Product informaiton file

This section of the website applies to requirements of the Technical regulations on cosmetic products that will become effective from August 3, 2022. For earlier requirements please refer to the following page. 

Cosmetic products placed on the market from August 3, 2022 must comply with the requirements of the Technical Regulations approved by Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021 and other applicable legislative acts in the scope of technical regulation.

Before placing a product on the market, the manufacturer must ensure that all national requirements are met, including the designation of a Responsible Person in Ukraine for a non-resident manufacturer, filling of the Product Information File for a cosmetic product, development of national labeling and notification (registration) of the product.

The responsible person must prepare the Product Information File (PIF) in accordance with the requirements of the Technical Regulations and keep it accessible to competent authorities for at least 10 years from the date of the last cosmetic product being introduced into circulation.

The documentation for cosmetic products must contain the following information:
Prior to notification (registration), the Qualified Person is obliged to prepare a cosmetic product information file. The file should contain the following information:

1. Description of product and data for its identification.
2. Cosmetic Product Safety Report (CPSR), drawn up by an expert that matches qualification requirements:
   • Part A: Information on the safety of cosmetic products;
   • Part B: Safety assessment of cosmetic products.
3. Description of manufacturing methods and declaration of conformity with GMP requirements (EN ISO 22716).
4. If necessary, confirmation of the declared effectiveness claims.
5. Details of any animal studies.

Also, the documentation should contain information for package labeling and a graphical file.

The responsible person ensures that:

• the safety assessment takes into account the intended use of cosmetic products and the expected effects of individual ingredients;
• safety assessment is based on the evidence from all sources based on available information;
• the cosmetic product safety report is consistent with all additional post-marketing information received.

The documentation should be updated as necessary.

The responsible person should ensure that the documentation is available in electronic or another format to the state market surveillance authority. The information should be provided in a language acceptable to the state market surveillance body.

Cosmetic Product Safety Report (CPSR)

The safety assessment report is an integral part of the product information file for a cosmetic product and is required to demonstrate conformity with the established requirements.

The report consists of two parts: Part A “Safety Information for Cosmetic Products” and Part B “Safety Assessment of Cosmetic Products”. The report is drawn up and signed by a qualified expert with higher education in the specialty “222 Medicine” or “226 Pharmacy, industrial pharmacy” or equivalent.

Part A: Information on the safety of the cosmetic product: 

1. Category and name of the cosmetic product, components, and quantities.
2. Physicochemical characteristics and stability of ingredients and finished product.
3. Microbiological properties.
4. Impurities, residues, information on packaging components.
5. Conditions of use or intended use of the product.
6. Effect of a cosmetic product.
7. The effect of substances.
8. Toxicological profile of substances.
9. Side effects and serious side effects.
10. Information on cosmetic products. 

Based on the documentation in Part A, an expert conducts a safety assessment, checks prohibited or restricted ingredients, proper testing, and other requirements. The expert calculates the systemic effect and the margin of safety (MoS) based on the level of no observed adverse effects (NOAEL) and prepares part B – the conclusion on safety:

Part B: Safety assessment of cosmetic products: 

1. Conclusion assessment, safety statement.
2. Warnings and instructions for use.
3. Rationale.
4. Expert data, qualifications and signature.

Our services 

Cratia provides comprehensive regulatory support and accompanies at all stages of regulatory compliance of cosmetic products in Ukraine:

• outsourcing of a Responsible Person (RP) in Ukraine;
• assessment of the composition of the product;
• filling of the Product Information File;
• Cosmetic Product Safety Report (CPSR);
• verification/development of labeling, instructions, and advertising materials;
• product notification;
• development and implementation of Good Manufacturing Practice in accordance with ISO 22716 (GMP);
• legal and consulting support of the manufacturer, Responsible person or distributor (importer).

We possess deep knowledge and experience, speak and write fluent English. We will take over the organization of the process, assist in filling of the set of documents and perform the required procedures in a short time.