SUMMARY

Disinfectant, including antiseptics requirements and market authorization vary globally, subject to the regulations of individual countries or regions. Key aspects include formulation compliance with safety standards, clear labeling detailing ingredients and usage instructions, and the need for scientific evidence to support health claims. The production, storage, transportation, use, and sale of disinfectants shall be carried out in compliance with the requirements of the relevant regulations. The use of disinfectants that are not registered in accordance with the established procedure, as well as those that have been manufactured, transported, or stored in violation of the requirements of technological regulations and other regulatory acts, is prohibited. Good Manufacturing Practices (GMP) are often mandated to ensure product quality, safety, and consistency. Some countries require pre-market approval or notification for disinfectants, with safety assessments, packaging specifications, and storage requirements integral to regulatory compliance. Market authorization agencies, such as the FDA in the United States, EFSA in the European Union, and analogous bodies in other regions, oversee disinfectant approvals. Post-market surveillance, including mandatory adverse event reporting, contributes to ongoing safety monitoring. Efforts for international harmonization aim to establish consistent guidelines globally, emphasizing the importance of manufacturers comprehending and adhering to specific market regulations for the lawful distribution of disinfectants.