Ukraine Notifies WTO of Draft Law on Biocidal Products Regulation

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.