Ukraine's Technical Regulation on Chemical Safety Aligning with EU REACH Standards

Amid the current chaos, On July 23, 2024 Ukraine took a significant step in enhancing its chemical safety standards by introducing the "Technical Regulation on the Safety of Chemical Products." This regulation, often referred to as "Ukraine REACH," marks a major milestone in Ukraine’s efforts to align its chemical management framework with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation. The new Ukraine REACH aims to protect human health and the environment while ensuring chemical products can be safely marketed within the country.

What is the Purpose and Scope of Ukraine REACH

The primary objective of Ukraine REACH is to safeguard public health and the environment by establishing strict safety protocols for the production, importation, and use of chemical substances in Ukraine. This regulation is directly modeled on the EU’s REACH framework, specifically referencing Regulation (EC) No 1907/2006, ensuring consistency and compatibility with European standards. Ukraine REACH applies to all chemical products within the country, encompassing those manufactured domestically, imported, or available on the market.

However, certain products are exempt from Ukraine REACH requirements, including:

• Radioactive materials
• Chemicals under customs control
• Non-isolated intermediates
• Transport of hazardous goods via various means

Ukraine REACH also allows the Ministry of Environmental Protection to grant exemptions in cases essential for state defense.

Exemptions and Ukraine REACH Registration

Ukraine REACH includes streamlined processes for substances that have already been registered under the EU’s REACH framework. These substances can be registered in Ukraine through a simplified procedure, provided they meet the criteria outlined in the annexes, including Annex XIII of REACH, which deals with the identification of persistent, bioaccumulative, and toxic (PBT) substances and very persistent, very bioaccumulative (vPvB) substances.

Furthermore, Ukraine REACH allows for specific exemptions and simplified registration processes for chemicals used exclusively for scientific research, reflecting the provisions of REACH Article 9. This ensures that research and innovation are not hindered by regulatory requirements while maintaining a high standard of safety.

What are The Key Definitions and Ukraine REACH Annexes

To ensure clarity and effective implementation, Ukraine REACH defines several key terms, such as "chemical substance," "manufacturer," "importer," and "polymer." These definitions are crucial for determining the scope of Ukraine REACH and its application across different sectors, aligning closely with those in the EU’s REACH framework.

Ukraine REACH also includes several important annexes that mirror the structure of REACH:

• Annex VI of REACH: This annex outlines the identification and contact details required from manufacturers or importers, alongside criteria for substance identification. These details are critical in ensuring traceability and proper categorization of chemicals under Ukraine REACH.
• Annex VII-XI of REACH: These annexes specify the necessary information, including studies required for different tonnage bands of chemicals. For example, Annex VII focuses on standard information requirements for substances manufactured or imported in quantities of 1 tonne or more per year, while Annex X provides guidelines for substances exceeding 1000 tonnes annually.

These annexes are integral to the registration process under Ukraine REACH, ensuring that all chemical substances are evaluated and managed according to their potential risks.

What is The Registration Process and REACH Alignment**

One of the key features of Ukraine REACH is the mandatory state registration of chemical substances before they can be marketed in the country. This process is closely aligned with the EU’s REACH regulation, specifically referencing Articles 41–46, which deal with the joint submission of data, and Articles 78–82, concerning the evaluation procedures by the European Chemicals Agency (ECHA).

Manufacturers or importers handling one tonne or more of a chemical substance per year must submit a detailed registration dossier to the Ministry of Environmental Protection. This dossier must include:

• Comprehensive information about the substance, including its composition, physical and chemical properties, and intended uses
• Safety data reports and assessments, as required by the relevant annexes, particularly Annex VII-XI of REACH
• Details on risk management measures to control potential hazards associated with the substance, as mandated by Ukraine REACH

The registration process under Ukraine REACH also encourages joint submissions, reflecting REACH Article 11, which aims to reduce the duplication of data and testing, particularly those involving vertebrate animals.

Key Dates for Ukraine REACH

End of 2025: Target deadline for submitting registrations for existing substances to avoid disruption in business operations.

Manufacturers or importers handling one tonne or more of a chemical substance per year must submit a detailed registration dossier to the Ministry of Environmental Protection. This dossier must include:

• Comprehensive information about the substance, including its composition, physical and chemical properties, and intended uses
• Safety data reports and assessments, as required by the relevant annexes, particularly Annex VII-XI of REACH
• Details on risk management measures to control potential hazards associated with the substance, as mandated by Ukraine REACH
• The registration process under Ukraine REACH also encourages joint submissions, reflecting REACH Article 11, which aims to reduce the duplication of data and testing, particularly those involving vertebrate animals.

Safety Assessment and Risk Management of Ukraine REACH

For substances produced or imported in quantities of 10 tonnes or more per year, Ukraine REACH requires a detailed safety assessment, similar to the process outlined in REACH Annex I. This assessment must cover the hazardous properties of the substance, its impact on human health, and its environmental effects.

In cases where a substance is classified as hazardous, the manufacturer or importer is required to implement appropriate risk management measures. These measures must be documented and communicated to downstream users to ensure safe handling practices. Ukraine REACH also mandates that this information be updated regularly, in line with the dynamic requirements set out in REACH Article 14.

Conclusion

Ukraine REACH is a critical development in the country’s regulatory landscape, aligning its standards with those of the EU through the REACH framework. The regulation’s detailed annexes ensure that chemical substances are rigorously assessed and managed, providing a robust framework for protecting public health and the environment.

As Ukraine continues to integrate with European markets, Ukraine REACH will play a pivotal role in facilitating trade and ensuring that Ukrainian chemical products meet the highest international safety standards. For companies operating within Ukraine, understanding and complying with Ukraine REACH, including the specific REACH clauses and annexes, will be essential for maintaining market access and upholding safety commitments.