Enhancing cryopreservation of organoids via diffusion kinetics analysis using Cryo-Raman microspectroscopy

In the process of European integration, Ukraine is gradually adapting its legislation to the requirements of the European Union, not only in the economic and administrative spheres, but also in the agricultural sector, in particular animal husbandry.One of the important areas is the use of cryotechnologies for the preservation, selection and transport of genetic material of farm animalsnamely sperm and embryos.Considering the growing role of reproductive biotechnologies in the production of productive livestock, harmonising the Ukrainian regulatory framework with European requirements is a necessary condition for expanding international cooperation, exports and quality control in this area.Th erefore, the aim of the study was to analyse the regulatory requirements for sperm cryopreservation stations and laboratories working with the production and storage of embryos in EU countries, compare them with Ukrainian regulations and identify ways to adapt Ukrainian legislation for European integration in the fi eld of animal reproductive biotechnology.Th e study analysed over 150 scientifi c publications (articles in Scopus/Web of Science, reports of the European Food Safety Authority (EFSA), FAO), as well as 10 key EU and Ukrainian regulations governing the fi eld of cryopreservation of gametes and embryos in animal husbandry.Th e main sources are Regulation (EU) 2016/429 (Animal Health Law), Delegated Regulation (EU) 2020/686 and relevant clarifi cations from the European Commission.For the Ukrainian side, the Law of Ukraine "On Veterinary Medicine", "On Biosafety", as well as orders of the Ministry of Agrarian Policy regulating requirements for reproductive materials were reviewed.A comparative analysis of the structural elements of legislation was carried out, in particular the requirements for infrastructure, personnel, traceability, epizootic status, transport and storage.In the EU, the activities of establishments for the collection, processing and storage of semen and embryos are subject to strict certifi cation and control.Th e key requirements are: registration of the establishment in the central register, presence of qualifi ed personnel, clear traceability of biomaterial, compliance with biosafety requirements, presence of clean areas, proper documentation, and control of the quality of media and reagents.Ukrainian legislation partly covers these aspects, but needs to clarify concepts, introduce mandatory registration for cryopreservation centres, and update requirements for the transport and labelling of biomaterial.Th ere is also no centralised open register of approved institutions, as implemented in the EU.In conclusion, the sector of gamete and embryo cryopreservation in animal breeding in Ukraine is functioning and has practical applications, but is not currently harmonised with EU legislation.To ensure the export of genetic material and integration into European markets, it is necessary to adapt the regulatory framework and implement European standards for certifi cation, traceability, infrastructure compliance and veterinary control.Th is will allow the development of a competitive biotechnology industry in compliance with European requirements.