Ukraine's Cosmetics Technical Regulation 2026: what changes on 3 August and how to prepare

# Ukraine's Cosmetics Technical Regulation 2026: what changes on 3 August and how to prepare

Less than a year remains until 3 August 2026. For every manufacturer, importer or distributor of cosmetics on the Ukrainian market, this is not an abstract date on the calendar — it is a hard legal deadline, after which products without e-notification will be considered to be in circulation unlawfully.

> In brief: The Technical Regulation for Cosmetic Products (CMU Resolution No. 65) is the principal law for cosmetics in Ukraine, harmonised with EU Regulation 1223/2009. From 3 August 2026, all cosmetic products in circulation must be registered through the Ministry of Health's electronic notification system, have a Product Information File, and meet GMP requirements.

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What the CMU No. 65 Cosmetics Technical Regulation is and when it entered into force

The Technical Regulation for Cosmetic Products was approved by [Cabinet of Ministers of Ukraine Resolution No. 65 of 20 January 2021](https://zakon.rada.gov.ua/laws/show/65-2021-п). The document is structured as a direct adaptation of [Regulation (EC) No 1223/2009](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223) into the Ukrainian legal framework — a key fact that simplifies compliance planning for businesses also targeting the EU market.

Before the UA TR entered into force, the market was regulated by sanitary and epidemiological requirements that involved obtaining certificates. From 1 October 2023, sanitary-epidemiological certification was abolished and replaced by a new system based on the principle of manufacturer responsibility. This is a conceptual shift: the state no longer issues product authorisations — the responsible person independently ensures safety and maintains supporting documentation.

The Regulation establishes requirements for:

• the safety of cosmetic products and their composition;
• documentation (Product Information File, Cosmetic Product Safety Report);
• labelling and packaging;
• manufacturing practice (GMP);
• notification via the Ministry of Health's electronic system;
• the responsible person as the central subject of compliance.

According to [Cratia](https://cratia.ua/en/service/technical-regulation-on-cosmetic-products/), the regulation covers all cosmetic products sold in Ukraine, regardless of country of manufacture. This means that imported products fall under UA TR requirements in the same way as those produced domestically.

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Key dates: 3 August 2024, 1 December 2025, 3 August 2026

Three dates form the regulatory timeline that every market operator needs to know.

| Date | Event | Content | |------|-------|---------| | 01.10.2023 | Abolition of sanitary-epidemiological certification | Transition from a permit-based to a notification-based system | | 03.08.2024 | UA TR fully in force | The Regulation entered into force; products may comply either with the UA TR or with general product safety legislation | | 01.12.2025 | Launch of e-notification | The Ministry of Health opened the electronic notification portal for cosmetic products (Order No. 2147 of 18.12.2023) | | 03.08.2026 | Hard deadline | All cosmetic products in circulation in Ukraine must be fully compliant with the UA TR and notified |

The launch of the e-notification system on 1 December 2025 has been confirmed by [The World Law Group](https://www.theworldlawgroup.com/membership/news/news-ukraine-launched-e-notification-for-cosmetic-products). In effect, active product registration began on that date. About eight months remain after the portal's launch until 3 August 2026 — a narrow window for companies with a large SKU portfolio.

A practical calculation: if a company has 100 SKUs and the preparation of a PIF + CPSR for each takes 2–4 weeks, planning must begin no later than the fourth quarter of 2025. For new products launched onto the market after 3 August 2026, notification is mandatory before being placed on the market.

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The Responsible Person in Ukraine: who can be one and what they are required to do

The concept of the Responsible Person (RP) is a central element of the UA TR, taken directly from EU 1223/2009. The Responsible Person bears legal liability for the product's compliance with all requirements of the Regulation.

According to [EcoMundo](https://ecomundo.eu/en/blog/ukraine-regualtion-cosmetics-eu) and [Cratia](https://cratia.ua/en/service/technical-regulation-on-cosmetic-products/), the Responsible Person in Ukraine may be:

| Type of entity | Condition | |---|---| | Domestic manufacturer | A legal entity or sole proprietor that is a resident of Ukraine | | Importer | A person that first brings the product into the customs territory of Ukraine | | Authorised representative | Appointed by the manufacturer on the basis of a written mandate |

Key requirement: the Responsible Person must be a resident of Ukraine. A foreign manufacturer without a presence in Ukraine is required to appoint a Ukrainian importer or authorised representative.

