to Provide Information on Chemical Safety to Public

The creation of this register follows a public consultation process that ended on 12 August 2024, during which the draft resolution for the register was open for feedback from stakeholders.

According to Ukraine’s Deputy Minister of Environmental Protection and Natural Resources, Olena Kramarenko, the mandatory registration of these substances is in line with the recently adopted Technical Regulation on the Safety of Chemical Products (also known as Ukraine-REACH), which implements the EU's REACH Regulation. The register, which will be accessible through the national EcoSystem platform, will be a publicly accessible database containing key information on chemical manufacturers, importers and suppliers, as well as details on the potential risks and safety measures associated with these substances.

The Cabinet of Ministers of Ukraine has introduced a draft resolution entitled "On Approval of the Procedure for Maintaining the State Register of Chemicals" and opened it for public consultation unti...

The Cabinet of Ministers of Ukraine has introduced a draft resolution entitled "On Approval of the Procedure for Maintaining the State Register of Chemicals" and opened it for public consultation until 12 August 2024. This draft resolution represents a significant step towards improving chemical safety in Ukraine by aligning the country’s regulations with those of the European Union, in particular those set out in the REACH Regulation (Regulation (EC) No 1907/2006). The draft resolution was developed in accordance with the requirements of Articles 9 and 39 of the Law of Ukraine "On Chemical Safety and Chemicals Management"

Purpose and Objectives

The main objective of the draft resolution is to approve the procedure for maintaining the State Register of Chemicals as part of the Ukrainian Chemical Safety Information System (EcoSystem). This Register will serve as a centralised database providing detailed information on hazardous chemicals present on the Ukrainian market. The initiative aims to protect public health and the environment by ensuring that key data on the identification, hazard classification and environmental impact of these chemicals are readily available to the public. More details about the system can be found here.

Alignment with European Standards

The draft resolution developed by the Ministry of Environmental Protection and Natural Resources of Ukraine, harmonises the Ukrainian chemical safety framework with European legislation. By mirroring EU procedures and regulations, the resolution aims to meet Ukraine’s commitments to European integration and improve both domestic safety standards and international cooperation in chemicals management.

Public Consultation and Implementation

To ensure broad input and transparency, the Ministry published the draft resolution on its official website and opened it for public comment. Stakeholders, including individuals, legal entities and associations, have one month from the date of publication to submit their feedback. This public consultation process is an important part of refining the legislation to ensure that it effectively achieves its objectives. Comments and suggestions can be submitted through the Ministry’s official website or by direct communication with the relevant department until 12 August 2024.

Financial and Legal Considerations

Importantly, the implementation of this resolution will not require any additional financial expenditure from the state or local budgets. The draft is also designed to avoid any legal conflicts, including issues related to corruption or discrimination. It is expected to have a positive impact on public health and environmental protection without compromising equal rights and opportunities for all citizens.

Expected Outcomes

Once adopted, the resolution will significantly increase public awareness of chemical safety risks. By providing free access to detailed information on hazardous substances, the State Register will enable citizens, businesses, and authorities to make informed decisions on the use and management of chemicals. This initiative is a major step forward in Ukraine’s efforts to protect both its people and environment from the dangers posed by hazardous chemicals. Public participation in the consultation process is essential to ensure that the final resolution is both effective and responsive to the needs and concerns of all stakeholders.