Legislation

The legislation of Ukraine significantly differs from European Union. The definition of “biocide” used in Directive 98/8/EC is not identical to the definition of “disinfection product” in Ukrainian legislation. Product requirements are yet significantly different. 

Product registration and placing on the market requires knowledge of industry legislation and other normative legal acts, including consumer protection, general non-food regulations, advertising and others. Below are the primary documents in the field of regulation of disinfectants and antiseptics in Ukraine:

Law of Ukraine “On the protection of the population from infectious diseases”

Law of Ukraine “On Ensuring Sanitary and Epidemiological Welfare of the Population” (valid until 01.10.2023)

Law of Ukraine “On the system of public health” (effective from 01.10.2023)

Law of Ukraine “On Ensuring the Functioning of the Ukrainian Language as a State Language”

Law of Ukraine “On consumer protection”

Law of Ukraine “On labor protection”

Decree of the Cabinet of Ministers of Ukraine No. 908 of July 3, 2006 “On Approval of the Procedure for State Registration (Re-Registration) of Disinfectants”

Decree of the Cabinet of Ministers of Ukraine No. 420 dated June 13, 1995 “Regulations on hygienic regulation and state registration of hazardous factors”

Decree of the Cabinet of Ministers of Ukraine No. 1401 of December 26, 2011 “On Approval of the Procedure for Submitting a Notification of Products that Do Not Meet the General Product Safety Requirement to State Market Supervision Authorities”

Order of the Ministry of Health of Ukraine dated March 23, 2010 No. 250 “Standard for the provision of administrative services by the Committee on Hygienic Regulation of the Ministry of Health for State Registration (Re-Registration) of Hazardous Factors”