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Always check disinfectants labelling

In the difficult moment of health and economic crisis we are living, unfortunately we should also pay attention to the activity of some companies that, taking advantage of the current emergency, are carrying out unfair business practices.

In particular, this applies to those companies that are marketing products not matching the advertised characteristics, without the required authorisation of the Ministry of Health or sold at excessive prices compared to the market prices.

To contrast such irregular activities, the counterfeiting task force of the Italian police (Carabinieri del NAS) are continuing their controls aimed at protecting consumers and fair operators, contrasting fraudulent and illegal behaviours by companies that are exploiting the current health emergency caused by Covid-19 for dishonest benefits.

In this context, the NAS have recently seized several packs of a product marketed as a disinfectant biocide for hands and claiming on the label the removal of bacteria, fungi and viruses (coronavirus, hiv, hbv, hcv). However, the product was lacking the required ministry authorisation that is mandatory for disinfectants. In fact, as reminded many times by the Authorities, products claiming disinfectant properties in the label must have been previously authorised as PMC (Presidi Medico Chirurgici – Medical Surgical Aids) or as Biocides.

Such authorisation ensures that for these products appropriate efficacy studies were carried out to give evidence to the disinfection/sanitation properties claimed in the label. Moreover, this authorisation ensures that the technical dossier of the product was assessed with a positive outcome by the Authorities, that authorised the use of the disinfectant ensuring the safety and efficacy of the product when complying with the use conditions reported in the label.

Therefore, before buying a product, its label should be read carefully. The labelling of disinfectant products (claiming sanitising, disinfecting activities against bacteria, fungi and viruses) shall mandatorily report a reference to the product authorisation. This can be authorised as a PMC or as biocide.

Moreover, in the case of a PMC, the label should also specify the manufacturing site, that must have also been authorised by the Ministry of Health. In Italy, to be able to produce disinfectants belonging to the category of the PMCs, specific requirements must be met (such as the presence of dedicated production lines, the appointment of a technical director, etc.) and a manufacturing license must be requested, that is issued by the Ministry only after the assessment of the relevant technical dossier, and following an inspection by the NAS.

In this period, in order not to hinder the manufacturing of disinfectant PMCs for hands and surfaces, the Ministry acknowledges the priority of these authorisation procedures and it is therefore possible to obtain the authorisation even in a very short time.

Of course, it is essential that the dossier submitted by the company is complete and that the documentation is appropriate. In fact, the content of the authorisation application to manufacture PMCs remains unvaried, even during the emergency, in order to ensure that the manufacturing sites comply with the safety and quality standards provided for by the relevant regulations.

Because of the higher demand of disinfectants, many companies have been thinking about the possibility to convert their activity to PMC manufacturing. Before starting such conversion, it is necessary to consider whether the manufacturing site meets all the requirements of the Italian law.

Also for disinfectants to be used in hospitals, one should refer to the PMC and biocides regulations in case of hard surfaces such as floors or other furniture. On the other hand, products for the disinfection of medical devices must comply with other requirements

Written by: Federica Montozzi