Chemical substances
- Document symbol
- G/LIC/N/3/UKR/18
- Original language
- English
- Published on
- 19/09/2025
Outline of Systems
Q1. Give a brief description of each licensing system as a whole and, with respect to each, reply to the following questions as relevant, placing all of the material with respect to a given system in sequence together, and using cross references as appropriate when elements which have already been described are also present in another system.
A chemical substance being imported is subject to mandatory state registration. State registration of chemical substances is carried out by the Ministry of Economy, Environment and Agriculture of Ukraine in accordance with the procedure established by the Cabinet of Ministers of Ukraine.
Purposes and Coverage of Licensing
Q2. Identify each licensing system maintained and state what products, appropriately grouped, are covered.
State registration of chemical substances is a mandatory requirement for the import of any chemical substance. The basis for conducting state registration is the annual total quantity of the substance placed on the market by a business entity, or the chemical product, which equals or exceeds 1 tonne per year. Chemical substances that have not undergone the identification procedure in accordance with Article 37 of the Law of Ukraine No. 2804-IX “On Ensuring Chemical Safety and Management of Chemical Products” of 1 December 2022, shall not be admitted for state registration.
Q3. The system applies to goods originating in and coming from which countries?
All countries.
Q4. Is the licensing intended to restrict the quantity or value of imports, and if not, what are its purposes? Have alternative methods of accomplishing the purposes been considered and if so which? Why have they not been adopted?
The system is not intended to restrict the quantity or value of imported goods. Its purpose is to establish a Unified State Register of Chemical Substances to systematize information on chemical substances that are imported or placed on the market, to monitor their circulation and to ensure the protection of human health and the environment from the harmful effects of these substances.
Q5. Cite the law, regulation and/or administrative order under which the licensing is maintained. Is the licensing statutorily required? Does the legislation leave designation of products to be subjected to licensing to administrative discretion? Is it possible for the government (or the executive branch) to abolish the system without legislative approval?
The Law of Ukraine No. 2804-IX "On Ensuring Chemical Safety and Management of Chemical Products" of 1 December 2022, available at https://zakon.rada.gov.ua/laws/show/2804-20#Text;
the Resolution of the Cabinet of Ministers of Ukraine No. 946 “On Approval of the Procedure for Maintaining the State Register of Chemical Substances” of 20 August 2024, available at https://zakon.rada.gov.ua/laws/show/946-2024-%D0%BF#Text;
This system cannot be abolished without legislative approval.
Procedures
Q6. For products under restriction as to the quantity or value of imports (whether applicable globally or to a limited number of countries or whether established bilaterally or unilaterally):
Q6.I. Is information published, and where, concerning allocation of quotas and formalities of filing applications for licences? If not, how is it brought to the attention of possible importers? Of governments and export promotion bodies of exporting countries and their trade representatives? Is the overall amount published? The amount allocated to goods from each country? The maximum amount allocated to each importer? How to request any exceptions or derogations from the licensing requirement?
Q6.II. How is the size of the quotas determined: on a yearly, six-monthly or quarterly basis? Are there cases where the size of quota is determined on a yearly basis but licences are issued for imports on a six-monthly or quarterly basis? In the latter case, is it necessary for importers to apply for fresh licence on a six-monthly or quarterly basis?
Q6.III. Are licences allotted for certain goods partly or only to domestic producers of like goods? What steps are taken to ensure that licences allocated are actually used for imports? Are unused allocations added to quotas for a succeeding period? Are the names of importers to whom licences have been allocated made known to governments and export promotion bodies of exporting countries upon request? If not, for what reason? (Indicate products to which replies relate.)
Q6.IV. From the time of announcing the opening of quotas, as indicated in I above, what is the period of time allowed for the submission of applications for licences?
Q6.V. What are the minimum and maximum lengths of time for processing applications?
Q6.VI. How much time remains, at a minimum, between the granting of licences and the date of opening of the period of importation?
Q6.VII. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
Q6.VIII. If the demand for licences cannot be fully satisfied, on what basis is the allocation to applicants made? First come, first served? Past performance? Is there a maximum amount to be allocated per applicant and, if so, on what basis is it determined? What provision is made for new importers? Are applications examined simultaneously or on receipt?
Q6.IX. In the case of bilateral quotas or export restraint arrangements where export permits are issued by exporting countries, are import licences also required? If so, are licences issued automatically?
Q6.X. In cases where imports are allowed on the basis of export permits only, how is the importing country informed of the effect given by the exporting countries to the understanding between the two countries?
Q6.XI. Are there products for which licences are issued on condition that goods should be exported and not sold in the domestic market?
Q7. Where there is no quantitative limit on importation of a product or on imports from a particular country:
The decision on state registration of a chemical substance or the refusal to register it shall be issued within 30 calendar days from the date the Ministry of Economy, Environment and Agriculture receives the application for state registration and the accompanying documents.
