Ukraine Regulatory News

On 23 July 2024, the Ukrainian Cabinet of Ministers of Ukraine adopted Resolution No. 847, which introduces new Technical Regulations on the Safety of Chemical Products (also known as Ukraine-REACH or...

On 23 July 2024, the Ukrainian Cabinet of Ministers of Ukraine adopted Resolution No. 847, which introduces new Technical Regulations on the Safety of Chemical Products (also known as Ukraine-REACH or UA-REACH). This Regulation, set to come into force on 23 January 2025, aims to enhance the safety and compliance standards for chemical products in the Ukrainian market. It requires the registration of all chemicals produced, imported or sold in Ukraine in quantities of more than one tonne per year (TPA).

Background and Alignment with EU Regulations

In December 2022, Ukraine adopted the Law ‘On Ensuring Chemical Safety and Management of Chemical Products’. This law, which entered into force on 29 June 2024, is the basis for building a national chemicals management system based on the European model and has created the foundation for further steps, including the implementation of two major EU technical regulations: CLP (Classification, Labelling, and Packaging) and REACH. The CLP Regulation was adopted on 10 May 2024 and will enter into force on 15 November 2024. With the introduction of UA-REACH, Ukraine continues to align its chemical safety standards with those of the European Union, marking significant progress towards EU membership.

Transitional Provisions for Chemical Products

The resolution outlines specific provisions for chemical products already available on the market before the new Regulation’s enforcement:

1. Market Availability: Chemical products that do not meet the new Technical Regulations can continue to be sold for one year from the date the resolution comes into force.

2. Registration Deadlines:

Pre-registration is expected to last for a year from the date of entry int force until 23 January 2026. The registration deadlines are set as follows:

The registration deadlines, originally proposed for 1 June 2025, 2026, and 2027, were extended following the public consultation for the Regulation.

Implementation and Compliance

The Ministry of Environmental Protection and Natural Resources is tasked with ensuring the implementation of the new Technical Regulation.  In addition, all relevant ministries and central executive authorities must update their regulatory acts to align with this resolution.

The full text of the regulation and the official resolution containing the registration deadlines can be accessed here (in Ukrainian).

On July 23, 2024, the Ukrainian government approved the Technical Regulation on the Safety of Chemical Products (UA-REACH), which is in line with EU-REACH standards. The regulation aims to protect hum...

On July 23, 2024, the Ukrainian government approved the Technical Regulation on the Safety of Chemical Products (UA-REACH), which is in line with EU-REACH standards. The regulation aims to protect human health and the environment from the risks associated with chemical substances, while facilitating their free circulation on the market.

Mandatory Registration

This regulation requires the registration of all chemicals produced, imported or sold in Ukraine in quantities of more than one tonne per year. Registration ensure the creation of  a comprehensive database on chemical properties, risks, and safe use, which will be managed by the Ministry of Environmental Protection and Natural Resources.

Broad Scope and Goals

Deputy Minister Olena Kramarenko emphasized the broad scope of the regulation, which covers industrial and everyday chemicals. The long-term goal is to replace hazardous chemicals with safer alternatives, thereby improving the protection of human health and the environment.

Support and Background

In December 2022, Ukraine adopted the Law ‘On Ensuring Chemical Safety and Management of Chemical Products’. The law is the basis for building a national chemicals management system based on the European model and has created the foundation for further steps, including the implementation of the two major EU technical regulations: CLP (Classification, Labelling, and Packaging) and REACH. The CLP Regulation was adopted on 10 May 2024.

The development of UA-REACH was supported by OSCE projects in Ukraine as part of the project ‘Environmental Monitoring of the War Against Ukraine and Recovery Strategy.

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

On 21 June 2024, the Ministry of Environmental Protection and Natural Resources (MEPNR) of Ukraine announced that the Cabinet of Ministers of Ukraine has approved the procedure for the creation and operation of the Information System for Chemical Safety. This is an important step towards modernising regulatory oversight in Ukraine. The platform will be launched as part of the national online platform EcoSystem, which provides up-to date information on the state of the environment.

Services for Companies and Improved Public Access

The new information system will provide a range of administrative services for companies and open registers for public access. Companies will be able to:

• Submit documents for registration of chemical substances.

• Obtain permits for the use of poisonous and particularly hazardous chemicals that are withdrawn from the market.

• Notify authorities of the use of alternative names for chemical substances.

• Report on the hazard classification of chemical products.

In addition, the system will provide comprehensive information on:

• Chemical products, their market volumes and hazardous properties.

