How Russia withdraws cosmetics and dietary supplements that fail TR CU 009 and 021 safety rules
A single batch of shampoo with an excess of a prohibited dye can drag a manufacturer into a chain of events that is hard to exit with minimal losses. Most companies learn about the actual product recall procedure only when they receive their first compliance order from Rospotrebnadzor. By that point, production has stopped, partners have been notified, and the company’s reputation is on the line.
Meanwhile, the action algorithm is clearly set out in the law and includes specific deadlines. The problem is not that companies are unaware of these norms. The problem is that they are unprepared to execute them: they lack a response plan, batch documentation, and notification templates. As a result, the 10-day windows the law allows for verification and for developing a remedial action program are spent on organizational chaos rather than substantive work.
The system for withdrawing and recalling products that fail to comply with the Technical Regulations of the Customs Union (TR CU) is structured on two levels. The first level is set by Federal Law No. 184-FZ «On Technical Regulation» dated December 27, 2002 (hereinafter — FZ-184): it covers all products subject to TR CU, including perfumery and cosmetics. The second level applies specifically to dietary supplements as a category of food products and is detailed in Government Decree No. 1612 dated October 7, 2020 (hereinafter — PP No. 1612), which remains in effect until January 1, 2027.
This regulatory framework came into sharp focus after another change: since 2025, the «Chestny ZNAK» digital track-and-trace system has covered most cosmetics. The regulator now sees every package in real time, and the response speed to incidents has increased several-fold.
Cosmetics and Dietary Supplements Under Different Regulations
Perfumery and cosmetic products are regulated by TR CU 009/2011 «On the Safety of Perfumery and Cosmetic Products.» This document establishes mandatory requirements for toxicological parameters, microbiology, and composition: maximum limits for heavy metals, a list of prohibited ingredients, and microbial contamination standards. The form of conformity assessment is either a declaration of conformity or state registration, depending on the product type. The recommended manufacturing standard, ISO 22716 (GMP for cosmetics), is voluntary.
Dietary supplements fall under TR CU 021/2011 «On Food Safety» and undergo mandatory state registration with Rospotrebnadzor to obtain a Certificate of State Registration (known in Russian regulatory practice as SGR). The mandatory production management system for dietary supplements is HACCP (Hazard Analysis and Critical Control Points). This is a strict requirement, not a recommendation: the absence of an implemented HACCP system is itself a violation of TR CU 021/2011.
The practical difference between the two categories becomes apparent when a non-compliance occurs.
| Parameter | Cosmetics (TR CU 009/2011) | Dietary Supplements (TR CU 021/2011) |
|---|---|---|
| Supervisory authority | Rospotrebnadzor | Rospotrebnadzor |
| General recall procedure | FZ-184, Articles 38-40 | FZ-184, Articles 38-40 |
| Special withdrawal procedure | None | PP No. 1612 (until 01.01.2027) |
| Expert review during withdrawal | Not separately regulated | Mandatory sanitary-epidemiological review |
| Mandatory HACCP | No | Yes |
| Digital traceability | «Chestny ZNAK» since 2025 | Scheduled rollout |
How the Mechanism Under FZ-184 Works
Chapter 7 of FZ-184, «Information on Violation of Technical Regulation Requirements and Product Recall» (Articles 38-40), builds a sequence of obligations tied to specific deadlines.
Signal verification within 10 days. Upon receiving any information about a non-compliance (from a laboratory, a partner, a consumer complaint, or an order from a supervisory authority), the manufacturer, seller, or entity performing the functions of a foreign manufacturer is required to verify it. The law directly states that until the verification is complete, measures must be taken to prevent any potential harm from increasing. In practice, this means a de facto suspension of shipments of the affected batch, without waiting for official confirmation.
Remedial action program within the next 10 days. If the non-compliance is confirmed, the company has another 10 days to develop a remedial action program to prevent harm. The program is coordinated with Rospotrebnadzor. It must include methods for notifying consumers, implementation deadlines, and the procedure for cost reimbursement. All costs are borne by the manufacturer or seller. If the threat cannot be eliminated through the program, the law requires the company to declare a product recall and compensate buyers for their losses.
In practice, companies lose the most time at the program development stage. Coordinating with the regulator requires a clear document structure, a precise description of measures, and realistic deadlines. A program written the night before the deadline is often sent back for revision, by which point the 10-day clock has already run out.
