Provisional text

OPINION OF ADVOCATE GENERAL

RANTOS

delivered on 20 May 2021 ( )

Case C‑29/20

Biofa AG

v

Sikma D. Vertriebs GmbH und Co. KG

(Request for a preliminary ruling from the Oberlandesgericht Köln (Higher Regional Court, Cologne, Germany))

(Reference for a preliminary ruling – Regulation (EU) No 528/2012 – Article 3(1)(a) and (c) – Concept of ‘biocidal product’ – Concept of ‘active substance’ – Article 9(1)(a) – Approval of an active substance – Implementing Regulation (EU) 2017/794 – ‘Kieselguhr’ or ‘diatomaceous earth’ – Mode of action other than mere physical or mechanical action – Scope of the approval)





I. Introduction

1. Does the approval of an ‘active substance’ by an implementing regulation of the European Commission, on the basis of Regulation (EU) No 528/2012, ( ) mean that that substance is automatically intended to act against a harmful organism according to a mode characterised as a ‘means other than mere physical or mechanical action’ within the meaning of Article 3(1)(a) of that regulation (‘biocidal mode of action’)? If so, if that substance is used in a product which is intended to control harmful organisms, must it necessarily be regarded as a ‘biocidal product’, within the meaning of that provision? In that context, what discretion does a national court have when assessing the ‘biocidal’ nature of such a product?

2. Such are the questions which arise in the present case and which will lead the Court to clarify the interaction between the approval of an active substance by an implementing regulation, on the basis of Regulation No 528/2012, and the classification of the product containing it as a ‘biocidal product’, within the meaning of that regulation.

3. In that regard, I recall that the Court has previously had the opportunity to specify the elements which a product must present in order to come within the concept of ‘biocidal product’, within the meaning of Article 3(1)(a) of Regulation No 528/2012. ( ) In doing so, it was guided by its case-law on the interpretation of the equivalent provision of Directive 98/8/EC, ( ) which preceded that regulation and established the rules on the making available on the market of biocidal products in the European Union. ( )

4. However, the Court has not yet had the opportunity to rule on the scope of the approval of an active substance in the determination of the biocidal nature of the product containing that substance. This case will therefore lead the Court to clarify the scope of approvals by means of an implementing regulation. That is a task of considerable practical importance, since the answer to the question referred is likely to affect the role of the national courts in the legal classification of biocidal products.

II. Legal framework

A. Regulation No 528/2012

5. Recitals 1, 2, 5 and 9 of Regulation No 528/2012 state:

‘(1) Biocidal products are necessary for the control of organisms that are harmful to human or animal health and for the control of organisms that cause damage to natural or manufactured materials. However, biocidal products can pose risks to humans, animals and the environment due to their intrinsic properties and associated use patterns.

(2) Biocidal products should neither be made available on the market nor used unless authorised in accordance with this Regulation. …

…

(5) Rules concerning the making available on the market of biocidal products within the [European Union] were established by [Directive 98/8]. It is necessary to adapt those rules in the light of experience and in particular the report on the first seven years of the implementation submitted by the Commission to the European Parliament and the Council …

…

(9) This Regulation should apply to biocidal products that, in the form in which they are supplied to the user, consist of, contain or generate one or more active substances.

…’

6. Article 1 of that regulation, entitled ‘Purpose and subject matter’, provides:

‘1. The purpose of this Regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. The provisions of this Regulation are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment. Particular attention shall be paid to the protection of vulnerable groups.

2. This Regulation lays down rules for:

(a) the establishment at Union level of a list of active substances which may be used in biocidal products;

(b) the authorisation of biocidal products;

…’

7. Article 3 of that regulation, entitled ‘Definitions’, provides, in paragraphs 1 and 3:

‘1. For the purposes of this Regulation, the following definitions shall apply:

(a) “biocidal product” means

– any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action,

– any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.

…

(c) “active substance” means a substance or a micro-organism that has an action on or against harmful organisms;

…

3. The Commission may, at the request of a Member State, decide, by means of implementing acts, … whether a specific product or group of products is a biocidal product or a treated article or neither. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).’

8. Article 4 of that regulation, entitled ‘Conditions for approval’, provides, in paragraph 1:

‘An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5). …’

9. Article 6 of Regulation No 528/2012, entitled ‘Data requirements for an application’, provides, in paragraph 1:

‘An application for approval of an active substance shall contain at least the following elements:

(a) a dossier for the active substance satisfying the requirements set out in Annex II;

(b) a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and

….’