• Potential risks associated with the use of chemicals and related safety measures.

• Manufacturers, importers, and suppliers of chemical products.

• Chemical incidents and identified threats to chemical safety.

Meeting EU Integration Obligations

The initiative stems from Ukraine's commitment to harmonise its chemical safety regulations with EU standards, required by the Law on Ensuring Chemical Safety and Management of Chemical Products, which will come into force on 29 June 2024. This legislation sets the framework for the adoption key EU technical regulations, including CLP (Classification, Labelling, and Packaging) and REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals).

CLP and REACH in Ukraine

On 10 May 2024, the Ukrainian government adopted the Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products. The Technical Regulation will enter into force on 15 November 2024, except for some parts which will enter into force on 1 January 2025

Regarding the implementation of Ukraine-REACH, the MEPNR has already developed the draft Technical Regulation on the Safety of Chemical Products, which will be submitted to the Government for consideration in the near future.

The MEPNR recently announced the completion of the public consultation process on the draft resolution for Ukraine-REACH. A significant outcome of the public consultation is the MEPNR’s decision to revise the deadlines for registration under Ukraine-REACH, allowing industry additional time to prepare. The revised deadlines, based on the tonnage band are as follows:

• 1 October 2026 for tonnages over 1000 TPA

• 1 June 2028 for the 100-1000 TPA tonnage band.

• 1 March 2030 for the 1-100 TPA tonnage band.

Chemical products on the market before the entry into force of the Regulation that do not comply with all or some of the requirements of the Technical Regulation may continue to be sold for up to one year after entry into force of the Regulation.

On 19 June 2024, the Ministry of Environmental Protection and Natural Resources (MEPNR) of Ukraine announced that the Cabinet of Ministers has approved a new procedure for registering notifications us...

On 19 June 2024, the Ministry of Environmental Protection and Natural Resources (MEPNR) of Ukraine announced that the Cabinet of Ministers has approved a new procedure for registering notifications using alternative names for chemical substances. This initiative was developed to implement the Law "On Ensuring Chemical Safety and Management of Chemical Products”, and to align Ukrainian legislation with EU standards. In fact, this procedure is already in place in the EU under the Classification, Labelling and Packaging (CLP) Regulation.

New Procedure Protects Chemical Formulas

The new procedures allow companies to protect their unique chemical formulas from competitors by using alternative names. Companies must apply to the MEPNR through the national online platform EcoSystem. Approved applications will be entered into the State Register of Notifications on the Use of an Alternative Name of a Chemical Substance. Once approved, companies may use the alternative name of the chemical substance in the hazard information and safety data sheet of chemical products.

CLP in Ukraine

On 10 May, the Ukrainian Government adopted the Technical Regulation on the Hazard Classification, Labelling and Packaging Chemical Products. This document aligns Ukraine with the EU CLP Regulation, which implements the UN's Globally Harmonized System (GHS) for Classification and Labelling of Chemicals. This Technical Regulation will enter into force on 15 November this year.

On 29 May 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine announced the completion of the public consultation process on the draft Resolution of the Cabinet of Minister...

On 29 May 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine announced the completion of the public consultation process on the draft Resolution of the Cabinet of Ministers of Ukraine "On the Approval of the Technical Regulation on the Safety of Chemical Products" by, commonly referred to as Ukraine-REACH or UA-REACH.

Ukraine-REACH Consultation

I accordance with the established procedure for public consultations on issues of state policy in Ukraine, the draft Resolution was initially published on the official website of the Ministry on 22 March 2024. The public was invited to submit written suggestions and comments for a two-month period.

During this period, feedback was received from various stakeholders, including the European Business Association (EBA), the Ukrainian Association of Tobacco Manufacturers "UKRTTYUTYN", the Association of Manufacturers and Formulators of Enzyme Products (AMFEP), the European Chemical Industry Council (Cefic), the Japan Chemicals Exporters and Importers Association (JCEIA) and the American Chamber of Commerce in Ukraine.

The Ministry has reviewed all submissions and published the results on its official website, providing a table summarising the comments and suggestions from these entities and organisations.

Revisions and Recommendations for REACH Implementation in Ukraine

A general concern of stakeholders participating in the consultation was the proposed timelines for chemical registration. There are significant concerns about the feasibility of the currently proposed deadlines for each tonnage band. This concern is based on past experience with e.g. KKDIK (Turkey REACH), which required significant extensions to allow industry to comply.

