New requirements for cosmetic products in Ukraine: What has changed since August 3 , 2024

On August 3, 2024, the Technical Regulation on Cosmetic Products came into force in Ukraine. This document introduces completely new requirements for cosmetic products, and defines the procedure for notification (provision) of information on cosmetic products. Along with it, the Notification Procedure came into force, which regulates the mechanism for providing information on cosmetic products and the procedure for the formation and maintenance of the Electronic NotificationSystem.

Transition period

Resolution of the Cabinet of Ministers of Ukraine No. 833 of July 26, 2022 introduced amendments to the Technical Regulation on Cosmetic Products, namely the”transition period”, which will last until August 3, 2026. During this period , it is allowed to place on the market cosmetic products that complies with the current legislation and was put into circulation before this date, without the need to undergo the procedure for compliance with the Technical Regulations, making changes to the Electronic Notification System and applying the appropriate labeling.

Cosmetic products put into circulation before August 3, 2026, may not be banned or restricted on the market due to non-compliance with the new requirements of the Technical Regulation, and may be freely placed on the market until its expiration date.

Good Manufacturing Practice (GMP)

The technical regulation on cosmetic products does not provide for conformity assessment with the involvement of designated authorities, as is the case, for example, with medical devices. However, the production of cosmetic products must comply with the requirements of good manufacturing practice (GMP). This means that all enterprises of the perfumery and cosmetics industry should develop implement and maintain good manufacturing practices in accordance with the standard DSTU EN ISO 22716:2015.

The main innovations of the Technical Regulations

With the entry into force of the new Technical Regulations, to place cosmetic products on the Ukrainian market, the following requirements must be met:

• Responsible person (manufacturer or its representative): For each cosmetic product placed on the Ukrainian market, must appoint a responsible person to ensure compliance with the requirements of the Technical Regulations.
• Labeling: The products must be properly labeled, and only such products may be admitted to the Ukrainian market.
• Notification: Before placing a product on the market , it is necessary to go through the notification procedure on the relevant portal.
• Production: The production of a cosmetic product must comply with GMP requirements.
• Documentation: The responsible person must ensure that complete documentation is available for each product, including a product safety report.
• Market surveillance: The State Service of Ukraine on Medicines and Drugs Control (SMDC) will exercise market supervision over the circulation of cosmetic products.
• Ban on animal testing: Testing of cosmetic products on animals is prohibited in Ukraine.

Issues to be addressed by the legislature

In implementing the new regulation , there are still some issues that need to be addressed:

• Approval of methodological recommendations.
• Launch and stable operation of the notification portal.
• Implementation of alternative testing methods.
• Recognition of EU reports.

Work that can be performed at a given time

For cosmetic products supplied to the territory of Ukraine:

• Obtain a power of attorney from the manufacturer as the responsible person to ensure compliance with the requirements of the Technical Regulation
• Request technical documentation for the product from the foreign manufacturer (the responsible person should ensure that each product has documentation with full information, including a product safety report, and request safety data sheets for raw materials from suppliers from the manufacturer )
• Bring labeling in line with the requirements of the Technical Regulation

For cosmetic products made in Ukraine:

• Bring labeling in line with the requirements of the Technical Regulation
• Bring production into compliance with the requirements of good manufacturing practice (GMP)
• Request all quality certificates from raw material suppliers

The new regulation creates an important step in ensuring the safety and quality of cosmetic products on the Ukrainian market, while ensuring harmonization with European standards.