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What is the appropriate classification of disinfectants?

In this difficult time of health emergency linked to the spreading of the COVID-19 virus, the demand of disinfectant products is becoming higher and higher, both for hands and surfaces. The appropriate classification of this type of product should be then clarified, as there are many products on the market, often with incorrect or unclear indications misleading consumers.

Recently, the Italian Competent Authorities (Ministry of Health and Higher Health Institute-ISS) also expressed on the matter in official documents to provide more clarifications on this issue for the benefit of all, including those who are not expert in this field.

In particular, it was clarified that only those products authorised as Presidi Medici Chirurgici (PMCs, Medical Surgical Aids) or as Biocides can be classified as disinfectants (for either hands or surfaces) and report such claim in the label.

These products were authorised by the Authorities; the details of such authorisation should be stated in the label. For such products, a technical dossier was submitted containing various studies on the product:

  • including a certificate for the determination of the active substance
  • a stability study
  • efficacy studies

that were then evaluated and approved by the ISS.

The efficacy of these products for the actions claimed in the label such as:

  • bactericidal
  • fungicidal
  • virucidal action

is therefore demonstrated.

On the market there are also products claiming ‘hygienizing’ properties that can contain the same ingredients of PMCs/biocides, but classified as free sale products. For these products no official approval is expected from authorities. The term ‘hygienizing’ is in fact related to personal or surface cleaning, therefore products classified in this way fall into the class of cosmetics (if used in humans) and detergents (if used on surfaces), and are not preliminarily authorised.

In order to protect consumers, the special task force on counterfeiting (NAS) has been controlling to make sure the norms on the contrast of COVID-19 contagion are complied: their attention is addressed to products sold as ‘hygienizing’.

To this end, several products were seized because they were marketed as ‘hygienizing’ products for hands and surfaces reporting misleading or forbidden indications in the label.
ISS is aware of the higher demand of disinfectant products in this period, and released a guideline regarding a simplified registration procedure for PMCs to be followed during the current health emergency.

In particular, the procedure refers to PMCs with disinfectant action on hands and surfaces. The simplifications concern the stability and the efficacy studies. The possibility is also provided to include a claim of partial virucidal action in the label. Of course, the PMCs must meet specific characteristics in order to benefit of this simplified procedure.

The Italian Competent Authorities (Ministry of Health and Higher Health Institute-ISS) have been working to continue their activities, trying to authorise as many disinfectant products in the shortest time possible, in order to contribute actively to the virus restrain.
In Europe, ECHA (the European Chemicals Agency) is also working to facilitate authorisation procedures of disinfectant products.