Conformity assessment of cosmetic products

The Technical regulation on cosmetic products was approved by the Cabinet of Ministers of Ukraine’s Resolution No. 65 dated January 20, 2021, and is based on Regulation (EC) No. 1223/2009 of November 30, 2009. The Technical regulation came into force on August 3, 2024.

To comply with the requirements of the Regulation, the following must be done:

• Ensure that the product qualifies as a “cosmetic product” and falls under the scope of this Regulation;
• Check the composition of the product for compliance with the requirements;
• Verify if the product falls under the scope of other technical regulations, and if so, meet the requirements of all applicable regulations;
• Designate a Responsible person in Ukraine;
• Conduct a product safety assessment and prepare a Cosmetic Product Safety Report according to Ukrainian requirements;
• Ensure that the manufacturing process complies with GMP requirements;
• Develop labeling and a graphical file for the packaging;
• Prepare a Product Information File that must be kept accessible to the market supervision authority;
• Notify the product on the Ministry of Health portal;
• Notify the packaging graphical file;
• Establish and maintain a system for collecting information on adverse effects;
• Keep the Product Information File accessible upon request by the market surveillance authority.

We provide professional services of market authorization (conformity assessment) of cosmetic products in Ukraine. We have deep knowledge of Ukrainian and European legislation, experience, and necessary resources. Our services: regulatory intelligence and consulting, feasibility study;  Responsible person in Ukraine; filling of UA PIF (product information file for Ukraine);  safety assessor services, filling of UA CPSR (cosmetic product safety report);  development of labeling and graphical file; development and implementation of GMP;  post-marketing and safety monitoring (cosmetovigilance).       Our team has an excellent knowledge of the legislation, is fluent in English, possesses broad experience, and will be able to answer all questions. Cooperation with us will grant you high-quality professional service and fast results.

    
Requirements for the composition of cosmetic products

The Regulation sets restrictions on the use of substances in cosmetic products. Substances may be prohibited or restricted in use. If colorants, preservatives, or UV filters are used, only those listed in the corresponding annexes of the Regulation can be used, with strict adherence to established restrictions and prohibitions.

The Regulation contains the following lists:

• Prohibited substances (Annex 2);
• Substances permitted under certain conditions (Annex 3);
• Permitted colorants (Annex 4);
• Permitted preservatives (Annex 5);
• Permitted UV filters (Annex 6).

Additionally, the use of CMR substances of categories 1A, 1B, and 2, according to Regulation (EC) No. 1272/2008 on the classification, labeling, and packaging of chemical substances, is prohibited.

Cosmetic products containing nanomaterials must be notified to the competent authority 6 months before they are placed on the market.
    

Other applicable technical regulations

Cosmetic products may be subject to several technical regulations simultaneously, if applicable. Most commonly, the following regulations apply to cosmetic products:

• The Technical regulation on the safety of chemical products (UA REACH), approved by the Cabinet of Ministers of Ukraine’s Resolution No. 847 dated July 23, 2024, which comes into force on January 26, 2025.
• The Technical regulation on aerosol dispensers, approved by the Cabinet of Ministers of Ukraine’s Resolution No. 154 dated February 21, 2023.
• The Technical regulation on prepackaged goods by weight and volume, approved by the Cabinet of Ministers of Ukraine’s Resolution No. 1193 dated December 16, 2015.
• The Technical regulation on the safety of toys, approved by the Cabinet of Ministers of Ukraine’s Resolution No. 151 dated February 28, 2015.

Additionally, chemical raw materials used in cosmetics production are subject to the Technical Regulation on the Classification, Labeling, and Packaging of Chemical Products (UA CLP), approved by the Cabinet of Ministers of Ukraine’s Resolution No. 539 dated May 10, 2024, which also comes into force on January 26, 2025.

If cosmetic products fall under several regulations, all applicable requirements must be adhered to simultaneously.
   

Responsible person

A responsible person must be appointed for each cosmetic product before it is placed on the market.

The responsible person is a legal or natural person residing in Ukraine, responsible for ensuring compliance with the requirements of the Technical regulation. A key principle of the Regulation is that the person or company placing the cosmetic product on the market is responsible for that product.

