Safety assessment report is a key component of the Product Information File, serving as confirmation of the product’s safety. This expert document consists of two main parts:

• Part A – contains detailed information necessary to identify potential risks associated with the use of the cosmetic product. It analyzes factors that may affect product safety, such as raw materials, packaging, manufacturing process, conditions of use, toxicological characteristics of the ingredients, and more. This section is prepared by the responsible person.
• Part B – is the actual safety assessment, based on the data from Part A. It is compiled by a safety assessor who draws a conclusion on the product’s safety, taking into account the evaluation of all ingredients and the overall safety of the product.

The report must be comprehensive, well-founded, clear, and up to date, including all information necessary for an objective evaluation of product safety. It should be updated in the event of any changes in formulation, method of use, manufacturing conditions, regulatory requirements, or the emergence of new scientific or toxicological data.

The report is stored by the responsible person along with other documentation as part of the Product Information File — either in electronic or paper format — at the address indicated on the packaging, for at least 10 years from the release date of the last batch of the product. Government market surveillance authorities must have access to this report upon request.

The safety assessment must be conducted by a specialist holding a higher education degree in the field of “222 Medicine” or “226 Pharmacy, Industrial Pharmacy” at the master’s level, or an equivalent qualification recognized by the Ministry of Education and Science of Ukraine. A copy of the diploma must be attached to the report. Choosing the assessor is a critical step, as the responsible person bears full responsibility for the product’s safety. It is recommended that the assessor not only holds a relevant degree but also has practical experience and specialized training in risk assessment.

The structure of the Safety Assessment Report is defined in Annex 1 to the Technical Regulation on cosmetic products. Although detailed requirements in Ukraine are not yet officially approved, it is advisable to follow Commission Implementing Decision 2013/674/EU of 25 November 2013, which provides guidelines for Annex I of Regulation (EC) No 1223/2009 of the European Parliament and of the Council.