How to register dietary supplements in Russia

Biologically active additives in Russia belong to the category of food products and are subject to mandatory state registration before being put on the market. This requirement is established by the regulatory legal acts of the Russian Federation and the Eurasian Economic Union. Dietary supplements cannot be legally produced and sold without state registration.
Registration of dietary supplements is carried out in the form of state registration with the receipt of a certificate of state registration (SGR). The authorized body that carries out this procedure in Russia is Rospotrebnadzor. Information about registered dietary supplements is entered into a Single Register, which is open and accessible to all market participants and consumers.
From the point of view of regulation, dietary supplements relate to food products, therefore, they are subject to the requirements of the technical regulations of the Eurasian Economic Union. First of all, TR CU 021/2011 "On Food Safety" is applied, which explicitly states that specialized food products, including dietary supplements, are allowed to be processed only after state registration. The requirements of TR CU 022/2011 "Food products in terms of their labeling" are also mandatory, defining the composition of information on packaging and restrictions on wording.
At the same time, confirmation of the compliance of dietary supplements with the requirements of the TR CU is carried out not through a declaration or certificate, but through state registration. The basis for issuing the SRS is a sanitary and epidemiological examination confirming the safety of products under the stated conditions of use.
It is worth noting that starting from September 1, 2025, the regulation of dietary supplements is supplemented with new requirements that relate not to the registration procedure itself, but to the procedure for product circulation on the market (Federal Law No. 150 of 06/07/2025). The changes that have entered into force strengthen control over the turnover of dietary supplements after receiving a certificate of state registration. The legislator introduces a mechanism for forming lists of dietary supplements approved for circulation, and also expands the powers of supervisory authorities to restrict sales of products that do not meet the established requirements. Since 2025, special attention has been paid to information about dietary supplements and their implementation channels. It is prohibited to disseminate information about products whose circulation is considered unacceptable, including posting information on the Internet and on marketplaces. Control over the reliability of statements about the properties of dietary supplements, their composition and purpose is being strengthened.
The procedure for registration of dietary supplements in Russia:
1. Preliminary examination of the dossier
At the first stage, experts evaluate whether it is even possible to register a product as a dietary supplement. They check the composition, dosages, formulations on the label and a set of documents to understand which materials are missing and which studies are needed.
2. Transfer of samples for laboratory testing
The manufacturer (or applicant) provides product samples. They are sent to an accredited laboratory where safety studies are conducted. They usually look at sanitary and chemical parameters, microbiology and, if necessary, control unwanted impurities.
3. Preparation and submission of a package of documents to Rospotrebnadzor
After receiving the protocols, a registration dossier is formed and submitted to Rospotrebnadzor. During the review process, experts accompany the examination and, if necessary, provide additional information at the request of the agency.
4. Obtaining a certificate and entering it into the register
If the examination is successful, the applicant is given a certificate of state registration (SRS), and information about the product is entered into the official state register. After that, dietary supplements can be legally released into circulation and sold.