European Court of Justice judgment concerning "biocidal product" and "active substance" notions
European Court of Justice rules on the interpretation "biocidal product" definition, established in Regulation (EU) No 528/2012 (BPR)
The German company Biofa AG, a developer and marketer of biocidal products, brought an action for a preliminary ruling against Sikma D. Vertriebs GmbH und Co. KG (Sikma), which sells online products to combat harmful organisms.
The application was made because Biofa AG, the only company on the Article 95 list (listing authorised suppliers) of the active ingredient “Silicium dioxide” used in biocidal products for product type 18 (comprising insecticides, acaricides and products intended to control other arthropods), found that Sikma was marketing its own product containing the same active ingredient, which was, however, not purchased from them (the only authorised supplier).
Sikma argues that the action of the active ingredient contained in its product is only physical or mechanical so its product is not a biocide as BPR understands it; therefore, they would have not the obligation to source by an authorized supplier.
The Court decided to refer the case to the European Court of Justice to define whether all products containing a certain active substance should automatically be defined as biocidal products (Art. 3 BPR) following the approval of this active substance by means of an implementing regulation.
The Court held that a product intended to destroy, eliminate, and render harmless harmful organisms, which contains an active ingredient approved by an implementing regulation, does not fall within the concept of 'biocidal product' in Article 3 of the BPR on the sole ground that the active ingredient it contains is approved. Indeed, it is for the competent national court to ascertain whether this product satisfies all the conditions for being a 'biocidal product'.
A product will automatically be defined as a biocidal product when its composition is identical to that of the representative biocidal product used at the time of application for the active substance approval.
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