Registration of Dietary Supplements in Russia: Specific Requirements and Key Stages

Dietary supplements, known in Russia as biologically active supplements (BAS), are specialized food‑category products incorporated into the daily diet to fine‑tune metabolic processes. They act as additional sources of vitamins, proteins, micro‑ and macro‑elements, carbohydrates, and other nutrients that may be under‑supplied in ordinary meals. By design, BAS support or enhance targeted physiological functions, yet they remain distinct from medicines in both purpose and regulatory status.

Despite that difference, the Russian state treats supplements as a sensitive public‑health commodity. Their manufacture, import, and retail sale are permissible only after a formal registration procedure that confirms safety, quality, and truthful labelling. The same obligation applies throughout the Eurasian Customs Union—which today comprises the Russian Federation, the Republic of Belarus, the Republic of Kazakhstan, and, in allied technical matters, Kyrgyzstan.

Why Registration Is Mandatory

Federal Government Decree No. 982 of 1 December 2009 and Customs‑Union Commission Decision No. 229 of 24 May 2010 make a Certificate of State Registration a legal prerequisite for every new supplement entering the market. The rules extend to both domestic products and imported lines supplied from abroad; no consignment can clear customs without the certificate.

In the Russian Federation, the competent body is the Federal Service for Supervision of Consumer Rights Protection and Human Welfare (Rospotrebnadzor). In Belarus and Kazakhstan, equivalent sanitary agencies hold identical authority. The certificate proves two things:

1. That an exhaustive safety evaluation has shown the product harmless for consumers when used as directed;
2. That the product is cleared for unrestricted circulation within Russia and all Customs‑Union states.

In other words, state registration is the central risk‑management tool that shields end‑users while structuring the rapidly growing supplement market.

Registration as the Core Step in Product Legalization

Even though BAS are not classified as pharmaceuticals, lawmakers insist on pre‑market approval. Manufacturers must secure their certificate at the earliest planning stage; foreign brands must do so before customs paperwork begins. The objectives of the procedure are threefold:

1. Analytical scrutiny of composition. Experts examine the full ingredient list, study how each component interacts in the human body, and identify any short‑ or long‑term risks to consumers and factory workers.
2. Specialized laboratory appraisal. Independent laboratories verify compliance with current sanitary‑epidemiological and hygienic norms. Supplements that contain raw materials of animal origin also need a separate veterinary‑sanitary conclusion.
3. Evaluation of manufacturing safeguards. Regulators check how well the producer prevents contamination, manages waste, and monitors expired or substandard stock.

The testing programmed normally covers:

• Microbiological purity (bacteria, yeast, mold)
• Levels of toxic metals and other hazardous elements
• Residues of pesticide compounds
• Concentrations of naturally occurring radionuclides

Although the regulatory bar for BAS is lower than for medicinal products, the standards are rigorous enough to guarantee safety and quality for everyday consumption.

Registration in Russia and the Wider Customs Union

Certificates in Russia come from Rospotrebnadzor; in neighboring states the competent bodies are:

• Belarus – Republican Centre for Hygiene and Public Health
• Kazakhstan – Consumer Rights Protection Committee, Ministry of National Economy
• Kyrgyzstan – Department for Disease Prevention and State Sanitary Surveillance

The Customs‑Union regime is technically unified, yet practical timelines and state fees differ by country. Importantly, each commercial name requires its own certificate, even if the formula is identical. Conversely, several dosage forms of the same supplement (e.g., capsules, powder, effervescent tablets) can share a single certificate.

Regulation evolves constantly. Recent amendments include:

• Abolition of the obsolete OKP‑2018 classifier codes
• Switch to updated OKVED‑2 and OKPD‑2 product codes
• A prohibition on registering supplements that contain ingredients regarded as medicinal analogues

Certificates issued in any Customs‑Union country are recognized across the entire bloc and remain valid indefinitely. Export to the European Union, however, demands separate approval in each destination state.

Professional Support for Registration

Preparing the dossier is labor-intensive. It involves collecting technical specifications, writing safety rationales, commissioning accredited laboratory studies, translating foreign‑language documents, and submitting multiple paper and electronic copies. Delays or errors can lead to expensive re‑testing or outright refusal. For that reason, many companies engage specialist consultants.

Our firm offers turn‑key or à‑la‑carte assistance. Acting as an authorized representative, we draft and lodge every document, monitor deadlines, and speak directly with regulator desks.

Domestic vs. Imported Supplements

Whether you are a Russian manufacturer or an overseas brand owner, “NVR Consult Group” supplies a full service bundle:

• Scheduling and supervising all laboratory analyses
• Making scientific or legal corrections at any stage
• Updating earlier expert opinions and certificates to new standards

Laboratory Research and Continuous Oversight

Regulations list a recommended roster of accredited test centers, but producers may choose any laboratory that holds a valid license in microbiology, toxicology, or radionuclide testing. Results from these labs carry formal legal weight.

We partner only with accredited facilities whose data are automatically accepted by Rospotrebnadzor. Our specialists track each study in real time, intervening if extra assays become necessary and ensuring final reports meet format guidelines.

Step‑by‑Step Registration Workflow inside the Customs Union

1. Preliminary audit. We review your existing documents, determine which tests are unavoidable, and prepare a cost–time schedule.

2. Contracting and document translation. We draft service agreements with chosen laboratories, translate foreign paperwork into Russian, and collect any missing declarations.

3. Laboratory testing. The supplement undergoes the agreed test battery. Our team confirms that sampling is representative and that each protocol follows state‑approved methods.

4. Dossier assembly. Test reports, product labels, specifications, and expert rationales are bound into a single package with continuous page numbering, dual inventories, and page‑count references—as required by Decree 982.

5. Submission and expert appraisal. The dossier is filed with Rospotrebnadzor (or the equivalent body abroad). Examiners may request clarifications; we prepare responses within statutory deadlines.

6. Certificate issuance and register entry. After a positive decision, the supplement is added to the Unified State Register, and the applicant receives the certificate that authorizes production, import, and retail sale across the Customs Union.

Thanks to our proven workflow and real‑time liaison with regulators, clients avoid repeated submissions and bring their products to market as scheduled.