Alignment of Ukraine with the European Union Cosmetic Regulation

For several years, Ukraine has been pursuing a gradual process of harmonization of its legislation with that of the European Union. The cosmetics sector is no exception. The adoption of the Technical Regulation on Cosmetic Products, approved by Resolution No. 65 of the Cabinet of Ministers of Ukraine dated January 20, 2021, constitutes a major step in this process.

This Regulation is largely inspired by Regulation (EC) No 1223/2009 on cosmetic products, which constitutes the main regulatory framework within the European Union. Its objective is to introduce in Ukraine similar standards in terms of product safety, technical documentation, and responsibility of economic operators.

A regulatory framework aligned with European standards

The Technical Regulation on Cosmetic Products introduces several fundamental concepts already implemented in the European Union:

• the designation of a Responsible Person for each cosmetic product placed on the market;
• the establishment of a Product Information File (PIF);
• the preparation of a Cosmetic Product Safety Report (CPSR);
• the application of Good Manufacturing Practices (GMP);
• the implementation of a cosmetovigilance system.

The Responsible Person may be a manufacturer established in Ukraine, an importer, or an entity mandated by them. This person is legally responsible for the compliance of the product with the Regulation and must ensure that all technical documentation is available to the competent authorities.

The Product Information File and safety assessment

As in the European Union, each cosmetic product placed on the Ukrainian market must have a Product Information File (PIF).

According to the Technical Regulation (paragraphs 24–26):

“The cosmetic product information file must contain a cosmetic product safety report.”

The Cosmetic Product Safety Report (CPSR) constitutes the core element of the PIF and must demonstrate that the product is safe under normal or reasonably foreseeable conditions of use.

The PIF must notably include:

• the description of the cosmetic product;
• the qualitative and quantitative composition;
• physico-chemical data;
• toxicological information on ingredients;
• exposure data;
• the product safety assessment;
• information on manufacturing and GMP.

This structure is practically identical to that required under the EU Cosmetic Regulation.

The issue of document language

A practical question frequently raised by international companies concerns the language of the CPSR and the PIF.

Paragraphs 24 to 26 of the Technical Regulation define the content of the dossier and of the CPSR but do not explicitly specify the language of the documents.

However, Article 13 of the Ukrainian law “On Ensuring the Functioning of the Ukrainian Language as the State Language” provides that documents drafted in another language must be accompanied by a Ukrainian translation.

In practice, this means that:

• the CPSR may be drafted in English,
• but it must be accompanied by a Ukrainian translation.

This approach facilitates harmonization with European practices, where English is widely used for scientific and regulatory documentation.

A transitional period until 2026

The Regulation provides for a transitional period allowing companies to adapt to the new regulatory framework.

As of August 3, 2026, all cosmetic products placed on the Ukrainian market must fully comply with the Technical Regulation.

This notably implies:

• the preparation of a complete Product Information File;
• the completion of a Cosmetic Product Safety Report;
• the designation of a local Responsible Person;
• the notification of products to the competent authorities.

How EcoMundo supports companies ?

In this context of regulatory harmonization, many brands and manufacturers seek to anticipate the transition to the new Ukrainian framework.

EcoMundo offers several services to facilitate compliance.

Formula review and labeling advisory

EcoMundo’s regulatory experts can analyze cosmetic product formulations to verify their compliance with the requirements of the Ukrainian Regulation aligned with EU legislation.

This service notably includes:

• regulatory review of formulas;
• identification of regulated or restricted substances;
• recommendations for adaptation where necessary;
• advice on labeling and mandatory claims.

This step allows potential non-compliances to be anticipated prior to placing products on the market.

PIF and CPSR preparation in English

EcoMundo can also support companies in the full creation of the Product Information File (PIF).

EcoMundo’s toxicologists and regulatory experts notably perform:

• drafting of the Cosmetic Product Safety Report (CPSR);
• full compilation of the PIF dossier.

The dossiers may be drafted in English, in line with international practices, and may subsequently be translated if required to meet local requirements.

Conclusion

The alignment of Ukrainian cosmetic regulation with the European model constitutes a major development for the beauty industry in the region.

The introduction of the PIF, CPSR, and the Responsible Person concept brings the Ukrainian framework significantly closer to the European Union Cosmetic Regulation.

For international companies, this harmonization represents both an opportunity and a challenge: preparing regulatory compliance now ahead of the 2026 deadline.

With its regulatory and toxicological expertise, EcoMundo supports brands and manufacturers throughout this transition, facilitating compliance with the new Ukrainian requirements.

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