Ukrainian safety assessor

To confirm the compliance of cosmetic products with the requirements of the Technical Regulation, the Responsible Person must ensure that a safety assessment is conducted before the product is placed on the market. The safety assessment should be based on a body of evidence from all available sources, including: data on substances and mixtures, impurities and packaging material; data on the final (finished) product, including laboratory test results, conditions of use of the finished product, and reasonably foreseeable conditions; data on adverse effects and information about the cosmetic product.

The safety assessment is documented in the form of a Cosmetic Product Safety Report, which must adhere to the structure approved in Appendix 1 to the Technical Regulation.

The Cosmetic Product Safety Report is a mandatory part of the product information file, which must be retained by the Responsible Person for 10 years from the date the last batch of the cosmetic product is placed on the market and provided upon request to the state market surveillance authority during inspections.

The safety assessment of the cosmetic product is conducted by an expert who has a higher education in “222 Medicine” or “226 Pharmacy, Industrial Pharmacy” at the master’s level, or other higher education recognized as equivalent by the Ministry of Education and Science of Ukraine (MES).

The safety assessor of cosmetic products – is a physical person who has a higher education in “222 Medicine” or “226 Pharmacy, Industrial Pharmacy” at the master’s level (or other higher education recognized as equivalent by the Ministry of Education and Science of Ukraine), the necessary additional knowledge, and who prepares the Cosmetic Product Safety Report, confirming their professional responsibility for the product’s safety assessment with their signature.

The safety assessor prepares the Declaration of Cosmetic Product Safety in accordance with the requirements of the Technical Regulation and indicates the need for any warnings (special precautions) and instructions for the use of the cosmetic product. The safety assessor must provide a reasoned justification, explaining the scientific rationale behind the safety conclusion, based on the information presented in Part A of the Safety Report.

The expert’s data, confirmation of their qualifications, and the date and signature by which they certify their professional responsibility are an integral part of the Safety Report.

It is clearly in the company’s (Responsible Person’s) interest to ensure that the safety assessment of the cosmetic product is well-founded and substantiated, so it is important to carefully select the expert conducting the assessment, as the Responsible Person is ultimately accountable for the product’s safety.

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

Frequently Asked Questions:

1. Is the signature of a foreign safety assessor who conducted the safety assessment in accordance with Regulation (EC) 1223/2009 sufficient?
   No, a safety report signed by a foreign expert in accordance with Regulation (EC) 1223/2009 is not sufficient to meet the requirements of the Ukrainian Technical Regulation. Similarly, a safety report signed by a Ukrainian expert under the Ukrainian regulation cannot be considered as confirmation of compliance with the EU Regulation. According to the Technical Regulation on cosmetic products, approved by the Resolution of the Cabinet of Ministers of Ukraine No. 65 dated January 20, 2021, the expert must have a higher education at the master’s level in the specialty “222 Medicine” or “226 Pharmacy, Industrial Pharmacy,” or other higher education recognized as equivalent by the Ministry of Education and Science of Ukraine (MES). The process of recognizing foreign educational documents is called “nostrification” and is conducted in accordance with the legally established procedure. The decision on the nostrification of a foreign educational document (diploma) in Ukraine is made by the Ministry of Education and Science, which issues a certificate of equivalence. A foreign expert whose educational document has been recognized as equivalent in Ukraine and who meets the requirements of the Technical Regulation can prepare and sign the cosmetic product safety report.       
2. Does the safety assessor have to be an employee of the Responsible Person or manufacturer, or should it be an independent external expert? Does the safety assessor have to be an employee of a scientific institute?
   The legislation does not define the relationship between the safety assessor and the Responsible Person or manufacturer. Therefore, the assessor can be either an internal specialist or external. The safety assessor can be an employee of the Responsible Person, importer, or manufacturer, as well as of a scientific institute or consulting company.
       
3. Can the safety assessor have a higher education in the specialty “Toxicology”?
   The Technical Regulation specifies only two specialties that a safety expert can have: “222 Medicine” or “226 Pharmacy, Industrial Pharmacy.” This differs from Regulation (EC) 1223/2009, which allows for education in pharmacy, toxicology, medicine, or a related discipline, or a course recognized as equivalent by a Member State.

We provide professional safety assessment services for cosmetic products, with qualified employees who have the appropriate education, qualifications, and experience.
    

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.