The article will discuss how to issue a sanitary-epidemiological conclusion. Its validity will also be considered.
What is a free economic zone?
(SEZ) is a document issued by state federal healthcare institutions, such as the Epidemiology and Hygiene Center, as well as other accredited experts and organizations. This document confirms the sanitary-epidemiological examination, examination, research, testing and toxicological, hygienic and other types of assessments that comply with the technical regulations, standards, and at the same time, methods and methods approved in the accepted order were used. The action of the sanitary and epidemiological conclusions has a limited duration.
The SEZ contains a justified opinion on the non-compliance of the subject of sanitary and epidemiological examination, testing, inspection, research and hygienic, toxicological and other types of assessment with state sanitary regulations, standards and rules. Test report, research is called a document that confirms the fact of a test or research. It contains the order and the result. This is what is included in the concept of sanitary-epidemiological conclusion. Validity will be considered below.
After the agreement on the rules for the transport of goods through customs and through the territory of the customs union began to apply, and the EurAsEC Rospotrebnadzor Agreement on sanitary measures came into force, the sanitary and epidemiological conclusion ceased to be issued on products from 1.07.2010.
Hygienic certificate
The Customs Union Commission approved:
- Decree on the rules for conducting state sanitary and epidemiological control.
- General requirements for the product are both hygienic and sanitary-epidemiological.
- A complete list of products that are subject to sanitary and epidemiological control.
What's next?
After the entry into force of this decision, the product receives documents that confirm its compliance with the unified hygiene and sanitary and epidemiological requirements:
- State certificate of the EurAsEC.
- Declaration of Conformity.
- Expert sanitary and epidemiological conclusion.
The validity of this document means that the executed sanitary and epidemiological conclusion is valid until the date indicated in it but no later than the moment when the regulations of the Customs Union for certain types of goods came into force.
Is this a required document?
The hygienic certificate of Rospotrebnadzor is not a binding document, it is drawn up if official confirmation of compliance of products with sanitary standards is necessary. Such a need arises if manufacturers or suppliers intend to increase the competitiveness of goods by providing information about their quality and safety for human health and life. The certificate of Rospotrebnadzor is a document that indicates the conformity of the goods subject to control, hygienic and sanitary and epidemiological requirements.
This is the sanitary and epidemiological conclusion of Rospotrebnadzor. Its validity is limited.
What documents are needed to get a hygienic conclusion?
For domestic goods:
- statistical codes of the applicant company;
- notification of the start of business;
- application for sanitary and epidemiological conclusion;
- certificate of assignment OGRN and TIN;
- copies of documents corresponding to which the products are manufactured (technical specifications, standards, certification, technological instructions, regulations);
- label for the consumer or its layout;
- product description - trademark, scope, article, basic material.
For imported goods:
- statistical codes of the applicant company;
- manufacturer's address and information about him;
- PSRN and TIN;
- product description - trademark, scope, article, basic material;
- label for the consumer or its layout;
- copy of the contract or manufacturer’s address and information about it.
In what order is the sanitary and epidemiological conclusion issued? Validity will be considered later.
The procedure for issuing SEZ
SEZ is issued for the following types of products:
- Food products (in processed or natural form; chewing gum; alcoholic and non-alcoholic drinks; including food products obtained from genetically modified sources and food raw materials), excluding products that are subject to registration by Rospotrebnadzor.
- Children's goods: toys and games, clothes, shoes, bedding, strollers, furniture, bags (briefcases, satchels, backpacks, etc.), as well as artificial materials (synthetics, polymers) used in the manufacture of an assortment of children's goods.
- Equipment, materials, devices and substances for wastewater treatment, drinking water supply and swimming pools. The exception is substances and materials that are subject to registration with Rospotrebnadzor.
- Hygiene products for the oral cavity, perfumes and cosmetics, excluding those that are subject to registration by Rospotrebnadzor.
- Petrochemical and chemical products for industrial needs, household chemical goods, excluding goods that are subject to registration by Rospotrebnadzor.
- Synthetics and polymers, which are intended for use in transport, in construction, in the manufacture of furniture and other household items; sewing knitted and textile materials containing auxiliary textile substances and chemical fibers; furniture; synthetic and artificial leather, as well as textiles for the manufacture of shoes and clothes.
- Products of industrial instrumentation, mechanical engineering, household and medical purposes, except for spare parts for household appliances and vehicles (with the exception of those in contact with food and water).
- Production of publishing houses: manuals and educational publications for general educational institutions of higher and secondary educational institutions, magazine and book publications for adolescents and children.
- Products that use natural raw materials that are processed during the manufacturing process (impregnation, painting, etc.).
- Products and materials for products that come in contact with human skin, shoes, clothes.
- Products and products that are sources of an ionizing substance, including generating, as well as goods and products that contain radioactive substances.
- Building materials and raw materials contain radioactive substances that regulate hygiene standards, as well as scrap metal and industrial waste for recycling.
- Equipment, products and materials through which food is handled.
