Safety and efficacy of everyday products
How can we be sure that a common disinfectant is really effective against bacteria and harmful organisms? And the doubt does not only concern disinfectants, but also all those products of daily use whose efficacy and safety we take for granted.
Usually, the guarantee that a certain substance has the properties attributed to it on the label is provided to us by the existence of regulations governing the placing on the market of the so-called “Medical-Surgical Devices”.
This class of products includes, among others, disinfectants, insecticides and rat poisons which, in order to be introduced on the Italian market, require a specific authorization, issued by the Ministry of Health, based on in-depth analyzes.
All this, in addition to providing the end user with greater safety and peace of mind, also ensures that a careful evaluation of individual products is carried out at a national level.
In the short term, however, the Italian legislation governing the placing on the market of medical-surgical devices will be replaced by the European legislation on “Biocides”, the aim of which is to introduce a single legislation capable of standardizing the behavior of individual states Europeans, while continuing to ensure a high level of control, safety and efficacy.
Directive 98/8 / EC, which regulates the placing on the market of biocides, has in fact introduced a ten-year review program (subsequently extended until 14 May 2014) of all active ingredients on the market before 14 May 2000, at in order to identify those substances whose use, for the preparation of biocides, can be considered suitable and safe.
The substances thus selected are included in Annexes I and IA of Directive 98/8 / EC, while those still under review are included in Annex II of the same directive. Obviously, this careful evaluation and identification of “acceptable” active ingredients 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.
And if on the one hand the fears and uncertainties of consumers decrease, on the other the responsibilities and work, which companies producing biocides have to take on, increase significantly.
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 made mandatory by the legislation on medical-surgical aids, thus making the trade in disinfectants and insecticides even more complicated and controlled.
In Italy the situation appears even more complex, since for the marketing of a disinfectant both the Italian legislation on medical-surgical aids and the European legislation on biocides must necessarily be taken into consideration.
Thus, while some active ingredients are under review, at a community level, and therefore their use for the preparation of biocidal products is not allowed, their registration among medical-surgical aids is still possible.
If we delve further into the intricacies of the difficult regulation of biocides, we note that the evaluation of the individual active ingredients also takes place considering the possible intended use, or, as described by the legislation, based on the “type of product” (PT ).
The possible biocidal formulations have in fact been divided into 23 types of products, for which each active ingredient is analyzed. To date, the only categories under review are:
wood preservatives
rodenticides
insecticides, acaricides and products intended for the control of other arthropods
repellents and attractants
At this point it is reasonable to ask the problem of how Italian companies can extricate themselves in the difficult path that goes from medical-surgical aids to biocides, as well as defining and preparing the necessary documentation for the request for marketing authorization, while guaranteeing the maximum safety of their products.