Forced recall by court order. If the manufacturer fails to comply with the authority’s order or ignores the agreed program, Rospotrebnadzor may file a lawsuit for a forced recall. Once the court ruling takes legal effect, the defendant must take specific actions within the time set by the court. Information about the forced recall must reach consumers through the media or other means no later than one month from the date the ruling becomes legally binding. Violating recall requirements triggers criminal and administrative liability under Russian law.
In parallel, Rospotrebnadzor has a faster tool available: in the event of a threat to public health, the authority may order an immediate suspension of sales and independently inform consumers through the media, without waiting for the results of the company’s own review.
Special Procedure for Dietary Supplements Under PP No. 1612
For dietary supplements, FZ-184 works alongside a specialized act. Government Decree No. 1612 dated October 7, 2020, issued to implement Federal Law No. 29-FZ «On the Quality and Safety of Food Products» (hereinafter — FZ-29), sets out the procedures for withdrawing, storing, and destroying low-quality and dangerous food products. Since dietary supplements are classified as food products, PP No. 1612 applies to them in full.
PP No. 1612 establishes the owner’s obligation to withdraw non-compliant products from circulation, either voluntarily or upon an order from a supervisory body, and to arrange temporary storage. Records of withdrawn products must be kept separately from compliant stock, in paper or electronic form. If the owner avoids withdrawal, state supervisory authorities will petition the court for withdrawal and subsequent destruction.
Except for the cases listed in paragraphs 7 and 8 of the Regulation, withdrawn products are sent for a sanitary-epidemiological review. Based on the results, a conclusion is issued on whether the products can be processed for other use or must be destroyed. Destruction of hazardous products takes place in the presence of a representative of the state supervisory authority, either in person or remotely via video link.
PP No. 1612 remains in effect until January 1, 2027. After that date, the procedure will be governed by a new act. At the time of writing, that act has not yet been adopted. We recommend monitoring publications on the official legal information portal pravo.gov.ru starting in the autumn of 2026.
What Digital Labeling Has Changed
Since 2025, the «Chestny ZNAK» labeling system has covered most categories of cosmetics and household chemicals. Under Government Decree No. 1681 dated November 30, 2024, mandatory labeling was rolled out in stages: soap and detergents from May 1, 2025; hair and shaving products and deodorants from July 1, 2025; cosmetics and toothpaste from October 1, 2025. From July 1, 2026, the entire supply chain is required to report product movement data to the system through electronic document exchange and point-of-sale equipment.
This fundamentally changes the recall process. Previously, a manufacturer had to physically check warehouses and contact partners to localize a problematic batch. Now the regulator can see the entire path of each package: where it was shipped from, where it is located, and which till it passed through. Blocking a batch in the monitoring system in theory stops its sale at any till in the country without an inspector needing to be physically present.
A consumer who buys a product and scans its DataMatrix code through a mobile app receives the product’s current status. For businesses, this means a strict requirement to keep data synchronized: if the records in «Chestny ZNAK» do not match actual stock, that mismatch is itself a violation, one that will surface during the very first inspection.
The shift to digital traceability also affects how a recall is documented. Previously, a remedial action program relied on paper registries and phone notifications to partners. Today, the regulator expects updated data in «Chestny ZNAK» as part of executing the program. Failing to record a batch block in the system while removing it from physical warehouses creates a discrepancy that is treated as incomplete fulfillment of the company’s obligations.
Traceability as the Foundation of Recall Management
The speed and scope of a recall depend directly on the quality of the company’s traceability system. In practice, the regulator often requires a recall of all products from a given period, not just the problematic batch. The reason is simple: the manufacturer cannot document the exact boundaries of the defect.
Effective incident management requires four documents. The first is a shipment register linked to batch numbers, dates, and a list of recipients. The second is an internal response plan with assigned roles and contacts. The third is a list of accredited laboratories for prompt testing (for dietary supplements, laboratories licensed to perform sanitary-epidemiological review). The fourth is a set of notification templates for partners and the media, pre-approved by the legal department.
For cosmetics manufacturers already connected to «Chestny ZNAK,» traceability becomes largely automatic: the system records the movement of every unit. This only works, however, if data is entered correctly at every stage of production, from code application to the retail till.
