Sanitary-epidemiological conclusion (Hygiene certificate) – is a document giving a permission of the competent authorities of RosPotrebNadzor to manufacture or import products that comply with all stipulated requirements, current hygienic standards and sanitary regulations (HS and SanPin) and confirming that a product is safe for human life and welfare.

Sanitary-epidemiological conclusion was issued on the basis of test results and confirmed by the reports of respective tests. The cost of sanitary-epidemiological conclusion was defined individually depending on difficulty and period of time needed for getting sanitary-epidemiological conclusion.

How to obtain a sanitary-hygienic certificate?

To obtain a certificate is possible only after examination of the product. All baby products, food products, all kinds of clothes, all goods contacting with human skin should be examined. The examination is conducted by the Authorities of State Sanitary and Epidemiological Supervision Department operating all over the country and some kinds of products must be examined only at the Federal Service for Supervision in the Sphere of Protection of Consumer Rights and Human Welfare.

To obtain a sanitary-epidemiological conclusion you are to submit the following documents:

Sanitary-hygienic conclusion for series-produced goods of domestic origin:

1. Certificate of the state registration (OGRN) and certificate of the registration with the tax authority (INN);
2. Standard technical documentation for the manufactured product (Specifications (TU) or GOST);
3. Document confirming a proprietary right for working area or lease contract;
4. Permission of Sanitary-Epidemiological Agency (SES) for manufacture (recommended);
5. Certificates for materials used in manufacturing process.

Sanitary-hygienic conclusion for goods of domestic origin supplied in accordance with a contract:

1. Contract
2. A sample of supplied product and several kinds of goods;
3. Stamp with a head’s signature on applications and act of sample taking;
4. Description of a manufactured product (composition, trade dress, field of application) or safety data sheets for each kind of product;
5. Certificates of conformity, certificates of origin, information about country-manufacturer;
6. Specification to the contract or invoice;
7. Certificate of state registration and certificate of registration with a tax authority.

Sanitary-hygienic conclusion for goods of foreign origin supplied in accordance with a contract:

• Copy of the contract;
• Specification to the contract or invoice;
• Articles of Association (three first and the last pages);
• Certificate of the state registration (OGRN) and certificate of the registration with the tax authority (INN);
• Description of a manufactured product (composition, trade dress, field of application) or safety data sheets for each kind of product;
• Certificates of quality of a country-manufacturer (if any).

Sanitary-hygienic conclusion for series-produced goods of foreign origin:

1. Description of a manufactured product (composition, trade dress, field of application) or safety data sheets for each kind of product;
2. Name of manufacturing company and its address;
3. Document confirming quality of a manufactured product (recommended).

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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