BIOLOGICALLY ACTIVE SUPPLEMENTS

Food supplements (in other words biologically active dietary supplement or biologically active additives) are subjected to obligatory registration in the Russian Federation and other countries of the Customs union (Belarus, Kyrgyzstan, Kazakhstan, and Armenia).
The Technical Regulations of the Customs Union TR CU 021/2011 “On Safety of Food” contains main requirements to the Biologically active food supplements and prescribe this type of product to be Registered in order to obtain EAC mark. 

THE STATE REGISTRY CERTIFICATE

The State Registry Certificate issued for food supplements is an approval document that gives the right to its producer to import and sell products on the territory of the Customs union (CU).

MAIN STAGES OF REGISTRATION

There are several stages that assumed under the process of food supplements registration:

STAGE 1: Product analysis.
This stage includes the preliminary investigation on the ingredient list of food supplement and determining basic ingredient and features. It can give us the overview whether the product can obtain the State Register Certificate or any correction must be done in order to meet the Customs union law.

STAGE 2: Preparing of the Registration dossier
The Registration process assumes analysis of the technical documents provided in the Russian language, namely technical specification, formulation, application instruction (Core Data Sheet), Free Sale Certificate, Registration documents of the manufacturing company, label etc. While working on the Registration dossier we are preparing test schedule and requesting samples for tests in the accredited laboratory on the territory of the CU. 

STAGE 3: Safety and Достоверность Expertise
The provided samples should be tested in the accredited certification laboratory in the CU to confirm the safety of the product (microbiological tests) and applied ingredients and concentrations. This stage lasts 1-2 month and ends by Expert Conclusion – special report that contains the tests results in overview and recommendations for Registration.
Stage 4: Obtaining the State Registry Certificate
The test reports and expert conclusion as so as Registration dossier are the main documents for submission for issuing of State Registry Certificate which is the final stage on the way to receive the EAC mark for the food supplements. 

WWBRIDGE CONSULTANCY

During the process of registration of food supplements WorldWideBridge team helps with the translation of all necessary documents to the Russian language, successfully import the samples for tests and make all customs clearance procedures, providing the label recommendations in order to meet all requirements of TR CUs.
We can also act as your Local Representative on the territory of Customs union countries because only a Customs union residential company can apply for State Registry Certification of the biologically active additives on the base of Local representative agreement.

Feel free to apply for certification via [email protected].

For more information, you can refer to the TR EAEU 021 through this link and to the TR EAEU 022 through this link.