Сonsultation

Labeling and language requirements

There is no single document that would describe all the requirements for the labeling of disinfectants; labeling text and graphics are not approved during registration. The labeling is checked by the state market control during import and state market supervision during circulation on the market. Labeling inconsistencies can lead to import difficulties, fines, or withdrawal from circulation.

Proper product labeling is the responsibility of the manufacturer and distributors. Each market operator in the distribution chain is obliged to verify that the labeling complies with legal requirements.

Product information requirements, the scope of information and limitations are set by many legal acts, including:

  • Law of Ukraine “On consumer rights protection”,
  • Law of Ukraine “On the General Safety of Non-Food Products”,
  • Law of Ukraine “On ensuring the functioning of the Ukrainian language as a state language”,
  • Law of Ukraine “On Advertising”,
  • Order of the Ministry of Economic Development No. 914 “On approval of the definitions of the basic units of SI” and others. 

Information requirements are not harmonized with EU requirements and may differ significantly.

Information is provided to consumers in the accompanying documentation attached to the product, on the labeling or otherwise.

The language of labeling and accompanying documentation (instructions – leaflet) is Ukrainian. Other languages are allowed, provided that the amount of information in Ukrainian is not less than in other languages.

It is allowed to use a sticker for labeling, provided that it does not obscure the necessary information. 

The information must contain at least:

  • the product’s name,
  • data on the main properties of the product,
  • nominal quantity (mass, volume, etc.),
  • name and address of the manufacturer,
  • production date,
  • lot number,
  • storage conditions,
  • rules and conditions for the efficient and safe use of products;
  • information about the content of substances harmful to health,
  • the necessary precautions,
  • expiration date, information about the necessary actions of the consumer after expiry, as well as the possible consequences in case of failure to perform these actions,
  • other information as needed.

Units of measurement (volume, mass, etc.) on the labeling of disinfectants placed on the market from January 1, 2021 must be indicated taking into account the requirements of the Order of the Ministry of Economy No. 914 regarding SI units.

 

Symbols for labeling disinfectants

The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is a system for the classification and labeling of chemicals and mixtures created by the United Nations to bring to a single standard the criteria for assessing the hazard of substances used in different countries, as well as labeling and hazard communication systems.

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 the form of text.

However, such symbols are usually intuitive to the consumer and will increase the safety of product use:

Flammable

Harmful

Toxic

Health hazard

Environmental hazard

 

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

  • communication in the professional English language,
  • all necessary consultations regarding the requirements of the legislation, the list of necessary documents and the procedure for their legalization,
  • checking the composition of the product (feasibility study), 
  • translation of documents into Ukrainian,
  • development of the labeling, instructions for use (leaflet), Application, cover letters and other documents in the Ukrainian language, 
  • import of unregistered samples,
  • organization of sanitary and epidemiological assessment,
  • submission and registration of disinfectants (biocides). 

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.

We professionally perform registration of medicines, conformity assessment of medical devices, certification of cosmetics, disinfectants and special food products in Ukraine.
Our partners, international corporations and national manufacturers can best tell about our expertise and quality of work. For more than 15 years of work we have performed works for:

  • more than 150 manufacturers of medicines and active substances,
  • more than 800 manufacturers of medical devices and equipment,
  • more than 300 manufacturers of special food products and cosmetics.
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