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Description
of content: The draft Resolutions
provides for the approval of the Procedure for state registration of
hazardous factors (hereinafter referred to as the Procedure), 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.
Compared to
the previous version notified in document G/TBT/N/UKR/274/Rev.1, the
procedures for reviewing applications for state registration of a hazardous
factor have been enhanced in line with the provisions of the Law of Ukraine
"On Administrative Procedure"; the provision allowing the
submission of a joint application for state registration of a hazardous
factor—when a specific biological hazardous factor is produced and imported
by one or more producers and importers—has been revoked; the requirements for
storing the Certificate of State Registration of a hazardous factor,
including its registration number and validity period in the State Register,
have been removed.
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 Abstracts Service
(CAS) and/or the number of European Inventory of Existing Commercial Chemical
Substances (EINECS); 8) the scope of application of the hazardous factor; 9)
a list of confidential information that cannot be disclosed or shared at the
request of third parties (confidential information cannot include data
regarding the properties of hazardous factors that pose a risk to human
health and the environment,, as well as information that is included in the
Register); 10) a safety data sheet for chemical products, drawn up in
Ukrainian and approved by the applicant, in paper or electronic form. The
requirements for the safety data sheet are outlined in Annex II to the
Technical Regulation on the Safety of Chemical Products, approved by the Resolution
of the Cabinet of Ministers of Ukraine No. 847 of 23 July 2024; 11)
identification of the similarity of the hazardous factor; 12) data on the
classification of hazards and labelling of the chemical substance.
The
application for state registration of a hazardous factor and the documents
specified above shall be submitted by the applicant or an authorized
representative to the Ministry of Health through personal submission, by post
mail, or in electronic form. The application in electronic form shall
submitted through the electronic cabinet of the Register, provided that the
technical capability of submission to the Register is available.
The Committee
examines the registration materials on a contractual basis between the
Committee and the applicant or an authorized representative 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 10 calendar days.
Based on this
conclusion, the Ministry of Health of Ukraine makes a decision within 10
calendar days on state registration of the hazardous factor or refusal of
such registration.
The state
registration of a hazardous factor is indefinite, except in cases specified
in clause 17 of the Procedure.
State
registration of chemicals and substances of biological origin includes
recording data in the State Register of Hazardous Factors (hereinafter - the
State Register). The State Register 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 State Register will contain information about chemical and biological
hazardous factors, specifically: the name of the substance; the source of
origin (production); data on the intended use of the substance, its
biological effects, hazard class, and its impact on the environment;
detection methods; the established state medical and sanitary standards for
the substance, and, if necessary, the state medical and sanitary regulations
for its use (application).
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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