Mandatory labeling of dietary supplements: the experiment starts in April 2021

Less than a year ago, we wrote about the introduction of a system for monitoring the movement of drugs and highlighted the need to introduce a similar system for dietary supplements. As we wrote earlier, the prerequisites for initiation of the experiment were obvious (the head of the Rospotrebnadzor Anna Popova addressed to the Ministry of Industry and Trade with an official letter on this occasion).

According to the Federal portal of normative legal act drafts, on February 8, 2021, the preparation of the draft Decision “On conducting an experiment in the territory of the Russian Federation on labeling by means of identification of biologically active additives to food” started. The experiment is scheduled to be carried out between April 1, 2021 and March 1, 2022. According to the draft of Decision, participation in the project is voluntary.

Within the framework of the project, identification tools are planned to be used for the following categories of dietary supplements: vitamin A, as well as mixtures of vitamins and minerals; protein concentrates used in sports nutrition; lozenges from sore throat and cough tablets; enzyme preparations; products based on extracts, essences and coffee concentrates, etc. The codes of the EAEU foreign trade union are indicated in the list of the Decision.

The main objectives of the experiment are:

  • Determination and coordination of the composition of information about the product, allowing to uniquely identify the commodity unit of dietary supplements;
  • Testing the possibilities of using technologies for applying identification tools to dietary supplements and the composition of the information contained therein;
  • Approbation of completeness and sufficiency of dietary supplements labeling mechanisms by means of identification to ensure counteraction against the illegal import, production and circulation of dietary supplements, including counterfeit, as well as for increasing the collection of taxes and customs payments;

The full list can be found in the text of the Decision draft.

The experiment will be carried out with the participation of the Ministry of Industry and Trade and LLC “Operator-CRPT”, a company that already supervises the labeling of medicines. The Ministry of Industry and Trade needs to develop and approve methodological recommendations and schedule of the experiment, as well as requirements for the information system and information security system until July 15, 2021.

It should be noted that such a project is also under development of the Ministry of Industry and Trade for medical devices. Manufacturers are now voluntarily marking wheelchairs. The experiment will last until June 1, 2021. It was also planned to extend the experiment to coronary stents and diapers from February 1, 2021, but there is no information about the project implementation.

Computer tomographers and hearing aids were also considered among other potential categories of medical devices for the experiment extension.

However, according to the Russian Association of manufacturers of medical devices, it is not advisable to introduce labeling for all medical devices since “heavy” medical equipment is unlikely to be falsified, and products like medical masks are economically unprofitable to be labelled.