According to Article 3(1)(c) of the Biocidal Products Regulation, an ‘active substance’ is any substance or micro-organism that has an action on or against harmful organisms. This implies that the definition of the term ‘biocidal product’ must be interpreted broadly. It includes products that have an indirect effect on harmful organisms, not just those that have a purely physical or mechanical effect.
On December 19, 2019, the European Court of Justice 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 the authorities consider to be a biocidal active substance that is not registered with ECHA as such. As a result, the authorities classified the product as an unauthorized biocidal product.
The bacteria in the product produce enzymes that absorb and digest organic waste, which serves as a breeding ground for micro-organisms. The treated surface will have 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 argues that it is not a biocidal product because it is applied to surfaces where the fungus has to be removed first. Since there is no direct interaction with the target organisms, this should not be classified as a biocide.
The European Court of Justice answered the following questions:
- Does the term ‘biocide’ also apply to substances/bacteria that do not act directly on a harmful organism, but that act on the living environment of harmful organisms?
- Is it relevant to the answer to Question 1 whether the product is applied if the harmful organism is not present?
- Is it relevant to the answer to Question 1 within what period of time the effect on the living environment takes place?