Why Old Rules No Longer Work?

The Ukrainian cosmetic products market is rapidly changing. With the entry into force of the Technical Regulation on Cosmetic Products, our legislation has been harmonized with the European Regulation (EU) No 1223/2009. This means one thing: requirements for safety and market access have become stricter, and simple quality certification is now a thing of the past.

For businesses planning to supply or manufacture cosmetics in Ukraine, two concepts are critically important: “placing on the market” and “notification”. Misunderstanding these processes leads to significant financial and reputational risks.

Time is Running Out: The Transitional Period and Its Pitfalls

The Resolution on the Approval of the Technical Regulation established a transitional period from August 3, 2024 to August 3, 2026. This gave businesses time to adapt to the new rules.

What does this mean for your business?

Protection for old batches:Products that were placed on the market before August 3, 2026, cannot be prohibited or restricted on the market solely due to non-compliance with the new Regulation requirements. This is an important safeguard for selling off inventory.Obligation for new batches:All products being placed on the market for the first time right now must comply with all Regulation requirements, including requirements for the Responsible Person, documentation, and notification.

Responsible Person: Your Legal Shield and Safety Guarantor

Placing on the market is the first making available of a cosmetic product on the Ukrainian market. A key requirement of the Technical Regulation: no product can be placed on the market until a “Responsible Person” (RP) has been designated for it.

A Responsible Person is a legal or natural person-resident who undertakes to ensure the product’s compliance with all legislative requirements.

Critically important: According to the Technical Regulation, a manufacturer is not only the one who physically produces the product, but also the one who commissions its development or manufacture and markets it under their own name or Trademark (TM).

Product Information File (PIF): The Secret Folder of Your Business

Unlike old certificates, the Responsible Person is obliged to compile and store for 10 years the so-called Product Information File (PIF). This is a complete legally substantiated archive that must be available to inspection authorities upon first request.

The PIF must be updated as necessary and contain the following key elements:

1. Detailed product description that allows unambiguous identification.
2. Cosmetic Product Safety Report (CSR): A scientifically substantiated risk assessment.
3. Description of manufacturing methods and a statement on compliance of production with Good Manufacturing Practice (GMP).
4. Proof of claimed effectiveness (where justified by the nature of the product’s effects).
5. Information on any animal testing conducted by the manufacturer, their authorized representatives, or suppliers.

Collecting and legally substantiating these five points is highly qualified work. Any inaccuracy or absence of one of the points jeopardizes the legality of placing the product on the market.

Notification: The Digital Key to the Market

The next mandatory step, which must occur before the actual placing of the product on the market, is notification.

Notification is an electronic notification to the state authority (Ministry of Health) about the intention to place a product on the market. This is not a permit in the traditional sense, but a mandatory procedure without which you violate the law.

Notification requires submission of a clearly defined volume of data by electronic means, including:

• Full name and location of the Responsible Person and contact person details.
• Full name and categorization of the cosmetic product (country of origin).
• Detailed information on composition, including the presence of nanomaterials or substances with restricted use.
• Formula framework, which is taken into account for providing emergency medical care in case of complications.
• Graphic file of labeling (label).

How We Can Help

The DEXTRA LAW firm team specializes in European and national regulatory requirements for the cosmetics sector.

We will help you:

• Optimize the role of the Responsible Person and develop internal procedures to ensure compliance.
• Form a complete package of Product Information File (PIF), verifying the safety report compliance.
• Correctly conduct electronic notification of your cosmetic products.

Need a Consultation?

Don’t let regulatory barriers stand in the way of your business. Contact us today to receive professional consultation and ensure smooth, and most importantly — legal introduction of your cosmetic products to the Ukrainian market.

Get a consultation on placing cosmetic products on the market