Ukraine Regulatory News

On 13 February 2025, Ukraine officially notified the World Trade Organization (WTO) of its Draft Law "On Making Available on the Market and Use of Biocidal Products", developed (issued) by the Ministr...

On 13 February 2025, Ukraine officially notified the World Trade Organization (WTO) of its Draft Law "On Making Available on the Market and Use of Biocidal Products", developed (issued) by the Ministry of Health.  This law aims to regulate the approval, production, market placement, circulation, and safe use of biocidal products and processed products, while ensuring compliance with standards for the protection of human and animal health  and the environment .

Key Objectives of the Draft Law

• Approval of Active Substances: Establishes legal provisions for the approval, renewal, or revision of active substances in biocidal products.

• State Registration: Implements procedures for state registration of biocidal products, including a simplified process.

• Market Supervision: Defines the legal framework for the safe use and circulation of biocidal products.

• Compliance with EU Regulations: Aligns with Regulation (EU) No. 528/2012 on biocidal products (BPR).

Authorized Body for Biocidal Product Evaluation

The draft law proposes the designation of an authorized state enterprise or institution under the central executive authority responsible for state healthcare policy. This body will:

• Evaluate applications for approval, renewal, or revision of active substances.

• Prepare expert opinions on state registration or refusal of registration of biocidal products.

• Provide evaluation services for a fee, as per agreements between applicants and the authorized body.

Fee Structure and Implementation

The law stipulates that:

• Fees for registration services will be calculated based on the minimum living wage for working-age individuals.

• The central executive authority will regulate the fee-setting process for evaluation services.

• The Cabinet of Ministers of Ukraine will approve the criteria and procedures for authorizing bodies.

Establishment of the State Register of Biocidal Products

In order to streamline market regulation, the law provides for:

• The establishment of the State Register of Biocidal Products by 1 January 2029.

• The modernization of the existing State Register of Disinfectants into the new registry.

Legislative Context

The draft aligns with key Ukrainian laws, including:

• “On Public Health System”

• “On Ensuring Chemical Safety and Management of Chemical Products”

• “On Veterinary Medicine”

• “On State Control Over Compliance with Legislation on Food, Feed, Animal By-products, Animal Health and Welfare”

Implementation Timeline and Comment Period

The date of adoption of the Law is yet to be determined. The Law will enter into force on the day following the day of its publication and will be enacted 36 months after its entry into force, except for specific provisions which will apply from 1 January 2029. Stakeholders have a 60-day window from the date of notification to review the draft and provide feedback to the Ministry of Economy of Ukraine.

Impact of the Draft Law

The adoption of this legislation will enhance the domestic market for biocidal products while ensuring high standards for human, animal, and environmental health. By aligning with EU regulations, Ukraine will strengthen its regulatory framework and market oversight, promoting safer and more transparent distribution of biocidal products.

On July 23, 2024, Ukraine officially adopted the Technical Regulation on the Safety of Chemical Products, known as UA-REACH, aligning its chemical safety legislation with the European Union’s REACH ...

On July 23, 2024, Ukraine officially adopted the Technical Regulation on the Safety of Chemical Products, known as UA-REACH, aligning its chemical safety legislation with the European Union’s REACH framework. The regulation mandates the registration, classification, and risk management of all chemical substances manufactured, imported, or sold in Ukraine in quantities exceeding one tonne per year. Its primary objective is to protect human health and the environment by ensuring that companies properly assess and manage risks throughout the life cycle of chemicals. The Ministry of Environmental Protection and Natural Resources of Ukraine oversees the enforcement of UA-REACH, managing the registration process, compliance evaluations, and enforcement actions against non-compliant entities.

Under UA-REACH, companies are required to register chemicals, submit technical dossiers, and, for quantities above 10 tonnes per year, provide Chemical Safety Reports detailing hazard assessments and risk management measures. Hazardous chemicals, especially those that are carcinogenic, mutagenic, and reprotoxic (CMRs) or those harmful to aquatic life, face more stringent assessment requirements, with staggered registration deadlines ranging from October 2026 to March 2030. The pre-registration period runs from January 26, 2025, to January 26, 2026, after which a public list of pre-registered substances will be published. Compliance includes structured procedures, classification by IUPAC and CAS numbers, and adherence to Group Standard approvals. UA-REACH applies to manufacturers, importers, authorized representatives, and industrial end-users, with penalties ranging from administrative fines to market restrictions and criminal sanctions for non-compliance.