10. Article 9 of that regulation, entitled ‘Approval of an active substance’, reads as follows:

‘1. The Commission shall, on receipt of the opinion of the [European Chemicals Agency; “the ECHA”] referred to in Article 8(4), either:

(a) adopt an implementing Regulation providing that an active substance is approved, and under which conditions, including the dates of approval and of expiry of the approval; …

…

2. Approved active substances shall be included in a Union list of approved active substances. The Commission shall keep the list up to date and make it electronically available to the public.’

11. Article 17 of that regulation, entitled ‘Making available on the market and use of biocidal products’, provides, in paragraph 1:

‘Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.’

12. Article 19 of that regulation, entitled ‘Conditions for granting an authorisation’, provides, in paragraph 1(a) and (b):

‘A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:

(a) the active substances are included in Annex I or approved for the relevant product-type and any conditions specified for those active substances are met;

(b) it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised …, fulfils the following criteria:

(i) the biocidal product is sufficiently effective;

…’

13. Article 89 of Regulation No 528/2012, entitled ‘Transitional measures’, states, in the third subparagraph of paragraph 1 and in paragraph 3:

‘1. …

In order to facilitate a smooth transition from Directive 98/8/EC to this Regulation, during the work programme the Commission shall adopt either implementing regulations providing that an active substance is approved, and under which conditions, or, in cases where the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2), are not satisfied or where the requisite information and data have not been submitted within the prescribed period, implementing decisions stating that an active substance is not approved. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3). Regulations approving an active substance shall specify the date of approval. Article 9(2) shall apply.

…

3. Following a decision to approve a particular active substance for a specific product-type, Member States shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled, as appropriate, in accordance with this Regulation within three years of the date of approval.

…’

14. Article 95 of that regulation, entitled ‘Transitional measures concerning access to the active substance dossier’, amended by Regulation No 334/2014, as corrected in the German language version, ( ) with effect from 1 September 2013, provides:

‘1. As of 1 September 2013, the [ECHA] shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier … has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that Directive (“the relevant substances”). For each relevant substance, the list shall also include all persons having made such a submission …

A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (“the substance supplier”) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (“the product supplier”), may at any time submit to the [ECHA] either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired. …

…

2. As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not 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.

…’

B. Implementing Regulation 2017/794

15. In the words of Article 1 of Implementing Regulation (EU) 2017/794, ( ) ‘silicon dioxide Kieselguhr is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex’.

III. The dispute in the main proceedings, the questions for a preliminary ruling and the procedure before the Court

16. Biofa AG, the applicant in the main proceedings, is a German company which develops and markets products for the agricultural sector, mainly on a biological basis.

17. Among those products, it markets products containing the active substance ‘silicon dioxide’, also known as ‘diatomaceous earth’ or ‘kieselguhr’ (‘kieselguhr’), ( ) under the trade name InsectoSec®. Those products are used to control certain insects and mites in poultry houses. ( )

18. Biofa applied, for that purpose, to the ECHA for approval of kieselguhr as an active substance, in accordance with Regulation No 528/2012. During that approval procedure, the effectiveness and safety of kieselguhr for use in biocidal products were tested and evaluated positively.

19. By Implementing Regulation 2017/794, the Commission – following the favourable opinion of the ECHA – ( ) approved kieselguhr as an active substance for use in biocidal products of product-type 18 (insecticides, acaricides and products to control other arthropods), ( ) subject to the specifications and conditions set out in the annex to that implementing regulation.

20. Biofa is the sole producer of kieselguhr as an active substance and is thus on the list of suppliers referred to in Article 95(1) of Regulation No 528/2012. In accordance with Article 95(2) of that regulation, only active substances which have been purchased from suppliers on that list may be used in biocidal products. For kieselguhr that means that, where it is used in a biocidal product, that active substance must be purchased from Biofa.

21. Sikma D. Vertriebs GmbH und Co. KG, the defendant in the main proceedings (‘Sikma’), is a German company which markets online products intended for animal owners and the compound feed industry, including for the purpose of ‘parasite management, especially in the poultry sector’. It distributes, among other products, the product known under the brand name ‘HS Mikrogur’ (‘the product at issue’), used to control poultry mites. That product contains kieselguhr, ( ) but Sikma does not buy it from Biofa.

