The Technical Regulation on cosmetic products entered into force on 3 August 2024 and provides for a two-year transitional period until 3 August 2026. During this period, the placing on the market of cosmetic products that were introduced before 3 August 2026 may not be prohibited or restricted solely due to non-compliance with the requirements of the Technical Regulation.
As of 3 August 2026, cosmetic products may be placed on the Ukrainian market only if they fully comply with the Technical Regulation on cosmetic products approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 dated 20 January 2021.
For manufacturers and importers, this means mandatory conformity assessment of cosmetic products, preparation and continuous maintenance of required documentation (PIF and CPSR), as well as prior registration (notification) of cosmetic products before placing them on the market.
Pharma Navigation treats cosmetic product notification as a comprehensive regulatory process, not a formal administrative step. We have practical experience in dossier preparation, ingredient assessment and cooperation with foreign manufacturers, including professional communication in English. This enables accurate adaptation of European documentation to the requirements of the Ukrainian Technical Regulation.
If you are planning to place cosmetic products on the market or require an assessment of readiness for compliance with the Technical Regulation, please contact us to discuss the most appropriate regulatory approach.
What Is Considered a Cosmetic Product
A cosmetic product is any substance or mixture intended to be applied to the external parts of the human body (epidermis, hair, nails, lips, external genital organs), teeth or the mucous membranes of the oral cavity exclusively or mainly for the purpose of:
- cleaning;
- perfuming;
- changing appearance;
- protecting;
- keeping in good condition;
- correcting body odour.
This definition is used for regulatory classification of cosmetic products.
Requirements for Cosmetic Product Composition
Cosmetic products must not contain:
- prohibited substances (Annex 2 to the Technical Regulation);
- restricted substances in violation of established conditions (Annex 3);
- unauthorised colourants, preservatives or UV filters (Annexes 4–6);
- CMR substances of categories 1A, 1B and 2 in accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances.
Composition control is a key element of preparation for cosmetic product notification.
Regulatory Framework for Cosmetic Product Notification
The obligation to notify cosmetic products is established by the Technical Regulation. Specific requirements for the notification procedure are set out in the Procedure for Notification (Submission) of Information on Cosmetic Products approved by Order of the Ministry of Health of Ukraine No. 2147 dated 18 December 2023.
The Technical Regulation establishes mandatory requirements for cosmetic products placed on the Ukrainian market in order to ensure a high level of protection of human health.
The Regulation is based on Regulation (EC) No 1223/2009 on cosmetic products, providing for:
- harmonisation of approaches to cosmetic product safety assessment;
- identical requirements for composition, labelling and documentation;
- application of national standards identical to harmonised European standards.
As a result, cosmetic product regulation in Ukraine has been effectively aligned with the European regulatory model, significantly facilitating access of Ukrainian cosmetic products to EU markets.
A Responsible Person
A cosmetic product may be placed on the market only if a Responsible Person is designated — a natural or legal person resident in Ukraine.
Depending on the origin of the product, the status of Responsible Person is assigned to:
- the resident manufacturer — for cosmetic products manufactured in Ukraine;
- the importer — for imported cosmetic products.
A manufacturer or importer may designate another natural or legal person resident in Ukraine as the Responsible Person, subject to written consent. Such designation is made on the basis of a written mandate.
If a product is imported simultaneously by several economic operators, each of them is considered a Responsible Person unless a third party is designated.
The Responsible Person carries out notification of cosmetic products and is responsible for:
- product safety;
- compliance of manufacturing with Good Manufacturing Practice (GMP);
- correctness of labelling;
- availability and maintenance of the Product Information File (PIF) and the Cosmetic Product Safety Report (CPSR).
In addition, the Responsible Person bears financial liability and is required to comply with instructions of the market surveillance authority in cases where non-compliant or unsafe cosmetic products are placed on the market.
The name and address of the Responsible Person must be indicated on the labelling of each cosmetic product unit.
Conformity Assessment of Cosmetic Products
Cosmetic products placed on the market must be safe for human health under normal or reasonably foreseeable conditions of use. A product is considered safe if it complies with the Technical Regulation.
Conformity assessment includes:
- verification of product composition for prohibited substances;
- designation of a Responsible Person;
- verification of manufacturing compliance with GMP (DSTU EN ISO 22716:2015);
- preparation of the cosmetic product dossier (PIF);
- performance of product safety assessment and preparation and signing of the Safety Report;
- development of labelling and packaging artwork;
- notification of the cosmetic product via the electronic notification portal of the Ministry of Health of Ukraine;
- establishment of a system for reporting serious undesirable effects.
In addition, cosmetic products may be subject to other technical regulations, including:
Technical Regulation on Aerosol Dispensers (Resolution of the Cabinet of Ministers of Ukraine No. 154 dated 21 February 2023);
Technical Regulation on Toy Safety (Resolution No. 151 dated 28 February 2018);
Technical Regulation on Chemical Safety (UA REACH) (Resolution No. 847 dated 23 July 2024);
Technical Regulation on Classification, Labelling and Packaging of Chemicals (UA CLP) (Resolution No. 539 dated 10 May 2024).
Where several technical regulations apply to a cosmetic product, the product must comply with all applicable requirements simultaneously.
Particular attention is paid to the prohibition of placing on the market cosmetic products which, due to their shape, appearance, smell, packaging or labelling, may be mistaken for food products, especially by children.
The provision of warnings or precautions does not exempt the Responsible Person from compliance with other requirements of the Technical Regulation.