Key News from 2024

Ukraine Implements CLP Regulation to Align with EU Standards

On May 10, 2024, Ukraine adopted the Technical Regulation for the Classification of Hazards, Labelling, and Packaging of Chemical Products to align with the EU's Classification, Labelling and Packaging (CLP) Regulation. Effective November 15, 2024, this regulation standardizes the hazard classification, labelling, and packaging requirements for chemical products in Ukraine. Market participants will need to ensure compliance with these new standards in order to continue operating in the Ukrainian market. Read more here and here.

Ukraine Implements UA-REACH Regulation

On July 23, 2024, the Ukrainian Cabinet of Ministers adopted Resolution No. 847, introducing the new Technical Regulations on the Safety of Chemical Products, known as UA-REACH. Effective January 26, 2025, this regulation mandates the registration of all chemicals produced, imported, or sold in Ukraine in quantities exceeding one tonne per year. The aim is to improve safety and compliance standards for chemical products in the Ukrainian market. Read more here and here.

Ukraine Aligns with EU on Ozone-Depleting Substances

Ukraine has adopted new labelling requirements for ozone-depleting substances and fluorinated greenhouse gases. On September 9, 2024, Ukraine notified the WTO of the adoption of Order No. 661, entitled "On Approval of the Procedure for Labeling of Controlled Substances, Goods, and Equipment". The Order was issued by the Ministry of Environmental Protection and Natural Resources on June 10, 2024, and will enter into force on March 1, 2025. Read more here.

Ukraine Adopts Restrictions on Hazardous Substances in Electronics

Ukraine has adopted new restrictions on the use of hazardous substances in electrical and electronic equipment, in line with global standards to reduce environmental and health risks. The move aims to control the presence of harmful chemicals in electronics and promote safer manufacturing and disposal practices. Read more here.

Ukrainian Ministry of Environmental Protection Launches EPR Pilot Project

The Ministry of Environmental Protection and Natural Resources of Ukraine has launched a pilot project on Extended Producer Responsibility (EPR). The project aims to increase environmental accountability by requiring manufacturers, brand owners, and importers to manage the life cycle of their products, including waste collection and recycling. The initiative focuses on different waste streams to promote sustainable practices. Read more here.

Key Dates for 2025

Ukraine-REACH was implemented on January 26, 2025, marking a key milestone in the country’s chemical regulation framework. On the same day, pre-registration for existing substances begins, allowing companies to prepare for compliance.

By November 15, 2025, companies must meet the CLP notification deadline for substances placed on the market before November 15, 2024, while substances introduced after this date must be notified within 30 days of their first placement. Additionally, by this date, all chemical products available on the Ukrainian market before November 26, 2024, must comply with classification, labeling, and packaging (CLP) requirements, ensuring accurate hazard communication.

The pre-registration deadline is set for January 26, 2026, with late pre-registration permitted within six months of the first manufacture or import after this date but before applicable registration deadline.

On 23 January 2025, Ukraine notified the World Trade Organization (WTO) of its draft Regulation entitled "Procedure for State Registration of Hazardous Factors" (Rev. 2). This Regulation, issued by th...

On 23 January 2025, Ukraine notified the World Trade Organization (WTO) of its draft Regulation entitled "Procedure for State Registration of Hazardous Factors" (Rev. 2). This Regulation, issued by the Ministry of Health of Ukraine, provides a comprehensive framework for the registration of chemicals, biological substances, and mixtures containing hazardous factors. This initiative underscores Ukraine's commitment to ensuring systematic oversight of hazardous substances, whether they are produced, used, or imported into the country.

What’s New in Rev. 2?

Building on the earlier version notified in September 2024, Rev. 2 introduces several changes:

1. Enhanced Application Review Process: Aligned with the Law of Ukraine "On Administrative Procedure.

2. Joint Applications Removed: Producers and importers must now submit individual applications for hazardous factor registration.

