Ukraine Regulatory News

 On 2 February 2024, the Ministry of Health of Ukraine notified the World Trade Organization (WTO) that Order No 2104 ‘On Approval of Special Requirements for Plastic Materials and Articles Intende...

 On 2 February 2024, the Ministry of Health of Ukraine notified the World Trade Organization (WTO) that Order No 2104 ‘On Approval of Special Requirements for Plastic Materials and Articles Intended to Come into Contact with Foodstuffs’ was adopted on 11 December 2023 and will enter into force on 19 November 2025. At the same date the Law of Ukraine No 2718 - IX "On Materials and Articles Intended to Come into Contact with Food" of 3 November 2022 will come into force.

Order No 2104

The purpose of Order No 2104 is to validate specific requirements for plastics intended to come into contact with food by incorporating the provisions of European Union Regulation (EU) 10/2011 (on plastic materials and articles intended to come into contact with food). Key points of the Order include:

• Defining the scope of food contact plastics

• Specifying that ion exchange resins, rubber, silicones, printing inks, adhesives, and varnishes/coatings are exempted.

• Outlining the compositional requirements for food contact plastics including the use of authorised monomers, starting substances, macromolecules from microbial fermentation (listed in Appendix 1) or substances included in the State Register for the manufacture of food contact plastics.

• Establishing general requirements, restrictions, and technical specifications, such as specific migration limits (SML), overall migration limits (OML), and limits for primary aromatic amines (PAA)

• Providing regulations for plastic multi-layer materials and articles, as well as multi-material multi-layer materials and articles.

The Order provides that plastic materials and articles intended to come into contact with food and manufactured before the entry into force of the Order, may be in circulation until their expiry date.

The full text of the Order (in Ukrainian) can be found here.

Law No 2718

Ukraine introduced Law No. 2718-IX of 3 November 2022, 'On Materials and Articles Intended to Come into Contact with Food,' effective from 20 November 2022, with key provisions applicable from19  November 2025. This law incorporates elements from EU regulations on materials and articles intended to come into contact with food and includes the following:

Section I - General provisions:

• Scope: Covers food contact materials (FCMs) and articles.

• Exemptions: Antiques, protective coatings, fixed water supply equipment.

• Defines: Terms, powers of government agencies.

Section II - Requirements for materials and articles:

• Compliance: FCM must comply with Good Manufacturing Practice (GMP).

• Safety Requirements: General safety, non-deceptive labelling.

• Special Requirements: 18 FCM groups may have specific criteria.

• Recycled Plastics: Allowed if obtained through a state-registered process.

Section III - State registration of articles:

• Outlines requirements and procedures for state registration.

Section IV - Marking, declaration of conformity and ensuring traceability of materials and items:

• Labelling: Information for materials not yet in contact with food.

• Active and Intelligent Materials: Special labelling requirements.

• Declaration of Conformity: For materials with special requirements.

• Traceability: Ensures traceability at all stages for control and recall.

Section V - Good manufacturing practices:

• Details: GMP requirements, quality assurance, and control systems.

Section VI - State control and responsibility:

• Defines: Powers granted to government agencies.

The full text of Law No. 2718-IX of 3 November 2022, can be found here.   

On 19 October 2023, the Ministry of Health of Ukraine introduced an important draft law aimed at regulating and supervising the state registration of hazardous factors, with a particular focus on chem...

On 19 October 2023, the Ministry of Health of Ukraine introduced an important draft law aimed at regulating and supervising the state registration of hazardous factors, with a particular focus on chemical and biological elements. The draft law, entitled the “On Approval of the Procedure for State Registration of Hazardous Factors”, outlines a comprehensive procedure for the state registration of these potentially harmful elements. The draft law was notified to the World Trade Organization (WTO) on 3 November 2023. The WTO is accepting comments for 60 days from the date of notification.

Details of the draft law

The main focus of the draft law is to establish a structured process for the state registration of chemical and biological hazardous factors. All individual chemicals, substances of biological origin as well as those present in mixed products are subject to registration. This is the case regardless of whether the substances are produced, used within Ukraine's borders, or imported into the country. The full text can be found here in Ukrainian.

Scope of registration: All individual chemical and biological hazardous factors, either as single substances or as part of mixed products, are subject to state registration in Ukraine. A hazardous factor that is part of a product or mixed product is subject to registration under the following conditions:

• Intentional release during use of the product or mixed product

• The concentration of the hazardous factor that is part of the product or mixed product is 0.1 % or more

• Impurities formed during the process of production or use of a substance are registered as individual substances.

Application and registration procedure: Applications for state registration of a hazardous factor may be submitted to the Ministry of Health, either in writing or electronically. In addition, if several manufacturers and importers are involved in the production or import of a particular hazardous factor, a joint application for registration is required.

Confirmation of registration: The registration of a hazardous factor is confirmed when the registration is recorded in the State Register of Hazardous Factors. Subsequently, the Ministry of Health issues a certificate confirming the registration.

State Register of Hazardous Factors: The following information on the substances is entered into the State Register:

• Name of the substance

• Source of origin (production

• Data on the purpose of the substance

• Characteristics of the biological action of the substance

• Hazard class

• Nature of action of the substance in the environment

• Methods of indication

• State medical and health standards established for the substance

• State medical and health rules for use (if necessary)

Hazard classification: The hazard classification of chemicals and chemical products follows the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). The procedure for classification and labelling of chemicals and chemical products is established by the technical regulations approved by the Cabinet of Ministers of Ukraine.

Timeline: The proposed date of entry into force is 1 January 2024.

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...

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.

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 (W...

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.