Certification of dietary supplements in Russia: what documents are needed and how to register?
Biologically active supplements (BAS) are a popular category of goods, but they must undergo mandatory certification before entering the market. Without official confirmation of quality and safety, the sale of BAS in Russia is impossible.
In this article, we will look at what documents are needed, how certification takes place, and how long the process takes.
1. Why is certification of dietary supplements mandatory?
Dietary supplements are not medicines, but they affect the body, so their quality and safety are regulated by the legislation of Russia and the EAEU countries.
Mandatory registration of dietary supplements allows:
✔ To guarantee product safety to consumers.
✔ Avoid problems with Rospotrebnadzor.
✔ Legally sell supplements on marketplaces (Wildberries, Ozon, Yandex.Market).
✔ Enter the international market.
2. What documents are needed to register dietary supplements?
To certify dietary supplements in Russia, you will need:
📌 Technical documentation:
- Full description of the composition.
- Production standards (GOST, TU).
- Information about expiration date.
📌 Test protocols:
- Microbiological safety studies.
- Toxicology tests.
- Analysis of the content of vitamins, minerals, active substances.
📌 State Registration Certificate (SGR):
- Issued by Rospotrebnadzor after checking the safety of the product.
📌 Declaration of conformity TR CU 021/2011 (EAEU):
- A mandatory document for sale in Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
3. How does the certification process for dietary supplements work?
Stage 1. Preparation of documents
The manufacturer or importer collects the necessary documentation, including composition, technical characteristics and test reports.
Stage 2. Laboratory research
The products are tested in an accredited laboratory, where their safety is assessed (presence of toxins, heavy metals, microbes).
Stage 3. Registration with Rospotrebnadzor
Based on the tests, Rospotrebnadzor issues a State Registration Certificate (SGR).
Step 4. Obtaining the EAEU declaration
Based on the SGR, a declaration of conformity with the requirements of the Customs Union is issued.
Stage 5. Registration with Rospotrebnadzor
After registration, the products are officially allowed for sale in Russia.
4. How long does certification take?
- Laboratory testing – 3-4 weeks.
- Registration with Rospotrebnadzor – 20-30 days.
- Registration of declaration TR CU 021/2011 – 10-15 days.
Total period: about 2-3 months.
5. How much does certification of dietary supplements cost?
The cost depends on the composition of the product, the number of studies and the type of certification.
💰 Approximate prices:
- Laboratory tests: from 50,000 RUB.
- State registration certificate (SGR): from 100,000 RUB.
- EAEU declaration: from RUB 30,000.
‼ Important! Some marketplaces require additional certification, which increases costs.
6. Is it possible to sell dietary supplements without certification?
🚫 No! Selling dietary supplements without registration may result in fines and blocking of goods.
If the product is not certified, it may be removed from Wildberries, Ozon and other marketplaces.
✅ Advice: If you do not have the opportunity to certify your products, consider working with official distributors who already have the necessary documents.
Conclusion
Certification of dietary supplements is a mandatory process for legal sale. It requires time and financial investment, but guarantees product safety and customer trust.
Want to sell certified dietary supplements wholesale? Contact us for cooperation! 🚀