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 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.