For the first time in Ukraine, methodological recommendations have been developed: "METHODOLOGY OF TOXICOLOGICAL STUDIES FOR ASSESSING THE SAFE USE OF NEW SUBSTANCES IN FOOD PRODUCTS PROPOSED FOR PLACING ON THE MARKET AS DIETARY SUPPLEMENTS"
In order to harmonize the regulatory framework in Ukraine regarding new dietary supplements, on the basis of the guidances developed by the European Food Safety Authority: "Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283" [Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283] and "Guidance for submission for food additive evaluations", 2021 [Guidance for submission for food additive evaluations, 2021] and the current regulatory framework on improving the regulation of the production and circulation of dietary supplements, specialists of the State Expert Center of the Ministry of Health of Ukraine have developed the methodological recommendations "Methodology of toxicological studies for assessing the safe use of new substances in food products proposed for placing on the market as dietary supplements", which were approved at a meeting of the Scientific Expert Council of the State Expert Center of the Ministry of Health of Ukraine (minutes dated 23.10.2025 No. 26).
The purpose of the methodological recommendations is to improve the safety of the use of dietary supplements in Ukraine and to accelerate the appearance of new products on the market. The methodological recommendations may be useful to applicants, holders of registration certificates, developers and manufacturers of dietary supplements, researchers, expert and regulatory authorities in the development of new dietary supplements, for conducting toxicological studies and evaluating preclinical study materials.
The methodological recommendations consider methods that can be used to identify new dietary supplements (together with data on production and composition) and hazard characterization. For toxicological studies, these methodological recommendations describe a tiered approach that ensures a balance between data requirements and risk for the safety assessment of new dietary supplements, and also takes into account animal welfare through the use of animal study strategies in accordance with the 3-R principle (replacement, refinement, reduction). The tiered approach covers such main areas as toxicokinetics, genotoxicity, toxicity (subchronic toxicity, chronic toxicity and carcinogenicity), as well as reproductive toxicity and developmental toxicity, and, if necessary, other additional studies: immunotoxicity, hypersensitivity and food intolerance, neurotoxicity studies, endocrine activity, etc.
The text of the methodological recommendations can be found on the website of the State Expert Center of the Ministry of Health of Ukraine in the section "Audit Department/Guidelines and methodological recommendations on conducting preclinical and clinical trials" at the link
