Ukraine publishes draft law on biocidal products

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.