Product information file (UA PIF)

From August 3, 2024, cosmetic products placed on the market may comply with the requirements of the Technical Regulation on cosmetic products, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021, and other legislative acts in the field of technical regulation. From August 3, 2026, all cosmetic products placed on the market must comply with the requirements of the Technical Regulation.

The Regulation requires that for each cosmetic product placed on the market, the Responsible Person must prepare documentation (the product information file). The purpose of this file is to demonstrate the safety of the cosmetic product under reasonably foreseeable conditions of use.

The product information file is a detailed technical dossier for the cosmetic product that contains all necessary and up-to-date information and documentation related to the product. It includes elements concerning the identity, quality, and safety of the product.

The documentation and information cover not only the finished product but also the raw materials and packaging materials – data on research, safety, identification, certificates, specifications, etc. These data and documents for the file come from various sources: raw material suppliers, packaging material suppliers, the product manufacturer, testing laboratories, and the safety assessor who signs the Cosmetic Product Safety Report.

The Regulation requires that the documentation consists of five parts:

1. Description of the cosmetic product. The description must allow for a clear link between the cosmetic product and its documentation.
2. Cosmetic Product Safety Report. A document resulting from the safety assessment conducted to ensure the product’s safety for human health and life.
3. Description of manufacturing methods and a declaration of compliance with GMP. A brief description of the manufacturing methods must be provided, including equipment and materials, with reference to detailed production documentation.
4. Evidence supporting the claimed efficacy of the cosmetic product. Relevant evidence must be collected to support all claims made about the product on the labeling and in marketing (advertising, website, etc.).
5. Information on any animal testing. Data on animal testing conducted by the manufacturer or suppliers during the safety assessment or development of the cosmetic product, its ingredients, and raw materials must be provided.

The product information file must be continuously updated when new scientific data, regulatory requirements, changes in the production process, raw material suppliers, or data on adverse effects become available.

The file must be stored by the Responsible Person in electronic and/or paper form at the address indicated on the product packaging for a significant period – at least 10 years from the date the last batch of the cosmetic product was placed on the market. The Responsible Person must ensure access to the documents for the state market surveillance authority.

While the product information file is not subject to public disclosure and remains the intellectual property of the Responsible Person, the Regulation requires that certain product information be accessible to the public. This includes the qualitative and quantitative composition of the product (concerning hazardous substances), the name and code of perfume and fragrance compositions, the name of their supplier, and available data on adverse effects and serious adverse effects resulting from the use of the cosmetic product.
    

1. Description of the cosmetic product
   

   This section should include a detailed description of the cosmetic product to ensure that competent authorities and safety assessors have a clear understanding of its form, purpose, conditions of use, and product information.

   The trade name and type of the cosmetic product must be indicated, for example, shampoo, lotion, or cream. The description should clearly state the purpose of the product, explaining what it is designed for: skin hydration, hair cleansing, etc.

   The physical form of the product must be described. This includes its type—whether it is a lotion, cream, gel, spray, solid, or powder—and other characteristics such as color, fragrance, and texture. The description of color must be precise, considering potential changes during storage or after application. Additionally, the product’s fragrance should be explained, including its intensity and specific scent profile (e.g., floral, citrus, or musk). Texture is another important aspect, and the description should include whether the product is thick, liquid, smooth, or grainy.

   A description of the packaging should be provided. The primary packaging that directly contacts the product (e.g., bottles, tubes, or jars) should be detailed, including materials (plastic, glass, or metal) and the type of packaging (e.g., pump dispenser or spray). If there is secondary packaging, such as boxes or outer wraps, it should also be described. The size or volume of the product, including its net content (e.g., 50 ml or 100 g), should be clearly indicated, as well as the method of opening and closing the packaging (e.g., screw cap or flip-top).

   In addition to the packaging, the appearance of the product should be presented with images or photographs showing both the product itself and its packaging. The information on the label should also be provided, showing the product name, ingredient list, usage instructions, warnings, and any claims made on the packaging.

