Although mandatory certification of cosmetic products is no longer required in Ukraine, Technical Regulation No. 65, which entered into force on 3 August 2024, introduced mandatory product notification (registration) and the requirement to prepare a Cosmetic Product Safety Report (CPSR).
A transitional period remains in effect until 3 August 2026, after which all cosmetic products placed on the Ukrainian market must comply with requirements aligned with EU Regulation (EC) No. 1223/2009, including Good Manufacturing Practice (GMP) in accordance with ISO 22716.
Key Stages of Cosmetic Product Compliance
- Appointment of the Responsible Person A legal entity or individual must be designated as the Responsible Person, assuming responsibility for ensuring the product’s compliance and safety on the market.
- Preparation of the Product Information File (PIF) A Product Information File (PIF) is compiled, containing the product formulation, safety assessment, toxicological data, manufacturing information, and all documentation required under the applicable legislation.
- Laboratory Testing Product samples undergo the necessary laboratory testing, including microbiological analysis, pH testing, stability studies, and toxicological safety assessment, as applicable.
- Labelling Compliance Assessment Product labels are reviewed to ensure compliance with Technical Regulation No. 65, including ingredient listings, shelf life, manufacturer information, warnings, and other mandatory labelling requirements.
- Product Notification (Registration) Following successful compliance assessment, the cosmetic product is notified through the electronic notification system administered by the Ministry of Health of Ukraine before being placed on the market.
Regulatory Changes Effective from 3 August 2024:
Transition from Certification to Regulatory Compliance Mandatory cosmetic certification has been replaced by a system based on Declaration of Conformity, product notification, and compliance with the applicable technical regulations.
Good Manufacturing Practice (GMP) Compliance with ISO 22716 (Good Manufacturing Practice for Cosmetics) has become the recognised quality standard, aligning Ukrainian requirements with European regulatory practices.
Transitional Period Cosmetic products that were lawfully placed on the Ukrainian market before the new regulation entered into force may continue to be marketed during the transitional period, which ends on 3 August 2026.
Cost of the Compliance Procedure The cost of achieving cosmetic product compliance depends on the product category, formulation, required laboratory testing, and the scope of regulatory documentation needed for the conformity assessment process.
