Chemicals and substances of biological origin, as well as those that are part of mixed products

Draft Resolution of the Cabinet of Ministers of Ukraine "On Approval of the Procedure for State Registration of Hazardous Factors"; (11 page(s), in Ukrainian)

The draft Resolutions provides for the approval of the Procedure for state registration of hazardous factors, which defines the order for state registration of chemical and biological hazardous factors - chemicals and substances of biological origin, as well as those that are part of mixed products, produced and/or used in the territory of Ukraine or imported, and establishes the procedure for maintaining the State register of hazardous factors.

According to the draft Procedure all individual chemical and biological hazardous factors - chemicals and substances of biological origin, as well as those that are part of the product or mixed product, produced and/or used on the territory of Ukraine or imported are subject to state registration.

A hazardous factor that is part of the product is subject to registration if it is intentionally released during the use. A hazardous factor that is part of a mixed product is subject to registration if the concentration of the hazardous factor that is part of the mixed product is 10 % or more. Additives formed in the process of production or use of substances are registered as individual substances.

The state registration of a hazardous factor is carried out by the Ministry of Health of Ukraine on the basis of an application for state registration of a hazardous factor and the results of the examination of registration materials for such a factor conducted by the expert institution, such as the State enterprise "Committee on Hygienic Regulation of the Ministry of Health of Ukraine" (hereinafter referred to as the Committee). The application for state registration of a hazardous factor submitted by the manufacturer or importer shall contain the following:

1) full and abbreviated name of the applicant; 2) address of the applicant's location; 3) telephone number and e-mail address; 4) surname, full name, patronymic (if any) of the authorised person; 5) commercial name of the chemical substance or substance of biological origin; 6) chemical name (for a chemical substance) in accordance with the nomenclature of the International Union of Pure and Applied Chemistry (IUPAC) and other international classifiers; 7) registration number of the chemical compound of Chemical Abstacts Service (CAS) and/or the number of European Inventory of Existing Commercial Chemical Subsyances (EINECS); 8) the scope of application of the hazardous factor.

If the production and/or import of a particular chemical and biological hazardous factor is planned by one or more producers and importers, a joint application for state registration of the hazardous factor is submitted.

The application for state registration of a hazardous factor is submitted in electronic form through the electronic cabinet of the Register, if the relevant technical capability of submission to the Register is available. Until the technical capability is introduced, the application may be submitted in written or electronic form.

The Committee examines the registration materials on a contractual basis between the Committee and the applicant within 30 calendar days and, based on the results of the examination, prepares an expert conclusion on the possibility of registering a hazardous factor or refusing to register it within 5 calendar days.

Based on this conclusion, the Ministry of Health of Ukraine makes a decision within 15 calendar days on state registration of the hazardous factor or refusal of such registration.

A hazardous factor is considered registered from the moment of a registration record is made in the State Register.

The state registration of a hazardous factor is indefinite, except in cases specified in the Procedure for State Registration of Hazardous Factors.

The State Register of Hazardous Factors is intended to provide electronic services to implement the rights and obligations of applicants for the collection, accumulation and processing of data on hazardous factors registered in Ukraine, who have applied to the Ministry of Health of Ukraine for registration of the factor(s) in accordance with the established procedure.

The hazard classification of chemicals and chemical products is based on the Globally Harmonized System of Classification and Labeling of Chemicals (GHS).