L.I. Medved’s Research Center of Preventive Toxicology, Food and Chemical Safety, Ministry of Health, Ukraine (State Enterprise), Kyiv, Ukraine

ABSTRACT. Cosmetic products must be safe for human health and are rarely associated with serious risks in practice, yet the possibility of adverse effects cannot be excluded. Therefore, the safety assessment of cosmetic products is subject to strict regulation and control in developed countries.

Aim. To summarize modern methods of assessing the safety of perfumery and cosmetic products and to analyse the prospects and limitations of implementing alternative methods for their assessment in Ukraine.

Materials and Methods. An analytical review of the EU regulatory documents and national legislation on the safety of perfumery and cosmetic products was conducted. A rapid in vitro toxicity assessment method was used, employing a suspension culture of bull spermatozoa.

Results and Discussion. In Ukraine, the Technical Regulations on the Safety of Cosmetic Products was approved by the Cabinet of Ministers Resolution No. 65 on January 20, 2021. However, due to martial law and the specifics of the national market, its implementation was postponed until August 2024, with a transition period until August 3, 2026. In the EU, alternative testing methods for perfumery and cosmetic products and their ingredients are widely used. These methods have been approved by the EU reference laboratory (EURL ECVAM) and recommended by OECD guidelines for assessing both local effects of chemicals on skin and eyes and toxicological indicators. However, several obstacles hinder the implementation of alternative methods (in vitro, in silico, in vivo/ex vivo, etc.) in Ukraine. These include legislative shortcomings, the absence of national production of test systems and accredited laboratories, state regulatory authorities, and the lack of consensus among market operators regarding the implementation of technical procedures that comply with the EU requirements.

Conclusions. The implementation of alternative testing methods offers a path to simplifying safety assessment procedures for consumers of cosmetic products. This is particularly relevant for replacing complex and costly methods such as toxicological studies on animals and clinical trials involving humans.

Keywords: perfumery and cosmetic products, safety assessment, alternative methods.

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The article was received by the editorial office on January 15, 2025.