Ukraine Reach Regulation for Various Sectors

Summary of UA-REACH

On July 23, 2024, the Ukrainian government officially adopted the Technical Regulation on the Safety of Chemical Products, commonly referred to as UA-REACH. This regulation aligns Ukraine’s chemical safety legislation with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) framework. This regulation enforces strict requirements for the registration, classification, and safety management of chemical products in Ukraine. It 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.

Who is the Regulatory Authority?

The Ministry of Environmental Protection and Natural Resources of Ukraine 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 one tonne or more per year must be registered with the Ministry of Environmental Protection.

   • 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 that are classified as carcinogenic, mutagenic, or reprotoxic (CMRs) or that pose a significant risk to aquatic life, must undergo a stricter registration and assessment process.

   • Deadlines for registration of hazardous substances are staggered according to the tonnage and properties of the chemical:

     • By October 2026: For chemicals produced or imported in quantities of 1,000 tonnes or more per year, CMR substances (Category 1A and 1B) over 1 tonne per year and toxic effects to aquatic organisms (acute or chronic) over 100 tonnes per year.

     • By June 2028: For chemicals between 100 and 1,000 tonnes per year.

     • By March 2030: For chemicals between 1 and 100 tonnes per year.

Compliance Requirements and Categorization

To comply with UA-REACH, companies must follow a structured procedure for classifying and categorizing chemicals. The key steps include:

1. Submission of Technical Dossier:

   • Companies must submit a technical dossier through the DIIA Portal, which provides an electronic means for documentation.

   • The dossier must contain the following:

     • The name of the chemical substance as classified according to the International Union of Pure and Applied Chemistry (IUPAC).

     • CAS number (if available).

     • Detailed information on any restrictions on production or use.

2. Chemical Safety Reports:

   • The Chemical Safety Report (CSR) is mandatory for higher-risk chemicals and requires companies to outline hazard control measures and identify potential risks during production, use, and disposal.

   • The CSR must detail the properties of nanomaterials if applicable, and justify the information used in the hazard assessment.

Who Needs to Comply?

The UA-REACH Regulation applies to the following groups:

• Manufacturers and Importers: Any entity that manufactures or imports chemical substances into Ukraine must register its chemicals with the appropriate authorities.

• Authorized Representatives (OR): Non-Ukrainian companies must appoint a Ukrainian legal entity or authorized representative to handle the registration and compliance processes.

• End Users: Companies that use chemicals in their industrial processes are also required to comply with UA-REACH, especially with regard to record keeping and safety assessments.

Penalties and Enforcement

Non-compliance with UA-REACH can result in a range of penalties, 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 places strong emphasis on the 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.