Official Mexican Emergency Standard publishes requirements for topical ethyl alcohol-based antiseptics

Mexican Foreign Trade Single Window (VUCEM)

One of the preventive recommendations of national and international health authorities to avoid the spread of the SARS-CoV2 virus has been the use of alcohol-based hand sanitizers, which is why this type of product has proliferated in the market. Simultaneously with its use, health agencies around the world have pointed out deficiencies in the quality of some of them, among others, the presence of methanol, which makes them a health risk due to their toxic nature; in other cases, due to the ineffectiveness of the product as it does not contain the concentrations that guarantee its antimicrobial or viricidal effectiveness. Although the WHO emphasizes the use of ethanol (ethyl alcohol) and 2-propanol (isopropyl alcohol), the use of their mixtures for antiseptic purposes is also common.

The use of alcohols for this purpose is justified by their ability to denature proteins of microorganisms, however, higher concentrations of alcohol in the product make it less potent since proteins are not easily denatured in the absence of water.

Therefore, it is necessary to regulate the quality specifications that guarantee the quality and effectiveness of said health supplies and their verification methods.

Given that the effectiveness of alcohol-based antiseptics, against coronaviruses, depends on a minimum exposure time of 30 seconds, this standard also indicates necessary legends for their proper use, as well as precautionary or commercial legends that are necessary. to give the most information on topical antiseptics based on ethyl or isopropyl alcohol or their mixtures, gel or solution.

In this regard, this Official Mexican Emergency Standard establishes the requirements and the sanitary and commercial specifications that the processes of preparation, mixing, production and distribution of topical antiseptics based on ethyl or isopropyl alcohol or their mixtures, in gel or solution, must comply with and indicates the test methods to verify them.

This Official Mexican Emergency Standard is mandatory for all establishments dedicated to the manufacture, import, and distribution of ethyl or isopropyl alcohol-based topicals or their mixtures, in gel or solution, intended to be marketed in the national territory.