Ukraine Regulatory News

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.

On 22 February 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine published the Draft Law of Ukraine on Plant Protection Products and Fertilizers. The draft law was notifi...

On 22 February 2024, the Ministry of Environmental Protection and Natural Resources of Ukraine published the Draft Law of Ukraine on Plant Protection Products and Fertilizers. The draft law was notified to the World Trade Organization (WTO) on 27 February 2024. This legislative initiative is a proactive step to ensure Ukraine’s compliance with EU standards.

Alignment with EU Standards for Plant and Fertilizer Products  

The proposed draft law aims to establish comprehensive procedures for introducing plant protection products (PPPs) and fertilizers to the market in line with current EU regulations. In particular, it aims to align with Regulation (EU) 2019/1009, which sets out rules for the availability of fertilizer products in the EU and Regulation (EC) No 1107/2009 on the placing of plant protection products on the market.

The purpose of the draft law is to:

- Define terminology and basic concepts for the authorisation of active substances, antidotes, and synergists in preparative forms of plant protection products.

- Specify unacceptable co-formulants that cannot be included in plant protection products.

- Harmonise procedures for making fertilizers available on the market.

- Define the procedure for the management of hazardous waste arising from the use of plant protection products.

Conformity Assessment

The legislation sets out the obligations of companies in carrying out conformity assessments and managing the placing of fertilizers on the market. In addition the legislation announces the forthcoming adoption of a separate government resolution on the Technical Regulation on conformity assessment of fertilizing products.

Current Legislation on Pesticides and Agrochemicals

Currently fertilizers and PPPs in Ukraine are regulated by Law No. 86/95-BP on Pesticides and Agrochemicals. This law will be repealed when the draft law enters into force. However, all valid pesticide registrations made in accordance with the Law on Pesticides and Agrochemicals and in force on the date of the draft law's enactment, will remain valid until the expiry of the registration period without requiring approval for antidotes or synergist substances within the preparative form.

Timeline

The date of adoption of the draft law has not yet been determined. The law will enter into force the day after its publication and will be enacted 24 months later, except for certain provisions which will enter into force after 36 months.

On 16 February 2024, the Ukrainian Cabinet of Ministers published a draft resolution aimed at improving chemical product safety standards. The proposed legislation, entitled "On the Approval of the Te...

On 16 February 2024, the Ukrainian Cabinet of Ministers published a draft resolution aimed at improving chemical product safety standards. The proposed legislation, entitled "On the Approval of the Technical Regulations for the Classification of Hazards, Labelling, and Packaging of Chemical Products," aims to align Ukraine's chemical safety protocols with European Union standards and United Nations guidelines.

Developed under the provisions of the Law of Ukraine on Ensuring Chemical Safety and Management of Chemical Products and other relevant national laws, this draft resolution is an important step towards harmonising Ukraine's chemical safety regulations with international benchmarks, in particular the EU Regulation No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (the CLP Regulation) and the UN Globally Harmonized System (GHS) on the Classification and Labelling of Chemicals.

The draft resolution was notified to the World Trade Organization (WTO) on 27 February 2024.

Key Highlights of the Draft Resolution

- The resolution mandates the adoption of the Technical Regulation for the Classification, Labelling, and Packaging of Chemical Products, ensuring compliance with both EU legislation and UN standards.

- The Ministry of Environmental Protection and Natural Resources will be tasked with overseeing the implementation of these technical regulations.

- A transition period is proposed to allow chemical products that do not fully comply with the new regulations to remain on the market for a period of time to ensure a smooth transition for businesses.

- Amendments to existing laws and executive orders will be required to bring them into line with this resolution, underlin the comprehensive approach to chemical safety.

- The resolution is scheduled to enter into force on 29 June 2024, with certain provisions coming into force on 1 January 2025 to address implementation logistics.

Objective and Scope

The primary objective of this Regulation is to protect public health and the environment by establishing strict criteria for the hazard classification, labelling, and packaging of chemical products. By setting clear requirements for the identification and communication of chemical hazards, Ukraine aims to facilitate the safe handling of chemical substances and mixtures, thereby ensuring the well-being of its citizens and the ecological integrity of its territories.

