Sanitary-Epidemiological Conclusion (formerly known as the hygienic certificate) is the document that confirms the authorization by the Ministry of Health and Social Development (also known as the Ministry of Health or another Gossanepidnadzor) of production or import of goods consistent with statutory requirements, hygiene and sanitary regulations (GN and SanPin), and also serves as an official confirmation of product safety for human health.
As experience shows, often issuing the sanitary-epidemiological conclusion is a necessary condition for carrying out mandatory certification of products and obtaining the certificate of system conformity GOST R. In addition, the availability of sanitary-epidemiological conclusions is a mandatory requirement for transportation across the border and to commercialize products to be subject to obligatory sanitary and epidemiological evaluation.
Currently, the sanitary-epidemiological inspection of products by the territorial offices (registration of conclusions) and the Centers for Hygiene and Epidemiology (testing) of Rospotrebnadzor, while before the whole procedure could take place in a single center GosSanEpidemNadzor (Sanitary Inspection) of Russia (CGSEN). Several lines of sanitary-epidemiological assessment, as before, remain the exclusive prerogative of direct Rospotrebnadzor (formerly the Department of Sanitary Inspection in the Ministry of Health of the Russian Federation).
It is decided to allocate the following schemes for the registration of the sanitary-epidemiological conclusion (the hygienic certificate):
- the contract (without specifying the size of the lot, for the seller);
- for serial production (without a contract and lot size, for the manufacturer.)
The need for testing is determined by the sanitary physicians in each case separately, depending on the set of presented documents that confirm the safety of products for human health (test reports, safety data sheets, etc.), and, consequently, affects the overall cost of the sanitary-epidemiological examination of products.
