The degree of harmonization of the national legal framework with EU

Regulation and registration of chemicals
Ukraine has a special system of hygienic regulation and registration of chemicals, the object of which is not chemical substances according to the generally accepted definition, but dangerous chemical factors (DF).
The main legislative documents regulating the procedure of regulation and registration of dangerous factors are:

  • Regulation on hygienic reglanentation and state registration of dangerous factors (approved by the CMU Resolution of June 13, 1995 N 420)
  • About improvement of activity in the sphere of the state registration of dangerous factors and maintenance of the State register of dangerous factors (the Resolution of the Ministry of Health, the State sanitary-and-epidemiological service, the Chief State Sanitary doctor of Ukraine from 15.08.2002 No. 32)

The current regulation of the DFs is based on hygienic reglamentation, which is the development of scientifically sound hygienic normatives (reglaments) on the basis of modern data that ensure safety and (or) absence of hazard of DFs from surrounding (including industrial) environment, compliance with which provides optimal or acceptable living conditions.

Hygienic reglamentation precedes the state registration of DF and stipulate that hygienic normatives shall be established before the registration for DF, namely - the maximum allowable concentrations in various objects of environment (air, water, soil, food, materials in contact with food, air of the working area, etc.), depending on the use of dangerous factors.

Hygienic regulation of dangerous factors is provided by the Committee on Hygienic Reglamentation of the Ministry of Health of Ukraine.
All individual chemical and biological substances (compounds) for which a hygienic normative has been established are subject to registration, including polymers and materials based on them, as well as part of mixtures that are produced and (or) used in Ukraine or imported from abroad. Substances that contain impurities formed during production or use are registered as individual substances.

Dangerous factors are identified according to the principle of the established hygienic normative and the established value of the maximum permissible concentration in the air of the working area (MPC) ≤ 10 mg/kg, which corresponds to 1-3 hazard classes according to the standard for classification of hazardous substances GOST 12.1.007-76 “SSBT. Hazardous substances. Classification and general requirements ». (canceled)
Data about the state register of dangerous factors are posted on the website of the Committee for Hygienic Regulation of the Ministry of Health of Ukraine. The list of DFs contains 1873 dangerous factors as of the end of 2015, which does not reflect the actual amount of chemicals on the Ukrainian market.

According to the Law of Ukraine "On Ensuring Sanitary and Epidemic Welfare of the Population" (4004-XII), Article 9 and the resolution of the Cabinet of Ministers of Ukraine of 13.06.95 N 420 (420-95-n) the state registration of the dangerous factor is obligatory for hazardous chemical substances (and also biological substances) and is active for a period of 5 years, but there is a variant for temporary registration for 1 year period.
State registration of DFs is not harmonized with global approaches (including the European REACH Regulation) concerning the registration, inventorization, and maintenance of chemical registers.

Stewardship of chemical products
Resolution of the Chief State Sanitary Doctor of Ukraine of May 20, 2002 No. 19 approved the Dangerous factor sheet as a mandatory accompanying document for individual chemical and biological substances, including polymers and materials based on them, as well as part of mixed products which are produced and/or used on the territory of Ukraine, as well as goods imported from abroad.
The dangerous factor sheet is provided to the customer of state registration of a specific substance together with the certificate of state registration of dangeropus factor and is an official document confirming the fact of state registration of hazardous factor together with the relevant certificate.
In terms of content and structure, the dangerous factor sheet is an obsolete form of safety data sheet (according to Directive 91/155 / EEC), issued only for DFs and developed by the Committee on Hygienic Reglamentation. It is not harmonized with the GHS and the REACH Regulation.

Hazard classification and precautionary labeling
The globally harmonizes classification and labeling system for chemicals (GHS) has not been implemented in Ukraine. Currently, Ukraine has adopted several acts which implemented certain provisions of the GHS without systematic and full implementation of this document.
There are some legal documents based on the GHS system:

  • DSTU GOST 31340: 2009 "Precautionary labeling of chemical products. General requirements ", which is mandatory under certain conditions (transportation, export).
  • DSTU GOST 30333: 2009 "Safety data sheet of chemical product. General Requirements ”which is voluntary to comply with.

It should also be mentioned that in Ukraine there is no national standard that establishes the criteria for classification of chemicals, which would be harmonized with the GHS system, and those classification criteria presented in DSTU GOST 31340: 2009 are insufficient for qualitative hazard classification.
Threre are three one current main normative document that regulate the principles and norms of classification of hazardous chemicals, namely:

  • GOST 12.1.007-76 "Hazardous substances. Classification and general safety requirements"; (cancelled)
  • GOST 12.0.003-74 "Dangerous and harmful production factors. Classification »; (cancelled)
  • DSTU 4500: 2006 “Dangerous goods. Classification".

