March 13, 2025

Introduction

The registration of food and dietary supplements in Russia, Belarus, and Kazakhstan follows the regulations established by the Eurasian Economic Union (EAEU). The process ensures product safety, quality, and compliance with regional laws before supplements can enter the market. This blog provides a detailed overview of the registration process, regulatory authorities, documentation requirements, and key compliance considerations.

Regulatory Framework

The EAEU, comprising Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan, has harmonized regulations governing the circulation of food and dietary supplements. The primary regulatory framework includes:

  • Technical Regulation of the Customs Union (TR CU 021/2011) on Food Safety
  • TR CU 022/2011 on Food Labeling
  • TR CU 029/2012 on Food Additives, Flavors, and Processing Aids
  • Sanitary and Epidemiological Regulations issued by national health authorities

Each country has its national regulatory bodies:

  • Russia: Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing (Rospotrebnadzor)
  • Belarus: Ministry of Health, Center for Hygiene and Epidemiology
  • Kazakhstan: Committee of Sanitary and Epidemiological Control under the Ministry of Health

Registration Process

The registration process typically includes the following steps:

1. Preliminary Classification and Product Evaluation

  • Determine whether the product qualifies as a dietary supplement or functional food.
  • Check ingredient compliance with the EAEU and national positive and negative lists.

2. Preparation of the Dossier

The following key documents are required for submission:

  • Product composition and formulation details
  • Manufacturing process description
  • Certificate of Analysis (CoA) from the manufacturer
  • Safety and efficacy studies (if applicable)
  • Labels and packaging compliance with TR CU 022/2011
  • Manufacturing Good Manufacturing Practice (GMP) certificate
  • Free Sale Certificate (FSC) from the country of origin

3. Submission and Safety Testing

  • The application is submitted to the relevant national authority (Rospotrebnadzor, Ministry of Health, etc.).
  • The product undergoes toxicological, microbiological, and nutritional testing in accredited laboratories.

4. Expert Evaluation and Approval

  • National regulatory bodies review the dossier and test results.
  • If compliant, a registration certificate is issued, valid for five years.
  • The product is included in the Unified Register of Registered Products in the EAEU.

Labeling and Compliance Requirements

Labels must be in Russian and meet TR CU 022/2011 requirements. Key labeling elements include:

  • Product name and classification (e.g., "Dietary Supplement")
  • List of ingredients and nutritional values
  • Expiry date and storage conditions
  • Manufacturer details and country of origin
  • Recommended usage instructions and warnings
  • Compliance marks and registration number

Post-Market Surveillance and Renewals

  • Manufacturers must ensure ongoing compliance with safety and quality standards.
  • Regular market surveillance and inspections are conducted.
  • The registration must be renewed every five years with updated documentation.

Common Challenges and Solutions

Challenges:

  • Complex regulatory landscape due to national-specific requirements.
  • Long approval timelines and extensive testing.
  • Changing regulatory updates and interpretations.

Solutions:

  • Engage with local regulatory consultants and experts.
  • Ensure thorough documentation to avoid rejections.
  • Stay updated with EAEU regulatory amendments and guidelines.

How Maven Can Support

Navigating the regulatory landscape of Russia, Belarus, and Kazakhstan can be challenging. Maven offers expert regulatory consulting services to assist with dossier preparation, ingredient compliance checks, safety assessments, and submission processes. Our team ensures that food and dietary supplement manufacturers meet all EAEU requirements efficiently, enabling smooth market entry and compliance.

Conclusion

Registering food and dietary supplements in Russia, Belarus, and Kazakhstan requires adherence to EAEU regulations, national sanitary laws, and extensive testing. By understanding the process, documentation requirements, and compliance obligations, manufacturers can successfully navigate the regulatory landscape and access the lucrative markets of these countries. Partnering with regulatory experts like Maven can significantly streamline the registration and market entry process.