Sanitary-and-Epidemiologic Certificate

Sanitary-and-Epidemiologic Certificate of the Ministry of Health (MH)
(“hygienic certificate”)

Sanitary-and-epidemiologic certificate or hygienic certificate is a document certified that the products, activity category or technical specifications are complied with accepted hygienic codes and sanitary regulations that are currently in force in RF.

Sanitary-and-epidemiologic certificate is given by Sanitary-and-epidemiologic Supervision Bodies (Centers of Hygiene) after products expertise (conditions of production) on the basis of test report and submitted documents. The products imported in Russia have to be subjected to sanitary-and-epidemiologic expertise. There are three types of sanitary-and-epidemiologic certificate (further – certificates):

  • for products;
  • for activity category (production, trade, catering, etc.);
  • for technical specifications ( TS );

We are further considering the question of sanitary-and-epidemiologic certification for products imported in Russia .

The period of certificate validity is from 1 month up to 5 years. The decision depends on the products type, submitted documents, and, surely, on expertise body responsible for the matter.

Unfortunately, the nomenclature of products subjected to sanitary-and epidemiologic expertise is not determined clearly enough. The approved list is quite general (Appendix 1 and Appendix 3 of the Ministry of Health Order N 325 of 15.08.2001) and is not adjusted to existed classifiers (OKP and CUSTOMS CODE codes). That is why sometimes it is uncertain whether it is necessary to carry out the hygienic certification.

From the standpoint of the RF Federal Customs Service Letter N 07-61/1249 of 05.10.2004 this circumstance can have quite unpleasant consequences for organizations-importers when customs getting-up of cargoes.

For more information see the first primary source (the Order N 325 of 15.08.2001 and in addition to it the Ministry of Health Order N 84 of 18.03.2002).

The next peculiarity of the sanitary-and-epidemiologic expertise is as follows. The expertise can be carried out not only by the Centers of Hygiene of the Ministry of Health but also by accredited Centers of other Ministries and Departments (the ministry of Defense, the Ministry of Internal Affairs, and others). The certificates given by those ministries are valid on the territory of Russian Federation.

However, there is the list of products (Appendix 3 of the MH Order N 325) for which expertise can be carried out only in the Federal Department on supervision in the sphere of consumers' protection and human well-being (the former name – Department of the State Sanitary-and-Epidemiologic Supervision, Ministry of Health of Russia ). These are different biological and other food supplements, products of medical prescription; all the household chemical goods in aerosol package and many others (see the list). In this case one has to be very careful. The hygienic certificate (it is made on the different headed note-paper) is given only after tests, their costs is by order of magnitude higher than for products from the list of Appendix 2. We do not deal with hygienic certificates for that kind of products.

Sanitary-and-epidemiologic products expertise and certification procedures:

  • booking and registration of application for products expertise;
  • determination of the necessary expertise extent;
  • drawing up of a contract for payment of works for expertise;
  • documentation expertise carrying out;
  • laboratory and instrumental research and tests carrying out;
  • decision-making on the basis of the products expertise results;
  • issue of the certificate and its registration in the List of sanitary-and-epidemiologic certificates for the products subjected to sanitary-and-epidemiologic expertise.

The Applicant submits documents given here for the products sanitary-and-epidemiologic expertise.

It is also possible to carry out sanitary-and-epidemiologic expertise of products with the inspection of production conditions. The products expertise with the inspection of production conditions is carried out on voluntary basis on the manufacturer demand and conducted with the purpose of sanitary-and-epidemiologic expertise for the whole products nomenclature. For more details see link.

In conclusion we mention where you can register officially the hygienic certificate for the products first of all in Moscow . It is the Moscow City ЦГСЭН , 4/9 Graphskij Per.

NOTE: sanitary-and-epidemiologic certificates given on the basis of application-declarations or letters of guarantee and not containing the products hygienic characteristics (the area underside of the sanitary-and-epidemiologic certificate is not filled in) are considered to be invalid. We recommend everyone to take this into account as problems at entry point will be unavoidable.