Labeling of hazardous chemical products in Ukraine is carried out in accordance with DSTU GOST 31340: 2009 "Precautionary labeling of chemical products. General requirements (GOST 31340-2007, IDT) ", if the product is exported. Labeling of products on the domestic market in accordance with GOST 31340: 2009 is not mandatory, but is welcomed.
Labeling of chemical products during transportation is carried out in accordance with DSTU GOST 4500-5: 2005 "Dangerous goods. Labeling".

State regulation and registration of pesticides and agrochemicals.
Law of Ukraine № 86/95-VR on pesticides and agrochemicals from 02.03.1995 regulates legal relations related to state registration, production, procurement, transportation, storage, trade and safe use of pesticides and agrochemicals for human health and the environment, defines the rights and responsibilities of enterprises, institutions, organizations and citizens, as well as the powers of executive bodies and officials in this sphere.
State registration of pesticides and agrochemicals is carried out by the Ministry of Ecology and Natural Resources of Ukraine in the manner established by the Cabinet of Ministers Resolution No. 295 of March 4, 1996 "On approval of the procedure for state testing, registration, managing of lists of pesticides and agrochemicals allowed for use on the basis of positive test results and research materials", and only after the registration of the active substance as a dangerous factor in the Committee on Hygienic Regulation of the State Sanitary and Epidemiological Service of Ukraine.

As a result of state registration, a sample label is approved, the product is entered into the State Register of Pesticides and Agrochemicals Permitted for Use in Ukraine, which is published on the website of the MinEnvironment.
In turn, the Order of the Ministry of Health of Ukraine of 05.08.1997 approved the List of pesticides banned for use in agriculture, which can not be registered or re-registered in Ukraine. The List contains especially dangerous active substances of pesticides, trade names of drugs and the degree of hazard (toxicity, allergenicity, potent poisonous substances) with LD50 values. Most of the hazardous substances contained in the list are also listed in the Rotterdam and Stockholm Conventions.

The current regulation of pesticide circulation does not comply with EU Regulation (PPP) 1107/2009, and the regulation on fertilizers does not comply with EU Regulation (FPR) 2019/1009.

Hazard classification of agrochemical products
Mandatory condition for proper regulation of pesticides is the establishment of criteria and rules for their classification for hazards and appropriate labeling.
By the Resolution of the First Deputy Chief State Sanitary Doctor of Ukraine № 2 of 28.08.1998 State sanitary rules and hygienic norms “Hygienic classification of pesticides according to the degree of danger” were introduced (DSP, which establishes the criteria for classification and safety requirements for humans during production, use and storage of active substances and preparative forms of pesticides (emulsion concentrates, granules, microcapsules, solutions, mixtures, etc.).
Pesticides, as products containing hazardous chemicals, must also be classified according to hazard classes according to the state standard GOST 12.1.007-76 “SSBT. Hazardous substances. Classification and general requirements » (cancelled).

State registration of disinfectants

The Law of Ukraine 1645-III "On Protection of the Population from Infectious Diseases" defines the legal and organizational principles of government, enterprises, institutions and organizations activities aimed at preventing the spread of infectious human diseases, localization and elimination of outbreaks and epidemics,

Chemicals, biological agents and medical devices used for disinfection measures (ie disinfectants) are subject to hygienic reglamentation and state registration in accordance with the procedure established by the CMU Resolution of July 3, 2006 № 908.

The use of unregistered disinfectants, as well as those in the process of manufacture, transportation or storage of which the requirements of technological regulations have been violated, is prohibited.

Державній реєстрації підлягають засоби, на які встановлені гігієнічні нормативи та види використання яких визначені у Постанові. Державну реєстрацію (перереєстрацію) засобів проводить МОЗ на підставі поданих документів за переліком.

As a result of state registration of the product, information about it is entered into the State Register of Disinfectants, which is published on the official website of the Ministry of Health for free access.

The term of state registration is five years.

Research of specific activity, safety, quality (efficiency) of desinfectants and tests in practice are carried out by the enterprises, establishments, the organizations accredited for the right of carrying out of the corresponding works in the order established by the legislation. The Ministry of Health also approves the procedures for conducting these studies, as well as establishes methods for testing of disinfectants.

The current regulation of the circulation of disinfectants does not comply with Regulation (EC) №528/2012 (BPR) and does not include all products that are considered as biocides. The definition of "biocide" is missing.

Regulation of the circulation of cosmetic products

Технічний регламент на косметичну продукцію був прийнятий Постановою КМУ від 20 січня 2021 р. № 65 та набирає чинності 3 серпня 2024 року.

The technical regulation is as harmonized as possible with Regulation (EC) № 1223/2009 and lays down requirements for cosmetic products placed on the market in order to ensure a high level of protection of human health.

Оскільки досі в Україні система GHS не імплеметована, у технічному регламенті застосоване пряме посилання на Регламент (ЄС) № 1272/2008, так як це дозволяється (як перехідне положення) Законом України 124-VIII “Про технічні регламенти та оцінку відповідності”.