   Clear instructions for use should be provided: how the consumer is to use the product. This includes the method of application, whether the product is applied directly to the skin, hair, or nails, and how often it should be used (e.g., daily, weekly). It is also important to indicate the target area for the product, whether for the face, body, or a specific area such as the scalp or hands.

   The description should also consider the target audience for the product. It should specify whether the product is intended for adults, children, or a specific group (e.g., men, women, or sensitive skin). Any warnings or restrictions, such as age limits or cautions (e.g., “for external use only” or “avoid contact with eyes”), should be clearly indicated to ensure safe consumer use.

   If the product has specific claims, such as “anti-aging” or “moisturizes for 24 hours,” they should be noted in the description. While detailed evidence of the product’s efficacy is provided in another section of the product file, these claims should be briefly listed here. If the product has multiple variants, such as different fragrances or formulas for sensitive skin, each should be described, explaining how they differ from the main product.

   The shelf life and period after opening are critical for product safety. If applicable, the product’s shelf life should be stated, with a detailed description of the time it can be safely used before opening. The period after opening should also be included, explaining how long the product can be used after opening (e.g., 12 months).

   The product description should include the product code or reference for internal identification, as well as a description of the batch numbering system. This facilitates traceability, ensuring the product can be easily found in the event of a recall or safety concerns. The batch number on the packaging should be explained with a clear understanding of how batches are organized.
       

2. Cosmetic Product Safety Report
   

   The Cosmetic Product Safety Report is the most important part of the product information file.

   Before the cosmetic product is placed on the market, the Responsible Person must ensure that the cosmetic product is safe for human health under normal conditions of use. To do this, a safety assessment must be conducted based on relevant information, and the report is compiled based on the results of this assessment.

   The safety assessment is a scientific justification of the product’s safety. It is conducted by an expert (safety assessor) who meets the qualification requirements established by the Regulation, such as having a higher education in “222 Medicine” or “226 Pharmacy, Industrial Pharmacy” at the second (master’s) level or other higher education recognized as equivalent by the Ministry of Education and Science of Ukraine (MES). The name, address, and qualifications of the safety assessor must be indicated in the report.

   For a complete safety assessment, suppliers and manufacturers of raw materials, as well as other technical experts, may be involved. It is not sufficient to evaluate each ingredient separately; the composition of the product as a whole must be evaluated, taking into account the potential interaction between ingredients.

   The report considers safety data sheets for the ingredients, necessary warnings and usage instructions listed on the product label, and restrictions established by the Regulation for certain ingredients. It also includes safety calculations (systemic action and safety margin), performed based on No Observed Adverse Effect Levels (NOAEL), Lowest Observed Adverse Effect Levels (LOAEL) of individual ingredients, exposure levels, daily usage levels, and the method of product use.

   A special safety assessment must be conducted for cosmetic products intended for use by children under the age of three, taking into account the physiological, metabolic, and behavioral characteristics of infants.

   The Regulation establishes the requirements for the structure and content of the report. The report must consist of two parts:

      

   Part A – Information on the Safety of the Cosmetic Product

   • Category and name of the cosmetic product, quantitative and qualitative composition.
   • Physico-chemical characteristics and stability of the ingredients and finished product.
   • Microbiological characteristics.
   • Impurities, residual substances, information on packaging material.
   • Conditions of use or intended purpose of the product.
   • Exposure to the cosmetic product.
   • Exposure to substances.
   • Toxicological profile of substances.
   • Adverse effects and serious adverse effects.
   • Information on the cosmetic product.
         

   Part B – Cosmetic Product Safety Assessment

   • Safety conclusion assessment, safety declaration.
   • Warnings and usage instructions.
   • Justification.
   • Expert data, qualifications, and signature.

   Part A is prepared by the Responsible Person, while Part B is prepared and signed by the safety expert based on the documentation in Part A. The expert conducts the safety assessment, checks for prohibited or restricted ingredients, verifies the correct testing procedures, and ensures other requirements are met.

