Ukraine Reach Regulation For Various Sectors

Summary of UA REACH

On 26 January 2025, the Ukrainian Technical Regulation on the Safety of Chemical Products - commonly referred to as UA REACH – which was adopted in July 2024, entered into force. UA REACH aligns Ukraine’s chemical safety legislation with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) framework. It enforces strict requirements for the registration, classification, and safety management of chemical products in Ukraine. The regulation applies to all chemical substances manufactured, imported, or sold in Ukraine in quantities exceeding one tonne per year. The regulation ensures that companies properly assess and manage the risks associated with the production, use, and distribution of chemical products, thereby promoting the protection of human health and the environment.

Regulatory Authority

The Ministry of Economy, Environment and Agriculture of Ukraine (MEEA) is responsible for overseeing the enforcement of, and compliance with, the UA REACH Regulation. The Ministry is tasked with managing the registration process, evaluating compliance, and ensuring that chemical products meet the required safety standards. In addition, the Ministry has the authority to impose sanctions or corrective actions on companies that fail to meet regulatory requirements.

Mandatory Registration and Key Provisions

Under UA REACH, any company involved in the import, production, or sale of chemical substances in Ukraine must comply with the following provisions:

1. Mandatory Registration:
   • All chemicals in quantities of 1 tonne or more per year must be registered with the MEEA.
   • Companies must submit a technical dossier containing detailed information on the properties of the chemical substance, its intended use, and risk management measures.
   • Non-compliance with the registration requirement may result in administrative penalties or suspension of market access for the product.
2. Chemical Safety Report:
   • Companies that handle chemicals in quantities exceeding 10 tonnes per year are required to submit a Chemical Safety Report that evaluates the potential risks to human health and the environment.
   • The report must include hazard assessments, exposure scenarios, and safety measures for the entire life cycle of the chemical substance.
3. Hazardous Chemicals:
   • Substances classified as carcinogenic, mutagenic, or reprotoxic (CMR, Category 1A or 1B) in quantities above 1 tonne per year, and substances that are hazardous to the aquatic environment (chronic, Category 1) in quantities above 100 tonnes per year are subject to priority registration deadlines.
   • These substances must be registered earlier than general chemicals according to the staggered registration schedule set by UA REACH.
4. Pre-registration:
   • From 26 January 2025 to 26 January 2027, companies must pre-register existing chemical substances to benefit from transitional provisions.
   • Pre-registration should be submitted by completing the official Excel form and sending it to the designated MEEA email address.
   • Following the pre-registration period, a comprehensive list of existing chemical substances for which registrants have successfully pre-registered will be published on the official MEEA website by February 26, 2027, within one month of the pre-registration deadline.
   • Late pre-registration may apply to substances that are manufactured or imported for the first time after the pre-registration period but before the applicable registration deadline. This must be completed within six months of the first production or import of the substance.    
5. Registration Deadlines:

The deadlines for registration of chemicals are staggered according to the tonnage and properties of the chemical:

5. • • 1 October 2028: CMR substances (Category 1A and 1B) manufactured or imported in quantities above 1 tonne per year and substances hazardous to the aquatic environment (chronic, Category 1) manufactured or imported in quantities above 100 tonnes per year.  
     • 1 October 2029: Chemicals manufactured or imported in quantities of 1,000 tonnes or more per year,
     • 1 June 2031: Chemicals manufactured or imported in quantities between 100 and 1,000 tonnes per year.
     • 1 March 2033: Chemicals manufactured or imported in quantities between 1 and 100 tonnes per year.
6. Simplified registration:

• Substances registered under EU REACH are subject to simplified registration.

• To qualify for this procedure, the chemical must have an existing EU REACH registration and registrants must adhere to the joint data submission as outlined in the UA REACH framework.

Compliance Requirements and Categorization

To comply with UA REACH, companies must provide structured information about chemical substances and follow the required registration and risk assessment procedures. The main steps are:

1. Submission of Technical Dossier:
   • Companies must submit a technical dossier via the Ukrainian electronic system (e.g., EcoSystem).
   • The dossier should include:
     • The substance’s name according to IUPAC standards.
     • CAS number (if available).
     • Classification of the substance according to its hazard properties (physical, health, and environmental hazards) in line with UA CLP.
     • Key physicochemical, toxicological and ecotoxicological information necessary to assess the substance’s hazards and risks.
     • Information on uses and any restrictions on production or use.
2. Chemical Safety Reports:
   • The Chemical Safety Report (CSR) is mandatory for substances manufactured or imported in quantities of 10 tonnes or more per year.
   • The CSR must include:
     • Assessment of hazards and exposure throughout the substance’s life cycle (production, use, disposal)
     • Risk management and control measures.
     • Information on nanomaterials, if applicable.
     • Justification of the data used in hazard and risk assessment.

Concerned Bodies under UA REACH

The UA REACH Regulation applies to the following groups:

• Manufacturers and Importers: Companies that manufacture chemical substances in Ukraine or place them on the market through import are responsible for ensuring that applicable UA REACH registration obligations are properly fulfilled.  
• Only Representatives: Non-Ukrainian manufacturers may appoint a Ukrainian legal entity to act as an Only Representative (OR) and assume responsibility for registration and compliance processes. As a result, the related importers are relieved of registration obligations and operate as downstream users.

• Downstream Users (End Users): Businesses that use chemical substances in industrial or professional activities must follow applicable safety information, maintain internal documentation, and apply appropriate risk control measures, even though they are not responsible for submitting registrations.

Penalties and Enforcement

Non-compliance with UA REACH can result in penalties ranging from administrative fines to criminal sanctions, depending on the severity of the violation. Companies found to be in violation of registration requirements or safety standards may face market restrictions or revocation of their registration.

Conclusion

UA REACH represents a significant step towards aligning Ukraine's chemical safety standards with those of the EU. The regulation emphasizes safe handling, production and use of chemical substances to protect both public health and the environment. By ensuring compliance with these regulations, companies can continue to operate smoothly in the Ukrainian market while meeting global safety standards.

For more information or assistance with registration and compliance, please contact Global Product Compliance (GPC) at compliance@gpcregulatory.com or visit www.gpcregulatory.com.