- Materials and equipment for filtration, air purification and air treatment.
- Agrochemicals and pesticides.
- Anti-icing reagents.
- Tobacco raw materials and cigarettes.
- Personal protective equipment.
The shelf life of the sanitary-epidemiological conclusion for each group of goods is different.
Who issues the free economic zone?
The issuance of a sanitary and epidemiological conclusion on compliance with sanitary rules for the products listed below is carried out only by the head of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being. He is the chief state sanitary doctor of the Russian Federation. Also involved in this are the deputy heads of the Federal Service for Supervision of Consumer Rights Protection and Human Well-being, that is, the deputy chief medical officer of the Russian Federation.
The products mentioned include:
- dietary fiber, herbal tea, raw materials necessary for the production of baby food, including raw medicinal plants; plant extracts used in the food industry, energy drinks (low alcohol and non-alcohol) ,;
- textbooks for primary and general vocational education, on which is the signature stamp of the Ministry of Education and Science of Russia;
- reagents used for the preparation of drinking water, except for those that must be registered with Rospotrebnadzor;
- household devices for the purification of drinking water;
- agrochemicals and pesticides;
- ionizers and materials necessary for the manufacture of ventilation systems;
- hygiene products, instruments and medical equipment, as well as medical, diagnostic and physiotherapeutic equipment;
- products that contain ionizing sources, including those that are designed for serial production or when new technologies are used; products and materials in which the effective specific activity of radionuclides exceeds 740 Bq / kg;
- new raw materials used for drinking water supply.
What is a sanitary-epidemiological opinion on the type of activity?
Types of activities requiring the issuance of SEZ
- Medical.
- For the production of drugs.
- Pharmaceutical
- An activity that involves the use of microorganisms that cause infectious diseases.
- Educational.
- For the production and turnover of ethyl alcohol, alcohol-containing and alcoholic products.
- For storage, disposal, production, placement, operation, maintenance of sources capable of ionizing a substance.
- On the use of water bodies for domestic and drinking water supply, sports, medicinal purposes, bathing and recreation.
- For the production of new types of food additives, products and food materials that are being introduced and developed into production for the first time.
- On the use, collection, transportation, disposal and disposal of hazardous waste.
So what is the term of the sanitary-epidemiological conclusion? We will understand further.
Project documentation
Sanitary and epidemiological certificates for project documentation, products and activities that are intended for use in the defense industry and defense, internal affairs and security facilities, as well as for other special purposes, are issued in industry organizations in which dangerous working conditions and some other territories are carried out chief state sanitary doctors (and also their deputies) of federal state institutions of federal executive bodies and structural units, which provide sanitary and epidemiological surveillance of the Armed Forces of the Russian Federation, other troops, bodies and military units at defense production and defense facilities, internal affairs and security, etc. These FEZs operate only at supervised facilities and territories issued by the main state sanitary doctors.
Organizational and technical measures related to the issuance of SEZs and sanitary-epidemiological examinations are carried out by the Federal State Healthcare Institution (epidemiology and hygiene centers) with the consent of the territorial bodies of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare.
SEZ Duration
- Design documentation - until the expiration of this documentation.
- Products, except scrap metal, - 5 years. The same period of validity of the sanitary-epidemiological conclusion on water.
- Work with sources capable of ionizing the substance - no more than 5 years.
- An experimental batch of products, a batch of scrap metal - up to 1 year.
- Services, work, activities - indefinitely, exceptions are work with sources that can ionize the substance and seasonal work. The same validity of the sanitary-epidemiological conclusion for the school.
When is renewal necessary?
SEZ is subject to reissuance upon reorganization, upon change of name, full name (if any), a change in the location of the legal entity, the place of residence of the individual entrepreneur, or a change in the scope of the products. In order to reissue the sanitary-epidemiological statement, the above-mentioned people must submit an application for re-issuing the SEZ by attaching documents confirming the changes. When the SEZ is reissued, a new one is issued by assigning it a new number and date with the details (date and issue number) of the SEZ, instead of which a new one is issued.
The sanitary and epidemiological conclusion, which was reissued, is returned to Rospotrebnadzor at the place of its receipt. In opposite cases, re-issuance is not carried out.
In case of non-compliance
If it was revealed that the factors of the habitat area (services and work, products, economic and other activities) were not authorized, authorized persons issued a sanitary and epidemiological report on the inconsistency of factors in the habitat area (or services and works, or products, or economic and other activities) with the state sanitary and epidemiological standards and rules with indicating the reasons for non-compliance. All the necessary information is entered into the register of sanitary and epidemiological conclusions of Rospotrebnadzor on the non-compliance of services, works or activities, design documentation, products with the requirements of state sanitary and epidemiological standards and rules.
The authorities of Rospotrebnadzor certify copies of the conclusions at the place of issuance of this application, and they are also protected by two holographic signs in the same places where they are located on the original or are certified in the prescribed manner.
We examined such a concept as the sanitary-epidemiological conclusion of Rospotrebnadzor. Validity period depends on the type of product and activity.