The Judgment of the Court (Ninth Section) was published in the Official Journal of the European Union on the 19th of December 2019, relating to a dispute on the applicability of the biocides regulation to a product with preventive action on the formation of microorganisms.

The product contains the bacterial species Bacillus ferment, which generates enzymes which assimilate and consume all the organic waste that the microorganisms feed on, so that, on the surfaces treated with this product, biotopes favorable to the development of microorganisms such as the mushrooms. Please note that the bacterial species 'Bacillus ferment' is however not notified to ECHA as an active biocidal substance.

The manufacturing company does not classify the product as a biocide and has never required the authorization. However, the authority (Staatssecretaris van Infrastructuur en Milieu), based on the manufacturer's and distributor's descriptions on the efficacy of the product, classified the formulation as a biocidal product under Article 3 (1) (a) of the Regulation on biocides and ordered the company to withdraw the product from the market, in addition to providing for a penalty of EUR 1,000 per week, up to a maximum amount of EUR 25,000.

The point is not obvious, so that the Court of Appeal for administrative litigation in economic matters has decided to suspend the procedure and to submit 3 preliminary questions to the Court, in order to decide on the applicability of the definition of biocidal product to a product with the characteristics of the one in question.

The final judgment, which can be consulted at the Eur-Lex website, highlights some aspects not taken for granted These are decisive for the evaluation of ''classification of a product under the Biocides Regulation". In general, the ruling underlines that the notion of "biocidal product" pursuant to Article 3, paragraph 1, letter a), of Regulation no. 528/2012 must be understood in a broad sense and extends in particular to preventive products. In particular, it must be considered that:

1. The term biocide refers in general to products intended to destroy, eliminate, render harmless, prevent the action or exert other control effect on harmful organisms. The regulation extends the scope to any "means other than mere physical or mechanical action". This implies that article 3 also includes products that do not act directly on target organisms but, for example, on the appearance or persistence of a "substrate" favorable to their presence (provided that these products act with a mechanism other than a mere physical action or mechanical, such as the mechanical removal of fertile soil favorable to the pest).
2. If acts as described above, a product can be classified as a biocide even if it is applied to a substrate from which the target organisms have already been removed. In fact, the regulation includes, among the purposes of biocides, both the destruction of harmful organisms and their prevention. As proof of this, in ally V there are a series of classes of biocides with preventive action, used in contexts free of harmful organisms
3. The term within which a product acts does not affect whether or not it can be qualified as a biocidal product, as this element is not considered among the criteria and definitions of the BPR.
4. In this decision of the authority, which then triggered a lawsuit and the sentence reported in the Official Gazette, the much discussed claim played an essential role. In fact, the concept of substance or mixture “intended to” produce certain effects is at the basis of the definition of biocidal product. This purpose is made explicit through the information provided by the seller and contained on the label, but also in the instructions for use, advertising, etc ...

In fact, the label of the product covered by the ruling states that the product must be used "to ensure the absence of fungi" and for "the elimination and prevention of unpleasant odors", bringing a healthy and safe microflora on the vaporized surfaces.

In addition, the Company's website has published the information according to which "probiotic cleaning products act like traditional techniques. They remove visible stains. However, there is an important difference. Any pathogens such as harmful fungi and bacteria also disappear. By eliminating the culture broth, the number of bad bacteria and fungi will be significantly reduced. In addition, the product is safe and durable. It is made of good bacteria and water, which makes it the most environmentally friendly product that can be found on the professional market ".

As reported in the conclusion of the general lawyer Juliane Kokott, these are elements that have brought the authority to consider that the biocidal product has opened the doors for further actions.