22. In unfair competition proceedings before the Landgericht Köln (Regional Court, Cologne, Germany), Biofa maintained, in essence, that the product at issue cannot be placed on the market and that its marketing should therefore cease. More specifically, it claimed that, by marketing that product, Sikma placed a biocidal product on the market, since the action of kieselguhr is not a mere physical or mechanical action, so that a product containing that active substance must be classified as a ‘biocidal product’ within the meaning of Article 3(1)(a) of Regulation No 528/2012. Consequently, since Sikma does not obtain kieselguhr from Biofa, although Biofa is the exclusive supplier of that active substance – and is mentioned in that capacity on the list referred to in Article 95(1) of that regulation – the marketing of that product by Sikma is a commercial practice that infringes, inter alia, Article 95(2) of that regulation and must therefore cease. ( )

23. Sikma contended, on the contrary, that the product at issue cannot be classified as a ‘biocidal product’, within the meaning of Article 3(1)(a) of Regulation No 528/2012, on the ground that kieselguhr acts by a mere physical or mechanical action, not by a chemical action. ( ) Sikma maintains that it therefore does not infringe Article 95(2) of Regulation No 528/2012 by not obtaining kieselguhr from Biofa. ( )

24. The Landgericht Köln (Regional Court, Cologne) dismissed Biofa’s action. Taking the view that it had jurisdiction to verify the mode of action of kieselguhr, that court, although Implementing Regulation 2017/794 approved kieselguhr as an active substance intended for use in biocidal products, ordered evidence-gathering measures in order to verify, in particular, whether the product at issue comes within the concept of ‘biocidal product’ within the meaning of the first indent of Article 3(1)(a) of Regulation No 528/2012. On the basis of an expert report, that court concluded that the product at issue does not come within that concept, since kieselguhr acts only by mere physical or mechanical action, not by chemical action.

25. Biofa lodged an appeal against that decision before the referring court, the Oberlandesgericht Köln (Higher Regional Court, Cologne, Germany).

26. The referring court states that it adopts the findings of fact made by the Landgericht Köln (Regional Court, Cologne) and proposes to follow the expert opinion, according to which the product at issue is not a ‘biocidal product’ within the meaning of the first indent of Article 3(1)(a) of Regulation No 528/2012.

27. The referring court wonders, however, whether the approval, in accordance with Article 9(1)(a) of Regulation No 528/2012, of an active substance by an implementing regulation such as Implementing Regulation 2017/794 has the consequence, in particular for national courts in judicial proceedings, that products containing that active substance must be classified automatically as ‘biocidal products’ within the meaning of Article 3(1)(a) of Regulation No 528/2012, and that they therefore act by a biocidal mode of action. If so, that court acknowledges that an expert report such as that prepared at first instance should not have been ordered. In the contrary situation, it would be necessary to determine whether it is for that court to determine, in the context of its findings of fact, whether the substantive conditions laid down in Article 3(1)(a) of that regulation are met.

28. In those circumstances, the Oberlandesgericht Köln (Higher Regional Court, Cologne) decided to stay the proceedings and to refer the following question to the Court of Justice for a preliminary ruling:

‘Where an active substance is approved in an implementing regulation adopted pursuant to Article 9(1)(a) of [Regulation 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 that regulation] 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 that regulation] are fulfilled even after an implementing regulation has been adopted?’

29. Written observations were submitted by both parties to the main proceedings and by the Commission. They all also answered the written questions put by the Court.

IV. Analysis

A. Preliminary observations

30. The present request for a preliminary ruling was made in the context of a dispute between two competing companies – Biofa and Sikma – concerning the marketing of products intended to control harmful organisms in the poultry sector. Biofa, which develops and markets such biocidal products and obtained approval, by Implementing Regulation 2017/794, of kieselguhr as an active substance intended for use in those products, is mentioned as the exclusive supplier of that active substance on the list referred to in Article 95(1) of Regulation No 528/2012. Sikma sells, inter alia, a product used for pest control in the poultry sector which contains kieselguhr, but does not obtain that substance from Biofa. Sikma submits that that substance makes it possible to control pests by a simple physical or mechanical action and that, accordingly, the product which it markets does not come within the concept of ‘biocidal product’. Accordingly, it is not required to obtain supplies of kieselguhr exclusively from Biofa, pursuant to Article 95(2) of Regulation No 528/2012.

31. The referring court considers that it is called upon to rule on the classification of the product in question, that is to say, on whether a product containing an active substance approved by the Commission implementing regulation necessarily comes within the concept of ‘biocidal product’ within the meaning of Article 3(1)(a) of Regulation No 528/2012. It is in that context that it wonders, in particular, whether the approval of an active substance by an implementing regulation is binding on a Member State and its courts when they are required to classify a product containing that substance.

