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You are here: Doing business Certification and licensing in Russia Which types of approval are there in Russia? Sanitary-Epidemiological Conclusion Certificate (Hygienic Certificate)

Sanitary-Epidemiological Conclusion Certificate (Hygienic Certificate)

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Application scope: Consumer & Industrial
Supervising authority: Rospotrebnadzor
When needed: GOST R certification, Customs clearance & Point of sale

What is Sanitary-Epidemiological Conclusion Certificate

The Sanitary-Epidemiological Conclusion Certificate (or Hygienic Certificate) confirms that products, activities or technical conditions conform to applicable hygienic standards and sanitary regulations in Russia.

The Sanitary-Epidemiological Conclusion Certificate is a pre-requisite for obtaining a GOST R Certificate of Conformity.

Application Scope

Hygienic Certification is required for the following:

  • FOOD STUFF - Foodstuff and beverages, food additives, biologically active additives, preservatives;
  • FOOD or SKIN – RELATED PRODUCTS - Materials and equipment that are in direct contact with food or skin or whose vapors can be inhaled, i.e. cosmetics, textiles, toys, food processing machinery, water treatment units, packaging materials, furniture, detergents and certain household appliances, chemical and petrochemical products for industrial application;
  • KIDS PRODUCTS - All kinds of products intended for children, including games, training appliances, stationery, baby carriages, satchels, artificial polymeric and synthetic materials used to manufacture products for children.

Sanitary-Epidemiological Conclusion Certification Schemes

  • Product – certification of products assures that their characteristics, whether they are made locally or imported, to be sold or used within Russian territory, complies with Russian hygienic standards.
  • Type of Activity – certification for types of activity to be carried out within Russian territory confirms that these activities comply with Russian sanitary standards.
  • Technical solutions – certification for technical solutions confirms that the product to be manufactured within Russian territory will be produced in compliance with Russian hygienic and sanitary standards.

Manufactures can request inspection of their production facilities to be issued a hygienic certificate for all of their manufactured products. Manufacturing conditions, quality control with regard to raw materials and technological processes and also safety and sanitary parameters of the final goods will be the focus of the inspectors.

Design and Content of the Certificates

Click here to view a sample of a Sanitary-Epidemiological Conclusion Certificate.

Procedure

Sanitary-Epidemiological Conclusion Certificates are only issued by the Russian Federal Service for Supervision in the Area of Consumer Rights and Welfare Protection or Rospotrebnadzor (formerly Gossanepidnadzor).

Two independent organizations, both part of Rospotrebnadzor, are involved in hygienic certification:

  • Center of Hygiene and Epidemiology – test protocol analysis and other documentation
  • Territorial Office of Rospotrebnadzor – issues final certificate based on the expert conclusion drawn by the Center of Hygiene and Epidemiology provided that the product conforms the compliance of the goods to the Russian Hygienic Standard

The nature of the product and the validity period of the certification command the depth of the technical review as well as the duration of the testing methods.

Certificate Validity

A Sanitary-Epidemiological Conclusion Certificate is valid for 1 or 5 years depending on:

  • type of product and associated risks to human health
  • shelf life
  • validity of previous hygienic certificates if there are any

Source: SGS

Samuel Ariaga Florez
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