Oct-24-2023 Biocides EU REACH Ukraine BPR
On 2 October 2023, the Ministry of Health of Ukraine published a draft Law ‘On the supply and use of biocidal products on the market’. The draft law was notified to the World Trade Organization (W...
Read More
On 2 October 2023, the Ministry of Health of Ukraine published a draft Law ‘On the supply and use of biocidal products on the market’. The draft law was notified to the World Trade Organization (WTO) on 12 October 2023. The WTO is accepting comments until 11 December 2023.
The draft Law has been developed with the aim of implementing the Regulation of the European Union No. 528/2012 of the European Parliament and the Council of 22 May 2012, regarding the supply and use of biocidal products on the market (BPR Regulation) in the Ukraine. It aims to regulate the placing on the market and use of biocidal products while ensuring a high level of protection of human and animal health and the environment against harmful organisms, such as pests or bacteria, and against the effects of active substances contained in biocidal products.
Provisions of the Draft Law
The Draft Law provides for the regulation of legal relations in relation to:
Approval of active substances of biocidal products.
Obtaining authorisation to place biocidal products on the market.
Production, trade, and safe use of biocidal products for human, animal and environmental health.
Placing treated articles on the market.
Defining the rights and obligations of companies, organisations, and individuals.
Defining the powers of government bodies and officials in this area.
In order to ensure a high level of protection for human health, animal welfare, and the environment, active substances with the worst hazard profiles will not be authorise for use in biocidal products unless they qualify for a derogation. Possible reasons for a derogation are:
Low risk of exposure to the substance
Disproportionate adverse effects in case of non-approval
Disproportionate negative impact on society in case of non-approval
When deciding on the approval of such active substances, the availability of suitable and sufficient alternative substances or technologies will also be considered.
The Draft Law will not apply to the following areas:
Medicinal feeds
Medical devices
Medicinal products and veterinary drugs
Feed and feed additives for animals
Food hygiene products
Food additives
Food flavorings and ingredients with flavoring properties intended for use in and on food products.
Phytosanitary products
Plant protection products
Cosmetic products
Timeline
The law will enter into force the day after its publication and will be enacted after 12 months. The proposed date of adoption has not yet been set.
The full text of the draft law in Ukrainian can be found here.
Read LessOn 20 September, the Ministry of Environmental Protection and Natural Resources of Ukraine notified the draft Technical Regulation on the Safety of Chemical Products to the World Trade Organisation (W...
Read More
On 20 September, the Ministry of Environmental Protection and Natural Resources of Ukraine notified the draft Technical Regulation on the Safety of Chemical Products to the World Trade Organisation (WTO). This notification signals Ukraine's commitment to aligning its regulatory framework with international practices.
This draft regulation draws inspiration from and seeks to incorporate most of the provisions found in Regulation (EC) No 1907/2006 of the European Parliament and of the Council of December 2006, concerning the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). By doing so, Ukraine aims to harmonize its standards with those of the European Union.
Stakeholders and interested parties now have a 60-day window, starting from the date of notification, to provide their input on this proposed regulation, contributing to the shaping of Ukraine's chemical safety landscape.
Content of the technical regulation
The regulations introduced outline the procedures for:
Government registration of chemical substances before they are placed on the market, requiring companies to assess the intrinsic hazardous properties of substances through testing and to carry out chemical safety assessments (10 tonnes/year and above) using a risk-based approach.
Data sharing to avoid unnecessary testing by companies in the course of government registration of substances, which should be common only for identical substances.
In-depth evaluation of chemicals by authorised central executive authorities.
Provision of safety information by suppliers in the form of safety data sheets (including exposure scenarios where developed) down the supply chain.
Identification of particularly hazardous substances in line with the EU's Substances of Very High Concern (SVHCs) and Toxic Substances (Acute Toxic and Specific Target Organ Toxicity (STOT)) and compilation of relevant lists.
Imposing restrictions on the manufacture, placing on the market and use of certain chemical products that pose an uncontrolled risk to human health and/or the environment.
Purpose of the technical regulation
The purpose of the draft Technical Regulation is to implement the framework provisions of the Ukrainian Law on Ensuring Chemical Safety, Security and Management of Chemical Products, which entered into force on 29 December 2022 and will be applicable from 29 June 2024.
It aims to ensure a high level of protection of human health and the environment, the free movement of chemical products on the internal market, the promotion of the use of alternative methods for assessing the hazards of chemical products and the promotion of innovation while increasing competitiveness, and to define the basic requirements for ensuring chemical safety in the manufacture, placing on the market and use of chemical products by economic operators.
Timeline
The date of adoption of the technical regulation has not yet been set. It will enter into force 3 months after its publication.
Read LessGlobal Product Compliance (GPC) specializes in Global Regulatory Compliance Solutions across sectors
globally. SSS Europe, a familiar name in chemical regulatory and compliance services now formally belongs
under the umbrella of GPC Holding Sweden.
Since 2008, we have emerged as one of the leading names among Global Regulatory Compliance Service
Providers with Representation services in Europe, Asia and Middle East for respective chemical
regulations.
© Copyright 2025 | Global Product Compliance