Request a DemoOn July 23, 2024, the Cabinet of Ministers of Ukraine adopted the Resolution No. 847 On the Approval of the Technical Regulation on the Safety of Chemical Products, also known as Ukraine REACH. This Resolution shall take effect on January 26, 2025.
The Technical Regulation is modeled after Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (EU REACH). It establishes a comprehensive legal framework for chemical management in Ukraine, aimed at ensuring a high level of protection of human health and the environment.
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Ukraine REACH: Resolution No.847 On the Approval of the Technical Regulation on the Safety of Chemical Products On July 23, 2024, the Ukrainian government released Resolution No. 847 On Approval of the Technical Regulation on the safety of chemical products, which is modeled after EU REACH. This resolution shall take effect on January 23, 2025.
1. Application Scope
In general, Ukraine REACH applies to all chemicals that are produced, imported or placed on the market on the territory of Ukraine. It does not apply to:
radioactive materials;
those temporarily stored in custom zone for re-export or transit
non-isolated intermediates;
transportation of dangerous goods by air, sea, road, rail or inland waterways;
2. Registration
With a “no data, no market” principle similar to EU REACH, non-registered substances must not be manufactured, imported, placed on the market, or used on their own, in mixtures or in articles in Ukraine.
2.1 Registration scope
Registration shall apply to new and existing chemicals that meet any of the following conditions:
Substance on its own, manufacture/import ≥ 1 t/yr;
Substance in a mixture, manufacture/import ≥ 1 t/yr;
Substance intended to be released in an article (≥ 0.1% concentration) , manufacture/import ≥ 1 t/yr;
On-site isolated intermediate, manufacture ≥ 1 t/yr;
Monomer or other chemical substance as part of the polymer in an amount of 2% (by mass) or more and is chemically bound, manufacture/import ≥ 1 t/yr.
The registration is not applicable to the following:
medicinal products
veterinary medicine;
food products (including flavorings and food additives);
feed (including feed ingredients and additives);
chemicals listed in Annex IV that pose a minimal risk
chemicals listed in or meet the definitions of Annex V to this Technical Regulation;
registered substances exported from Ukraine and re-imported to Ukraine
registered substances recovered in the territory of Ukraine
polymer
For chemical substances used solely for scientific and research purposes, manufacturers or importers may apply for an exemption from the Ministry of Environment. The exemption shall be granted for a period of 5 years and can be extended for a maximum of 5 more years.
2.2 Only representative for foreign manufacturers
A foreign manufacturer that produces a chemical substance on its own, in a mixture or in an article that are imported into Ukraine, may appoint a natural or legal person resident of Ukraine as an authorized only representative, to fulfill the requirements for registration.
2.3 Pre-registration
Pre-registration is required for existing substances so that manufacturers and importers can benefit from the transitional regime and continue their chemical activities while preparing registration.
The pre-registration starts from January 26, 2025 and ends on January 26, 2026. The applicant shall submit the following information:
Chemical substance identifiers (name, molecular and structural formula, composition, etc.)
Manufacturer or importer identification and contact details
Expected registration deadline and annual tonnage band
Information on the QSAR and read-across in accordance with Clauses 1.3 and 1.5 of Annex XI
2.4 Registration timeline
After this Technical Regulation takes effect on January 26, 2025, new chemical substances must be registered before being manufactured or imported in Ukraine. For existing chemical substances that have not been pre-registered, certain registration deadlines are applied based on tonnage bands.
Here is a flow chart of registration timeline:
Note: existing substances with the following hazard classification in accordance with the Technical Regulations for Hazard Classification, Labeling and Packaging of Chemical Products must be registered before October 1, 2026:
Carcinogenicity, mutagenicity, andreproductive toxicity (CMR) category 1A or 1B that are manufactured or imported ≥1 t/yr
Hazardous to aquatic environment - chronic hazard, category 1 that are manufactured or imported ≥100 t/yr
2.5 Registration information
The registrant shall submit an application to the Ministry of Environment either on paper or online via the Action Portal (Порталу Дія), along with the following documents:
A technical dossier;
A chemical safety report if the registrant manufactures or imports a substance in quantities of 10 tonnes or more per year; and
information on the calculation of the registration size and payment
In particular, the technical dossier shall include the following information:
Identification and contact details of the manufacturer or importer
Chemical substance identifiers
Classification of the chemical substance
Information on the production and identified Uses
Safety use instructions
Scientific studies
Reliable research applications
Proposals for conducting new tests
Information on the levels of impact on humans and the environment
A request for confidentiality claim of the information
Ukraine REACH also offers a simplified registration procedure for the manufacture or import of chemical substances that have been previously registered under EU REACH.