Q7.a. How far in advance of importation must application for a licence be made? Can licences be obtained within a shorter time-limit or for goods arriving at the port without a licence (for example, owing to inadvertency)?
No.
Q7.b. Can a licence be granted immediately on request?
No.
Q7.c. Are there any limitations as to the period of the year during which application for licence and/or importation may be made? If so, explain.
No. An application can be submitted at any time of the year.
Q7.d. Is consideration of licence applications effected by a single administrative organ? Or must the application be passed on to other organs for visa, note or approval? If so, which? Does the importer have to approach more than one administrative organ?
To undergo state registration procedure for a chemical substance, a business entity shall submit an application for state registration to the Ministry of Economy, Environment and Agriculture.
The application may be submitted either in printed form or electronically via the Unified State Web Portal of Electronic Services, including through information systems of state authorities and local self-government bodies integrated with the portal, as well as through the Chemical Safety Information System.
Q8. Under what circumstances may an application for a licence be refused other than failure to meet the ordinary criteria? Are the reasons for any refusal given to the applicant? Have applicants a right of appeal in the event of refusal to issue a licence and, if so, to what bodies and under what procedures?
The grounds for refusal of state registration of a chemical substance are as follows:
1) the submission of incomplete documents that are required to accompany the application for state registration of a chemical substance;
2) inconsistency of the results of analytical studies conducted to identify the chemical substance with the information about the chemical substance provided with the application for state registration, or if such analytical studies were conducted using invalid methods that differ from the methods specified in Article 37 of Law No. 2804-IX.
The decision to refuse state registration shall be provided to the applicant exclusively in electronic form.
The decision on refusal may be appealed to the district administrative court in accordance with the provisions of the Code of Administrative Proceedings of Ukraine.
Eligibility of Importers to Apply for Licence
Q9. Are all persons, firms and institutions eligible to apply for licences: (If not, is there a system of registration of persons or firms permitted to engage in importation? What persons or firms are eligible? Is there a registration fee? Is there a published list of authorized importers?) a) under restrictive licensing systems? b) under non-restrictive systems?
The application may be submitted by a person authorised by the business entity.
Documentational and Other Requirements for Application for Licence
Q10. What information is required in applications? Submit a sample form. What documents is the importer required to supply with the application?
The application for state registration of a chemical substance shall be accompanied by:
1) information on the chemical substance:
a) the name of the chemical substance in accordance with IUPAC nomenclature;
b) other names of the chemical substance (trivial names, trade names, abbreviations);
c) the registration number assigned by the Chemical Abstracts Service (CAS number) (if available);
d) other identifiers of the chemical substance (if available);
e) the chemical and structural formulas of the chemical substance (including a simplified molecular-input line-entry system specification, if available);
f) information on the optical activity and typical ratio (stereo)isomers of the chemical substance (if available and applicable);
g) the molecular weight or molecular weight range of the chemical substance;
h) the degree of purity of the chemical substance (concentration of the main component or main components in percent);
i) identifiers of impurities, including isomers and by-products;
j) the concentration of main impurities in percent;
k) identifiers and concentrations of additives, listed in descending order (in parts per million or in percent) (e.g., stabilizing or inhibitory agents);
l) results of analytical studies conducted for the purpose of identifying the chemical substance in accordance with Article 37 of Law No 2804-IX;
2) information on the specified types of use of the chemical substance or chemical products for which the application for state registration is submitted;
3) data on the hazard classification of the chemical substance in accordance with Article 35 of Law No 2804-IX;
4) a summary of studies on the hazardous properties of the chemical substance, including a description of the objectives, methods, results and conclusions of such studies;
5) instructions for the safe use of the chemical substance;
6) a chemical safety report resulting from the chemical safety assessment carried out in accordance with Article 25 of Law No 2804-IX, or information on the levels of impact of the chemical substance on human health and/or the environment where a chemical safety assessment is not required;
7) proposals for conducting new tests on the chemical substance, if the results of new tests are necessary for the chemical safety assessment;
8) a request for the protection of confidential information submitted in the application for state registration of the chemical substance;
9) documentary confirmation of the registration of the chemical substance within the relevant mass quantity range for placing the chemical substance on the market of the European Union (if available);
10) information on the calculation and payment of the fee for state registration of the chemical substance.
The forms of documents to be attached to the application for state registration of a chemical substance shall be established by the Ministry of Economy, Environment and Agriculture.
In the case of submitting an application for state registration of an identical chemical substance, a business entity may refer to relevant documents previously submitted by other business entities, provided that they have officially authorized such references.
In the case of submitting an application for state registration of an identical chemical substance, business entities shall jointly submit the information specified in points 3, 4, 6, and 7 above.
The rules for the joint submission of information in applications for state registration of identical chemical substances shall be determined by the Cabinet of Ministers of Ukraine.
If any information specified in the documents attached to the application for state registration changes, business entities shall submit updated information to the Ministry of Economy, Environment and Agriculture, taking into account the rules for joint submission of information for identical chemical substances.