Product information File (PIF) for Cosmetic Products
Cosmetic product documentation must be continuously kept up to date and include, in particular:
- a description of the cosmetic product;
- the Safety Report;
- a description of manufacturing methods and confirmation of GMP compliance;
- substantiation of claimed efficacy (where applicable);
- information on animal testing (if conducted).
The Responsible Person must retain the documentation for 10 years after the date of placing the last batch of the product on the market and ensure its availability to market surveillance authorities.
Cosmetic Product Safety Report (CPSR)
The Safety Report is a mandatory part of the cosmetic product dossier.
Minimum requirements and structure are defined in Annex 1 to Technical Regulation No. 65.
The Safety Report consists of Part A — Cosmetic Product Safety Information. Part B — Cosmetic Product Safety Assessment.
The report must be signed by a qualified safety assessor holding higher education in Medicine or Pharmacy / Industrial Pharmacy.
Notification of Cosmetic Products
From 3 August 2026, all cosmetic products must be notified prior to being placed on the market.
Notification is the submission of product information by the Responsible Person via the Electronic Cosmetic Product Notification System of the Ministry of Health of Ukraine.
Notification must be completed before actual placing on the market (except for products placed on the market before 3 August 2026).
The notification system is a free online platform for submission of information on cosmetic products intended to be placed on the market. The system was established in accordance with Technical Regulation No. 65 and is operated by the Ministry of Health of Ukraine.
Notification is carried out in accordance with the Technical Regulation and the Procedure approved by Order of the Ministry of Health No. 2147 dated 18 December 2023.
Information submitted during notification includes, in particular:
- product category and name;
- Responsible Person and address;
- country of origin;
- contact person;
- presence of nanomaterials;
- CMR substances (categories 1A and 1B);
- formulation frame;
- labelling and packaging artwork.
Any change to the notified information requires immediate submission of an updated notification.
Notification of Cosmetic Products
From 3 August 2026, all cosmetic products must be notified prior to being placed on the market.
Notification is the submission of product information by the Responsible Person via the Electronic Cosmetic Product Notification System of the Ministry of Health of Ukraine.
Notification must be completed before actual placing on the market (except for products placed on the market before 3 August 2026).
The notification system is a free online platform for submission of information on cosmetic products intended to be placed on the market. The system was established in accordance with Technical Regulation No. 65 and is operated by the Ministry of Health of Ukraine.
Notification is carried out in accordance with the Technical Regulation and the Procedure approved by Order of the Ministry of Health No. 2147 dated 18 December 2023.
Information submitted during notification includes, in particular:
- product category and name;
- Responsible Person and address;
- country of origin;
- contact person;
- presence of nanomaterials;
- CMR substances (categories 1A and 1B);
- formulation frame;
- labelling and packaging artwork.
Any change to the notified information requires immediate submission of an updated notification.
Notification of Products Containing Nanomaterials
A special notification procedure applies to cosmetic products containing nanomaterials.
Such products must be notified by the Responsible Person six months prior to placing on the market, unless they were already placed on the market before the entry into force of the Technical Regulation.
This requirement does not apply to nanomaterials used as colourants, UV filters or preservatives regulated under Section 37 of the Technical Regulation.
The submitted information must include:
1) identification of nanomaterials, including chemical name (IUPAC);
(IUРАС) and other data as specified in Annexes 2–6 of this Technical Regulation;
2) characteristics of nanomaterials, including particle size and physical and chemical properties;
хімічні властивості;
3) estimated annual quantity of nanomaterials used;
продукції, яка призначена для введення в обіг протягом року;
4) toxicological profile;
5) safety data relating to the cosmetic product category;
6) cosmetic products, if it is used in such products;
7) reasonably foreseeable exposure conditions.
Consequences of Non-Compliance with the Technical Regulation
Cosmetic products fall within the scope of state market surveillance (Resolution of the Cabinet of Ministers of Ukraine No. 1069 dated 28 December 2016).
The market surveillance authority is the State Service of Ukraine on Medicines and Drugs Control.
Market surveillance is carried out during customs clearance, in retail and warehouse premises, beauty salons, hairdressers, exhibitions and trade fairs, among others.
Both scheduled inspections (in accordance with the Sectoral Plan) and unscheduled inspections (based on consumer complaints or requests from authorities) may be conducted.
The authority verifies compliance with the Technical Regulation, including validity of notification data, correctness of labelling and packaging artwork, and compliance with storage conditions.
Where non-compliance is identified, restrictive (corrective) measures may be taken:
· withdrawal from the market;
· product recall;
· restriction or prohibition of placing on the market.
· Prohibition of the supply of products on the market;
Fines may be imposed on distributors, importers, manufacturers or the Responsible Person:
· UAH 102,000 for placing products posing a serious risk (UAH 340,000 for repeat violation within three years);
· UAH 34,000–51,000 for non-compliant products (UAH 68,000 for repeat violation within three years).
Fines apply per model, article or batch, regardless of the number of units.
Regulatory Support by Pharma Navigation
Pharma-Navigation provides comprehensive regulatory support for cosmetic product notification, including:
- consultations on regulatory requirements;
- preparation of the product information file (PIF) and Cosmetic product safety report (or adaptation of existing documentation);
- ingredient and formulation assessment;
- designation of the Responsible Person;
- development of labelling and packaging design;
- submission of notification via the Ministry of Health portal;
- assessment of compliance with other applicable technical regulations.
Pharma Navigation approaches cosmetic product notification as a structured regulatory process, supporting projects both at the stage of initial documentation development and where existing PIF and CPSR require review or adaptation. Our practical experience, including direct cooperation with foreign manufacturers and professional communication in English, ensures accurate preparation and alignment of documentation with Ukrainian regulatory requirements.