What is happening with cosmetics regulation in Ukraine

 
On 3 August 2024, the Technical Regulation on Cosmetic Products approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 of 20 January 2021 entered into force. The Regulation is harmonised with European Regulation (EC) No. 1223/2009 and effectively transposes the entire European cosmetics regulatory model onto Ukrainian soil — a notification-based, declaratory model with personal legal liability of the Responsible Person.
 
The legislature granted the market a two-year period for adaptation. This transitional period ends on 3 August 2026. Until that date, the old rules remain in force (DSanPiN sanitary standards and SES expertise conclusions); from the next day onward, only the new rules apply.
 
The fundamental difference of the new model: cosmetics are not certified or registered by the state. The Ministry of Health does not issue any “permit” or “certificate.” Instead, the market operator independently assumes full responsibility for product safety, prepares the documentation set, and notifies the state through an electronic system. Control shifts from “market entry approval” to “post-market surveillance.”
 
This model is faster and more flexible, but at the same time requires significantly greater regulatory maturity from market operators. A mistake will not result in a “refusal to issue a permit,” but rather in product withdrawal from the market and a fine.
 
 

Two legal realities after 3 August 2026

 
From this date, market operators must clearly distinguish between two categories of cosmetic products:
 
Category A — products placed on the market FOR THE FIRST TIME from 03.08.2026. That is, the first delivery from the manufacturer or importer to the next participant in the supply chain (distributor, pharmacy, marketplace) takes place on 3 August 2026 or later. Such products fall fully under the new Technical Regulation and require the entire set of procedures.
 
Category B — products ALREADY PLACED on the market before 03.08.2026. The first delivery took place on 2 August 2026 or earlier. Such products may remain in circulation under the old rules until expiry of their shelf life, with no additional procedures, no notification, and no labelling rework.
 
The legal watershed is precisely the date of first delivery — not the date of manufacture, not the date of customs clearance, and not the date of notification. The market operator must be able to prove this date documentarily — through invoices, delivery notes, customs declarations (VMD), and supply contracts.
 
 

Category A: cosmetics placed on the market from 3 August 2026

 
To place a new product on the market, the market operator must complete ten basic steps.
 
1. Designate a Responsible Person — a Ukrainian resident. This is a mandatory participant in the process. Without a designated Responsible Person, the product cannot lawfully remain on the market. For foreign manufacturers, the Responsible Person becomes the importer by default, but the function may be delegated in writing to a third party — for example, a specialised consulting or law firm. The legal address of the Responsible Person is indicated on the product packaging.
 
2. Verify the product composition. The Technical Regulation contains six annexes with ingredient requirements: prohibited substances (1,383 entries), restricted substances, permitted colourants, preservatives, and UV filters. CMR substances of categories 1A, 1B, and 2 are subject to a special regime. If the composition is not aligned with the annexes of TR No. 65, the product cannot be notified.
 
3. Ensure GMP compliance of manufacturing (ISO 22716). The manufacturer must hold a valid ISO 22716 certificate or an equivalent document confirming compliance with Good Manufacturing Practice.
 
4. Compile the Product Information File (PIF). This is the complete documentation package that the Responsible Person stores at the address indicated on the packaging for ten years from the date the last batch was placed on the market.
 
5. Prepare the Cosmetic Product Safety Report (CPSR). The document consists of Part A (factual data on composition, exposure, toxicological profile) and Part B (expert conclusion). The CPSR is signed by a qualified safety assessor — a specialist with a higher medical, pharmaceutical, toxicological, or chemical education. The pool of such specialists in Ukraine is limited.
 
6. Adapt the labelling into Ukrainian. The packaging must include: the full name and address of the Responsible Person, country of origin, nominal content, shelf life or PAO (Period After Opening) symbol, INCI ingredient list, special warnings, product function, and batch number.
 
7. Issue the Declaration of Conformity. A self-confirmation document signed by the Responsible Person attesting the product’s conformity with the Technical Regulation.
 
8. Submit the electronic notification. Information about the product is entered into the official System for Electronic Notification (Submission) of Information on Cosmetic Products of the Ministry of Health of Ukraine. The system operates under MOZ Order No. 2147 of 18.12.2023. Submission requires a qualified electronic signature. For products containing nanomaterials, notification must be submitted six months before actual market placement.
 
9. Set up the cosmetovigilance system. Collection, registration, and analysis of reports on undesirable effects. Serious undesirable effects must be reported immediately to Derzhlikslzhba.
 
10. Document the first delivery. The date of first delivery to the next participant in the supply chain is the date of placing on the market. This date must be confirmed by properly executed primary documents.
 
Important for multi-product brands: completing the full cycle for one product from scratch takes 8–12 weeks. For a portfolio of 20–30 SKUs, this work will stretch over months. Given the 3 August 2026 deadline, the market is currently in a phase of peak load — and the closer to the deadline, the higher the risk of “not making it.”
 
 

Category B: products already placed on the market before 3 August 2026

 
For transitional inventory, a substantially more lenient regime applies. Batches that were already first placed on the market before 03.08.2026 may be sold until expiry of the shelf life printed on the packaging. Such products do not require: notification submission; preparation of a new Declaration of Conformity; relabelling; preparation of a PIF or CPSR; implementation of ISO 22716 by the manufacturer at the level of these batches.
 
