Mishustin appointed Rospotrebnadzor controller of dietary supplements labeling

BAA (dietary supplements)

Main article: dietary supplements (dietary supplements)

2023: Mishustin appointed Rospotrebnadzor controller of dietary supplements labeling

Prime Minister Mikhail Mishustin signed a decree appointing Rospotrebnadzor as the controller of the labeling of biologically active additives (dietary supplements) in Russia. The corresponding document on the official portal of legal acts was published on August 10, 2023.

According to the order of the government, Rospotrebnadzor will monitor the pace of legalization of the dietary supplement market, a decrease in the volume of turnover of expired products, as well as goods with revoked state registration certificates. Another indicator is a decrease in the turnover of dietary supplements, which include an underestimated amount of raw materials of animal origin.

Mikhail Mishustin

The document was signed on the eve of the mandatory labeling of dietary supplements, which is introduced on September 1, 2023. 21 categories of products fall under it, including natural and synthesized vitamins and their derivatives, provitamines, mixtures of vitamins and minerals and other dietary supplements. According to the Ministry of Industry and Trade, 1.6 thousand companies engaged in the turnover of dietary supplements took part in the experiment.

In August 2023, the Government of the Russian Federation also approved indicators for assessing the effectiveness of federal executive bodies using data and tools of the state information system for monitoring the turnover of goods subject to mandatory labeling by means of identification (GIS MT). The indicators also apply to dietary supplements. According to the Ministry of Industry and Trade, the approved KPIs (key performance indicators) are aimed at achieving effects in two main areas of countering product trafficking: legalization (whitewashing) of the market and control of product quality and safety - identifying goods with unconfirmed quality characteristics and permits in circulation.

Order of the Government of the Russian Federation No. 2137-r dated 08.08.2023

2022

Dietary supplement manufacturers will receive up to 50 million rubles from the FRP for the purchase of equipment for digital marking

Dietary supplement manufacturers in Russia will be able to receive up to 50 million rubles from the Industrial Development Fund (FRP) for the purchase of equipment for digital labeling of their products. We are talking about preferential loans at 1% for two years, said on September 16, 2022, Deputy Minister of Industry and Trade of the Russian Federation Vasily Shpak during a visiting meeting of the Ministry of Industry and Trade of the Russian Federation on the issue of labeling by means of identification of dietary supplements.

As for other manufacturers who are already participating in the labeling system, we plan to provide a preferential loan from the Industry Development Fund for the dietary supplement commodity group, he said.

Dietary supplement manufacturers will be able to get a loan at 1% for marking equipment

According to Shpak, all manufacturers who began to participate in the labeling system note its effectiveness both for business development and for consumers. The experiment on voluntary labeling of dietary supplements is carried out from May 1, 2021. From April 1, 2023, manufacturers will be required to apply digital marking codes to each product unit. According to Shpak, work on equipping production with marking equipment should be started six months before the planned date.

Deputy General Director of the CRPT Revaz Yusupov assured of the availability of stocks of the necessary equipment.

These reserves are designed for at least six months and are constantly replenished. Therefore, there are no problems with equipment on the market and is not predicted, "he said.

By mid-September 2022, about 2.5 thousand organizations are participating in the dietary supplement labeling experiment, of which 167 are dietary supplements manufacturers, 163 are importers. More than 18 million marking codes have already been issued, most of the technological and business processes that take into account the specifics of the production and turnover of dietary supplements have been tested.^[1]

The Ministry of Industry and Trade approved the mandatory digital labeling of dietary supplements

In August 2022, the timing of the introduction of mandatory digital labeling of dietary supplements became known - from April 1, 2023.

Establish that participants in the circulation of dietary supplements, <...>introducing said biologically active food additives into circulation; applying identification means to the consumer packaging, including by applying a label to the consumer packaging; comprising identification means, said biologically active food additives and presenting to the monitoring information system information on application of identification means and introduction into circulation of said biologically active food additives in accordance with the rules; approved by this resolution, from October 1, 2022, - said in a document published on the portal of draft regulatory legal acts.

Ministry of Industry and Trade approved digital labeling of dietary supplements and children's water

The deadlines are also set for providing information on turnover and withdrawal from it: from September 1, 2023 for retail trade, from November 1, 2023 - for wholesale trade within the framework of volume-article accounting, and from March 1, 2025 - for wholesale trade within the framework of sample accounting.

By August 2022, an experiment on the labeling of dietary supplements is underway in Russia. More than 1,000 companies participate in it, of which 83 are manufacturers and 101 are importers.

On March 1, 2023, Russia plans to begin labeling children's drinking water according to the Honest Sign system. In August 2022, the director of the department of the system of digital labeling of goods and legalization of the turnover of products of the Ministry of Industry and Trade RFkaterina Prizhedeva told about this.

Now such water is excluded from labeling, but, as practice has shown, unfortunately, unscrupulous participants use this exception in order to get away from labeling, "she said (quoted by TASS).[2]

2021

Almost half of the participants in the association of dietary supplements manufacturers are participants in the labeling experiment

From May 1, 2021, an experiment was launched on the labeling of dietary supplements for food, which will last until August 2022. The largest participants in the association, controlling up to 40% of the dietary supplement pharmacy market, have already announced their intention to take part in the experiment, the Union of Dietary Supplement Manufacturers for Food reported on May 25, 2021.