   The Safety Report must be regularly updated and supplemented with additional relevant information obtained throughout the product’s lifecycle.

   When conducting the safety assessment, the Responsible Person must ensure that:

   The intended use of the cosmetic product and the expected exposure of individual ingredients are considered.

   The safety assessment is based on a body of evidence from all sources using available information.

   The Cosmetic Product Safety Report is consistent with all additional post-market information obtained.
      

3. Description of manufacturing methods and GMP compliance declaration
   

   This section of the product information file provides a detailed description of how the cosmetic product is manufactured, ensuring that all processes meet the safety and quality requirements in accordance with Good Manufacturing Practice (GMP).

   Information about the manufacturer or manufacturers must be provided, including the name, address, and other identifying details of the manufacturing facility.

   A description of the stages of cosmetic product manufacturing must be provided, from the procurement and processing of raw materials to the final packaging of the product. The stages of production must be described, including mixing, heating, cooling, and filling, if applicable. Each stage should detail how the product is processed to maintain its stability, quality, and safety. The description should also include information about the equipment used during production and its compliance with cleanliness and accuracy requirements.

   The description must also cover how the facility performs quality control throughout the manufacturing process. This includes testing procedures for raw materials, process control at different stages, and testing the finished product to ensure it meets specifications. Quality control systems should be implemented to ensure that the product is free from contaminants, the correct ingredients and formulations are used, and the packaging is properly sealed and labeled.

   In addition to quality control, this section should describe traceability and accountability systems during production. This may include a batch numbering system that tracks the production of each batch of products from raw materials to distribution, allowing for the traceability of products to specific production batches in the event of a recall or quality issues.

   A description of deviation management procedures, corrective actions, and continuous improvement in the production process should also be provided. Any issues that arise during production, such as deviations from standard operating procedures, must be documented and resolved. Procedures for addressing these issues, such as corrective and preventive actions (CAPA), should be outlined, demonstrating that the manufacturer takes steps to continuously improve processes and resolve any issues that may affect product quality.

   A key element of this section is the confirmation that the manufacturing process complies with Good Manufacturing Practice (GMP). GMP compliance refers to guidelines that ensure the consistent production and control of products according to quality standards. These guidelines cover all aspects of production, from raw materials to personnel hygiene, equipment, and facilities. This section should provide evidence that the manufacturer follows recognized GMP standards, such as ISO 22716. If the manufacturer is ISO 22716 certified, a copy of the certificate should be attached.

   Another key element is the GMP Compliance Declaration, which must be prepared by the Responsible Person. The Responsible Person is accountable for ensuring that the cosmetic product’s manufacturing process complies with GMP requirements.
      

4. Justification of claims 
   

   According to the requirements of the Technical Regulation, the texts, names, trademarks, photographs, and other signs on the labeling and advertising of cosmetic products offered on the market must not give the impression that the product has characteristics or functions it does not possess.

   Claims – are promises of any result from using the cosmetic product on its packaging, the manufacturer’s website, or in advertising. Any claims must be substantiated, for example, through laboratory or consumer research, scientific data, or literature.

   In the European Union, the criteria for justifying claims regarding cosmetic products are regulated by EU Regulation 655/2013, which, at the time of writing, has not yet been adopted in Ukraine. Since Ukrainian legislation is gradually being harmonized with EU law, we also rely on the requirements, practices, and recommendations of the European Union.

   This section must demonstrate the effectiveness of the cosmetic product and the accuracy of any claims or statements based on adequate and verified evidence.

   This section should begin with a list of claims. These claims can range from functional benefits (e.g., “moisturizes for 24 hours” or “reduces wrinkles”) to more specific properties, such as “hypoallergenic” or “dermatologically tested.” Claims may also relate to performance, such as “increases skin firmness” or “provides UV protection.”

