On 3 August 2026, the two year transitional period under the Technical Regulation on Cosmetic Products, approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 of 20 January 2021 (the “Technical Regulation”), comes to an end. From that date, cosmetic products may be placed on the Ukrainian market only in full compliance with the requirements of the Technical Regulation, which is harmonized with Regulation (EC) No. 1223/2009 of the European Parliament and of the Council on cosmetic products.
The Technical Regulation entered into force on 3 August 2024 and replaced the previous sanitary rules based regime for cosmetics. Resolution No. 65 provides for a two year transitional period: the making available on the market of cosmetic products placed on the market before 3 August 2026 may not be prohibited or restricted on the grounds of non-conformity with the Technical Regulation.
The decisive legal concept is the placing on the market, defined under the Law of Ukraine “On Technical Regulations and Conformity Assessment” as the first making available of a product on the market of Ukraine. Accordingly:
- Products placed on the market before 3 August 2026 (that is, batches for which the first supply on the Ukrainian market is documented before that date) may continue to be sold until the end of their shelf life without being brought into conformity. Primary accounting documents (delivery notes and supply contracts) evidencing the date of the first supply will be the operator’s key defense in the event of a market surveillance inspection.
- Products first placed on the market on or after 3 August 2026 are subject to the full set of requirements of the Technical Regulation, without exception.
What is required to remain on the market from 3 August 2026
Every cosmetic product first placed on the Ukrainian market on or after 3 August 2026 must satisfy, in particular, the following requirements:
- Responsible Person (RP). A resident legal or natural person must be designated as the Responsible Person for each product. For products manufactured in Ukraine, the RP is the resident manufacturer (or a resident person appointed by a written mandate accepted in writing). For imported products, each importer acts as the RP in respect of the products it places on the market. A distributor assumes RP status where it markets a product under its own name or trademark or modifies a product already placed on the market in a manner capable of affecting its conformity.
- Product Information File (PIF). A complete technical dossier, comprising the product description, specifications, the Cosmetic Product Safety Report, GMP evidence, labelling and packaging artwork, and a declaration of conformity, must be compiled and kept available for inspection by the authorities for 10 years after the last batch of the product is placed on the market.
- Cosmetic Product Safety Report (CPSR). A safety assessment (Part A, safety information; Part B, safety assessment), signed by a qualified safety assessor holding the requisite medical or pharmaceutical qualification, must be completed before the product is placed on the market.
- Good Manufacturing Practice (GMP). Manufacturing must comply with the standard identical to ISO 22716, as evidenced by a certificate or audit report.
- Composition compliance. The formulation must conform to the lists of prohibited, restricted, and permitted substances set out in Annexes 2 to 6 of the Technical Regulation.
- Electronic notification. Prior to placing a product on the market, each product must be notified through the electronic notification system administered by the Ministry of Health of Ukraine pursuant to MoH Order No. 2147 of 18 December 2023.
- Ukrainian language labelling. Labelling must contain the mandatory particulars required by the Technical Regulation, including Ukrainian language information, the INCI ingredient listing, and the batch number.
Compliance is enforced by the State Service of Ukraine on Medicines and Drugs Control through scheduled and unscheduled inspections. Cosmetic products are included in the list of products subject to state market surveillance approved by Resolution of the Cabinet of Ministers of Ukraine No. 1069 of 28 December 2016. The Responsible Person of record must respond to market surveillance requests and keep the Product Information File available at a Ukrainian address of record.
Should you require assistance or additional information, please contact us at regulations@iprgroup.info.
