Cosmetic Product Safety Report (UA CPSR)

The most important element of the product information file, in terms of safety, is the Cosmetic Product Safety Report.

The Cosmetic Product Safety Report is an expert document consisting of two parts: Information on the Safety of the Product (Part A) and the Safety Assessment (Part B).

Part A is aimed at collecting data necessary for the clear identification and quantitative assessment of hazards that may arise from raw materials, packaging, the manufacturing process, conditions of product use, the toxicological profile of substances, and other factors, as well as the risks the cosmetic product may pose to human health. This part of the report is prepared by the Responsible Person.

Part B is the safety assessment that allows for a conclusion on the safety of the product. This part of the report is prepared by a safety expert who, when making the decision and forming the conclusion on the product’s safety, relies on the data collected in Part A and considers the safety of each ingredient and the overall safety assessment of the product.

The report must be detailed, well-argued, clear, up-to-date, and include all necessary data for the product’s safety evaluation.

The Responsible Person must ensure that the report is prepared by a qualified safety expert (assessor) and complies with all the requirements established by the Technical Regulation. 

The Cosmetic Product Safety Report must be continuously updated and kept current. A reassessment and update of the report should be performed in the event of any changes, including changes in legislative requirements, the emergence of new scientific or toxicological data on substances that could alter the results of the existing safety assessment, changes in the composition or specifications of raw materials, changes in conditions of use, an increase in the nature, severity, or frequency of adverse effects, changes in manufacturing conditions, and more.

The report must be stored together with other product documentation (the product information file) 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 cosmetic products is placed on the market.

The Responsible Person must ensure access to the Cosmetic Product Safety Report and other documents for the state market surveillance authority.
    

Safety assessor (expert) 

The expert, or safety assessor of the cosmetic product, must have the appropriate education – a higher education degree 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 education must be confirmed by a diploma, a copy of which is attached to the report.

It is in the company’s (Responsible Person’s) best interest to ensure that the cosmetic product safety assessment is well-founded and substantiated. Therefore, it is important to carefully select an expert to conduct the assessment, as the Responsible Person holds accountability for the product’s safety.

It is recommended that, in addition to the appropriate education, the expert has significant experience and has undergone relevant training in risk assessment.
    

Structure of the Cosmetic Product Safety Report

The Cosmetic Product Safety Report consists of two parts – Parts A and B. A brief structure of the report is provided in Appendix 1 to the Technical Regulation on Cosmetic Products. Detailed requirements for the report are not yet approved in Ukraine, but it is recommended to apply the Commission Implementing Decision 2013/674/EU of November 25, 2013, regarding the guidelines in Annex I to Regulation (EC) No. 1223/2009 of the European Parliament and the Council on cosmetic products (guidelines for the cosmetic product safety report).
   

Part A – Information on the Safety of the Cosmetic Product

1. Quantitative and qualitative composition of the cosmetic product
   This section should include the precise quantitative and qualitative composition of the finished product, starting from the raw materials. The name and identification of each substance (including chemical name, INCI, CAS, Einecs/ELINCS, where possible) and the amount of each substance in the product must be indicated. All substances included in commercial mixtures must be described in detail, including preservatives, antioxidants, chelating agents, buffers, solvents, and other additives. The intended function of each substance should be stated. If aromatic or perfume compositions are used, the name and code number, as well as the identification of the supplier and qualitative and quantitative information about regulated substances in these compounds, should be provided.
        
2. Physico-chemical characteristics and stability of the cosmetic product
   This section should include a description of the relevant physical and chemical characteristics of the substances or mixtures used in the product, as well as the finished cosmetic product itself. Physico-chemical properties, such as chemical identification, physical form, molecular weight, solubility, partition coefficient, substance purity, should be described in detail. The report should also include an assessment of the stability of the cosmetic product under the expected storage conditions, the methodology for determining the product’s minimum shelf life, and any specific precautions regarding product storage.
       
3. Microbiological quality
   This section should include an assessment of the microbiological quality of raw materials and the finished product. Special attention should be paid to products used on sensitive body areas or for specific groups (children, the elderly, immunocompromised individuals). Acceptable microbiological specifications for raw materials and products, as well as the results of preservative tests, if applicable, must be provided. For products with high microbiological risk, results of preservative stability tests and microbiological quality tests of the finished product must be included.
       
4. Impurities, traces, information on packaging material
   This section should include information on impurities and traces of undesirable substances in the raw materials and the finished product. Data on the purity of raw materials, identification of toxicologically relevant undesirable substances, and evidence of the technical inevitability of the presence of banned substances in trace amounts should be provided. The report must also include information on the relevant characteristics of packaging materials, including the composition of the packaging material, possible migration of substances from the packaging, and interaction of the product with the packaging material.
       
5. Conditions of use or reasonably foreseeable conditions
   This section should include a clear explanation of the normal and reasonably foreseeable use of the product to determine the appropriate exposure scenario. The intended use of the product and any possible unintended uses should be considered. Including a photograph of the packaging or product design, as well as references to warnings and labeling, may be helpful.
       
6. Exposure to the cosmetic product
   The report must include a quantitative assessment of human exposure to the cosmetic product under normal and reasonably foreseeable conditions of use. The assessment should consider the type of product, area of application, amount per application, duration and frequency of use, possible routes of exposure, and the target user group.
       
7. Exposure to substances
   This section should include a calculation of the exposure to each substance in the product to assess the risk associated with each substance. The exposure to each substance is calculated from the exposure to the finished product and the concentration of individual substances in it. The exposure to substances that may form or be released during product use should also be evaluated.
       
8. Toxicological profile of substances
   This section should include a description of the toxicological hazards of each substance in the finished product, the determination of potential exposure, and the risk characterization. Relevant endpoints, such as acute toxicity, irritation, skin sensitization, repeated dose toxicity, mutagenicity, genotoxicity, carcinogenicity, reproductive toxicity, toxicokinetics, and phototoxicity, must be considered. The report should also include the calculation of the safety margin for each substance.
       
9. Adverse effects and serious adverse effects
   This section should include a system for monitoring adverse effects after the product is placed on the market, including data on adverse and serious adverse effects. Any adverse effects discovered during product use should be documented and managed, and serious adverse effects must be reported to the competent authorities. The report should include statistical data on adverse effects and measures taken to address them.
       
10. Information on the cosmetic product
    The report should include any additional information that is not covered in other sections of Part A but is important for the safety assessment of the product. This may include studies on human volunteers or data related to specific substances, as well as information on the use of substances in other industries, such as the food or pharmaceutical industries.
       

Part B – Cosmetic Product Safety Assessment

1. Safety conclusion assessment
   The report must include a conclusion, which is a statement of the safety of the cosmetic product in accordance with safety requirements. The conclusion should be clearly justified and easy to understand, taking into account all identified hazards related to the product and its exposure.
      
2. Warnings and instructions for use
   This section should include information on warnings and instructions for using the product to ensure its safe use. Clear recommendations for product usage must be provided, along with any precautions that need to be taken.
       
3. Justification
   The report should include detailed considerations by the safety expert regarding the identified hazards and the product’s exposure. The expert must take all relevant data into account and make well-justified conclusions regarding the safety of the product.
      
4. Expert credentials and approval
   The report must include information on the qualifications of the expert who conducted the product assessment. The expert must have the necessary knowledge and experience to carry out the safety assessment. The expert’s final approval should be attached to the report, confirming their professional responsibility for the product’s safety assessment.
      

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.