Registration of disinfectants (biocides) in Ukraine
Disinfectants (biocides) are subject to state registration before placing on the market. Registration and maintenance of the state register are performed by the Ministry of Health of Ukraine.
The definition of “disinfectant”, the requirements for composition, quality, safety and specific activity, and labeling information are yet not harmonized with European legislation. The definition of “biocide” used in Directive 98/8/EC is much more comprehensive and includes some groups of products that in Ukraine do not fall under the definition of “disinfectant”. The list of substances allowed for disinfectants in Ukraine differs significantly from those approved by the European Chemicals Agency (ECHA) for use in biocides.
Disinfectants are the products intended for:
- disinfecting measures in residential, industrial, educational, sanitary and other premises, healthcare facilities,
- hand disinfection (antiseptics),
- disinfection of air, water (except for drinking water), industrial and domestic wastewater;
- scaring away and destruction of carriers of pathogens of infectious diseases, insects, rodents;
- pre-sterilization cleaning, “cold” sterilization and quality control of sterilization of medical devices.
Market requirements for disinfectants are regulated by the Laws of Ukraine “On the protection of the population from infectious diseases”, “On ensuring the sanitary and epidemic well-being of the population” (from 01.10.2023 will be replaced by the Law “On the public health system”), Resolution of the Cabinet of Ministers No. 908 of 03.07. 2006 “On approval of the procedure for state registration (re-registration) of disinfectants” and others.
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We have been providing professional consulting services on state registration of disinfectants in Ukraine since 2006. We have registered disinfectants, antiseptics, cleaning and cold sterilization agents, insecticides and rat control agents from more than 60 foreign and national manufacturers.
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Requirements for the composition
We recommend carefully checking the product’s composition before starting registration activities. Not all disinfectants can be registered, as the legislation establishes specific requirements:
- the active ingredients of the disinfectant must be registered and listed in the register of hazardous factors of Ukraine, and
- active substances must be included in the hygiene regulations approved by the Orders of the Ministry of Health of Ukraine, and
- the disinfectant must receive the conclusion of the sanitary-epidemiological examination.
All requirements must be met. Failure to meet any may lead to the refusal of the Ministry of Health of Ukraine to register the such product.
Hygienic regulation and registration of active substances (hazardous factors)
The active ingredients of disinfectants are hazardous factors subject to hygienic regulation and registration in accordance with Article 9 of the Law of Ukraine “On Ensuring Sanitary and Epidemiological Welfare of the Population”. A similar provision is approved by Article 46 of the Law “On the Public Health System”, which will enter into force on 01.10.2023.
Hygienic regulations for active substances (hazardous factors) are approved by Orders of the Ministry of Health of Ukraine.
State registration of hazardous factors is carried out by the State Enterprise “Committee on Hygienic Regulation of the Ministry of Health of Ukraine” in accordance with Section II “Regulations on Hygienic Regulation and State Registration of Hazardous Factors”, approved by the Resolution of the Cabinet of Ministers of Ukraine dated June 13, 1995 No. 420.
Chemical and biological substances (compounds) that are produced or used on the territory of Ukraine or imported from abroad must be registered. State registration of hazardous factors is an obligatory requirement for issuing a permit for import, use and manufacture, introducing hazardous factors into regulatory and design documentation, and issuing a hygienic conclusion.
The register of approved hazardous factors is maintained in open electronic form on the Committee for Hygienic Regulation website.
The procedure for state registration of disinfectants
The registration procedure is approved by the Decree of the Cabinet of Ministers of Ukraine No. 908 of July 3, 2006; the competent authority is the Ministry of Health of Ukraine.
The order defines two routes of registration:
- based on a positive conclusion of the sanitary and epidemiological examination – until the entry into force of the procedures for the assessment of specific activity, safety, quality (efficacy) and their testing in practice,
- or based on an examination of documents – after the entry into force of the assessment procedures.
Since the procedures for assessing the specific activity, safety, quality (efficacy) of disinfectants and their testing in practice have not been approved yet, registration is carried out only based on the conclusion of the sanitary and epidemiological examination.
For registration it is required:
- To review the composition of the product and make sure that all the requirements of the hygienic regulation and registration of hazardous factors are met,
- To fill in a set of administrative and technical documentation, including cover letters, labeling and instructions in Ukrainian language,
- To submit an Application to the competent authority for sanitary-epidemiological assessment,
- To submit a set of documents and samples to an authorized institute for examination and testing, respond to deficiencies if necessary,
- To obtain a positive conclusion of the sanitary-epidemiological assessment,
- To submit an Application and conclusion to the Ministry of Health of Ukraine, respond to deficiencies if required,
- To be included in the Order of the Ministry of Health of Ukraine on registration of disinfection products.
