+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


From PMCs to Biocides – An Ariadne’s thread to navigate the labyrinth of Italian and European legislation

Let’s face it, the introduction of a European directive on biocides has greatly confused and frightened the many interesting industries in the production or marketing of what today are still defined as Medical Surgical Devices (PMC), even if such denomination is now in the process of extinction. Disinfectants, insecticides, insect repellents, rat poisons and others are now part of a much broader category of products, that of “biocides”, carefully described in Directive 98/8 / EC which also regulates their placing on the market.

The need to create legislation governing these products throughout the European community is adequately explained in the three objectives initially set: standardize the behavior of individual European states, provide a high level of control and safety, ensure that the product is effective against target species. Important objectives therefore, which mainly aim to safeguard the interest and well-being of the consumer.

And how to achieve the achievement of such a milestone? The main idea behind the biocides directive was to select from the countless quantities of substances on the market only those which, due to their efficacy and safety characteristics, can be considered suitable for the preparation of biocidal formulations. It is easy to imagine how much this has translated into an extremely large and complicated job, assigned to various European countries and which is still in progress today. Therefore, a list of active ingredients present on the market up to the date of May 14, 2000 was first created to be analyzed.

A ten-year review program (subsequently extended until May 14, 2014) of the selected substances was then introduced, many of which are still undergoing chemical studies or awaiting evaluation. The active ingredients thus chosen are included in Annexes I and IA of Directive 98/8 / EC while the others continue to occupy the still long list of Annex II of regulation 1451/2007 / EC, including all substances subject to the revision. Obviously, this careful analysis and identification of the “acceptable” active ingredients has, as already said, of enormous importance since it ensures the consumer that the purchased product really has the characteristics and properties shown on the label and, at the same time, guarantees the absence of highly toxic or harmful substances.

It should be noted that the numerous substances are evaluated based on the possible intended use of the biocidal product, or, as described by the legislation, based on the Product Type (PT). The so-called “biocides” have in fact been divided into 23 types and to date the only categories for which the active ingredients have been subjected to revision are:

wood preservatives
insecticides, acaricides and products intended for the control of other arthropods
repellents and attractants
So far, so good. The real problem arises when individual companies decide to produce and market formulations that fall within the category of biocides, but which at the same time can still be considered PMCs as they contain active ingredients currently under review. Or, and above all, when you intend to market biocidal products according to the requirements of the European directive and you do not have a clear idea of ​​how to prepare a presentable biocide dossier.

In the first case it is clear that, being in a transition period, it is not enough to follow the legislation for the marketing authorization of PMCs, but some requests of the biocides directive must also be taken into consideration; chemical analyzes, for example, should be carried out “in sight” of the biocidal products, so as to facilitate a future registration of the individual product as a biocidal product. In fact, the registration of a product as a PMC is only possible for a preparation containing an active ingredient registered in Annex II for the PT of interest and is valid until the date of inclusion of the active ingredients in Annex I or IA. After this date, the authorization as a PMC automatically expires and it is therefore necessary to request the authorization of a biocide.

The second hypothesis is much more complicated. It occurs when the active substances present in a biocidal formulation are included in Annex I or IA of Directive 98/8 / EC. In this case it is necessary that those interested in placing biocides on the market inform themselves in due time, or rather study, perhaps with the help of experts, on how to draw up a biocide dossier, which studies to carry out, which documents to submit.

Directive 98/8 / EC, in fact, introduces a new series of mandatory analyzes (toxicological and ecotoxicological), which flank the bactericidal and fungicidal efficacy studies, already provided for by the legislation on PMC, thus making the placing on the market of disinfectants and insecticides