The draft resolution covers a wide range of chemical products, excluding only those explicitly listed, such as radioactive materials, non-isolated intermediates, and certain products used exclusively in scientific research, among others.

Public and Stakeholder Engagement

The Cabinet of Ministers is inviting public feedback and stakeholder input on the draft resolution, underscoring the government's commitment to transparency and collaborative policymaking. This participatory approach is expected to refine the regulations and ensure their effectiveness in protect human health and the environment. The deadline for comments is 16 March 2024.

Conclusion

Ukraine's proactive measures to update its chemical safety standards reflect its commitment to protecting the environment and public health. By aligning with international regulations, Ukraine is not only improving its domestic safety protocols but also facilitating the smoother cross-border trade and handling of chemical product.

 On 2 February 2024, the Ministry of Health of Ukraine notified the World Trade Organization (WTO) that Order No 2104 ‘On Approval of Special Requirements for Plastic Materials and Articles Intende...

 On 2 February 2024, the Ministry of Health of Ukraine notified the World Trade Organization (WTO) that Order No 2104 ‘On Approval of Special Requirements for Plastic Materials and Articles Intended to Come into Contact with Foodstuffs’ was adopted on 11 December 2023 and will enter into force on 19 November 2025. At the same date the Law of Ukraine No 2718 - IX "On Materials and Articles Intended to Come into Contact with Food" of 3 November 2022 will come into force.

Order No 2104

The purpose of Order No 2104 is to validate specific requirements for plastics intended to come into contact with food by incorporating the provisions of European Union Regulation (EU) 10/2011 (on plastic materials and articles intended to come into contact with food). Key points of the Order include:

• Defining the scope of food contact plastics

• Specifying that ion exchange resins, rubber, silicones, printing inks, adhesives, and varnishes/coatings are exempted.

• Outlining the compositional requirements for food contact plastics including the use of authorised monomers, starting substances, macromolecules from microbial fermentation (listed in Appendix 1) or substances included in the State Register for the manufacture of food contact plastics.

• Establishing general requirements, restrictions, and technical specifications, such as specific migration limits (SML), overall migration limits (OML), and limits for primary aromatic amines (PAA)

• Providing regulations for plastic multi-layer materials and articles, as well as multi-material multi-layer materials and articles.

The Order provides that plastic materials and articles intended to come into contact with food and manufactured before the entry into force of the Order, may be in circulation until their expiry date.

The full text of the Order (in Ukrainian) can be found here.

Law No 2718

Ukraine introduced Law No. 2718-IX of 3 November 2022, 'On Materials and Articles Intended to Come into Contact with Food,' effective from 20 November 2022, with key provisions applicable from19  November 2025. This law incorporates elements from EU regulations on materials and articles intended to come into contact with food and includes the following:

Section I - General provisions:

• Scope: Covers food contact materials (FCMs) and articles.

• Exemptions: Antiques, protective coatings, fixed water supply equipment.

• Defines: Terms, powers of government agencies.

Section II - Requirements for materials and articles:

• Compliance: FCM must comply with Good Manufacturing Practice (GMP).

• Safety Requirements: General safety, non-deceptive labelling.

• Special Requirements: 18 FCM groups may have specific criteria.

• Recycled Plastics: Allowed if obtained through a state-registered process.

Section III - State registration of articles:

• Outlines requirements and procedures for state registration.

Section IV - Marking, declaration of conformity and ensuring traceability of materials and items:

• Labelling: Information for materials not yet in contact with food.

• Active and Intelligent Materials: Special labelling requirements.

• Declaration of Conformity: For materials with special requirements.

• Traceability: Ensures traceability at all stages for control and recall.

Section V - Good manufacturing practices:

• Details: GMP requirements, quality assurance, and control systems.

Section VI - State control and responsibility:

• Defines: Powers granted to government agencies.

The full text of Law No. 2718-IX of 3 November 2022, can be found here.