The complex world of biocides: all supporting guidelines
We often talk about biocides and biocidal properties of a product, but the meaning of these terms is not always clear to everyone. Let’s start with the definition. According to the regulation, a biocide is defined as any substance or mixture, 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.
Thus, it is important to identify the ingredient or the ingredients with biocidal action, which are referred to as active ingredients. Obviously, not all the ingredients are considered as active ingredients, as only those allowed and approved for a specific use are considered as such.
The biocidal action refers to different activities, distributed over in 22 PTs or Product Types, based on the intended use of the relevant product.
We can start with disinfectants (PT 1 to 5), then move on to preservatives (PT 6 to 13), products used for pest control (PT 14 to 20) and end with the last two PTs, which include anti-fouling products and fluids used in embalming and taxidermy.
It is therefore immediately evident that we are talking about a very broad and extremely diverse set of products that all fall under the same regulation.
Therefore, the handling of biocides is not so simple and immediate; it is necessary to have a deep knowledge of the legislation, which also includes a very large number of guidelines and technical supporting documents, in addition to the European relevant regulation.
In fact, before placing the product on the market, it is necessary to apply for an authorization to the competent authority by submitting a technical dossier. There is no universal registration guide that applies to all the biocidal products, but reference must be made to the relevant documentation for each type of biocide. The general structure of the dossier is obviously the same for all the biocidal products, but depending on the product type, specific studies will be required to demonstrate, for example, the efficacy and safety of the biocide.
The active ingredients allowed to be used in biocidal products are typically chemical substances, but also ingredients that are of natural origin can be used, which is why some biocides are often referred to as natural biocides.
This this kind of products also requires prior authorization by the competent authority. In this case, less data supporting the registration is required and the authorization process should be quicker.
Therefore, the registration of natural biocidal products also requires the filing of a dossier with data, along with prospective studies confirming the biocidal activity and safety of the product.
Written by: Federica Montozzi
Foto di Squirrel_photos da Pixabay