32. I am of the view that, in order to answer the referring court’s questions, it is necessary to analyse three aspects, namely, first, whether an active substance necessarily acts by a mode of biocidal action (C); second, whether a product which contains an active substance is necessarily a biocidal product (D); and, third – in the light of the answers called for by the first two aspects – what discretion the competent national authorities have when classifying – as biocidal or non-biocidal – a product containing a biocidal substance (E).

33. In the light of the technical nature of those aspects, I consider that it will be helpful, before embarking on my analysis of each of them, to present an overview of the regulatory framework applicable to biocidal products (B).

B. The regulatory framework applicable to biocidal products

34. The regulatory framework in the sphere of biocidal products was established by Directive 98/8, ( ) which was repealed and replaced by Regulation No 528/2012 in order to adapt the rules which it contained in the light of experience. ( )

35. As is apparent from Article 1(1) of Regulation No 528/2012, the purpose of that regulation is to improve the functioning of the internal market through the harmonisation of the rules on the making available on the market and the use of biocidal products, whilst ensuring a high level of protection of both human and animal health and the environment. Those provisions are underpinned by the precautionary principle, the aim of which is to safeguard the health of humans, the health of animals and the environment.

36. In the words of Article 1(2)(a) and (b) of Regulation No 528/2012, that regulation lays down rules governing (i) the establishment at EU level of a list of active substances which may be used in biocidal products and (ii) the authorisation of biocidal products. Those two levels of rules determine jointly which biocidal products may be made available and used on the EU market.

37. Under Article 17(1) of that regulation, only biocidal products authorised in accordance with the provisions of that regulation may be made available on the market or used. ( )

1. The concepts of ‘biocidal product’ and ‘active substance’

38. In the words of Article 3(1)(a) of Regulation No 528/2012, ‘biocidal product’ means ‘any substance or mixture’ which has ‘the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism’ (‘biocidal purpose’) ‘by any means other than mere physical or mechanical action’ (‘biocidal mode of action’).

39. Such substances or mixtures may be those ‘consisting of, containing or generating one or more active substances’ ( ) and may be ‘generated from substances or mixtures which do not themselves fall under the first [type of substances or mixtures]’. ( ) In the present case, given that the case in the main proceedings concerns a product consisting of an active substance, the first type of substances or mixtures alone is relevant. In that connection, it may be inferred from recital 9 of Regulation No 528/2012 that the EU legislature’s objective was to include in the scope of that regulation biocidal products which, ‘in the form in which they are supplied to the user, consist of, contain or generate one or more active substances’. ( )

40. When interpreting the equivalent provision of Directive 98/8, namely Article 2(1)(a) thereof, ( ) the Court has held that the definition of biocidal products is structured around three cumulative elements, namely (i) the presence of an active substance, (ii) the pursuit of certain biocidal purposes and (iii) a biocidal mode of action. ( ) As Regulation No 528/2012 has repealed and replaced Directive 98/8, the interpretation of the provisions of that directive provided by the Court also applies to that regulation whenever the provisions of the two instruments of EU law may be regarded as equivalent. ( )

41. As regards the first element, namely the presence of an active substance, I consider at the outset that the first indent of Article 3(1)(a) of Regulation No 528/2012, read in conjunction with recital 9 of that regulation, may be regarded as equivalent to Article 2(1)(a) of Directive 98/8. In addition, Article 3(1)(c) of that regulation defines ‘active substance’, of which a ‘biocidal product’ may be composed, as ‘a substance or a micro-organism that has an action on or against harmful organisms’. ( ) It follows that the constituent elements of that concept are also relevant for the purpose of classifying a product as a ‘biocidal product’. ( )

42. As regards the second element, namely the pursuit of a biocidal purpose, Article 3(1)(a) of Regulation No 528/2012 reproduces the wording of Article 2(1)(a) of Directive 98/8. ( ) The Court has held that, by that provision, Regulation No 528/2012 effects a gradation of the purposes of biocidal products ranging from the destruction of the organisms to their prevention. ( ) It was, inter alia, on the basis of that preventive purpose that the Court held that the concept of ‘biocidal product’ had to be given a broad interpretation. ( )

43. As regards the third element, relating to the mode of action of the product in question, it should be observed that Article 3(1)(a) of Regulation No 528/2012, unlike Article 2(1)(a) of Directive 98/8, does not limit that element to ‘chemical or biological means’, but extends it to ‘any means other than mere physical or mechanical action’. ( ) That extension of the definition of the ‘mode of action of a biocidal product’ has been held to be consistent with the objective of that regulation consisting in ‘adapting the rules of Directive 98/8 “in the light of experience”, and in ensuring an increased level of protection of human and animal health and of the environment’. ( ) By way of example, the Court held that ‘the fact that a product has a probiotic effect, and not a chemical effect, [did] not in itself preclude its classification as a “biocidal product” within the meaning of that regulation. ( )

2. The procedure for the approval of active substances

44. Active substances that can be used in biocidal products are approved at EU level by the Commission, in accordance with Chapter II of Regulation No 528/2012. The approval procedure may be summarised as follows.

