Rules for the production and labeling of dietary supplements – 2023.

Rospotrebnadzor plans to amend the technical regulations of the Customs Union “On food safety” (TR CU 021/2011) and “On the safety of certain types of specialized food products, including dietary therapeutic and dietary preventive nutrition” (TR CU 027/2012).

The changes will concern the production, sale and labeling of dietary supplements. Thus, with the help of amendments to the regulation TR CU 027/2012, Rospotrebnadzor expects to eliminate the threat to the health and safety of consumers associated with the release of dietary supplements in consumer packaging that has an external resemblance to drug packaging, which misleads the consumer regarding the purpose of the product. Also, the changes will make it possible to clarify the terminology of dietary supplements in accordance with the proposals of the EAEU member states.

Changes in the regulation TR CU 021/2011 are aimed at classifying dietary supplements as specialized food products (to be regulated by the technical regulation TR CU 027/2012), as well as specifying the composition of dietary supplements and establishing a dosage form of release.

And what about the experiment on labeling dietary supplements with individual codes?

The experiment was originally scheduled to end on August 31, 2022. But the Ministry of Industry and Trade extended it for another six months (Decree of the Government of the Russian Federation No. 1240 of 08/20/2022).

As a result, the deadline for completing the pilot project for labeling dietary supplements was set for February 28, and from March 1, labeling should have become mandatory. According to the latest data, the mandatory start of mandatory labeling has been postponed until autumn 2023.

During the experiment, dietary supplements market participants faced a number of problems. According to the online portal Pharmaceutical Bulletin, one of the problems associated with the introduction of mandatory labeling of dietary supplements was the supply of equipment. For large-scale production, in most cases, it is foreign equipment that is needed.

Some participants had to change supplier. For example, Evalar expects new deliveries by April this year.

Another problem was the inaccurate declaration of products. So, for some dietary supplements, declarations of conformity were and are being issued as for complex food additives, plant-based food concentrates and other types of food products, which removes them from mandatory labeling.