According to Article 3(1)(c) of the Biocidal Products Regulation, the term 'active substance' covers any substance or micro-organism having an action on or against harmful organisms. According to the European Court of Justice, the word 'against' also implies an indirect effect and thus means that the definition of the term 'biocidal product' must be interpreted broadly. A product should not be seen as a biocide only when there is a purely physical or mechanical effect.
On 19December 2019, the Court of Justice of the European Union (the European Court) ruled in a court case between the State Secretary for Infrastructure and Water Management and a company that puts a probiotic cleaner on the market. The cleaner contains the bacterial species 'Bacillus ferment’ which is considered by the authorities as a biocidal active substance that is not registered with ECHA as such. The authorities classified the product therefore as an unauthorized biocidal product. The bacteria in the product produce enzymes that absorb and digest the organic waste, which serves as a breeding ground for micro-organisms. As a result, there is or will be no more nutrition and no suitable living environment for harmful micro-organisms, so that they can no longer (start to) grow on the treated surface. The company indicates that it is not a biocidal product, because it is applied on surfaces where the fungus has to be removed first. There is no direct interaction with the target organisms and therefore this should not be classified as a biocide.
The questions answered by the court summarize as follows:
The European Court of Justice concludes that a product that acts on the living environment of harmful organisms is a biocidal product in accordance with the Biocides Regulation, unless that product acts solely physically or mechanically. The fact that a product must be applied after the removal of harmful target organisms does not affect the classification as a biocidal product. The period within which a product takes effect is not of further relevance.
This legal opinion could greatly increase the scope of the Biocides Regulation, because more products could be classified as 'biocides'. What the ultimate consequences of this ruling of the European Court of Justice are, is still unclear.
The full decision can be read here.
(Source: Nieuwsbrief Kennisnetwerk Biociden)