An active ingredient approval still does (not) make a biocidal product

Philipp Reusch

The ECJ comments on the scope of an authorisation within the framework of the Biocidal Products Regulation

Recently, in Case C-29/20 (Biofa) (only in German), the ECJ had the opportunity to address a question referred by the Higher Regional Court of Cologne on the scope of an active ingredient approval when qualifying a product as a biocidal product.

State of affairs and initial proceedings

Biofa AG (Biofa) manufactures biocidal products containing the active ingredient "diatomaceous earth". The application for authorisation was granted pursuant to Article 9 of Regulation (EU) No 528/2012 (Biocidal Products Regulation) in conjunction with Article 1 of Implementing Regulation (EU) 2017/794 . Biofa is the only manufacturer of this active ingredient.  Sikma D. Vertriebs GmbH und Co. KG (Sikma) sells a product containing the same active ingredient, but does not purchase this active ingredient from Biofa. Biofa then brought an action for desistance from unfair competition before the Highter Regional Court of Cologne.

Already in the first instance proceedings, the parties disputed whether the scope of application of the Biocidal Products Regulation was open. In Sikma’s view, the use of the active ingredient is irrelevant because it does not have a merely physical or mechanical effect in their product. Thus, one of the constituent elements of a biocidal product was not fulfilled in any case.

In the appeal proceedings, the Higher Regional Court of Cologne dealt with the prerequisites of Article 3(1)a, Alternative 1 of the Biocidal Products Regulation and submitted a question for preliminary ruling to the ECJ, which can be summarised as follows in simplified form: "Does a product already constitute a biocidal product if it contains an active ingredient approved under an implementing regulation?"

Basically, all prerequisites must be met

As expected, the ECJ refers to the reasoning in Case C-592/18 (Darie), clarifying that the prerequisites of Article 3(1)a must be cumulatively met. Thus, a product continues to be a biocidal product only if - in simplified terms -  

  • it contains a substance or a mixture containing an active substance,
  • the active ingredient does not act merely physically or mechanically, and
  • the active substance is intended to control harmful organisms.

"Weighty evidence", scope and circumstantial effect of active substance approval

However, the ECJ places the requirements in a broad context and, when interpreting, establishes a reference to both the system and the objectives of the Biocidal Products Regulation.

The definition of an "active substance" in Article 3(1)c is based only on the composition of the substance and not on the mode of action. At the same time, classification as a biocidal product requires an examination of the effect. For this reason, both aspects are taken into account within the framework of the approval procedure (Article 4(1)): an active substance approval is not to be carried out in isolation, but (also) in relation to the product. An application for authorisation must also be accompanied by a dossier for at least one representative biocidal product containing the active substance to be authorised (Article 6(1)).

The ECJ established the link between the authorisation and the definition of a biocidal product. The composition of the representative biocidal product determines the classification of other products as biocidal products. It would be contrary to the harmonisation objectives of the Regulation if, on the one hand, an active substance were authorised in a representative biocidal product, but at the same time it was possible that a product with an identical composition was not a biocidal product. The following gradation can thus be derived from the judgment:

  • if the composition of a product is identical to that of an approved representative biocidal product, then the product is a biocidal product (regardless of the other conditions);
  • if a product contains an approved active ingredient, there is merely evidence that it is a biocidal product. This means in particular that the other requirements of Article 3(1)a must be met.

Summary

The ruling provides market players within the scope of application of the Biocidal Products Regulation with a tangible delimitation criterion. At the same time, those concerned will have to pay more attention to the composition of their products in the future and undertake comparisons with approval dossiers. If an identical composition is determined on the basis of this test, it can no longer be argued that a product is not a biocidal product by reference to the other requirements in Article 3(1)(a).

[November 2021]