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Description
of content: 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).
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