September 26, 2020

Not all hydroalcoholic gels offer guarantees against the coronavirus

During the worst moments of the pandemic, back in March and April, masks became one of the rarest and most demanded items worldwide due to the coronavirus pandemic. Within weeks, orders for FFP and surgical masks soared, while the companies responsible for their manufacture were unable to keep up with the huge demand. Such was the shortage that many health professionals in Spain had to reuse masks for more than a week and some even more than a month. Against this background, counterfeit masks, with no guarantees of efficacy, have exploded in many countries thanks to the general desperation to get them.

In the background, beyond the media and serious lack of masks, other precious elements used to prevent coronavirus infections also threatened to become scarce on the market: hydroalcoholic gels. The Government took exceptional measures to ensure the supply of these products. Among the decisions that were made, the special use of bioethanol (alcohol of vegetable origin) was allowed for the production of hydroalcoholic gels, along with the rest of the countries of the European Union. In addition, to increase the availability of these items, multiple distillery, cosmetic, and perfume companies have reconverted to produce hydroalcoholic gels. Thus, exceptionally, The Spanish Medicines Agency (AEMPS) authorized the manufacture of hydroalcoholic solutions and gels to 9 cosmetic manufacturers and medicines and also authorized all those companies that manufacture ethyl alcohol (such as distilleries) to use it to make these hand hygiene products.

This drastic reconversion of different industries to substantially increase the production of hydroalcoholic gels had, however, an important restriction: the regulatory demonstration of the disinfecting efficacy, in general, and viricidal, in particular, of these products. The process for a gel or hydroalcoholic solution to be marketed as a biocide (that is, as a “disinfectant”, “antiseptic” or “viricide”) is long, slow and requires the performance of specialized tests that demonstrate activity against viruses, bacteria, fungi and / or other microorganisms. In addition, the AEMPS must review and grant authorization to these products that want to be sold as disinfectants. The consequence of this process is that the majority of hydroalcoholic gels on the market are sanitizing: cosmetics that do not offer the guarantees of biocides and are not required to have disinfectant effects. These cosmetic gels are intended to clean the hands and legislation prevents them from having a biocidal claim, as, for example, “antiseptic”, “disinfectant”, “sanitizer”, “effective against coronavirus” or any other claim that refers to protection against contamination or infection by microorganisms, since its disinfectant effectiveness is not proven or guaranteed.

The reality is that the majority of the population does not know the differences between disinfectant and sanitizing gels, but the requirements and guarantees offered by both types of products against the coronavirus are very different. The disinfectant gels that comply with the UNE-EN 14476 standard have proven viricidal efficacy and have been authorized by the AEMPS. The agency itself has published on its website a list of antiseptics for healthy skin with proven virucidal efficacy.

On the other hand, sanitizing gels have not been authorized by the AEMPS, nor do they have guaranteed disinfectant activity. Does that mean that all sanitizing gels are useless against coronavirus and other microorganisms? No, but knowing its composition (the percentage of alcohol or other disinfectant molecules it contains) is key to knowing if it could have a disinfectant effect, although it does not legally offer guarantees of this. In general, those products that have between 60 and 90% alcohol should be effective against the coronavirus. If they contain other disinfecting substances such as chlorhexidine or benzalkonium chloride, it is also essential to know their concentration to find out if they could be effective.

The problem is that there are many hydroalcoholic sanitizing gels that either do not have an adequate percentage of alcohol (less than 60%) and do not have other disinfectant molecules or do not indicate the concentrations of the disinfectant molecules in the list of ingredients. In the first case, the sanitizing gel will not be effective against the coronavirus or other microorganisms. In the second case, the consumer will have no way of knowing the usefulness of the gel, trusting it will be a leap of faith. Furthermore, some of these products, which do not indicate the concentration of their ingredients, they don’t even mark that the product is flammable, a mandatory requirement for those who have a minimum percentage of alcohol.

Certain sanitizing gels have caused problems both inside and outside the borders of our country. In May, the Union of Nursing in Malaga reached demand the immediate withdrawal of a hydroalcoholic gel from all health centers dependent on the Costa del Sol Health Agency that it was sanitizing and that it did not mark the percentage of alcohol it had. In July, the French Directorate-General for Competition, Consumption and Fraud Control also withdrew a sanitizing gel produced in Spain for not having “antibacterial and antiviral efficacy”Since the product did not contain enough ethanol or isopropanol, it did not comply with labeling regulations and did not destroy viruses or bacteria.

Aware that a large part of the population is unaware of the characteristics of sanitizing gels and disinfectants, the Collegiate Nursing Organization published a press release with materials and infographics to inform about these products. Florentino Pérez Raya, president of the General Nursing Council, explained the following: “It must be remembered that one of the main weapons against the virus is hand hygiene. The ideal would be to wash with soap and water, especially for the general population. But we are aware that we do not always have a sink nearby to carry it out. In these cases, hydroalcoholic gels should be used, but before buying them, one must take into account the concentration of alcohol they carry and against which microorganisms they are effective. We are concerned because citizens are buying and using some gels that do not work against the virus and their use gives them a false sense of security that can expose them to COVID-19, with the fatal consequences that this can lead to “.


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