45. The applicant for approval of a substance is to submit its application for approval to the ECHA, to which it communicates, in addition to the requisite data, ( ) the name of the competent authority of the Member State that it proposes should evaluate the application. Upon receipt of the fees payable by the applicant, the ECHA is to accept the application and inform the evaluating competent authority. Within 365 days of the validation of the application, that authority is to prepare and submit to the ECHA an evaluation report and the conclusions of its evaluation. ( ) Within 270 days of receipt of those conclusions, the ECHA is to prepare and submit to the Commission an opinion on the approval of that active substance having regard to the conclusions of the evaluating competent authority. ( ) On receipt of the opinion of the ECHA, the Commission is to adopt an implementing regulation providing that an active substance is approved, and under which conditions. ( )

46. An active substance is to be approved, in principle, for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet all the conditions for grant of authorisation. ( ) That approval is to be restricted to those product-types for which relevant data have been submitted, ( ) namely, in particular, ‘a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance’. ( ) Last, the approval is to specify conditions such as, inter alia, the product-type and manner and area of use. ( )

47. Those active substances are to be included in an EU list of approved active substances, which the Commission is to keep up to date on a regular basis. ( ) For the purposes of the systematic examination of all existing active substances carried out on the basis of Directive 98/8, the approval of those active substances is to be based on the transitional provisions set out, in particular, in the third subparagraph of Article 89(1) of Regulation No 528/2012, which provides, in particular, that the Commission is to adopt implementing regulations providing that an active substance is approved, and under which conditions.

3. The procedure for the authorisation of biocidal products

48. Unlike the procedure for the approval of active substances, Regulation No 528/2012 makes provision for a number of different ways of obtaining authorisation for biocidal products, namely national authorisation (Chapter VI, Articles 29 to 31), a mutual recognition procedure (Chapter VII, Articles 32 to 40) and EU authorisation (Chapter VIII, Articles 41 to 46). In addition, there is a simplified authorisation procedure for certain biocidal products (Chapter V, Articles 25 to 28). Those authorisations may be granted for a single biocidal product or for a biocidal product family, for a maximum period of 10 years, ( ) and are to stipulate, in particular, the conditions of the making available on the market and the use of the single biocidal product.

49. A more detailed description of those procedures does not seem necessary to me in the context of the examination of the present case. What is relevant is that all those means of obtaining authorisation have a common element, namely the approval of an active substance at EU level or its inclusion in Annex I to Regulation No 528/2012. Article 19(1)(a) of that regulation, which sets out the conditions for granting an authorisation, provides that a biocidal product is to be authorised if, in particular, the active substances are approved for the relevant product-type and all the conditions specified for those active substances are met. In addition, Article 25(a) of that regulation, which is concerned solely with the simplified authorisation procedure, provides for eligibility for that procedure if ‘all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex’.

50. The transitional provisions in Article 89(3) of Regulation No 528/2012 state that Member States are to ensure that authorisations relating to biocidal products of a particular product-type containing an approved active substance are granted, modified or cancelled as appropriate within three years of the date of approval.

4. The interaction between the procedures for authorisation of biocidal products and for approval of active substances

51. It follows from the preceding description that the two procedures are intrinsically linked.

52. First, under Article 19(1)(a) of Regulation No 528/2012, only biocidal products the active substances of which have been approved for the relevant product-type may be authorised, and only if any conditions specified for those active substances are met. That means that a biocidal product may be authorised only if the active substance which it contains has first been evaluated by the ECHA and approved by the Commission.

53. Second, Regulation No 528/2012 ensures that only active substances which are contained in at least one biocidal product expected to be authorised may be approved. That rule makes it possible to avoid the laborious procedure for approving an active substance when it cannot be used in any biocidal product eligible for approval. In fact, Article 4(1) of that regulation expressly provides that an active substance may be approved only if at least one biocidal product containing that active substance may be expected to meet the criteria for authorisation of biocidal products laid down in Article 19(1)(b) of that regulation. In order to ensure that that is so, Article 6(1)(a) and (b) of that regulation states that the application for approval of an active substance must include not only ‘a dossier for the active substance’ itself, but also ‘a dossier satisfying the requirements [on the information to be supplied] set out in Annex III for at least one representative biocidal product that contains the active substance’.

