Notification of cosmetic products in Ukraine

According to the requirements of the Technical Regulation, the Responsible Person is required to submit a range of information (data) about the product to the Electronic Notification System for Cosmetic Product Information (hereinafter – the System) before placing any cosmetic product on the market.

When a product is placed on the market, the Responsible Person must also notify the System about the original labeling (graphic file of the labeling) and, if necessary, provide a photograph of the respective packaging.

The notification system or notification portal – is a free online system for notifying information about cosmetic products, created to comply with the requirements of the Technical Regulation, and is owned by the Ministry of Health of Ukraine.

The access to the System is available to:

• The central executive authority responsible for technical regulation in the field of cosmetic products (Ministry of Health of Ukraine),
• The market surveillance authority for cosmetic products (State Service of Ukraine on Medicines and Drugs Control),
• Responsible persons,
• Healthcare institutions.

Information that Responsible Persons and, in certain cases, distributors of cosmetic products must submit to the System about the products they place on the market:

• Category of cosmetic product;
• Product name;
• Responsible Person – name and address;
• Country of origin (for imported products only);
• Contact details of the individual who can be contacted if necessary;
• Nanomaterials – identification, conditions of exposure;
• CMR substances (Category 1A, 1B) – identification;
• Frame formulation;
• Graphic file of the labeling;
• Photograph of the original packaging.

If any of this information changes, the Responsible Persons or distributors must promptly update it. In the case of such changes in the data of the notified cosmetic product, the reason for the changes must be indicated, along with which part of the product information the changes apply to.

Access to this information is granted to the Ministry of Health of Ukraine, the market surveillance authority (for the purposes of market surveillance, market analysis, evaluation, and consumer information), and healthcare institutions (for medical treatment purposes).
   

Products containing nanomaterials

Additional notification requirements are established for products containing nanomaterials (except those used as colorants, preservatives, and UV filters). For such products, additional notification is required six months before they are placed on the market.

The information provided must include the following:

• Identifying characteristics of the nanomaterials, including the chemical name (IUPAC) and other data according to Annexes 2-6 of the Technical Regulation;
• Characteristics of the nanomaterials, including particle size, physical and chemical properties;
• An estimate of the quantity of nanomaterials contained in the cosmetic products intended to be placed on the market within a year;
• Toxicological indicators of the nanomaterial;
• Data on the safety of the nanomaterial related to the category of cosmetic products, if it is used in such products;
• Conditions of reasonably foreseeable exposure.

The Responsible Person may designate another legal or natural person to notify information about nanomaterials by providing them with the appropriate written authorization.
   

Notification procedure

The mechanism for notification (submission) of information about cosmetic products is established by the “Procedure for notification (submission) of information about cosmetic products,” approved by Order of the Ministry of Health of Ukraine No. 2147 dated December 18, 2023.

The Procedure also defines the process for forming and maintaining the Electronic notification system for cosmetic product information (Ukrainian cosmetic products notification portal). 

The Procedure establishes two notification mechanisms depending on whether the product is a single-component (an individual cosmetic product independently placed on the market, including as part of a set) or a multi-component (comprising several cosmetic product components that are not sold separately from one another).

By notifying (submitting) information about a cosmetic product, the Responsible person certifies the absence of prohibited ingredients in the cosmetic product.

It is important to note that the successful notification of a product through the Portal does not mean that the product fully complies with all requirements of the Technical Regulation on cosmetic products.
   

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.