According to Alexander Zhestkov, executive director of the Union of Dietary Supplement Manufacturers SRO, "Brands such as Sun Pharma, Evalar, Amway, Queisser Pharma, VPlab nutrition and others have already confirmed their participation in the experiment."

The experiment will take place in several stages: first, it will affect only manufacturers, then distributors will connect, then retail chains. Until July 15, according to a government decree, the Ministry of Industry and Trade, together with Rospotrebnadzor, will develop and approve guidelines for labeling, as well as an accurate schedule for the experiment. The first interim results of the experiment will be summed up until November 30, 2021.

According to Zhestkov, the labeling of dietary supplements for food is introduced to ensure transparency in the market. On the one hand, with the help of a special application "Honest Sign," the buyer will be able to obtain reliable information about the product at any point in the distribution chain. On the other hand, labeling will reduce the level of illegal turnover and prevent "overflows" of products on the market.

Alexander Zhestkov also expects that the introduction of labeling will become a certain tool for obtaining analytical data: "Over the past few years, the e-comm sales channel has been actively developing, through which there is no consolidated analytics. I hope that with the introduction of labeling, manufacturers will be able to see data on the turnover of their goods and expand the possibilities for analysis and forecasting in the digital segment. "

"The dietary supplement market is actively developing, the number of companies supplying their products to the market is growing, sales channels are developing. Under these conditions, it is critical to create an effective product quality control system. Labeling will reduce the share of low-quality and unsafe products and protect the interests of consumers. The CRPT works with manufacturers and is ready to develop various methods for applying codes that are optimal for different types of companies for their comfortable integration into the system, "said Revaz Yusupov, Deputy General Director of the Center for the Development of Advanced Technologies.

As of May 2021, the self-regulatory organization "Union of Dietary Supplement Producers" (SRO SP Dietary Supplement) unites 30 Russian and foreign companies, manufacturers of dietary supplements and other specialized food products.

Determination of the terms of the experiment on the labeling of dietary supplements

An experiment on the labeling of biologically active food additives will be held in Russia from May 1, 2021 to August 31, 2022. The corresponding government decree was published on May 4, 2021 on the official Internet portal of legal information.

As of May 2021, the CRPT is working with dietary supplement manufacturers, for our part we are ready to start the experiment. As part of the experiment, optimal technical solutions will be developed, including the use of existing equipment and the integration of information systems. The experiment is voluntary. By introducing dietary supplements labeling and reducing illegal turnover, bona fide manufacturers will be able to increase their market share, and, accordingly, their profits. Marking is not just a code application, but digital traceability along the entire chain from the manufacturer to the counter. It cuts off products of incomprehensible origin from stores, - said Yegor Zhavoronkov, head of the Pharma commodity group of the Center for the Development of Advanced Technologies (CRPT).

Plans for the start of labeling of dietary supplements

On February 8, 2021, it became known about the upcoming introduction of digital labeling of dietary supplements (dietary supplements). The corresponding experiment will begin on April 1, 2021 and will last until March 1, 2022.

The list of products to be labeled as part of the experiment will include mixtures of vitamins and minerals intended for a balanced supplement to nutrition, fish oil, gelatin and its derivatives, sore throat lozenges and cough tablets, etc.

Companies will be able to participate in the experiment on a voluntary basis. To do this, they need to submit an application in accordance with the methodological recommendations approved by the Ministry of Industry and Trade and Rospotrebnadzor.

Ministry of Industry and Trade begins digital labeling of dietary supplements

In order to work out the tasks of the experiment at the production sites of manufacturers, including the choice of optimal technologies for applying identification means, for the period of the experiment, its participants will be provided with specialized equipment free of charge.

The Ministry of Industry and Trade must, by July 15, 2021, develop and approve guidelines and a schedule for the experiment, as well as requirements for the information system and information security. Reports on the results of the experiment must be submitted to the Government of the Russian Federation by February 1, 2022.

It is noted that the Center for the Development of Advanced Technologies (CRPT) will perform the functions of an information system operator during this experiment. The CRPT is already responsible for labeling drugs.

Rospotrebnadzor previously proposed to extend the mandatory labeling to dietary supplements. The head of the department, Anna Popova, explained that labeling is necessary due to the fact that falsified and counterfeit products are present on the consumer market. Labeling will reduce illegal trafficking in products, she assured.^[3]

Total Turnover Control System

• State Information System for Marking Goods
• Counterfeit Goods Monitoring System
• National Commodity Traceability System (NSP)
• CRPT: National Catalogue
• System of accounting (marking) of tobacco products
• Monitoring of Drug Product Movement
• Digital marking of dietary supplements
• Digital labeling of footwear products
• Mineral and potable bottled water labeling
• Labeling of dairy products
• RFID-labeling of alcohol in Russia
• Perfume labelling
• State system in the field of control over the turnover of precious metals, precious stones and products from them (GIIS DMDK)
• Marking of fur coats and fur products
• Animal labelling

• A system of total control of trade turnover is being created in Russia

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