State Registration Certificate - GBSI - Global Business Service Information

State Registration Certificate (SRC, sanitary and epidemiological inspection report, hygiene certificate) is an official document issued by a body of Rospotrebnadzor (Russian Federal Service for the Oversight of Consumer Protection and Welfare) or its territorial administrations confirming that the products specified therein are safe for human consumption and meet the requirements of the current standards and hygienic rules.

State registration of products is done with the following purposes:

• to identify and define certain properties of products that may pose danger to the life and health of consumers, as well as the existence of any possible harm caused to human during production, use (consumption) and circulation of the products;
• to assess the conformity of the products, their circulation and manufacturing conditions with the requirements of the state sanitary and epidemiological or veterinary rules and regulations, as well as hygienic standards;
• to determine the efficiency of measures for prevention (or termination) of harmful impact on human health from the products at their manufacturing, use or consumption, as well as upon demolition or utilization.

List of commodities subject to mandatory state registration

Availability of the state registration certificates gives a right to the products manufacturer or supplier to sell certified goods without constraints in the territory of Russia and other countries that are members to the economic community of the Customs Union.

The Registration certificate is necessary for:

• biologically active supplements;
• sport nutrition;
• alcohol containing products, including beer and low alcohol beverages;
• bottled drinking water and mineral table water;
• food supplements and flavorants;
• beverages with tonic properties;
• baby food;
• cosmetic products (with the exception of special preparations);
• biological and chemical substances or materials posing danger to human and to the environment;
• household chemical goods;
• disinfectants;
• transgene products;
• paints and lacquers (primers, varnishes, mastics, enamels, putty pastes, fillers);
• personal hygiene items for children or adults;
• equipment used in the drinking water supply systems;
• goods for breast-feeding mothers or pregnant women.

State registration shall apply to biologic or chemical substances previously unused or newly introduced into production, as well as preparations produced on their basis that can potentially be dangerous and harmful for human health (except for medicinal products), new food products, items (materials) executed in Russia or coming into its territory for the first time.

Key steps for receiving a state registration certificate for the products

The process of state registration of products can conventionally be divided into the following steps:

• registration and acceptance of application;
• examination and analysis of the documents presented by the applicant describing the products’ properties and their conformance with the existing and effective rules, regulations and requirements (the set of such requirements is unique for each type of products);
• examination of results of the tests made in laboratory, assigning toxicology, sanitary, hygienic marks and other types of marks for evaluation of the products;
• reviewing of collected data against the laws of the ‘party’ where the registration takes place (if necessary);
• entering the products data and information into the State Register (if the procedure of state registration has been passed successfully);
• issuance and release of the document confirming the products state registration.

Registration certificate is issued in accordance with the unified format of the Customs Union states and is effective in its entire territory.

Documents required for obtaining state registration certificates for the products

State registration of domestic products takes place at the stage of their preparation for manufacturing, and for imported products – prior to their entry in the Russian territory.

Documents required for imported products:

• request for the execution of state registration of substances, products or preparations;
• copies of incorporation documents and contract;
• documents issued by appropriately authorized bodies of the country of goods origin and confirming their safety for people (mandatory legalization of the document is necessary);
• technical and regulatory documents used as guidance for production of imported products (regulations, standards, technical specifications, data sheets, manuals, formulations etc.) verified by stamps and signatures of the manufacturer;
• tare label or consumer label (its draft) in the Russian language certified with signatures and stamps of the applicant and manufacturer, as well as certified samples of the original label;
• examination reports of testing laboratories and protocols of testing;
• sample collection report completed in the prescribed form;
• verified copies of certificates for the trade mark (product mark) use (if it exists);
• powers of attorney authorizing to represent the interests of the manufacturer and directly receive the end document.

The documents of foreign origin must be translated into the Russian language, and their copies must be certified in full compliance with the established procedure.

Depending on the products peculiarities and characteristics the list of documentation can be extended or complemented with other documents.

Failure to observe the requirements with regard to the extent of safety of the manufactured products will involve responsibility as prescribed by the laws in the form of take-out of such goods from circulation in the consumer market or imposing a penalty on their manufacturer (supplier). In addition, if the products caused significant harm to human health, the level of the responsibility imposed can be much more severe depending on the volume, type and the extent of severity of inflicted damage.

Should you need a certificate of state registration, make use of the services provided by our company. We work on the execution of all necessary documents and render a whole range of extra services. To receive state registration, you can contact us whenever it is convenient. We will complete the entire procedure on a turnkey basis and consult you on any questions.

Not to come across all the above-mentioned difficulties, we recommend contacting a qualified company for state registration. We will do it on a turnkey basis and provide accurate information on every stage.