54. Having thus outlined the regulatory context, I shall now answer the three aspects of the question submitted by the referring court.

C. Whether an approved active substance necessarily acts by a biocidal mode of action

55. As stated in point 41 of this Opinion, in accordance with Article 3(1)(c) of Regulation No 528/2012, ‘active substance’ means ‘a substance or a micro-organism that has an action on or against harmful organisms’. Although that definition clearly indicates that an active substance has a biocidal purpose, within the meaning of Article 3(1)(a) of that regulation (‘action on or against harmful organisms’), ( ) the mode of action of that substance is not expressly stated in that definition. The fact that, contrary to the definition of ‘biocidal product’ contained in Article 3(1)(a) of that regulation, the definition of the ‘active substance’ does not specify the biocidal mode of action thereof could serve as an indication that an ‘active substance’ could act by a mode of action other than biocidal.

56. However, despite the fact that that definition is silent on that point, I consider that, in the light of the context and purpose of Regulation No 528/2012, the biocidal mode of action of an active substance approved by an implementing regulation is inherent in the very concept of ‘active substance’ and is binding on all Member States and, consequently, on their competent courts and authorities.

57. As a preliminary point, it must be borne in mind that an active substance often constitutes in itself a biocidal product. In that scenario, all the substantive conditions that define a biocidal product, as laid down in Article 3(1)(a) of Regulation No 528/2012, will also have to be met by the active substance, including, in particular, the biocidal mode of action. However, that consideration will not in itself suffice to establish that a certain active substance always acts by a biocidal mode of action. Where a biocidal product contains several active substances, the biocidal action of such a product may result from one of its other active substances, or indeed from a new active substance generated by a chemical synthesis in that product.

58. In that connection, despite that statement, I note that the biocidal mode of action of an active substance flows from the fact that that mode of action forms part of the examination for the approval of an active substance, that mode of action being assessed both for that substance and for the related representative biocidal product. Moreover, given that the present case concerns the legal consequences of an approval of an active substance, the conditions for that approval are decisive in that regard.

59. First, as regards the mode of action of the active substance, Annex II to Regulation No 528/2012, which refers to the ‘information requirements for active substances’, contains, under point 6.5 of column 1 of Title 1, a table requiring information on the ‘mode of action (including time delay)’. Accordingly, if the mode of action of the (biocidal) active substance were not relevant for the purpose of its approval, such information would not be required.

60. Second, as regards the mode of action of the representative biocidal product, as was stated in points 46 and 53 above, the application for approval of an active substance must contain a file relating to ‘at least one representative biocidal product’. The biocidal mode of action of such a product is therefore also examined in the course of the procedure for approval of an active substance. If it transpires that that mode of action is not present, the representative product will be unable to be accepted for authorisation and, for that reason, approval of the active substance could not be granted either, as the requirement, laid down in Article 4(1) of Regulation No 528/2012, that at least one biocidal product containing that active substance must be eligible for authorisation would not be met.

61. In this instance, Biofa, with its application for approval of kieselguhr, was also required to submit a dossier for the representative product InsectoSec®, composed entirely of kieselguhr. Kieselguhr was therefore evaluated – initially by the competent evaluation authority (in France) – with a view to its use in products coming within product-type 18, to which InsectoSec® belongs. In the evaluation report which it prepared, that authority expressly verified the mode of action of kieselguhr, and concluded that ‘by destroying the natural water barrier, the waxy layer of the cuticle and hence disrupting the functioning of the water preservation mechanism, [kieselguhr] interferes with physiological processes’. ( ) In order to reach that conclusion, that authority relied on the ‘Manual of Decisions for Implementation of [Directive 98/8]’. The ECHA, in turn, issued an opinion in the light of the authority’s conclusions. According to that opinion, ‘biocidal products of product-type 18 containing [kieselguhr] may be expected to satisfy the criteria of Article 19(1)(b) of Regulation [No 528/2012]’. ( ) It follows that the biocidal mode of action of the active substance was examined and confirmed when kieselguhr was approved. ( )

62. I therefore propose that the answer to this first aspect of the question referred for a preliminary ruling should be that an active substance approved, in accordance with Article 9(1)(a) of Regulation No 528/2012 or with the transitional measures provided for in the third subparagraph of Article 89(1) of that regulation, by an implementing regulation such as Implementing Regulation 2017/794 must necessarily be considered to act by a biocidal mode of action, within the meaning of Article 3(1)(a) of that regulation.