By default, the Responsible person for imported products is the importer, and for domestically produced cosmetic products, it is the manufacturer. The importer and manufacturer may appoint a third party, a resident of Ukraine, to be the Responsible Person through written authorization, provided that written consent is given.

If a foreign manufacturer has several importers in Ukraine, each of them will be considered a Responsible person unless a third party is designated. Each importer-responsible person should perform a safety assessment and prepare a CPSR signed by a Ukrainian safety assessor, prepare the PIF, prepare the labeling with its name and address as a Responsible person, and notify the cosmetic product under its own name. 

The Responsible person is responsible for compliance with requirements, including product composition, labeling information, instructions, and advertising materials, compliance of manufacturing with GMP standards, product safety assessment and demonstration, product notification to the competent authority, documentation storage, post-market surveillance, and reporting serious adverse effects.

The Responsible person is required to prepare documentation (the product information file) in accordance with the Regulation’s requirements and keep it available for inspection by authorities for at least 10 years from the date the last batch of the cosmetic product is placed on the market.

The address of the responsible person must be indicated on the labeling of each cosmetic product.

For cosmetic products under a private label (PL), there are several models in which the trademark owner can have the status of a Responsible Person, the status of a virtual manufacturer, or have no regulatory status at all. 

According to the definition, selling cosmetic products under one’s own name or trademark is a characteristic of the manufacturer. For the proper legal arrangement of the relationship between the trademark owner and the manufacturer, a License Agreement for the temporary non-exclusive use of the trademark, a Quality Agreement for contract manufacturing, and other documents may be required.

We offer the service of the responsible person in Ukraine. We have excellent knowledge of Ukrainian legislation in technical regulation of cosmetic products, have a strong and experienced team, and a robust quality management system. Cooperation with us will facilitate your business:  enhancing regulatory compliance and increasing the sustainability;  single point of keeping your PIF accessible to market supervision authorities;  validated solutions in local product labeling;  professional support of importers, distributors and retail in regulatory, quality and safety issues;  post-marketing, safety monitoring and many other benefits.

Product Information File (PIF) 

Before notification, the responsible person must prepare documentation – the product information file for the cosmetic product.

The file must include the following information:

• A description of the product and data for its identification.
• A cosmetic product safety report, compiled and signed by an expert (safety assessor):
  • Part A: Information on the safety of the cosmetic product;
  • Part B: Cosmetic product safety assessment.
• A description of manufacturing methods and a declaration of compliance with GMP (Good Manufacturing Practice) requirements.
• Evidence of the claimed effectiveness of the cosmetic product.
• Information about any testing on animals.

The documentation must also include labeling information and a graphical file for the packaging.

The documentation must be kept by the Responsible person at the address indicated on the product packaging for at least 10 years from the date the last batch of the product is placed on the market and must be provided upon request by the market surveillance authority.
   

Compliance with GMP requirements

The Regulation states that the production of cosmetic products must comply with Good Manufacturing Practice (GMP). By notifying a cosmetic product, the responsible person assumes responsibility for ensuring that the manufacturing complies with GMP requirements.

In Ukraine, the national standard DSTU EN ISO 22716:2015 “Cosmetics. Good Manufacturing Practice (GMP). Guidelines on Good Manufacturing Practice” has been adopted, which is identical to the EN ISO 22716:2007 standard. This is a specialized standard developed for the cosmetics industry, offering organizational and practical guidelines for managing human, technical, and administrative factors that affect product quality at each stage of production.

Obtaining a GMP certificate is voluntary but demonstrates compliance with the standard.
   

Labeling requirements

Each individual cosmetic product must have labeling that complies with the requirements of the Regulation and other legislative acts. The labeling of cosmetic products must be in Ukrainian (the state language), though information may also be provided in additional languages.

The information must be visible, legible, and indelible, and may be applied via a sticker, insert (leaflet), tag, or card.

