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

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.


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).


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