D. Whether a product which contains an approved active substance must necessarily constitute a biocidal product

63. It should be borne in mind at the outset that, because of the two-stage system described in points 44 to 54 of this Opinion, the active substance is first of all approved at EU level. Only subsequently, in the context, where appropriate, of a national procedure, is authorisation granted for the various biocidal products containing that active substance. It is therefore in that context that the question arises whether a product which contains an active substance must necessarily constitute a ‘biocidal product’ within the meaning of Article 3(1)(a) of Regulation No 528/2012.

64. As I observed in point 40 of this Opinion, it follows from the interpretation of the concept of ‘biocidal product’ that three elements must be present in order for a product to be classified as ‘biocidal’ within the meaning of the first indent of Article 3(1)(a) of Regulation No 528/2012. As the presence of an active substance is only one of those elements, the other two conditions relating to the biocidal purpose and the biocidal mode of action must also be met. ( )

65. Therefore, in order to answer that aspect of the question referred, two hypotheses can be envisaged.

66. First, if the product examined is composed entirely of an approved active substance – as, in this instance, Biofa’s representative product (InsectoSec®) or, clearly, the product at issue – the other two conditions, namely the biocidal purpose and the biocidal mode of action, will ipso facto also be fulfilled. Such a product will therefore necessarily have to be classified as a ‘biocidal product’ within the meaning of Article 3(1)(a) of Regulation No 528/2012 since, as has already been stated in this Opinion, the approval of an active substance assumes an evaluation of both the biocidal mode of action and the biocidal purpose.

67. Second, in so far as a biocidal product may also consist of ‘several active substances’, or indeed be ‘generated by substances or mixtures’, ( ) it is also necessary to envisage the hypothesis in which an active substance is only one of many components of a product. In that hypothesis, must a product also be classified as ‘biocidal’?

68. To my mind, the answer to that question varies according to the composition of the product in question. For example, a product which contains an active substance in a very limited quantity cannot be automatically classified as ‘biocidal’, since it will be unlikely to satisfy the biocidal purpose or the biocidal mode of action condition. It is for the national competent authority or, as in this case, the national court, in unfair competition proceedings, to examine whether such a product, composed of different substances or a mixture, constitutes a biocidal product, verifying whether all the substantive conditions laid down in Article 3(1)(a) of Regulation No 528/2012 are met.

69. I therefore propose that the answer to this second aspect of the question for a preliminary ruling should be that a product which contains an active substance approved by an implementing regulation will necessarily have to be classified as a ‘biocidal product’, within the meaning of Article 3(1)(a) of Regulation No 528/2012, if its composition is identical to that of the approved active substance.

E. The national courts’ discretion to classify a product as ‘biocidal’

70. On the basis of the foregoing analysis, it can be stated that the discretion of a national court to classify a product as ‘biocidal’ varies according to the composition of that product.

71. Where the product concerned is composed entirely of the active substance approved by an implementing regulation, the discretion of the national courts is non-existent. In such a context, where a national court is required to settle the question of the biocidal nature of such a product, it cannot order evidence-gathering measures in order to verify that the biocidal purpose or the biocidal mode of action condition is satisfied.

72. As Implementing Regulation 2017/794 provides, that regulation ‘shall be binding in its entirety and directly applicable in all Member States’. In this instance, since that implementing regulation approved kieselguhr as an active substance on 1 November 2018 for a specific product-type, the Member States are required, pursuant to Article 89(3) of Regulation No 528/2012, to grant, modify or cancel authorisations for biocidal products within three years of the date of approval, that is to say, by 1 November 2021.

73. On the other hand, where the product contains a mixture of substances, including an approved active substance, the national court has a certain discretion, which should not, however, run counter to the practical effect of the provisions of Regulation No 528/2012.

74. In that respect, I recall, as a preliminary point, that in order to ensure a consistent application of the classification of such a product at EU level, Article 3(3) of Regulation No 528/2012 provides that Member States may request the Commission to determine, by means of implementing acts, whether a specific product is a biocidal product. As the Commission states in its written observations, it cannot be precluded that Member States will request it to do so even where the active substance has already been evaluated and approved, but where there are doubts as to the biocidal nature of a product, in particular where, at the time when the active substance is approved, that product has not yet been evaluated as a representative biocidal product. ( )

75. While it is for the national courts to verify the existence of a biocidal purpose and a biocidal mode of action in order to be able to conclude that a product is biocidal, ( ) the following elements must, in any event, be taken into account by those courts.

