Safe or dangerous?

COSSMA: With the beginning of the Coronavirus pandemic, the need for disinfectants skyrocketed. To meet the demand, improvisation was carried out in many places. What was and is the risk here?

Mauro Bleve: Firstly, there were two main issues to consider: efficacy and safety. It is paramount to guarantee efficacy as a biocide. This efficacy has to be proven with specific tests respecting the EN standards for biocidal products, which are not cosmetics and follow different rules and regulations.

During the pandemic, most cosmetic manufacturers were called to provide their expertise and production capacity to answer the global emergency and to deal with an increased demand for disinfectants. 

The safety of consumers was also a top priority, without any doubt. Applying disinfectant and antibacterial products repeatedly which contain high levels of alcohol and biocidal agents can easily lead to skin sensitisation and skin reactions.

On some occasions, with the intent to make their products more appealing, some manufacturers include perfumes and other substances claimed to improve the antibacterial properties (like tea tree oil, or high levels of preservatives), thus exposing the skin to a high risk of skin reactions. Therefore, it is highly important to guarantee product safety through accurate tests, despite the immediate need for availability of hand sanitisers in the market.

Other potential risks include the quality of the final product, as increased demand means texture and how it feels on the skin after application become of secondary importance. Therefore, we experienced many products which left hands feeling sticky or with residue after drying. Other products took too long to dry and absorb, and some weren’t sold in user-friendly packaging or correctly dispensing the correct quantity for each dosage.

What do you have to pay attention to when formulating hand disinfectants and what must not happen under any circumstances?

The main purpose of disinfectants is the efficacy against pathogens, thus meaning the correct amount of active ingredient must be guaranteed. Since the beginning of the pandemic, the World Health Organisation (WHO) and many local country authorities started circulating guidelines and minimum requirements, as well as providing information on formulations to clarify the necessary amount and function of each ingredient.

It is important to follow the guidelines for the minimum and maximum level permitted for each active ingredient, as a higher content is not always the best solution. In the example of alcohol, the ideal amount in an efficacious hand sanitiser is between 60% and 80% v/v.

Do the risks only apply to hand disinfectants or also to other products used for disinfection?

Although I am not an expert in surface detergency, I suppose these requirements apply to any product for disinfection containing alcohol or other biocidal agents, as the efficacy depends on the characteristics of the pathogens and its interaction with the biocide.

What can happen if not enough care has been taken in putting the formulation and products together?

As mentioned before, the safety of the consumers could be put at risk, and the quality of the product could be affected too. We know that efficacy of these products is paramount, but a satisfying product experience cannot be avoided, as the consumption of this type of product achieved an exponential growth over the last 18 months. Additionally, attention must be paid to the directions of use and to the package design in relation to product dispensing in order to comply with the EN tests standards.

What are the requirements for a good product with a disinfectant effect?

The minimum requirements are similar between sanitising products and, to some extent, cosmetics. These include the content of antibacterial agents for an efficacious biocidal product, making sure that it does not decrease during the whole product lifetime, thus losing efficacy; a precisely described method of use and application to guarantee the expected efficacy; a proven stability for the whole declared lifetime of the product; and finally, safe, user-friendly and, if possible, child-proof packaging.

Who has the necessary knowledge and who should look for the appropriate support here, if necessary?

Manufacturers of biocides of course, but also manufacturers of medical devices, pharmaceutical, and to some extent cosmetic products. These manufacturers have experts and specific departments who are able to design and deliver efficacious and safe products that are compliant with regulations, because the technical dossier and product registration are very important steps to consider, as well as the formula development and production.