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ETS Certification

Ensuring the sanitary and epidemiological well-being of the population

Ensuring the sanitary and epidemiological well-being of the population is regulated by the Law of Ukraine «Про забезпечення санітарного та епідемічного благополуччя населення» /(On ensuring the sanitary and epidemiological well-being of the population).

Consider this law in terms of requirements for sanitary-epidemiological examination of products, goods, products, or equipment. It is important to remember that according to the Law, citizens have the right, including:

  • safe for health and life food, drinking water, working conditions, education, upbringing, life, recreation, and the environment;

  • compensation for damage caused to their health as a result of a violation of sanitary legislation by enterprises, institutions, organizations, citizens.

It should be noted that the scope of the provisions of this Law does not apply to food products, except for food products that are subject to sanitary and epidemiological investigations of diseases caused by infectious diseases, mass non-communicable diseases, poisoning, and radiation damage to humans.

In this case, any dangerous factor of physical, chemical, biological nature, present in the environment of human life, is subject to hygienic regulation. Hygienic regulation of dangerous factors is provided by the central executive body, which implements the state policy in the field of sanitary and epidemiological well-being of the population following the regulations approved by the Cabinet of Ministers of Ukraine.

The state sanitary-epidemiological examination consists of complex research of objects of examination for the purpose of revealing of possible dangerous factors in these objects, establishment of conformity of objects of examination to requirements of the sanitary legislation, and in case of absence of the corresponding sanitary norms - in substantiation of medical requirements on safety. for human health and life.

The state sanitary and epidemiological examination provides:

  • determining the safety of economic and other activities, working conditions, education, upbringing, life, which directly or indirectly negatively affect or may affect the health of the population;

  • establishing compliance of examination objects with the requirements of sanitary norms;

  • assessment of the completeness and validity of sanitary and anti-epidemic (preventive) measures;

  • assessment of the possible negative impact of dangerous factors associated with the activities of the objects of examination, determining the degree of risk they pose to public health.

The examination is subject to, including products, semi-finished products, substances, materials, and hazardous factors, the use, transfer, or sale of which may harm human health.

Products imported from abroad and put into circulation or distributed in Ukraine are subject to supervision and control in the manner prescribed by the Law of Ukraine "Про державний ринковий нагляд і контроль нехарчової продукції" / "On State Market Supervision and Control of Non-Food Products".

Approved in accordance with the Law Temporary procedure for conducting a state sanitary and hygienic examination. According to the norms of the order, the use or functioning of examination objects without the presence of a positive conclusion of the state sanitary-epidemiological examination is prohibited.

When importing new chemical and biological substances, raw materials, compounds intended for production and use into Ukraine, the precondition for conducting a state sanitary-epidemiological examination is state registration with the Committee for Hygienic Regulation of the Ministry of Health of Ukraine and, if necessary, hygienic regulation.

The term of performance of the state sanitary-and-epidemiological examination makes 30 days from the date of receipt of the documents provided by the Procedure to executors of examination. A separate opinion is prepared for each object of examination in accordance with the State Classification of Products and Services (ДКПП) or the Ukrainian Classification of Goods for Foreign Economic Activity (УКТЗЕД).

After approval, the conclusion is entered into the register of conclusions of the state sanitary-epidemiological examination and it is assigned the appropriate number. The conclusion is valid only if there is a registration number in the register. The conclusion is entered in the register based on the statement of the conclusion by the chief state sanitary doctor or the authorized deputy.

The conclusion of examination is valid during the term of the normative document accepted in accordance with the established procedure for this object of examination (products). For products of imported production, for which there are no regulations, the conclusion is issued for 5 (five) years.

Note that the Applicant is responsible for the inaccuracy of the submitted documents, materials, samples, and non-compliance with the requirements of the examination report.

At the same time, the state provides sanitary and epidemiological supervision. This is the activity of the state sanitary-epidemiological service to control the observance of sanitary legislation by legal entities and individuals in order to prevent, detect, reduce or eliminate the harmful effects of dangerous factors on human health and to apply legal measures against violators.

Measures to stop violations of sanitary legislation are defined in Art. 42 of the Law and stipulate that the chief state sanitary doctors (their deputies) take such measures to stop the violation of sanitary legislation, such as:

  • restriction, temporary prohibition or termination of enterprises, institutions, organizations, objects of any purpose, technological lines, machines and mechanisms, the performance of separate technological operations, use of floating means, rolling stock and planes in case of non-compliance with their requirements of sanitary norms;

  • a temporary ban on the production, ban on the use and sale of chemicals, technological equipment, building materials, biological products, consumer goods, sources of ionizing radiation in the absence of their hygienic regulations and state registration, as well as if they are recognized as harmful to human health;

At the request of officials of the state sanitary-epidemiological service, the implementation of measures to stop violations of sanitary legislation, if necessary, is carried out with the involvement of police officers.

It is necessary to comply with the Law, as for violation of sanitary legislation disciplinary and administrative liability to enterprises, entrepreneurs, institutions, organizations, and acts against public health committed as a result of a violation of sanitary legislation, entail criminal liability.

Penalties in some cases amount to 100% of the value of manufactured or sold products in respect of which violations have been identified. Payment of fines and financial sanctions provided for in Article 46 of this Law does not release violators from the obligation to compensate the enterprises, institutions, organizations, and citizens they have suffered as a result of a violation of sanitary legislation.

Manufacturers or importers who do not have the opportunity to study all the requirements of the Law, and also want to save their own time, our company "Conformity Assessment Body Eurotechstandard" will provide advice and services to obtain the conclusions of the state sanitary-epidemiological examination, other permits for products or equipment will be a guarantee of compliance with relevant laws.

We are working to increase the epidemic well-being and safety of the population!


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