The state register of disinfectants is maintained by the Ministry of Health of Ukraine in electronic form.
Exceptions to registration
During the COVID quarantine, amendments were made to the Law of Ukraine “On the Protection of the Population from Infectious Diseases”, which allow the production and use of disinfectants without state registration, in case if such disinfectant contains no active substances that are dangerous for human health.
Since the active ingredients of disinfectants are classified as hazards, this exclusion does not apply.
We are not aware of other exceptions or simplified registration procedures.
Labeling and instructions
The requirements for labeling and accompanying documentation of disinfectants are established by the Laws of Ukraine “On the Protection of Consumer Rights”, “On the General Safety of Non-Food Products”, “On Ensuring the Functioning of the Ukrainian Language as the State Language” and others.
The disinfectant manufacturer must provide information about products that, under certain conditions, can be dangerous to life, the health of the consumer and his property, and the possible consequences of its consumption (use).
Information is provided to consumers in the accompanying documentation attached to the product, on the label, or otherwise.
The language of labeling is Ukrainian; other languages on the labeling are allowed.
The information must contain at least:
- the product’s name,
- data on the main properties of products,
- nominal quantity (mass, volume, etc.),
- name and location of the manufacturer,
- production date,
- lot number,
- storage conditions,
- rules and conditions for the efficient and safe use of the product,
- information about the content of substances harmful to health,
- the necessary precautions,
- expiration date, information about the necessary actions of the consumer after their completion, as well as the possible consequences in case of failure to perform these actions.
Units of measurement (volume, mass, etc.) on the labeling of disinfectants put into circulation from January 1, 2021 must be indicated considering the requirements of the Order of the Ministry of Economy No. 914 regarding SI units.
In Ukraine, the GHS system is not introduced by law; using symbols (pictograms) is voluntary and does not exempt from the obligation to display information in a text.
Maintenance of registration, variations (changes) and renewal
The State Register of Disinfectants contains the name of the product, the name and address of the Applicant (holder) and the manufacturer, the scope of application, the registration date and order number, the expiry date.
There are no payments or other conditions to maintain registration.
There is no “sunset clause” for disinfection products.
To make changes or to renew registration for the next period, it is necessary to apply for re-registration. Re-registration is carried out identically to the new registration.
Safety vigilance
Producers and distributors, in accordance with the requirements of the Law of Ukraine “On the General Safety of Non-Food Products”, are obliged to immediately inform the state market supervision body about cases of introduction into circulation of products that pose risks for consumers (users) that are incompatible with the general requirement for product safety, and also take the necessary measures to minimize such risks.
The form of notification of non-conforming products and cases when the notification is not submitted are approved by the Resolution of the Cabinet of Ministers No. 1401 of December 26, 2011.
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We offer comprehensive consulting services on state registration of disinfectants (biocides) in Ukraine. We proactively and professionally organize the registration process in a short time. We provide
We provide preliminary consultations free of charge; call us at +38 (044) 364-33-55, 364-30-03, write us an e-mail info@cratia.ua, or come to a meeting at our office. |
Legislation
- Law of Ukraine “On the protection of the population from infectious diseases”
- Law of Ukraine “On Ensuring Sanitary and Epidemiological Welfare of the Population” (valid until October 1, 2023)
- Law of Ukraine “On the system of public health” (effective from October 1, 2023)
- Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as a State Language”
- Law of Ukraine “On consumer protection”
- Law of Ukraine “On labor protection”
- Decree of the Cabinet of Ministers of Ukraine No. 908 of July 3, 2006 “On Approval of the Procedure for State Registration (Re-Registration) of Disinfectants”
- Decree of the Cabinet of Ministers of Ukraine No. 420 dated June 13, 1995 “Regulations on hygienic regulation and state registration of hazardous factors”
- Decree of the Cabinet of Ministers of Ukraine No. 1401 of December 26, 2011 “On Approval of the Procedure for Submitting a Notification of Products that Do Not Meet the General Product Safety Requirement to State Market Supervision Authorities”
- Order of the Ministry of Health of Ukraine dated March 23, 2010 No. 250 “Standard for the provision of administrative services by the Committee on Hygienic Regulation of the Ministry of Health for State Registration (Re-Registration) of Hazardous Factors”
We provide preliminary consultations free of charge, call us by phone +38 (068) 064-78-31, +38 (044) 223-61-67, or write to info@cratia.ua, or come to the meeting directly to our office.