Responsibilities of the Responsible Person:

• Ensure the product's compliance with UA TR requirements before placing it on the market.
• Compile and maintain the Product Information File (PIF) for 10 years after the last batch is withdrawn from circulation.
• Carry out e-notification in the Ministry of Health's system.
• Take corrective measures if non-compliance or a health risk is identified.
• Inform market surveillance authorities of serious undesirable effects.
• Provide competent authorities with access to the PIF upon request.

Compared with EU 1223/2009, there is one main structural difference: the requirement of residency in Ukraine instead of residency in the EU. The remaining functional duties of the RP are practically identical.

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PIF and CPSR under the UA TR: what is required, and the language of documents

The Product Information File (PIF) is the documentation package that the Responsible Person is required to prepare and maintain. The UA TR sets out the list of mandatory components of the PIF, which corresponds to the structure of Annex I to EU 1223/2009.

Mandatory composition of the PIF under the UA TR:

1. Description of the cosmetic product (name, intended use, category). 2. Qualitative and quantitative composition (INCI names, concentrations). 3. Physico-chemical and microbiological characteristics. 4. Toxicological profile of ingredients. 5. Consumer exposure data (exposure assessment). 6. Cosmetic Product Safety Report (CPSR) — Parts A and B. 7. Declaration of conformity with GMP and description of the manufacturing process. 8. Substantiation of claimed effects.

The Cosmetic Product Safety Report (CPSR) is the core of the PIF. It consists of two parts: Part A — informational (composition, characteristics, stability, microbiology); Part B — the safety assessment itself, signed by a qualified safety assessor.

Language of the documents: the CPSR may be drawn up in English, but in accordance with Article 13 of the Law of Ukraine "On Ensuring the Functioning of the Ukrainian Language as the State Language", a Ukrainian-language translation is required — as confirmed by the analysis of [EcoMundo](https://ecomundo.eu/en/blog/ukraine-regualtion-cosmetics-eu). In practice, this means that if a manufacturer already has an EU CPSR in English, the document is technically acceptable but requires an official translation in order to be provided to surveillance authorities.

The PIF retention period is 10 years from the date of the last batch of the product in circulation. This is identical to the EU 1223/2009 requirement.

Important: the UA TR does not require the safety assessor to hold a Ukrainian qualification. However, the document must comply with the methodological standards based on the SCCS Notes of Guidance. For detailed CPSR requirements, see our [complete guide for the manufacturer](/news/cpsr-2026-povnyi-haid-vyrobnyka).

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E-notification on the Ministry of Health portal: a step-by-step process

E-notification is the equivalent of the CPNP (EU Cosmetic Products Notification Portal) for the Ukrainian market. The system was launched by the Ministry of Health on 1 December 2025 on the basis of Order No. 2147 of 18 December 2023, according to data from [The World Law Group](https://www.theworldlawgroup.com/membership/news/news-ukraine-launched-e-notification-for-cosmetic-products).

Notification is carried out by the Responsible Person — a resident of Ukraine. Information from the Ministry of Health portal is accessible to public health, market surveillance and toxicological control authorities.

### What to submit (category, INCI, nanomaterials, CMR substances)

In accordance with UA TR requirements, the following are submitted during notification:

• Type, shade and intended use of the cosmetic product.
• Country of origin.
• Image (graphic file) of the package labelling.
• Product category.
• Composition in INCI format.
• Presence of nanomaterials: where applicable — IUPAC name, particle size distribution, exposure conditions.
• Presence of CMR substances: where applicable — CAS and EC numbers.
• Contact person of the Responsible Person for prompt communication.

Note: the requirements regarding nanomaterials and CMR substances in the Ministry of Health notification system structurally correspond to the UK SCPN and EU CPNP requirements. Companies that have already completed EU notification can reuse a significant portion of the information already prepared.

Labelling in Ukraine is subject to a separate requirement: all mandatory information must be exclusively in Ukrainian. It may be applied by means of a sticker or insert, which allows importers to avoid full re-packaging — as confirmed by [Cratia](https://cratia.ua/en/service/technical-regulation-on-cosmetic-products/).

### Deadlines: 3 August 2026 for all products in circulation

The 3 August 2026 deadline is firm and does not allow for any transitional extension. By that date, notification must be completed for:

• all products already in circulation at the time the system is launched (1 December 2025);
• all new products placed on the market between 1 December 2025 and 3 August 2026.

