Ukraine’s 1-year-old cosmetic products regulation seeks to bring Ukraine in line with EU standards
The Technical Regulation on Cosmetic Products, also known as Resolution No. 65 of 20 January 2021, has been in force since 3 August 2024. Developed to align Ukrainian law with EU Regulation 1223/2009, the Regulation ensures consumer health protection and brings Ukrainian law in line with EU standards.
According to the Regulation, until 3 August 2026 cosmetic products may be placed on the Ukrainian market under either:
- The Law of Ukraine “On General Safety of Non-Food Products”, or
- The new Technical Regulation on Cosmetic Products.
From 4 August 2026, only products compliant with the new Regulation may remain on the market.
Responsible person in Ukraine
Every cosmetic product must have a designated Responsible Person in Ukraine. This person ensures the product complies with the Regulation in terms of:
- Composition;
- Labelling;
- GMP-compliant manufacturing;
- Safety documentation;
- Notification via the electronic system.
The Responsible Person can be:
- A Ukrainian manufacturer;
- An importer (for foreign-made products);
- An authorised third party (based in Ukraine) (e.g. regulatory service provider).
From 4 August 2026, placing products on the market without an appointed Responsible Person is prohibited.
Product Safety Assessment and documentation
The Regulation mandates a two-tier safety assessment:
- Ingredient-level safety;
- Finished product safety assessment by a qualified expert (e.g. medical or pharmaceutical master’s degree).
Cosmetic Product Safety Report
According to the Regulation, the Cosmetic Product Safety Report (CPSR):
- Must be compiled and signed by the safety assessor;
- Retained for ten years by the Responsible Person;
- Includes data on formulation, manufacturing methods, labelling, and product testing.
Manufacturing Practices
Manufacturers must produce in accordance with Good Manufacturing Practice (GMP).
- GMP certification is optional;
- Declaration of GMP compliance required;
- Compliance with DSTU ISO EN 22716 presumes GMP compliance.
Certification supports ongoing quality and hygiene monitoring.
Composition and ingredient controls
The Regulation introduces EU-style ingredient restrictions via:
- Annex II: Prohibited substances;
- Annex III: Restricted substances;
- Annexes IV-VI: Permitted colourants, preservatives, UV filters.
Other restrictions:
- No CMR substances (e.g. carcinogenic, mutagenic, reproductive toxicity);
- Nanomaterials must be notified six months before market entry.
Notification system
The online notification system is administered by the Ministry of Health and operated by State Enterprise "Electronic Health".
Responsible Persons must report products before placing them on the market. Required data includes:
- Product details;
- Graphic files of labelling;
- Photos of packaging (at least one per group).
Permits are not required, but notification is mandatory.
Labelling requirements
All mandatory information must be in Ukrainian (other languages may be added) and must include:
- Product name and manufacturer details;
- INCI ingredient list;
- Date of manufacture, shelf life or PAO, batch number;
- Volume/weight and storage conditions;
- Warnings, precautions, and usage instructions.
Market surveillance and enforcement
The State Service of Ukraine on Medicines and Drugs Control supervises compliance.
Inspections may occur:
- At customs;
- In retail and storage locations;
- At fairs and exhibitions.
Authorities may impose corrective measures for unsafe or non-compliant products.
Looking Ahead
A new regulatory authority for cosmetic products is expected from 1 January 2027, replacing the State Service and bringing Ukraine closer to the EU's institutional model.
Proposed amendments
On 3 July 2025, the Ministry of Health published for public consultation a Draft Resolution proposing amendments to the Technical Regulation on Cosmetic Products. The Draft Resolution proposes the following:
- Revising and reissuing Annexes II–VI (see section 5 above) to reflect updated lists of prohibited, restricted, and permitted substances (i.e. colourants, preservatives, UV filters).
- Introducing phased transition periods for products containing certain substances. Specifically:
- Placement on the market would be allowed until 3 August 2026-2028 (depending on the substance).
- Commercial distribution must cease between 2027 and 2030.
These changes are not yet adopted but are intended to align the Ukrainian framework with ongoing EU updates while giving industry operators time to adapt.
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