The Responsible person (national manufacturer or representative of a foreign manufacturer) is responsible for ensuring compliance with labeling requirements. Additionally, each distributor in the supply chain is required to verify that the required labeling information is present before making the product available on the market.

The Regulation sets out a list of mandatory information that must appear on the labeling:

• Name and address of the responsible person;
• Country of origin for imported products;
• Contents of the package in units of weight or volume, or the number of units of the product;
• Minimum expiration date or period after opening;
• Storage conditions;
• Warnings and precautions;
• Special information for professional use;
• Batch number or data for identification;
• Intended use of the product, if not obvious;
• List of ingredients using INCI (International Nomenclature of Cosmetic Ingredients) names.

Packaging layouts (a graphic file and/or photograph) must be notified to the competent authority.
   

Product notification

Before placing cosmetic products on the market, the responsible person is required to notify the product (provide information about the product) on the Ministry of Health portal.

Notification is carried out according to the “Procedure for Notification (Submission) of Information on Cosmetic Products,” approved by the Ministry of Health Order No. 2147 dated December 18, 2023.

The following information must be provided:

• Product category, its name, or identification data;
• Name and address of the responsible person;
• Country of origin;
• Contact details of a person who can be reached if necessary;
• Data on the presence of nanomaterials and methods of their identification;
• Name and identifiers of substances (CAS) or EC numbers of CRM substances;
• Formula framework, which is considered when providing emergency medical assistance.

In addition, the graphic file of the labeling and, if necessary, a photograph of the packaging must be notified.

Access to this information is available to:

• Responsible persons for entering product data; 
• The State Market Surveillance Authority (State Service of Ukraine for Medicines and Drugs Control) for the purposes of state market surveillance, market analysis, evaluation, and consumer information;
• The Ministry of Health of Ukraine;
• Healthcare institutions if treatment is necessary;

In case of any changes to previously notified data, the responsible person must update the information on the notification portal.
   

Safety vigilance 

The Regulation requires that cosmetic products placed on the market must be safe for human health. For this purpose, a mandatory safety assessment must be conducted before the product is placed on the market, and a Cosmetic Product Safety Report must be prepared.

Consumers may still experience negative effects on their health under normal or reasonably foreseeable conditions of use – referred to as adverse effects.

If a user experiences a reaction under normal or reasonably foreseeable conditions of use that leads to temporary or permanent functional disability, incapacity, hospitalization, congenital anomalies, or poses an immediate risk to life or health – a serious adverse effect – this must be reported immediately to the competent authority.

The responsible person (the national manufacturer or representative of the foreign manufacturer), distributors, healthcare professionals, and end-users must report to the competent authority information regarding:

• All serious adverse effects (side effects) that they are aware of or that can reasonably be expected;
• The name of the cosmetic product and its identification details;
• Corrective actions taken.

The competent authority responsible for organizing state supervision of cosmetic product safety is the State Service of Ukraine for medicines and drugs control.

There is no need to notify the competent authority of negative effects that are not serious and do not prevent the user from performing daily tasks.

Information about adverse and serious adverse effects must be collected and recorded by the responsible person, and the Cosmetic Product Safety Report must be updated to reflect this information.
   

State market surveillance

Cosmetic products that meet the requirements of the Regulation are subject to state market surveillance, which is regulated by the Law of Ukraine “On State market surveillance and control of non-food products” and other legislative acts.

The competent authority for state market surveillance is the State Service of Ukraine for Medicines and Drugs Control (SSUMDC).

Market surveillance is carried out at all stages of product distribution: during customs clearance, in retail and warehouse premises, at fairs or exhibitions. The market surveillance authority conducts scheduled inspections according to an approved sectoral plan, as well as unscheduled inspections based on consumer complaints, requests from government bodies, law enforcement agencies, and others.

The market surveillance authority checks the product’s compliance with the requirements of the Technical Regulation, including the presence and relevance of notified information about the cosmetic product, labeling requirements, and compliance of graphic layouts. In case of violations, decisions may be made to restrict or prohibit sales, remove products from circulation, or recall them. Fines may also be imposed on the retailer, importer, manufacturer, or their responsible person.
   

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.