Sanitary Expert Report & State Registration
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GOST R OFFICIALLY CEIZED TO EXIST. INSTEAD THE GOODS ARE CURRENTLY SUBJECT TO VERIFICATION UNDER THE TECHNICAL REGULATION.
The Hygiene Certificate for the Russian Federation: main definitions
As a part of the creation of the Customs Union and as the first step towards the border requirements standardization, the Sanitary Control based on the single list of products and the common requirements were implemented in 3 member states : Russia, Belarus and Kazakhstan by the Decree N° 299 issued by the Customs Union Commission on May 28, 2010.
So the Hygiene Certificate is no longer in existence. The Russian national hygiene certificates issued before July 01, 2010 are valid until January 01, 2012 only in the territory of the Russian Federation.
Scope and relevant products
This Decree which came into force on January 01, 2010 validates the single list of products which divides products into 3 groups:
- products requiring Sanitary Expert Report,
- those subject to the Sanitary Control in the form of State Registration,
- and the control-free products.
Below there is an extract from the first part of the single list of products whose compliance with common requirements must be certified by the Sanitary Expert report :
- GMO-free food with the following customs codes: 02-05; 07-09; 11-25; 27-29; 32-34; 35 ;
- goods for children except underwear, with the following customs codes: 32; 34; 39; 40; 42-44; 46; 48-5-; 60-65; 87; 94 and 95 ;
- cosmetics except for those subject to the registration with the customs code 33 ;
- textile and shoes with the following customs codes : 39; 40; 42; 43; 50-60 ;
- tobacco, customs code 22 ;
- products in direct contact with food except for those subject to the registration with the following customs codes: 39, 44, 45; 48; 63; 70; 73 and 76
The second part of the list brings together the products requiring the registration with the following customs codes:
- mineral water and alcohol (all wines and spirits), energy drinks ;
- certain food such as infant food, sports diet products, raw materials for food additives, food containing active ingredients ;
- food containing or made of genetically modified organisms;
- cosmetics and products for oral hygiene;
- disinfectants, insecticides;
- household goods for home maintenance;
- personal hygiene products, children underwear ;
- goods in contact with foodstuffs (except for kitchenware, tableware, industrial equipment) ;
- food and beverage, preservatives, food additives with active ingredients.
- materials and equipment in direct contact with food or skin, which vapors can be inhaled (cosmetics, textiles, toys, food processing machinery, devices for water treatment, packaging materials, some furniture, detergents and certain household appliances), chemicals and petrochemicals for industrial use;
- all types of goods for children, including toys, fitness equipment, stationery, prams and baby carriages, schoolbags, polymer and synthetic materials used in manufacturing products for children.
The third part of the single list of the Decree N°299 issued by the Customs Union Commission on May 28, 2010 includes the products which are not subject to the sanitary control.
- samples for sanitary and epidemiological expertise ;
- tobacco accessories ;
- laboratory products : chemical reagents, glassware (except for sources of ionizing radiation) ;
- raw materials (chicken and goose eggs, etc) for scientific research (e.g. nutrient broth) ;
- car spares parts, industrial equipment (except for those which has a risk of radioactive contamination) ;
- spares and accessories for computer equipment, electronics, household electrical appliances which don’t contact with food ;
- collectibles, cosmetic and photo accessories;
- products manufactured in the territory of the Customs Union but for external market ;
- exhibition items, promotional samples which are not for sale or for marketing in the territory of the Customs Union;
- products which have already been used including those distributed through appropriate outlets;
- collectibles made by pupils and students of educational institutions within the national and international contests.
Before placing on the market, the manufacturer or his agent should :
- Meet the common sanitary requirements of the Customs Union
- Provide the technical file
- Provide the instructions
- Implement the sanitary control procedure
- Obtain the State Registration / or Sanitary Control Certificate and ensure that it is enclosed to the products
In practice, the original of Sanitary Expert report/ State Registration certificate or its certified copy are required upon the product entry to the Russian market i.e. since the customs clearance in Russia and thereafter to accompany the product in the outlets and/or placing on the market.
State Registration Certificate
Sanitary expert report about product compliance with sanitary requirements of the Customs Union is issued by authorized centers in the member states. Several products from the same family can be grouped in one Sanitary Expert Report.
As for the registration, the criteria for gathering several products in one group are more restricted.
The registration procedure includes following steps:
- evaluation of the technical and administrative record provided by the manufacturer, especially product compliance analysis, manufacturing conditions and sanitary standards;
- Implementation of relevant tests : toxicological, clinical and others depending on the type of product;
- working out sanitary expert report about product compliance based on test records and documents review;
- registration of data related to the product as well as its manufacturer in the single sanitary database on the Customs Union;
- issue of the product registration certificate.
The evidence of Sanitary control (Sanitary Expert Report and State Registration certificate) are valid for the period of product circulation in the territory of the Customs Union.
The duration and receipt of the Sanitary control:
Type of certificate
Time of receipt
Time of working out certification file
By exporter (standard procedure)
By us (accelerated procedure)
Sanitary Expert Report
Valid while the test record is valid (about 1 year)
25 business days*
10 business days
State Registration certificate
Valid for life
50 business days*
10 business days
Our solutions :
- receipt of registration certificate
- receipt of sanitary control certificate
- advice on product identification and relevant applicable standards
- working out the certification file
- implementation of product analyses