After a decision on state registration of a chemical substance has been made, the Ministry of Economy, Environment and Agriculture shall enter the relevant data into the State Register of Chemical Substances.
The Ministry of Economy, Environment and Agriculture shall also enter information on state registration of a chemical substance into the Unified State Information Web Portal “Single Window for International Trade” in the form of an electronic document certified by an electronic signature, on the day of its registration.
Q11. What documents are required upon actual importation?
At the time of actual importation, information on state registration of chemical substances is required along with other necessary customs documents.
Q12. Is there any licensing fee or administrative charge? If so, what is the amount of the fee or charge?
A fee is charged for state registration of a chemical substance. The basic fee rate for state registration of a chemical substance is the amount of the subsistence minimum for able-bodied persons effective on the day of submission of the application for state registration of a chemical substance.
The amount of the fee is determined taking into account the following coefficients:
1) the mass quantity of a chemical substance that the applicant places on the market or intends to place on the market;
2) individual or joint submission of information attached to the application;
3) affiliation of the applicant to certain categories of economic entities (small, medium or micro-enterprises);
4) type of state registration procedure of a chemical substance.
To calculate the fee, the following coefficient values are set:
1) the mass quantity of a chemical substance that the applicant places on the market:
from 1 to 10 tons per year - 2.5
from 10 to 100 tons per year - 5
from 100 to 1000 tons per year - 25
1000 tons per year or more - 50
2) method of submitting information attached to the application:
individual submission - 2
joint submission - 1
3) type of state registration procedure of a chemical substance:
state registration of a chemical substance - 2
state registration of an intermediate chemical substance - 0.5
state registration of a chemical substance already registered in the European Union - 0.5
4) affiliation of the applicant to certain categories of economic entities:
business entity classified as a micro-enterprise - 0.25
business entity classified as a small enterprise - 0.5
business entity classified as a medium-sized enterprise - 0.75
business entity classified as a large enterprise - 1.
The amount of the fee is calculated by multiplying the basic fee rate by the corresponding coefficient.
Q13. Is there any deposit or advance payment requirement associated with the issue of licences? If so, state the amount or rate, whether it is refundable, the period of retention and the purpose of the requirement.
No deposit or advance payment is required to obtain the decision.
Conditions of Licensing
Q14. What is the period of validity of a licence? Can the validity of a licence be extended? How?
The decision on state registration of a chemical substance is valid indefinitely.
Q15. Is there any penalty for the non-utilization of a licence or a portion of a licence?
No.
Q16. Are licences transferable between importers? If so, are any limitations or conditions attached to such transfer?
Decisions are not transferable between importers. Business entities that are subsequent participants in the supply chain of a chemical substance or chemical product are not required to undergo state registration procedure, provided that a preceding participant in the supply chain has already completed state registration for that substance, taking into account the annual total quantity of the substance used by the subsequent entity.
Q17. Are any other conditions attached to the issue of a licence? a) for products subject to quantitative restriction? b) for products not subject to quantitative restriction?
Availability of a decision on state registration of chemical substances.
Other Procedural Requirements
Q18. Are there any other administrative procedures, apart from import licensing and similar administrative procedures, required prior to importation?
Prior to import chemical products, the importer shall:
1) identify the chemical substances being imported and placed on the market;
2) classify the hazards of the imported chemical products and develop hazard information where the chemical products are classified as hazardous;
3) conduct a safety assessment of the imported chemical substances, including those contained in chemical products, where the individual quantity is 10 tons or more per year;
4) identify the intended uses of the chemical products that are imported and placed on the market;
5) undergo the state registration of chemical substances that are imported in individual quantities of 1 ton or more per year;
6) obtain an authorization for the use of a toxic chemical substance if it is imported and placed on the market;
7) obtain an authorization for the use of a particularly hazardous chemical substance being withdrawn from the market if the importer intends to continue placing such a chemical substance (or group of chemical substances) on the market after the start of its withdrawal, and to ensure its use by consumers for a certain period;
8) register a notification on the use of an alternative name of a chemical substance in cases provided for by law;
9) provide the consumer of chemical products with a safety data sheet or instructions for safe use;
10) obtain from the manufacturer of a chemical product a safety data sheet or instructions for safe use and provide them to the consumer of the chemical product;
11) ensure compliance with the requirements set out in Article 30 of the Law No. 2804-IX in case of import or use of dual-use chemical substances in quantities exceeding the established limits.
A foreign manufacturer of a chemical product may fulfil the above requirements applicable to importers by appointing an authorized representative who is a legal entity in Ukraine and providing the importer with all information regarding compliance with these requirements, as well as the safety data sheet or instructions for safe use.
In such a case, the importer of chemical products of such foreign manufacturer is exempt from fulfilling the above requirements, provided that consumers are supplied with the safety data sheet or instructions for safe use along with information on the state registration of chemical substances and obtained authorizations.