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FAQ – PMCs and Biocides

A PMC (Presidio Medico Chirurgico, medical-surgical aids) is a category including products such as disinfectants, insecticides, insect repellents, rat poisons (*), that require a national authorisation from the Ministry of Health for their marketing.

(*) Please note: Mice and rats poisons for domestic and civil use, although falling into the definition of Presidential Decree 392 of 6 October 1998, are currently authorised only as biocidal products as per Regulation EU no. 52/2012, as the Community review program has been concluded for all the active substances included on this category of products.

Before establishing this, one should check the regulations in force in that particular country where the product is to be marketed.  Each country has its own regulations and therefore not all products that should be registered as PMC in Italy must necessarily follow a similar procedure in other countries.

Regulatory consultants can provide specific and updated information on the status of the single active substances and on the regulations in force, offering effective help in the preparation of a biocide or PMC dossier and assisting companies through the whole authorisation procedure.

The Commission adopts an implementing regulation establishing the conditions based on which an active substance is approved for one or more PTs or an implementing decision according to which an active substance is not approved.

It must be assessed if the intended use of that product falls into the classification of the PTs (Product Types) and if the active substances are included in the EU list for that particular PT.

In case an active substance is excluded from Annex II and is not included in the EU list for a specific PT, it will not be possible to authorise a product as a biocide containing that active substance for that particular intended use and it will be required to withdraw all PMCs or free sale products with biocidal properties containing this active substance from the market.

This is the review program of all active substances on the market before 14 May 2000.  The scope of this program is to identify, notify and group those substances whose use is considered suitable in the preparation of biocides.

According to the definition of Regulation (EU) no. 528/2012, biocide means any substance or mixture generated from substances or mixtures or in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism by any means other than mere physical or mechanical action.  A treated article that has a primary biocidal function shall be considered a biocidal product.

The authorisation is released for a maximum period of 10 years.  An application to renew this authorisation is to be submitted if one intends to continue the marketing of the biocidal product.

No. When the active substance of the PMC is approved for biocidal use, the submission of a new application to authorise the PMC as biocidal product is required, otherwise the PMC must be withdrawn from the market.

No. Only suppliers that are approved and reported in the List of Article 95 can make biocidal active substances available.

No. The dossier required to authorise a product as a biocide is more substantial than that of a PMC.  In fact, it also includes studies to determine the chemical and physical properties and the efficacy of the product as well as ecotoxicological studies.  Moreover, the biocidal dossier must be prepared and submitted via the dedicated programs.

An evaluation is required whether the active substance was approved for the intended use of the concerned product.