The registrant shall submit an application to the Ministry of Environment either on paper or online via the Action Portal (Порталу Дія), along with the following documents:
A technical dossier
A chemical safety report
Confirmation from the applicant or his authorized representative in the EU (OR) through the REACH-IT system
2.6 Joint Registration
After the pre-registration process, if production/import of an identical chemical substance is engaged by different manufacturers or importers, they will need to jointly submit registration. A Substance Information Exchange Forum (SIEF) will be established and a lead registrant will be selected on behalf of other co-registrants to provide core registration data. Co-registrant reserves the option to separately submit registration and shall include the explaination in the technical dossier. The joint registration shall be completed by their applicable deadlines.
3. Evaluation
The Ministry of Environment is responsible for developing prioritization criteria for the further evaluation of chemical substances using a risk-oriented approach. This will take into account the hazard information, exposure information and annual tonnage of each substance.
The Ministry of Environment conducts assessment of chemical substances based on its approved plan, and may request additional information from registrants within a specified timeframe. Upon completing the chemical assessment, the Ministry shall decide how to use the information in the authorization or restriction processes related to the production, import or supply of chemicals on the market.
4. Restriction
The restrictions established under Ukraine REACH are detailed in Annex XVII of this Technical Regulation. The Annex includes a list of 78 chemicals whose production, use or supply on the market is restricted for certain conditions or banned.
The restrictions apply to substances on its own, in a mixture or in an article, and do not apply to any on-site intermediates.
5. Authorization
5.1 Candidate List
The first step in the Authorization process under Ukraine REACH involves the identification of a Candidate List of especially hazardous chemical substances. This process is similar to the identification of substance of very high concern (SVHC) under EU REACH. The criteria for classifying chemical substances as especially hazardous are shown below:
Carcinogenicity, Mutagenicity, Reproductive toxicity(CMR) category 1A and 1B
Persistent, bioaccumulative and toxic (PBT), and very persistent and very bioaccumulative (vPvB)
Endocrine disruptors (ED)
The identification process includes a 60-day public consultation period, after which the Ministry of Environment will make a decision and publish the Candidate List on its official website.
5.2 Authorization List
Ukraine REACH maintains an Authorization List of 59 especially hazardous chemicals that are removed from the market under Annex XIV to this Technical Regulation, with the application date (April 1, 2027) and sunset date (June 1, 2027).
Manufacturers, importers who wish to continue placing these substances on the market and/or using them after their sunset date can apply to the Ministry of Environment for an authorisation for specific use(s) of the substances. They are also required to provide safety data sheet (SDS) for the listed substances and communicate safety information upon consumer request.
6. Toxic Chemical Permit
Ukraine REACH also formulates a list of toxic chemicals that is classified according to the following criteria:
Acute toxicity category 1, 2 and 3
Specific target organ toxicity (STOT) category 1 and 2
Persistent, bioaccumulative and toxic (PBT), and very persistent and very bioaccumulative (vPvB)
Endocrine disruptors (ED)
In pursuant to Article 49 of Law of Ukraine on Ensuring Chemical Safety and Management of Chemical Products, any economic entity that produces or uses toxic chemicals must obtain a permit for the use of a toxic chemical substance.
A permit is issued only for one chemical substance and/or groupds of chemical substances. To apply for a toxic chemical permit, an applicant should provide the basic information about the chemical substance (name, CAS number, concentration of main components, impurities, etc.), specified types of use, safety report, implementation of risk control measures, liability insurance, calculation of the payment amount and procedure. The permit shall stay valid for 3 years.