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(2 pages)

1. EXPERT SANITARY-EPIDEMIOLOGICAL APPROVALS
(also known as HYGIENIC CONCLUSIONS or SANITARY CERTIFICATES)

2. TOXICITY PASSPORTS

You will require both of the above documents in order to bring into or operate or sell equipment or goods on the territory of the Russian Federation if they fall into one of the categories listed below.  These documents are issued by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, a federal agency charged with enforcing health and safety guidelines (as cited below).

Click on the sample Expert Sanitary-Epidemiological Approval on the left to see a full-size version, or read an English translation.


We can obtain for you Expert Sanitary-Epidemiological Approvals (also known as Hygienic Conclusions or Sanitary Certificates) and Toxicity Passports. We can also translate and prepare complete documentation packages necessary for obtaining the above documents.

Because documentation required for Expert Sanitary-Epidemiological Approvals and Toxicity Passports differs greatly for various items, we are unable to provide a generic list of what must be furnished by the customer.

Please contact us with a specific list of items that you want to have certified, and we will reply with a list of documentation required for those items.



On the basis of the Russian Federation's Law Regarding Certification of Products and Services, the Ministry of Health of the Russian Federation has issued an Order demanding certification/approval of products and equipment dealing with various tasks demanding sanitary control.  The following is an excerpt from the Order attesting to the necessity of obtaining Expert Sanitary-Epidemiological Approvals for certain products.
Excerpt from Ministry of Health of the Russian Federation Order # 217 "On Expert Sanitary-Epidemiological Assessment of the Manufacture, Delivery and Distribution of Products and Commodities," Paragraph 2, from July 20, 1998, including changes from September 02, 1999 and January 01, 2001:

"It shall be determined that:

An expert sanitary-epidemiological approval shall be issued by the Department of State Sanitary and Epidemiological Supervision of the Ministry of Health of the Russian Federation, centers of state sanitary and epidemiological supervision in the subjects of the Russian Federation, regional centers of state sanitary and epidemiological supervision in transport, the Federal Center for sanitary and epidemiological supervision of the Federal Agency for Medical, Biological and Extreme Problems under the Ministry of Health of the Russian Federation, authorizing manufacture, delivery and distribution of products and commodities in accordance with the Regulations on Sanitary Assessment of Products, Commodities as well as Manufacturers (Annex 1) and the List of Products and Commodities Subject to Expert Sanitary-Epidemiological Assessment (Annex 2)...."

The following is taken from Annex 2 of the aforementioned Order #217 and shows the types of products that need to be certified/approved.
Annex 2 of Order # 217 of the Ministry of Health of the Russian Federation:

List of Types of Products and Commodities Subject to Expert Sanitary-Epidemiological Assessment

  1. Alimentary raw materials, foodstuffs, food additives, biologically active additives, preservatives; materials and their derivatives contacting foodstuffs.
  2. Products for children: games and toys, clothes (including bed linen), footwear, teaching aids, stationery, furniture, baby carriages, knapsacks, artificial polymer and synthetic materials used in the manufacturing of products for children.
  3. Materials, equipment and substances used in commercial and potable water supply practices.
  4. Perfumes, cosmetics, mouth care agents.
  5. Chemical and petrochemical products for industrial use, household chemicals.
  6. Polymer and synthetic materials intended for use in construction, transport and manufacture of furniture and other home-use articles; chemical threads and fibers, textile, sewed and knitted materials containing chemical fibers and textile auxiliary materials; artificial and synthetic leather and textile materials for footwear.
  7. Products of mechanical engineering and instrument-making of industrial, medicinal and home use designation.
  8. Printed products.
  9. Products derived form natural raw materials treated (painting, impregnation, ionizing radiation etc.) in the course of production.
  10. Materials for products in contact with human skin.
  11. Products and articles constituting a source of ionizing radiation, including generating radiation, as well as products and commodities containing radioactive substances.
  12. Building stock and materials in which the content of radioactive substances is restricted by hygienic standards, including industrial waste intended for recycling and use in business, as well as metal scrap.
  13. Mobile vehicles and products of transport designation.



The Government of the Russian Federation has approved a Resolution regarding Government supervision and control in the field of safety and quality control of consumable products.  In accordance with the Resolution, Decree #987 was signed by the Deputy of the Prime Minister of the Government of the Russian Federation, Mr. M. M. Kasianov.
EXCERPT FROM DECREE #987 REGARDING GOVERNMENT SUPERVISION AND CONTROL IN THE FIELD OF SAFETY AND QUALITY CONTROL OF CONSUMABLE PRODUCTS

In accordance with the Decree, government supervision and control in the field of safety and quality control of consumable products will be conducted by:

  • organs and establishments of the Government Sanitary/Epidemiological Service of the Russian Federation;
  • Government Standardization and Metrology Committee of the Russian Federation and its territorial organs;
  • Government Bread Inspectorate under the Government of the Russian Federation and its territorial organs;
  • Government Commerce, Product Quality, and Consumer Rights Protection Inspectorate of the Russian Federation and [the Inspectorate's] territorial organs.
The approved Resolution establishes the procedure for providing government supervision and control over materials and items coming in contact with consumable goods and used for preparation, packing, storage, transportation, and sale of consumable goods, fragrance and cosmetic products, substances and items used for oral hygienics and tobacco products, methods of their preparation, circulation, and consumption (use).



Excerpts from the Resolution regarding the Government Sanitation/Epidemiological Service of the Russian Federation and Resolution regarding sanitation/epidemiological regulation.
The Government Sanitation/Epidemiological Service of the Russian Federation has been created in order to provide sanitation/epidemiological well-being in the Russian Federation and is a single centralized federal system of organs and establishments providing sanitation/epidemiological supervision/control.

The Ministry of Health of the Russian Federation (a department for Government sanitation/epidemiological supervision), [as well as] structural subdivisions of federal organs with executive power and other organs of the Government in [their] service, and centers of Government sanitation/epidemiological supervision, in addition to [afore]mentioned functions, [also]:

  1. provide Government sanitation/epidemiological supervision;
  2. provide, according to the legislation of the Russian Federation, Government registration of potentially dangerous to humans chemical and biological substances, distinct types of products, radioactive substances, manufacturing and consumer waste products, as well as distinct types of products being brought into the territory of the Russian Federation for the first time.
According to the Resolution, there are federal sanitation rules in effect on the territory of the Russian Federation.  Government sanitation/epidemiological rules set general requirements for:
  • consumable goods, food additives, raw food materials, as well as materials and items that come in contact with them, as well as production technology;
  • products being brought into the territory of the Russian Federation;
  • objects [dealing with or coming in contact with] water;
  • potable water and equipment for providing potable water to the population.
 
Moscow
27 July 2000