State registration of a product.

Since the 1st of July 2010 to confirm safety of a product a certificate of state registration is issued that is valid on the whole territory of the member countries of the Custom Union*. The state registration of products, substances, materials, preparations is carried out in accordance with the Agreement of the Custom Union on sanitary measures (Resolution of the Government of the Russian Federation dated June 30, 2004, № 322 “On approval of Provision about Federal Service for Supervision in the Sphere of Protection of Consumer Rights and Human Welfare”).

List of the products subject to the state registration:

Please, note that the whole list of the products subject to the state registration can be registered only at the Federal Service for Supervision in the Sphere of Protection of Consumer Rights and Human Welfare (Rospotrebnadzor) (Moscow, Vadkovskiy pereulok, 18):

• Specialized food including infant food, products for pregnant and fostering women, dietary products (health food and protective diet food), food for sportsmen (hereinafter – specialized food); biological active additives, raw materials for biological active additives, organic food.

• Food supplements, complex food supplements, flavoring agents, plant extracts as flavors and raw components, starter cultures of microorganisms and starter materials, technological additives including ferments.

• Disinfectant, disinsection and deratization substances (in household use, for use in medical and preventive treatment institutions and in other objects (except use in veterinary).

• Potentially hazardous chemical and biological substances and produced on their base products representing a potential hazard for humans (except pharmaceutical products), individual substances (compounds) of natural or artificial origin having unfavorable impact on human welfare and environment at production, use, transportation or recycling.

• Materials, equipment, devices and other technical units of water treatment intended for use in domestic-water supply systems.

• Oral substances and products.

The rest of the products can be registered at any territorial body of the Federal Service for Supervision in the Sphere of Protection of Consumer Rights and Human Welfare (Rospotrebnadzor):

• Mineral water (table water, medicinal water), bottled potable water (including water used in infant food), tonic water, alcoholic beverages including low-alcoholic beverages and beer.

• Food products produced with use of genetically modified (transgenic) organisms including genetically modified microorganisms.

• Cosmetic products.

• Household products.

• Personal care items for children and adults; items for children under three years: dishes and items used for child nutrition, products for child hygienic care; clothes for children (first layer).

• Items contacted with food products (except dish, eating utensils, technological equipment).

What documents are needed for obtaining a certificate of state registration for a product?

1) For national manufacturers:

• Application;

• Copies of the documents in accordance with which a product is manufactured (standards, specifications, regulations, technological instructions, formulas, information about a content), authenticated by manufacturer (producer);

• Copies of manufacturer’s documents certifying safety and quality of the examined samples authenticated in accordance with legislation of the country where the state registration is carried out;

• Manufacturer’s (producer’s) document on usage (operation) of the products (instruction, operation manual, regulation, recommendations) or its copy authenticated by the applicant (if any);

• Copies of labels (package) or their models authenticated by the applicant;

• Copies of the documents about specific activity of biologically active additives for food (for products containing unknown components, unofficial protocols) authenticated by the applicant;

• Act of sample taking;

• Manufacturer’s (producer’s) declaration about presence of genetically modified (transgenic) organisms, nanomaterials, hormones, pesticides in food products;

• Research (testing) report, scientific reports, expert report;

• Statement from Unified State Register of Legal Entities or Unified State Register of Individual Entrepreneurs;

2) for foreign manufacturers:

• Application;

• Copies of the documents in accordance with which a product is manufactured (standards, specifications, regulations, technological instructions, formulas, information about a content), authenticated in accordance with the legislation of the country where the state registration is carried out;

• Manufacturer’s (producer’s) declaration about presence of genetically modified (transgenic) organisms, nanomaterials, hormones, pesticides in food products;

• Manufacturer’s (producer’s) document on usage (operation) of controllable products (instruction, operation manual, regulation, recommendations) or its copy authenticated by the applicant (if any);

• Copies of manufacturer’s (producer’s) documents certifying safety and quality of the examined samples authenticated in accordance with legislation of the country where the state registration is carried out;

• Copies of labels (package) or their models authenticated by the applicant;

• Copies of the documents about specific activity of biologically active additives for food (for products containing unknown components, unofficial protocols) authenticated in accordance with legislation of the country where the state registration is carried out;

• Originals and copies of the documents about toxicological characteristic of a product (for pesticides, agricultural chemicals, means of protection and phytohormones) authenticated in accordance with legislation of the country where the state registration is carried out;

• Copy of the document confirming a free circulation of the goods on the territory of the country-manufacturer (producer) authenticated in accordance with legislation of the country where the state registration is carried out or evidences about the lack of necessity to execute such document issued in accordance with legislation of the country-manufacturer (producer);

• Research (testing) report, scientific reports, expert report;

• Copies of the documents confirming import of product samples to the custom territory of the Custom Union authenticated in accordance with legislation of the country where the state registration is carried out;

Most of the necessary documents are issued by special authorities or by Chamber of Industry and Commerce of the country-manufacturer.
Translations of the manufacturer’s (producer’s) documents to foreign languages must be authenticated in accordance with legislation of the country where the state registration is carried out.
*Custom Union: the Russian Federation, Belarus Republic, Kazakhstan.

For more detailed information, please, contact us:
Moscow: tel: + 7 (495) 644-40-34; fax: + 7 (495) 660-94-83;
Saint-Petersburg: tel/fax + 7 (812) 303-86-00;
Vladivostok: Tel.: + 7 (4232) 42-91-86.

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