Opinion of the Advocate General — ECLI:EU:C:2021:411
Date: 2021-05-20
Language of the case: German
Subject matter: Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Germany

Translation C-29/20 — 1 
Case C-29/20 
Request for a preliminary ruling 
Date lodged: 
23 January 2020 
Referring court: 
Oberlandesgericht Köln (Germany) 
Date of the decision to refer: 
10 January 2020 
Applicant: 
Biofa AG 
Defendant: 
Sikma D. Vertriebs GmbH und Co. KG 
  
[…] Made on 10 January 2020 
[…]  
Oberlandesgericht Köln (Higher Regional Court, Cologne) 
Order 
In the case of 
Biofa AG, […] Gutsbezirk Münsingen, 
applicant and appellant, 
[…] 
v 
Sikma D. Vertriebs GmbH und Co KG, […] Everswinkel, 
defendant and respondent, 
EN 
REQUEST FOR A PRELIMINARY RULING OF 10. 1. 2020 — CASE C-29/20 
 
2  
[…] 
the 6th Civil Chamber of the Oberlandesgericht Köln (Higher Regional Court, 
Cologne) 
[…] 
hereby orders: 
I. The proceedings are stayed. 
II. The following question on the interpretation of Article 3(1)(a), 
Article 9(1)(a) and Article 95(3) of Regulation (EU) [Or. 2] No 528/2012 of the 
European Parliament and of the Council of 22 May 2012 concerning the making 
available on the market and use of biocidal products is referred to the Court of 
Justice of the European Union for a preliminary ruling: 
Where an active substance is approved in an implementing regulation adopted 
pursuant to Article 9(1)(a) of Regulation (EU) No 528/2012, can it be taken as 
given in court proceedings in a Member State that the substance on which the 
approval is based is intended within the meaning of Article 3(1)(a) of Regulation 
(EU) No 528/2012 to act by any means other than mere physical or mechanical 
action, or is it for the adjudicating national court to establish in fact whether the 
preconditions for the application of Article 3(1)(a) of Regulation (EU) 
No 528/2012 are fulfilled even after an implementing regulation has been 
adopted? 
Grounds: 
I. 
The parties are in dispute as to whether the defendant is entitled to distribute a 
pesticide containing Kieselguhr as an active substance, even though it is not 
obtained from a listed importer or manufacturer. 
The applicant is a medium-sized undertaking that develops primarily biologically-
based agricultural products, applies for authorisations and distributes the 
authorised products in the territory of the Federal Republic of Germany, other EU 
Member States or EEA Member States. 
Some of those products contain the active substance Kieselguhr (which is known 
by various names), which the applicant distributes under the ‘InsectoSec®’ brand 
name. These products are used to control creeping vermin, especially poultry red 
mite, in poultry houses. [Or. 3] 
The active substance Kieselguhr is a mineral obtained from microscopically small 
shells of dead diatoms and consists primarily of silicon dioxide. Contact with the 
active substance covers the harmful insects and mites with dust; this affects the 
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cuticle of their exoskeleton (which protects the insects from dehydration). This 
causes the harmful insects and mites to dehydrate and die. 
The applicant applied for authorisation of the active substance Kieselguhr in 
accordance with Regulation (EU) No 528/2012. It submitted the necessary 
dossier, which was compiled at no little financial cost. 
Silicon dioxide Kieselguhr was approved as an active substance for use in biocidal 
products of product-type 18 under Commission Implementing Regulation (EU) 
2017/794 of 10 May 2017 approving silicon dioxide Kieselguhr as an existing 
active substance for use in biocidal products of product-type 18, subject to the 
specifications and conditions set out in the annex thereto. The implementing 
regulation entered into force on the twentieth day following that of its publication. 
The applicant is entered on the list referred to in Article 95 of Regulation (EU) 
No 528/2012 […], currently as the only manufacturer of this active substance. 
The defendant supplies products for stock farmers and the compound feed 
industry, including for the purpose of ‘parasite management, especially in the 
poultry sector’ via an online shop and the online marketplace eBay. The range 
distributed includes a product used to control poultry mites, especially poultry red 
mites, sold under the brand name ‘HS Mikrogur’, which likewise contains the 
active substance Kieselguhr, which it does not obtain from the applicant. 
The applicant argues that the distribution of that product by the defendant 
infringes Paragraphs 3 and 3a of the Gesetz gegen den unlauteren Wettbewerb 
(Law on Unfair Competition; ‘the UWG’), read in combination with Article 95(2) 
and (3) of Regulation (EU) No 528/2012, and is thus anti-competitive, and that the 
active substance Kieselguhr does not act by mere physical or mechanical action. 
