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Transizione da PMC a Biocidi

The transition from PMCs to biocides

As provided for by article 1 of Presidential Decree no. 392 of 6 October 1998, the classification of PMCs (Presidi Medico Chirurgici, medical surgical aids) applies to the following types of products:

  • disinfectants and substances placed on the market as germicides or bactericides,
  • insecticides for domestic and civil use,
  • insect repellents,
  • rat and mice poisons for domestic and civil use.

According to Regulation (EU) 528/2012, biocides are:

  • any substance or mixture in the form in which it is supplied to the user, consisting of, containing or capable of generating one or more active substances, with the aim of destroying, eliminating, rendering harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action;
  • any substance or mixture, generated from substances or mixtures which are not covered as such in the first indent, used with the intent to destroy, eliminate, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by any means other than mere physical or mechanical action;
  • a treated article that has a primary biocide function is considered a biocide.

Biocides and PMCs are strictly related, because of the transition from a national legislation (on PMCs) to the European Regulation (on biocides). The national legislation governing the marketing of these products will be completely replaced by the European legislation on biocidal products, entailing the integration of most PMCs into the category of biocidal products.

This step is essentially due to the need of developing a European legislation appropriately regulating all those products falling into the biocidal classification, now subject to different legislations depending on the concerned country.

Directive 98/8/EC has set up a ten-year programme to review all active substances on the market before 14 May 2000, in order to identify and group those substance considered suitable for the preparation of biocidal products.

The first phase of the programme provided for the identification of the active substances on the market on 14 May 2000 (a date chosen based on Directive 98/8/EC of 14 May 1998 granting Member States two years for its national implementation). It also explained the procedure to be followed to reach this goal.

Following Directive 2009/107/EC, the review programme was extended until 14 May 2014, to allow its completion. This deadline has been further extended until 31 December 2024 by the Delegated Regulation (EU) no. 736/2013. Such situation involves the occurrence of a transition period, when national legislations add to the European regulations.

When Regulation (EU) no. 528/2012 has become effective, a Union List was introduced, including all active substances approved for use in biocidal products. If the active substances are included in the list of approved substances, a product shall be authorised as a biocidal product.

When even only one of the active substances included in a certain preparation is not reported in this list, then the product cannot be authorised as biocidal.

In the case of the Italian legislation, the registration of a product as PMC is therefore possible only for preparations containing an active substance included in Annex II of the Delegated Regulation (EU) no. 1062/2014 for the Product Type (PT) of interest, and applies until the date of inclusion of this active substance in the list of approved substances.

Products containing active substances that were excluded, or for which no evaluation was requested by any Member States by the end date of the review, are then automatically excluded from the market. For the purpose of the marketing authorisation, it is appropriate to consider first which are the active substances that can be used for the preparation of biocidal products, and which PTs can be considered for each single active substance.

Di Renzo Regulatory Affairs has a dedicated unit made up of regulatory experts in the field of biocides and PMCs (Presidi Medico-Chirurgici, medical surgical aids). We can therefore assist companies in all required activities, providing consultancy on the current Italian and European regulations and on the progress of biocide regulations.