   After listing the claims, detailed information on the scientific evidence or test data supporting each of them should be provided. Several types of evidence can be presented:
       

   Scientific studies or published scientific papers

   If the claims are based on general scientific knowledge or published research, relevant studies should be cited. These can be peer-reviewed articles or scientific papers that demonstrate the effectiveness of the ingredients or formula. For example, if the product claims to contain ingredients that reduce wrinkles, the file should include references to studies confirming the effectiveness of these ingredients. When using existing scientific literature, it is important to ensure that the studies are current, relevant, and based on generally accepted scientific principles.
      

   Clinical or consumer testing

   If the claims are based on clinical or consumer research, this data should be included in the product information file. Clinical trials, typically conducted in laboratories or controlled conditions, provide detailed and objective measurements of the product’s effects. These trials must be conducted under the supervision of qualified professionals, such as dermatologists or cosmetologists.

   The results of these studies should be summarized, including the methodology, number of participants, and the results obtained. For example, if the product claims “visible results in 4 weeks,” the corresponding clinical trial should show how the results were measured, the duration of the study, and the percentage of participants who saw the claimed effect.

   Consumer testing can also be used to support claims. This type of testing involves providing the product to a group of consumers to gather subjective feedback on its effectiveness. While consumer research is less scientific than clinical trials, it provides real-world insight into how the product is perceived and can be useful for claims related to user experience, such as “makes skin feel soft” or “easy to apply.”
       

   Instrumental and laboratory testing

   For certain claims, such as those related to sun protection (e.g., SPF claims) or anti-aging effects, instrumental testing conducted in laboratory conditions is required.

   For example, if the product claims to provide SPF 30 protection, the file should contain laboratory tests conducted using standardized methods that measure the product’s sun protection factor.    
        

   Claims based on specific ingredients

   Some claims are based on the known properties of specific ingredients, but it is important to note that according to EU Regulation 655/2013, ingredient claims do not automatically transfer to the final product.

   For example, if the product is “moisturizing” due to the presence of hyaluronic acid, evidence must be provided not only for the moisturizing properties of hyaluronic acid but also for its sufficient concentration in the final product to achieve the moisturizing effect, considering interactions with other ingredients.
        

   Comparisons with similar products

   If claims include comparisons, such as “better than leading brands” or “longer-lasting than similar products,” the product information file must include evidence supporting these comparisons. This can be achieved through comparative testing with competing products, where the effectiveness of the product is objectively compared under the same conditions. The methodology of these comparative tests should be clearly outlined, including how the products were tested and what criteria were used to evaluate the results.

   Regulatory and legal requirements

   It is necessary to ensure that all claims comply with current regulatory and legal requirements. For example, claims such as “organic” or “natural” must meet specific requirements, and supporting documents, such as certificates, must be included in the product information file.
       

5. Information on animal testing
   

   Without hindering the requirements for ensuring the safety of cosmetic products for human health under normal or reasonably foreseeable conditions of use, it is prohibited to:

   • Place on the market cosmetic products that have been tested on animals without using alternative methods after such methods have been officially adopted in Ukraine or other countries, considering the standards of the Organization for Economic Co-operation and Development (OECD);
   • Place on the market cosmetic products containing ingredients that have been tested on animals if alternative methods were not used after their official adoption in Ukraine or other countries;
   • Conduct animal testing of cosmetic products in Ukraine to comply with the requirements of this Regulation.

   Exceptions are allowed if the ingredients are widely used and have no substitutes, or if there are justified human health concerns and animal testing can confirm or refute the connection between the ingredient and harm to the user’s health.

   The Responsible Person may indicate on the product packaging or in any other document, notice, or label accompanying or referring to the cosmetic product that no animal testing has been conducted, but only if the manufacturer and suppliers have not conducted or initiated any animal testing on the finished cosmetic product, its prototype, or the ingredients used, nor used ingredients that were tested on animals for the development of the cosmetic product.

   Accordingly, this section should include a statement that no animal testing was conducted on the finished product or its ingredients by the manufacturer, suppliers, or any third parties. It is necessary to provide documentary evidence that all testing, if required to ensure safety or efficacy, was carried out using alternative methods that do not involve animals, such as in vitro (using human cells or tissues), in silico (computer simulations), etc.
       

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.