After 3 August 2026, any new product must be notified before being placed on the market. For products containing nanomaterials, by analogy with EU practice, notification is submitted before placing on the market. For a detailed comparison with the EU CPNP process, see our [step-by-step CPNP notification guide](/news/cpnp-notyfikatsia-2026-pokrokovyi-haid).

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GMP: DSTU EN ISO 22716:2015 — what needs to be evidenced

Good Manufacturing Practice (GMP) is a mandatory UA TR requirement. The harmonised standard for Ukraine is DSTU EN ISO 22716:2015 (Ukraine's national standard), which is a direct adoption of the international standard EN ISO 22716:2007 "Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices".

Compliance with DSTU EN ISO 22716:2015 provides a presumption of conformity with UA TR requirements on manufacturing practice. The standard covers:

• organisation of production and personnel;
• management of raw materials and packaging materials;
• in-process quality control during manufacturing;
• management of deviations and complaints;
• documentation and traceability;
• internal audit.

What must be evidenced in the PIF: a declaration of conformity with GMP is a mandatory section of the documentation package. In practice, this may be:

• a certificate of conformity with ISO 22716 issued by an accredited certification body;
• or the manufacturer's own declaration, stating the basis for it.

For Ukrainian manufacturers that previously held sanitary-epidemiological certification, GMP documentation is often only partial — so it is recommended to carry out a gap analysis against DSTU EN ISO 22716:2015 before submitting the notification.

Since EU 1223/2009 also refers to EN ISO 22716:2007 (the DSTU equivalent is identical), manufacturers compliant with UA GMP face minimal additional steps for their practice to be recognised on the EU market.

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UA TR vs EU 1223/2009: what already complies and what does not

The UA TR was developed as a harmonised document — according to expert assessments, it corresponds to EU 1223/2009 by approximately 70–80%, according to data from [research-ua-market.md](/home/user/workspace/research-ua-market.md). This is a substantial advantage for manufacturers preparing for the EU market in parallel.

| Requirement | UA TR (CMU No. 65) | EU 1223/2009 | Status | |--------|-----------------|--------------|--------| | Responsible Person | Resident of Ukraine | Resident of the EU | Equivalent structure, different jurisdiction | | PIF / CPSR | Mandatory, Annex I structure | Mandatory, Annex I | Identical requirements | | E-notification | Ministry of Health, Ukraine (from 01.12.2025) | CPNP (EU) | Equivalent purpose, separate systems | | GMP | DSTU EN ISO 22716:2015 | EN ISO 22716:2007 | Identical standards | | Labelling — language | Ukrainian | Language of the country of sale | Different language requirements | | Prohibited substances | UA TR Annex II (baseline 2021 version) | EU Annex II (updated by Omnibus VII, VIII and onwards) | UA lags behind by several Omnibus acts | | Nanomaterials | Notification to the Ministry of Health | Notification to the CPNP + 6 months before launch | Equivalent principles | | CMR substances | UA TR Annex II | EU Annex II + automatic update via CLP ATP | Partial divergence | | Allergen labelling (82 allergens) | Not included (based on 2021 EU version) | Mandatory from 31 July 2026 | The UA TR does not contain the new EU requirement | | Omnibus VII/VIII | Not included | Mandatory (09/2025, 05/2026) | The UA TR requires separate monitoring | | Microplastics ban | Not included | REACH 2023/2055 (phased) | Not contained in the UA TR |

Key strategic takeaway: a manufacturer that has met UA TR requirements (PIF, CPSR, GMP, notification to the Ministry of Health) is approximately 70–80% ready for EU compliance. What remains is:

1. Appoint an EU Responsible Person (a legal entity in the EU). 2. Notify the product on the CPNP. 3. Check the formulation against the latest Omnibus VII and VIII (in particular, new prohibitions on CMR substances). 4. Add labelling of the 82 allergens for batches placed on the EU market after 31 July 2026.

For a detailed look at labelling differences between the EU, UK, US and Ukraine, see our [2026 labelling guide](/news/markuvannya-kosmetyky-eu-uk-us-ukraina-2026).

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Fines for non-compliance and consequences: from UAH 51,000

The UA TR establishes legal liability for breaches of the Regulation's requirements. Administrative liability is governed by the Code of Ukraine on Administrative Offences.

Fines for breaches of cosmetic product requirements start from UAH 51,000 and upwards. This figure is a baseline benchmark, while depending on the nature of the breach, the severity of the consequences and recurrence, the level of sanctions may be substantially higher.