3. Simplified Certification Requirements: Eliminating storage obligations for registration certificates details (number and validity period) in the State Register.

These changes reflect Ukraine's forward-thinking approach to enhancing regulatory clarity, transparency, and efficiency.

Scope of the Regulation

The Regulation governs the registration of all chemical and biological hazardous factors, including:

• Individual substances of chemical or biological origin, produced, used, or imported into Ukraine.

• A hazardous factor that is part of the product if it is intentionally released during use.

• Mixed products containing hazardous factors in concentrations of 10% or more

• Additives formed during production or use.

Registration Process

The process of registration of 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".

Application Requirements:

1. Applicant’s full and abbreviated name.

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 name and chemical name 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.

7. Safety data sheet in Ukrainian.  

8.  Identification of the similarity of the hazardous factor.

9. Hazard classification and labelling data.

The application for registration shall be submitted to the Ministry of Health either electronically through the online system of the State Register or in written form, depending on technical availability.

Decision Process and Validity of Registration

The State Enterprise "Committee on Hygienic Regulation" examines the registration documents within 30 calendar days. The Ministry of Health then decides on registration or refusal within 10 calendar days, based on the Committee’s expert conclusion. 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.

State Register of Hazardous Factors

The State Register of Hazardous Factors, which will become operational upon the official publication of the resolution, is intended to provide electronic services to implement the rights and obligations of applicants for the collection, accumulation and processing of data on hazardous factors registered in Ukraine.

 The State Register will contain:

• Substance names and sources of origin.

• Data on intended use, biological effects, and hazard classification.

• Environmental impact and detection methods.

• State medical and sanitary standards.

Alignment with International Standards

The regulation follows the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), aligning the Ukrainian framework with global best practices. This alignment ensures safer handling and use of hazardous substances while supporting international trade.

Objectives and Benefits

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 the 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.

Legislative Context

The draft aligns with key Ukrainian laws, including:

• "On Public Health System"

• "On Protection of Population Against Infectious Diseases"

• "On Ensuring Chemical Safety and Management of Chemical Products"

Implementation Timeline and Comment Period

The date of adoption for the Regulation is yet to be determined. Stakeholders have 60 days from the notification date to review the draft and provide feedback.

The Ministry of Environmental Protection and Natural Resources of Ukraine is driving forward the adoption of key European Union regulations on ozone-depleting substances and fluorinated greenhouse gas...

The Ministry of Environmental Protection and Natural Resources of Ukraine is driving forward the adoption of key European Union regulations on ozone-depleting substances and fluorinated greenhouse gases. This strategic initiative is an integral part of preparations for the upcoming bilateral meeting with the European Commission under Chapter 27 on Environment and Climate Change.

New EU Regulations on Ozone-Depleting Substances and F-Gases

On 7 February 2024, the European Union introduced updated legislation with Regulation (EU) 2024/590 on substances that deplete the ozone layer and Regulation (EU) 2024/573 on fluorinated greenhouse gases, superseding previous frameworks and amending Directive (EU) 2019/1937. Ukraine is modernizing its legal and terminological framework to align with these changes.

Why This Matters?

• Alignment with EU Standards: Enables Ukraine to meet European environmental requirements, advancing its integration into the EU framework.

• International Cooperation: Reduces the risk of misunderstandings and legal contradictions in global and regional partnerships.

• Environmental Protection: Strengthens the ability to control substances harmful to the ozone layer and the climate.

Call for Stakeholder Participation

The Ministry is committed to transparency and collaboration and is now seeking input from businesses, public organizations, and individuals with expertise in environmental protection. Comments and suggestions can be submitted through the Ministry’s official website until 31 January 2025.

Looking ahead, the Ministry plans to actively engage all stakeholders in shaping and discussing these regulations to ensure broad consensus and effective outcomes.

New Labelling Rules Introduced

In addition to regulatory alignment, Ukraine has introduced new labelling rules for ozone-depleting substances and fluorinated greenhouse gases. On 9 September 2024, Ukraine notified the WTO of the adoption of Order No. 661, titled "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 take effect on 1 March 2025.

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.