Requirements for efficiency and safety of dietary supplements

In the first article of this heading general principles of certification of dietary supplements within the Customs Union were considered. However, certification is a process that involves an enormous preliminary effort to collect the documents and reports necessary to confirm the effectiveness and safety of a product.

It should be noted that the main document regulating the issues of safety indicators, conditions and processes of production, as well as the procedure of state registration is TR CU 021/2011. (“Biologically active supplements”). However, this document contains a large number of references to other regulatory documents, including MG “Determination of safety and effectiveness of dietary supplements to food”.

These guidelines provide definitions of the quality and safety of dietary supplements:

  • The quality of dietary supplements is a set of characteristics that determine consumer properties, efficiency and safety of dietary supplements to food.
  • Safety of dietary supplements means that there is no danger to the life and health of people of present and future generations.

The effectiveness and safety of dietary supplements as well as consumer properties are checked within the framework of a hygienic examination, which includes the following stages:

1.Initial expert evaluation of documents and materials characterizing this product;

2.Identification of the need for necessary research;

3.Conducting a complex of necessary sanitary-chemical, sanitary-microbiological and other types of research;

4.Experimental studies of toxicological, physiological and metabolic effects, confirming the declared profile of dietary supplements;

5.Clinical evaluation of effectiveness;

6.Comprehensive expert evaluation of the results, taking into account the data obtained in the course of research;

Research is carried out in institutions and laboratories accredited in the “Accreditation System for Laboratories of the State Sanitary and Epidemiological Service of the Russian Federation”.

Based on the results of the work, an expert opinion is prepared (the act of hygienic expertise), which is part of the registration dossier provided to the Rospotrebnadzor for subsequent review  (see article — “Biologically active additives”)


1.TR CU 021/2011

2.MG “Determination of safety and efficiency of dietary supplements to food”.



©Beawire — Dec 2018