Dietary Supplement Registration

Dietary Supplement Registration is a mandatory state procedure to confirm the safety and quality of dietary supplements before their market release in the Eurasian Economic Union (EAEU).

Dietary Supplements (DS) are compositions of biologically active substances intended for:

• Compensating nutrient deficiencies;
• Supporting normal bodily functions;
• Disease prevention;
• Improving functional states of organs and systems.

DS Categories:

• Nutraceuticals: Sources of vitamins, minerals, amino acids;
• Parapharmaceuticals: Support organ and system functions;
• Eubiotics: Contain live microorganisms and their metabolites.

Key Differences from Medicines:

• No therapeutic effects claimed;
• No clinical efficacy trials required;
• Simplified registration process.

Key Terminology in Dietary Supplement Registration:

• Rospotrebnadzor: Federal Service for Surveillance on Consumer Rights Protection and Human Well-being – the registering authority for dietary supplements;
• SGR (Certificate of State Registration): The document confirming successful registration;
• Technical-Production Dossier (TPD): The complete set of documents proving quality, safety, and compliance with EAEU technical regulations;
• TF (Technical File): Manufacturer’s technical documents for the product;
• TR CU 021/2011: Technical Regulation of the Customs Union “On Food Safety” – the core regulatory document;
• EAEU: Eurasian Economic Union (member states: Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan).

Estimated Timelines for Dietary Supplement Registration:

Dietary Supplement Registration Procedure: From 3 months, maximum 6 months

Timelines may vary depending on product composition, intended use, and completeness of documentation.

Official State Fees for Dietary Supplement Registration:

Our Service Fees for Dietary Supplement Registration:

Full-service dietary supplement registration: From $3 680

Includes document preparation, laboratory testing coordination, Rospotrebnadzor liaison, and certificate delivery.

Costs may vary based on product complexity and specific testing requirements.

Core Regulatory Framework for Dietary Supplement Registration:

1. Decision of the Customs Union Commission No. 299 of May 28, 2010 “On the application of sanitary measures in the Eurasian Economic Union”;
2. Federal Law No. 52-FZ of March 30, 1999 “On the Sanitary and Epidemiological Welfare of the Population”;
3. Federal Law No. 29-FZ of January 2, 2000 “On the Quality and Safety of Food Products”;
4. Federal Law No. 532-FZ of December 31, 2014 “On Amendments to Certain Legislative Acts of the Russian Federation Regarding Counteracting the Circulation of Counterfeit, Substandard, and Unregistered Medicines, Medical Devices, and Counterfeit Dietary Supplements”;
5. Federal Law No. 150-FZ of June 7, 2025 “On Amendments to Certain Legislative Acts of the Russian Federation”;
6. TR CU 021/2011 of December 9, 2011 “On Food Safety”;
7. TR CU 022/2011 of December 9, 2011 “Food Products in Terms of Their Labeling”;
8. TR CU 029/2012 of July 20, 2012 “Safety Requirements for Food Additives, Flavorings, and Processing Aids”;
9. Methodological Guidelines MUK 2.3.2.721-98 “2.3.2. Food Products and Food Additives. Determination of the Safety and Efficacy of Dietary Supplements”.

Need to register Your dietary supplement in the EAEU? Contact us for a free consultation on the registration process.