The Ministry of Environmental Protection and Natural Resources has responded to the concerns by revising the compliance deadlines. The revised deadlines, based on the tonnage of existing chemicals produced or made available on the market, are as follows:

Other recommendations by stakeholders:

• Simplify the registration process, especially for substances already registered under EU REACH.

• Adopt models from other countries (e.g. Switzerland or Türkiye) to reduce redundancy and administrative burden.

• Ensure clear and consistent regulations that in line with existing legislation and international practice to facilitate implementation and compliance.

For more details on the results of the public consultation, please visit the Ministry's official website here.

In a move to align with EU standards, the Ukrainian government adopted the Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products on 10 May 2024. This deci...

In a move to align with EU standards, the Ukrainian government adopted the Technical Regulation for the Classification of Hazards, Labeling and Packaging of Chemical Products on 10 May 2024. This decision is a significant step as Ukraine adopts the standards set out in the EU Regulation 1272/2008 on Classification, Labelling and Packaging of Chemicals and Mixtures (CLP Regulation), which implements the Globally Harmonized System of Classification and Labelling of Chemical Substances (GHS) established by the United Nations.

The Technical Regulation will enter into force on 15 November 2024, except for some parts which will enter into force on 1 January 2025 (Section 3 and clauses 130-133 of Section 6).

Key Provisions of the Technical Regulation

Key provisions of the Technical Regulation include the introduction of EU rules and criteria for the classification of chemical substances and products according to the 33 hazard classes. It also introduces strict requirements for the labelling and packaging of chemical products.

The responsibility of market participants increases. Before placing a chemical product on the market, manufacturers, importers, suppliers and other operators are required to gather all available information on its hazardous properties, assess the validity of this information, and classify the hazards of the chemical substance in accordance with the Technical Regulation.

In addition, companies must ensure that the chemical products they manufacture, import or provide on the Ukrainian market are classified for hazard according to the criteria of the GHS. Such products must be packaged appropriately and bear the necessary hazard labels.

The full text of the Regulation can be found here in Ukrainian including Annex VIII which compares the provisions of the EU CLP Regulation and the Technical Regulation.

Law on Chemical Safety and Chemical Product Management

The adoption of the Technical Regulation follows the adoption of the Law "On Ensuring Chemical Safety and Chemical Product Management" in December 2022, which will enter into force on 29 June 2024. This framework legislation, an integral part of Ukraine's EU-integration commitments, underlines the country's commitment to protecting its citizens and environment.

According to Minister Ruslan Striltsa, the law will serve as a basis for establishing a national chemicals management system in line with European standards. It lays the foundation for further steps in this area, including the implementation of EU technical regulations such as CLP and REACH. With regard to the implementation of the REACH regulation, the Ministry of Environmental Protection and Natural Resources of Ukraine has already developed a Technical Regulation on the Safety of Chemical Products, which will be submitted to the Government for consideration in the near future.

On 8 April 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine notified to the World Trade Organization (WTO) a revised draft Technical Regulation "On Approval of the Techn...

On 8 April 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine notified to the World Trade Organization (WTO) a revised draft Technical Regulation "On Approval of the Technical Regulation on Safety of Chemical Products" to. The revised version includes suggestions and technical modifications compared to the previous version notified on 20 September 2023 (G/TBT/N/UKR/179/Rev.1).

Stakeholders and interested parties now have a 60-day window from the date of notification to provide their input on this draft regulation and help shape Ukraine's chemical safety landscape.

Harmonisation with EU Standards

This draft Technical Regulation is based on the provisions of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, commonly known as EU-REACH.

By aligning with these European standards, Ukraine aims to synchronise its chemical safety practices with those of the European Union.

Key Elements of the Revision

The draft Technical Regulation has been drafted in accordance with the provisions of the Law of Ukraine "On Ensuring Chemical Safety and Management of Chemical Products." Its main objective is to ensure a high level of protection of human health and the environment, while facilitating the free circulation of chemical products, promoting alternative methods of assessing chemical hazards, and encouraging innovation to improve competitiveness. The Regulation sets out requirements for the safety of chemicals at all stages of production, distribution, and use stages, including chemicals in mixtures and products.

At the heart of the Regulation is the precautionary principle, which requires manufacturers, importers and users to ensure that their chemicals do not pose a risk to human health or the environment. Chemical products that do not meet the requirements of this Technical Regulation cannot be placed on the market in Ukraine.

Transitional Provisions and Timeline

A transitional period of one year from the date of entry into force of the Regulation is provided for chemical products already in circulation that do not comply with the requirements of the Regulation.

The date of adoption of the Technical Resolution is yet to be determined, and its enforcement is scheduled to take place six months after its publication.