The applicant therefore sought, as against the defendant, an order to desist, 
information, a determination as to its liability in damages and reimbursement of 
the costs of the warning notice. [Or. 4] 
Having taken evidence from an expert witness, the Landgericht (Regional Court) 
rejected the application. It found that, according to Paragraph 8(3).1 and 
Paragraphs 3 and 3a of the UWG, read in combination with Article 3(1)(a) and 
Article 95(2) and (3) of Regulation (EU) No 528/2012, the claims made did not 
have any basis. 
II. 
Judgment in these proceedings depends on the interpretation of Article 3[(1)](a) 
and of Article 9(1)(a) of Regulation (EU) No 528/2012 and the binding effect of 
an implementing regulation adopted pursuant to it. For that reason, before a ruling 
is given on the appeal, the proceedings may be stayed and a preliminary ruling 
obtained from the Court of Justice of the European Union pursuant to the first 
paragraph, under (b), and the second paragraph of Article 267 TFEU. The 
Chamber holds that this is necessary in the present proceedings. 
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1. The Landgericht found the application to be unfounded. It held in this regard 
that: 
although the parties are competitors and a specific competitive relationship exists, 
Article 95(3) of Regulation (EU) No 528/2012 is a provision that regulates the 
market within the meaning of Paragraph 3a of the UWG; that, however, the 
defendant had not made biocidal products available on the market in breach of 
Article 3(1)(a) and Article 95(3) of Regulation (EU) No 528/2012; that 
distribution of the defendant’s products does not infringe Regulation (EU) 
No 528/2012, because the product is not a product within the meaning of 
Article 3(1)(a), first indent, of Regulation (EU) No 528/2012; that the defendant’s 
product is not used with the intention of destroying, deterring, rendering harmless, 
preventing the action of, or otherwise exerting a controlling effect on harmful 
organisms by any means other than mere physical or mechanical action; that the 
Landgericht is entitled to examine this question, notwithstanding Commission 
Implementing Regulation (EU) 2017/794; and that it followed from the evidence 
taken that the defendant’s product does not fulfil the described preconditions for 
the application of that latter regulation. 
2. The question that arises in this case is whether, in the case where an active 
substance is approved in an implementing regulation adopted under Article 9(1)(a) 
of Regulation (EU) No 528/2012, it can be taken as given in court proceedings in 
a Member State that the substance is intended, within the meaning of 
Article 3(1)(a) of Regulation (EU) No 528/2012, to act by means [Or. 5] other 
than mere physical or mechanical action or whether it is for the adjudicating 
national court to establish in fact whether the preconditions for the application of 
Article 3(1)(a) of Regulation (EU) No 528/2012 are fulfilled. 
2. The merits of the claims at issue may follow from Paragraph 8(1) and 8(3).1 
and Paragraph 3(1) of the UWG, read in combination with Paragraph 3a of the 
UWG on breach of the law prohibiting unfair commercial practices, read in 
combination with Article 3(1)(a) and Article 95(2) and (3) of Regulation (EU) 
No 528/2012. The application of these provisions has given rise to questions 
concerning the interpretation of EU law. 
(a) The general preconditions for a desist claim under competition law based on a 
breach of law are fulfilled (Paragraph 8(1), Paragraph 3(1), Paragraph 3a of the 
UWG). 
[…]. 
(b) In order to decide whether the form of order sought by the applicant is 
justified, the referring court needs to establish whether the product ‘HS 
Mikrogur’, which is the specific subject matter of the form of order sought, comes 
within the scope of Article 3(1)(a) and Article 95(3) of Regulation (EU) 
No 528/2012. This gives rise to the question, which requires clarification, as to the 
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5 
binding effect of an implementing regulation adopted pursuant to Article 9(1)(a) 
of Regulation (EU) No 528/2012. 
(aa) Article 95[(2)] of Regulation (EU) No 528/2012 states that, as of 1 September 
2015, a biocidal product may not be made available on the market if the 
manufacturer or importer of the active substance contained in the product, or 
where relevant, the importer of the biocidal product, is not included in the list 
published by the Agency. [Or. 6] 
(1) The substance ‘Kieselguhr’ is an ‘active substance’ in the above sense that acts 
on or against harmful organisms as defined in Article 3(1)(g) of Regulation (EU) 
No 528/2012. It is common ground that certain mites (thus harmful organisms) 
dehydrate following contact with Kieselguhr and then die of dehydration. The 
defendant has also made available on the market products which contain 
Kieselguhr, a substance included in the list referred to in Article 95(1) of 
Regulation (EU) No 528/2012 and approved as of 1 November 2018 further to an 
application and the submission of a dossier. 
