Debate on establishing uniform requirements for skin disinfectants in the EAEU
On October 12, 2020, a public discussion began on the draft decision of the Council of the Eurasian Economic Community "On amendments to §20 of Chapter II of the Uniform sanitary, epidemiological and hygienic requirements for products subject to sanitary and epidemiological supervision".
Uniform Sanitary Requirements
The key issue is to supplement the Uniform Sanitary Requirements with provisions on skin disinfectants, a large amount of which has recently been observed on the market due to the SARS-CoV-2 coronavirus epidemic, which causes a dangerous disease classified as Covid-19.
Therefore, it is proposed to supplement Chapter 20, which contains the requirements for disinfectants, with the concept of "skin disinfectants (skin antiseptics)" with a new sub-chapter 1.12, and a new annex with number 3.
Establishing indicators and standards for disinfectants
The requirements to be implemented will be based on tests and indicators specific to skin antiseptics. The possible uses and the exact purpose of the disinfectant will be taken into account. For example, for a disinfectant concentrate, the indicators to be tested will be: acute dermal toxicity, acute inhalation toxicity, sensitization and irritation.
Documents for evaluation and toxicity testing
The newly created annex will include a developed list of documents for the assessment and testing of the toxicity of disinfectants, as well as their safety. The conclusion is presented in the form of a table, which indicates the name of the document regulating the method and information about the method validation.
The documents would include, inter alia, international standards with methods of testing the effect of chemical products on the human body, classified harmful substances, guidelines for sanitary and epidemiological tests, tests of the mutagenic effect of chemical substances, the Rospotrebnadzor manual with methods of laboratory testing of disinfectants and others.
The time to discuss the changes ends on December 11, 2020
The debate on the changes will last 60 days and will end on December 11 this year. The adoption of the amendment will establish uniform requirements for skin disinfectants, indicators of their toxicity and safety for people using them, and will ensure the comparability of the results of tests performed on disinfectants during the product registration procedure.