However, several important conditions and risks apply.
 
Condition one — proper documentation. The market operator must hold documents confirming the date of first delivery of each batch: invoices from the importer or manufacturer to the first buyer, customs declarations (VMD) for imports with the date of release into free circulation, supply contracts, and acceptance and transfer acts. Without these documents, proving during a Derzhlikslzhba inspection that a batch belongs to Category B will be difficult — and the presumption is not in the operator’s favour.
 
Condition two — no “new batches” under old rules. Each new delivery from importer to distributor after 03.08.2026 is treated as new placing on the market — even if it is the same product from the same manufacturer. The temptation to backdate a delivery would amount to a violation of the Law of Ukraine “On State Market Surveillance and Control of Non-Food Products,” with corresponding administrative and civil liability.
 
Risk three — MOZ initiative on a deadline for transitional sell-through. The Ministry of Health has initiated amendments that may limit the sale of transitional batches to 2030, regardless of shelf life. As of today, these amendments have not yet been adopted as a regulatory act, but operators relying on long-term sell-through of transitional inventory should monitor the legislation and be ready to adjust their strategy.
 
 

Common mistakes we see on the market

 
During our work supporting clients in cosmetic regulatory matters, we have identified several systemic mistakes against which we caution.
 
Mistake 1: “But we have an SES conclusion.” Sanitary-epidemiological expertise conclusions issued before TR No. 65 entered into force do not replace notification for new batches placed on the market after 03.08.2026. They remain valid only for that inventory which had already been placed on the market.
 
Mistake 2: “We’ll just convert our EU CPNP notification.” The Ukrainian Technical Regulation, although harmonised with the European one, does not provide for automatic recognition of European notifications. An EU CPSR may be used as a basis, but adaptation to the annexes of TR No. 65, verification of Ukrainian-language labelling, and submission to the Ukrainian system must be done by the Ukrainian operator.
 
Mistake 3: “The importer will notify it themselves when needed.” The importer is the Responsible Person by default, but this means accepting the full scope of legal liability for product safety, response to Derzhlikslzhba enquiries, cosmetovigilance management, and fines in case of non-compliance. Most importers objectively lack the in-house resources and qualifications to fully perform these functions.
 
Mistake 4: “We have a standard format — we’ll do it in 2 weeks.” Preparation of a PIF and CPSR even for a simple product takes a minimum of 4–6 weeks, assuming a complete dossier from the manufacturer. If additional testing or a CPSR from scratch is required — 8–12 weeks.
 
Mistake 5: “It’s not worth designating a Responsible Person for one product.” The legal institute of the Responsible Person allows no exceptions for small portfolios. A single SKU without a designated Responsible Person constitutes the same violation as an entire product line.
 
 

How ProPravo helps market operators

 
ProPravo Law Firm provides the full range of regulatory support services for cosmetic products on the Ukrainian market — from product readiness assessment under the Technical Regulation to representation before state authorities.
 
Performance of the Responsible Person function. We assume the legal Responsible Person function under a written mandate, with our address indicated on the product label and full liability before Derzhlikslzhba and consumers.
 
Preparation and support of the notification dossier. Regulatory review of composition against the annexes of TR No. 65, compilation of the PIF, preparation of the CPSR by a qualified safety assessor, adaptation of labelling into Ukrainian, issuance of the Declaration of Conformity, and submission of the notification to the Ministry of Health’s official electronic system.
 
Post-market support. Storage of the PIF at our address for 10 years, operation of the cosmetovigilance system, update of notifications upon changes to formulation or labelling, and regulatory monitoring of legislative changes with personalised information for our clients.
 
Legal support during inspections and corrective actions. Preparation of responses to Derzhlikslzhba enquiries, on-site inspection support, representation in disputes regarding placing on the market or product withdrawal, and management of product recall procedures.
 
Readiness audit and portfolio diagnostics. Before signing a contract, we conduct a free diagnostic review of your portfolio — assessing product complexity, availability of permits from the manufacturer, non-compliance risks, and the indicative cost estimate for bringing products into compliance.
 
We work with both Ukrainian manufacturers and importers, and with brands from the EU, the United Kingdom, the United States, Turkey, South Korea, and other countries. English-language support is a standard part of our service.
 
 

What you should do today

 
If you are a manufacturer, importer, or distributor of cosmetics on the Ukrainian market, we recommend that you act without delay:
 
1. Conduct a portfolio inventory as of today: which SKUs will be on the market as of 02.08.2026, and which need to be notified for further placing on the market.
 
2. Collect a complete dossier from manufacturers for notification: formulation, specifications, ISO 22716 certificate, test reports, existing CPSR.
 
3. Assess whether your enterprise is ready to perform the Responsible Person function in-house, or whether it makes sense to delegate it to a specialised firm.
 
4. Documentarily fix all deliveries in June and July 2026 — this is your legal protection of the transitional batch status.
 
5. Develop a transition plan for the first echelon of products and launch the notification preparation — so as to have ready, notified products on 3 August 2026, and not “scramble” after the old regime has ended.
 
The regulatory environment in Ukraine has now reached a qualitatively new level — the cosmetics market no longer operates on “permit” logic, and instead requires a thoughtful, integrated compliance strategy. ProPravo will be glad to be your partner in this transition.