Transition period till August 3, 2026

The technical regulation of cosmetic products in Ukraine is actively being harmonized with EU legislation.

As of October 1, 2023, significant changes have taken place in the regulation of cosmetic products. Prior to this date, cosmetics were introduced into circulation based on a permit document – a positive conclusion from sanitary-epidemiological assessment (so-called hygienic certificates or SES conclusion). This document was required by the Law of Ukraine “On ensuring sanitary and epidemiological well-being of the population.”

On October 1, 2023, the Law of Ukraine “On the public health system” came into force, which repealed the Law of Ukraine “On ensuring sanitary and epidemiological well-being of the population” and excluded SES conclusions from the List of authorization (permissive) documents, an annex to the Law of Ukraine “On the list of permit documents in the field of business activities.” 

Thus, SES conclusions are no longer considered permit documents, including for the purposes of confirming the safety of cosmetic products for human life and health, and for conducting business activities in the retail sector.

Regulatory requirements for cosmetic products can be divided into the following periods:
   

From October 1, 2023 

Only general safety requirements apply to cosmetic products. The Law of Ukraine “On general safety of non-food products” establishes the obligation for manufacturers and importers to place only safe products on the market, and for distributors, it prohibits supplying products they know do not meet safety requirements. The law also sets rules for proving the safety of products.

A product is considered safe if it complies with the safety requirements established by law.

The “State sanitary rules and standards of safety for perfumery and cosmetic industry products” (SanPiN 2.2.9.027-99) establish hygienic requirements and safety standards for human health in products of the perfumery and cosmetics industry.

Safety for human health in perfumery and cosmetics products refers to the absence of toxic, irritating, sensitizing, photo-sensitizing, dyschromic, or other adverse effects on human health, as well as the absence or limitation of contamination by pathogenic, conditionally pathogenic, and sanitary-indicative microorganisms when used according to the intended purpose during the warranty storage period.

The SanPiN also contains a list of prohibited substances in the composition of products. Compliance with the SanPiN requirements is mandatory for enterprises, organizations, and other business entities, regardless of their departmental affiliation and form of ownership, as well as for public associations and individuals.
    

From August 3, 2024 

As of 03.08.2024, the Cabinet of Ministers of Ukraine’s Resolution No. 65 dated January 20, 2021, “On approval of the Technical regulation on cosmetic products” (hereinafter referred to as the Regulation) will come into force. This regulation is based on Regulation (EC) No. 1223/2009 of November 30, 2009, on cosmetic products and sets out requirements for cosmetic products to ensure a high level of human health protection.

Since the regulation establishes specific safety requirements for certain types of products (cosmetic products), the Law of Ukraine “On general safety of non-food products” applies to the extent not regulated by the Regulation.

The Resolution also includes cosmetic products in the List of products subject to state market surveillance by state market surveillance bodies, approved by the Cabinet of Ministers of Ukraine’s Resolution No. 1069 of December 28, 2016.

The Resolution establishes a two-year transition period, during which the placing on the market of cosmetic products that were introduced into circulation before August 3, 2026, cannot be prohibited or restricted due to non-compliance with the Technical regulation. This means that cosmetic products placed on the market before 03.08.2026 can continue to be sold without being brought into compliance. In other words, cosmetic products manufactured or imported and introduced into circulation can be sold until their expiration date without any additional actions.

Thus, from 03.08.2024 to 03.08.2026, cosmetic products can be placed on the market under both the general safety legislation – the Law of Ukraine “On general safety of non-food products” and the Technical regulation on cosmetic products.
    

From August 3, 2026 

All cosmetic products introduced into circulation must comply with the requirements of the Technical Regulation and all other applicable acts.
    

Our services 

Cratia offers comprehensive regulatory support and assistance throughout all stages of placing cosmetic products on the Ukrainian market:

• Regulatory intelligence, consulting and feasibility study;
• Outsourcing of the Responsible person in Ukraine;
• Filling of the Product Information File (PIF);
• Filling of the Cosmetic Product Safety Report (CPSR) and Ukrainian safety assessor; 
• Review and/or development of labeling, instructions, and advertising materials;
• Notification (registration) of the cosmetic product on the portal; 
• Development of GMP according to ISO 22716; 
• Compliance with UA CLP and UA REACH regulations;
• Compliance with the Technical regulation on aerosol dispensers;
• Legal and consulting support for manufacturers, responsible persons, or distributors (importers).

We possess the necessary knowledge and experience to conduct these tasks, and we are fluent in spoken and written English. We will manage and organize the process, help compile the necessary set of documents, and carry out the procedure within a short timeframe.