The product ‘HS Mikrogur’ is intended to control harmful organisms. The 
‘intended purpose’ of a product is judged by how it is perceived by an averagely 
informed consumer. Although Kieselguhr can be used for a broad spectrum of 
applications, for example in the food industry as a supplement and as animal feed, 
it is advertised, supplied and distributed by the defendant in this particular case as 
a pesticide under the brand name ‘HS Mikrogur’. 
(2) It is common ground that the applicant is included in the list referred to in 
Article 95(2) of Regulation (EU) No 528/2012 as a sole substance supplier or 
product supplier and that the defendant did not obtain the substance from the 
applicant, even indirectly, which it should have done in keeping with Article 95(3) 
of Regulation (EU) No 528/2012 if the substance is a biocidal product within the 
meaning of that regulation. This is because the Agency publishes a list, in 
accordance with Article 95(1) of Regulation (EU) No 528/2012, of all active 
substances and of all substances used to generate an active substance for which a 
dossier complying with the requirements of Annex II to the Regulation or of 
Annex IIA or IVA to Directive 98/8/EC or, where appropriate, of Annex IIIA to 
that directive has been submitted and has been accepted or validated by a Member 
State in a procedure provided for in that regulation or in that directive. According 
to Article 95[(2)] of Regulation (EU) No 528/2012, a biocidal product consisting 
of, containing or generating a relevant substance included in the list referred to in 
paragraph 1, cannot be made available on the market unless either the substance 
supplier or the product supplier is included in the list referred to in paragraph 1 for 
the product-type(s) to which the product belongs. 
(3) The question arises as to whether the product distributed by the defendant is a 
biocidal product within the meaning of Article 3(1)(a), first indent, of Regulation 
(EU) No 528/2012, [Or. 7], that is to say, a substance (or mixture) consisting of or 
containing one or more active substances intended to destroy, deter, render 
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harmless, prevent the action of, or otherwise exert a controlling effect on harmful 
organisms by any means other than mere physical or mechanical action. 
Having heard the evidence, the Landgericht proceeded on the basis that the 
defendant’s product does not control harmful organisms by any means other than 
mere physical or mechanical action within the meaning of Article 3(1) of 
Regulation (EU) No 528/2012; that this could be taken as given on the basis of the 
convincing testimony of the expert witness called by the court; 
that the mechanism of action of the product is sorption through the accumulation 
of substances in one phase, in the case of Kieselguhr by adsorption, that is to say, 
the deposition of atoms and molecules on a surface; that, to be more precise, the 
primary mechanism of action is physical adsorption, during which the electronic 
structures of the adsorbate and the surface remain broadly unchanged; that the 
acting forces are weak and comparable to Van der Waals forces in molecules, that 
is to say, they are caused by dipole or multipole interactions; that the adsorbed 
molecules are not perturbed, but are polarised (unlike with chemical adsorption, 
during which the molecules decay and a new chemical bond can be formed with 
the adsorbent); 
that, as Kieselguhr is chemically inert, a direct chemical interaction following 
adsorption cannot be assumed; that, according to the testimony of the expert 
witness, it has to be assumed that no chemical bonds are formed or broken and 
that the interactions are essentially caused by Van der Waals forces with one 
dipole/dipole interaction or another; that the action is comparable to that of a 
sponge; that adsorption to the coarse Kieselguhr particles breaks the water barrier, 
resulting in dehydration via the broken surface; that, however, the lipid layer may 
be regenerated in a humid atmosphere; 
and that, although abrasive action cannot be entirely discounted, it can be 
disregarded in this situation and case, as it is a purely mechanical action. [Or. 8] 
The Chamber intends to uphold these findings made by the Landgericht. The 
expert witness, who was proposed by agreement between the parties and who is 
renowned for his research, including into Kieselguhr, clearly has the necessary 
expertise, as proven by numerous scientific publications. Furthermore, the expert 
witness provided the evidence requested by describing in detail how Kieselguhr 
acts on pests. That description essentially reflects the common ground between the 
parties. Then, having explained how scientific debate had progressed, he provided 
a clear and comprehensible explanation of the mechanism of action, which 
included a cogent classification. There do not appear to be any technical 
shortcomings in the expert testimony, nor have any been argued. 
Therefore, judgment in this case depends on whether authorisation as an active 
substance, which was granted in this case under Commission Implementing 
Regulation (EU) 2017/794 of 10 May 2017, necessarily requires the product to be 
a biocidal product within the meaning of Article 3(1)(a) of Regulation (EU) 
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No 528/2012, such that there is no need to consider in the present proceedings 
whether the preconditions for classification as a biocidal product within the 
meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 are fulfilled. 
[…]