A draft law on the placing on the market and use of biocidal products has been registered in the Verkhovna Rada of Ukraine
07 August 2025, 14:31
On 7 August 2025, the Verkhovna Rada of Ukraine registered Draft Law of Ukraine No. 13604 “On the Placing on the Market and Use of Biocidal Products,” submitted by the Cabinet of Ministers of Ukraine.
The purpose of this draft law is to harmonize European rules governing the placing on the market and use of biocidal products and treated articles, while ensuring a high level of protection for human and animal health, as well as the environment, from harmful organisms such as pests and bacteria, as well as from the effects of active substances contained in biocidal products.
The draft law was developed with the aim of implementing Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products.
Among other provisions, the draft law proposes to:
Regulate legal relations related to the approval of active substances in biocidal products, state registration, production, placing on the market, making available, and safe use of biocidal products and treated articles for human and animal health and the environment. It also aims to define the rights and obligations of enterprises, institutions, organizations, and individuals involved in these processes;
Introduce the definition of an “authorized body” — a state-owned enterprise (institution or organization) empowered by the central executive authority responsible for health policy to conduct expert reviews of materials related to the approval, renewal, or review of active substances. This body would prepare expert conclusions recommending approval or refusal of approval, as well as assess eligibility for simplified registration of biocidal products, and perform other assigned functions;
Stipulate that services related to the approval of active substances and state registration of biocidal products will be provided on a paid basis. The service fee would be calculated based on the subsistence minimum for able-bodied persons (or the minimum wage) established on the date of payment;
Establish that laboratory testing of active substances for dossier preparation may be conducted by legal entities — regardless of their organizational and legal form — that are accredited in accordance with the standards DSTU EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017, IDT) and/or DSTU EN ISO 15189:2015, by the National Accreditation Body of Ukraine, or by a foreign accreditation body that is a full member of ILAC (International Laboratory Accreditation Cooperation), or accredited under OECD Good Laboratory Practice (GLP), or by another foreign accreditation body compliant with DSTU EN ISO/IEC 17011:2017 (EN ISO/IEC 17011:2017, IDT; ISO/IEC 17011:2017, IDT);
Provide for the establishment of the State Register of Biocidal Products, which is set to become operational from 1 January 2030, and the transformation (through modernization) of the existing State Register of Disinfectants into the State Register of Biocidal Products.