A separate task is managing distributors and retail chains. A request to return a batch should be made in writing, stating the grounds, deadlines, and reimbursement terms. Supply contracts should include a clause giving the manufacturer the right to demand a halt to sales and the return of products once a TR CU non-compliance is confirmed. This makes it possible to act without litigation against partners and to stay within statutory deadlines.
What Triggers the Procedure and Who Is Liable
A recall procedure never arises in a vacuum. The law lists who carries the obligation: the manufacturer, the seller, or the entity performing the functions of a foreign manufacturer. For the cosmetics market, a Russian distributor of a foreign brand that has registered the declaration of conformity in its own name bears the full scope of liability under FZ-184, on par with the manufacturer.
Signals of non-compliance fall into internal and external sources. Internal sources include results of incoming raw material checks, retain-sample testing of finished products, warehouse stability monitoring, and failures detected at HACCP critical control points. External signals come from Rospotrebnadzor (orders and laboratory test reports), from trading partners, and from consumers through hotlines or the «Chestny ZNAK» mobile app.
A distinct category is hidden non-compliance: a product may be physically safe but legally classified as non-compliant with TR CU because of incorrect labeling. This includes missing warnings about contraindications, an incorrect list of ingredients, or the wrong country of origin. Under FZ-184, such products go through the same procedures as products posing an actual health risk. The difference is only in scale: for labeling violations, the remedial program is often limited to relabeling, and a physical market recall is not required. The full paper trail (notification, program, completion report) still has to be completed in full.
FZ-184 also gives Rospotrebnadzor the right to order an immediate sales suspension and inform consumers through the media in cases of an imminent threat to public health, before the company finishes its own review. When there is a direct threat to life and health, the regulator does not wait out the 10-day period.
Action Plan
Set up a recall management group. Include a quality director, a logistics manager, a lawyer, and a PR specialist. Put it in writing who authorizes a halt to shipments, who signs notifications to Rospotrebnadzor, and who coordinates communication with partners. The company has 10 days to verify a signal — without assigned roles in advance, that time will go to internal coordination instead.
Maintain a shipment register linked to batches. A list of recipients with dates and volumes should be available for every batch. If production runs through «Chestny ZNAK,» regularly reconcile actual stock against the system’s data.
Prepare a template for the remedial action program. The law requires the program to be coordinated with Rospotrebnadzor within 10 days of a confirmed non-compliance. A pre-built template shortens this process to a few hours.
For dietary supplements, set up a temporary storage area for withdrawn products. PP No. 1612 requires withdrawn products to be kept separately from compliant stock, with separate records. Make sure the facility has a designated, clearly marked area, along with a list of laboratories able to perform sanitary-epidemiological review.
Track the replacement of PP No. 1612 before the end of 2026. The current procedure for food products and dietary supplements expires on January 1, 2027. Watch pravo.gov.ru: changes to review and destruction procedures will require updates to internal instructions.
Companies that build an incident management system during calm periods go through recalls with minimal losses. Those facing a recall for the first time spend the very 10 days the law allows for verification and program development on organizational chaos instead. Being ready for the worst case is ordinary operational hygiene for a business handling products that directly affect human health. Investing in a response plan and a solid traceability system today costs far less than the administrative fines, legal costs, and reputational damage that come with a forced recall tomorrow.
Regulatory Framework:
1. Government Decree No. 1681 dated November 30, 2024 «On Approval of the Rules for Labeling Certain Types of Perfumery and Cosmetic Products and Household Chemical Goods with Identification Means»
2. Federal Law No. 184-FZ «On Technical Regulation» dated December 27, 2002 (as amended July 23, 2025), Chapter 7, Articles 38-40
3. Federal Law No. 29-FZ «On the Quality and Safety of Food Products»
4. TR CU 009/2011 «On the Safety of Perfumery and Cosmetic Products» (Decision of the Customs Union Commission No. 799 dated September 23, 2011)
5. TR CU 021/2011 «On Food Safety» (Decision of the Customs Union Commission No. 880 dated December 9, 2011)
6. Government Decree No. 1612 dated October 7, 2020 «On Approval of the Regulation on the Procedure for Withdrawal from Circulation, Expert Review, Temporary Storage, Processing, or Destruction of Low-Quality and (or) Dangerous Food Products…» (effective until January 1, 2027)