In addition to fines, market surveillance authorities are entitled to:

• Withdraw the product from circulation and block its sale.
• Require recall of the product from consumers.
• Suspend the operation of the enterprise.
• Initiate criminal proceedings in the event of harm caused to consumer health.

Practical risks of non-compliance after 3 August 2026:

• Lack of notification: the product is considered to be in circulation unlawfully, even if it is in fact safe.
• Absence of a PIF or CPSR: the Responsible Person cannot demonstrate the product's compliance — grounds for withdrawal from the market.
• Breach of GMP requirements: calls into question the safety of the entire manufacturing process.
• Non-compliant labelling (absence of Ukrainian-language information): a breach that is easy to detect during inspection.

Market surveillance of cosmetic products in Ukraine will be carried out in the context of preparation for EU membership, which entails a gradual alignment of surveillance standards with European ones. From 2027, a new regulatory authority is planned to be launched, consolidating the supervisory functions for medicines, medical devices and cosmetics.

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FAQ

Does every shade of a cosmetic product need to be notified separately?

Yes. By analogy with the CPNP, each colour variant (shade) is a separate product and requires a separate notification. If you have a foundation in 20 shades, that means 20 notifications. It is advisable to use a range format where the Ministry of Health system allows it — check the up-to-date technical documentation of the portal.

Is an EU CPSR automatically acceptable under the UA TR?

A CPSR drawn up to EU Annex I standards (SCCS Notes of Guidance) is methodologically acceptable under the UA TR, since the Regulation is built on the same architecture. However, a Ukrainian-language translation of the document is required. In addition, if the CPSR was drawn up before significant EU amendments entered into force (Omnibus acts, new CMR restrictions), it is advisable to verify that it is still current.

What happens to products notified before 3 August 2026 but with minor labelling discrepancies?

The UA TR provides that labelling must comply with the requirements in force at the time the product is placed on the market. Minor technical non-conformities (for example, an outdated way of indicating the period after opening) may serve as grounds for orders from surveillance authorities. It is advisable to carry out a labelling audit in parallel with preparation for notification.

Does the UA TR include the requirement for 82 allergens (the new EU requirement from 31 July 2026)?

No. The UA TR is based on the version of EU 1223/2009 as of around 2021. The expanded list of allergens introduced by Regulation (EU) 2023/1545 (82 allergens, deadline 31 July 2026) is not reflected in the UA TR. However, for products also sold on the EU market, this requirement is mandatory from 31 July 2026 — it must be monitored and complied with independently of the UA TR.

Is there a difference between the UA TR and the requirements for importers of cosmetics into Ukraine?

For importers, the duties of the Responsible Person pass to the first importer in the customs territory of Ukraine. It is the importer who is required to ensure that the PIF (or its equivalent from the manufacturer) is in place, to carry out the notification and to ensure the labelling is compliant. A foreign manufacturer without a presence in Ukraine cannot carry out these functions on its own.

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Conclusion: what to do right now

Less than a year remains until 3 August 2026. A practical action plan:

1. Carry out a portfolio audit: compile a full list of SKUs sold on the Ukrainian market. 2. Verify that a PIF and CPSR are in place for each product. 3. Verify the formulation against the UA TR list of prohibited substances. 4. Carry out a labelling gap analysis against the Ukrainian-language requirements. 5. Register on the Ministry of Health portal and start the notification process. 6. For products containing nanomaterials or CMR substances — ensure that additional sections are completed in the notification form.

VRC Cosmetics helps Ukrainian manufacturers go through the full UA TR compliance cycle — from preparing the PIF and CPSR to notification on the Ministry of Health portal — and at the same time prepares the documentation package for an EU CPSR, opening the way to the EU market in parallel.

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*Sources: [Cabinet of Ministers of Ukraine Resolution No. 65 of 20.01.2021](https://zakon.rada.gov.ua/laws/show/65-2021-п) | [EcoMundo — Ukraine Cosmetics Regulation](https://ecomundo.eu/en/blog/ukraine-regualtion-cosmetics-eu) | [The World Law Group — e-notification launch](https://www.theworldlawgroup.com/membership/news/news-ukraine-launched-e-notification-for-cosmetic-products) | [Cratia — Technical Regulation](https://cratia.ua/en/service/technical-regulation-on-cosmetic-products/) | [Regulation (EC) No 1223/2009](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)*