76. First, as stated in points 42 and 43 of this Opinion, the concepts of biocidal ‘purpose’ and biocidal ‘mode of action’ must be interpreted broadly. The Court has held that, by Article 3(1)(a) of Regulation No 528/2012, that regulation effects a gradation of the purposes of biocidal products ranging from the destruction of organisms to their prevention. It was on the basis of that preventive purpose that the Court considered that the concept of ‘biocidal product’ must be given a broad interpretation. ( ) Such an interpretation is also supported by the objective set out in Article 1(1) of Regulation No 528/2012, and based on the precautionary principle, of ensuring ‘a high level of protection of both human and animal health and the environment’. That objective could not be fully achieved if products containing ‘active substances’ were not classified as ‘biocidal’ owing to their preventive effect on the target harmful organisms and were not subject to the rules on placing on the market and use established in that regulation. ( ) It is the actual presence of the active substance that is liable to present a risk for the environment, irrespective of whether that substance acts directly or indirectly, or destructively or preventively, on the target organisms. ( )

77. Second, the Court has also held that the concept of ‘biocidal product’ had to be interpreted as covering products which act only by indirect means on the target harmful organisms, so long as they contain one or more active substances provoking a chemical or biological action which forms an integral part of a causal chain, the objective of which is to produce an inhibiting effect in relation to those organisms. ( ) The concept of ‘biocidal product’ therefore covers not only the direct effects of a product but also its indirect effects. That interpretation is consistent with the contextual interpretation of Regulation No 528/2012, in so far as the concept of ‘active substance’ includes two alternative strands, namely action ‘on’ and an action ‘against’ harmful organisms, which confirms that it includes not only direct actions on harmful organisms but also indirect actions against those organisms. ( )

78. Third, it must also be considered that, if the manufacturer of a product considers that a certain approved active substance must be present in the mixture constituting that product, it must be presumed that his or her objective is to achieve the effect sought by a biocidal product. The action of a biocidal product is, as a matter of principle, based on the action of the active substance it contains, not on the other substances in that product that are presumed to play a secondary role (for example, that of contributing to form, composition or marketing, or even to strengthen the action of that active substance). It may therefore generally be presumed that the product at issue is also ‘biocidal’, unless it is proved that that active substance does not pursue a biocidal purpose and that, on the basis of chemical considerations, the active substance contained in that product does not use its biocidal mode of action and that the presence of that active substance is therefore justified by other reasons unconnected with the biocidal mode of action or the biocidal purpose. It follows that the use of an active substance gives rise to a rebuttable presumption that the product containing it is, in fact, a biocidal product, in particular where that active substance has been evaluated and approved on the basis of Regulation No 528/2012.

79. In the light of all of the foregoing considerations, the answer to the question for a preliminary ruling is that Article 3(1)(a) of Regulation No 528/2012 must be interpreted as meaning that, where an active substance contained in a product has been approved by a Commission implementing regulation, under Article 9(1)(a) or the third subparagraph of Article 89(1) of that regulation, it is presumed that the condition of ‘otherwise exerting a controlling effect on … any harmful organism by any means other than mere physical or mechanical action’, within the meaning of Article 3(1)(a) of that regulation, is met. In the context of judicial proceedings, that presumption may be rebutted only if the biocidal mode of action of that active substance may be considered to be excluded in the case of that product. That presumption is irrebuttable, however, if the product is composed of an approved active substance or if its composition is identical to that of the biocidal product presented as representative in the application for approval of the substance.

V. Conclusion

80. In the light of the foregoing, I propose that the Court answer the question for a preliminary ruling referred by the Oberlandesgericht Köln (Higher Regional Court, Cologne, Germany), as follows:

Article 3(1)(a) of Regulation (EU) 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, as amended by Commission Delegated Regulation (EU) No 736/2013 of 17 May 2013 and Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014, must be interpreted as meaning that, where an active substance contained in a product has been approved by a Commission implementing regulation, under Article 9(1)(a) or the third subparagraph of Article 89(1) of that regulation, it is presumed that the condition of ‘otherwise exerting a controlling effect on … any harmful organism by any means other than mere physical or mechanical action’, within the meaning of Article 3(1)(a) of that regulation, is met. In the context of judicial proceedings, that presumption may be rebutted only if the biocidal mode of action of that active substance may be considered to be excluded in the case of that product. That presumption is irrebuttable, however, if the product is composed of an approved active substance or if its composition is identical to that of the biocidal product presented as representative in the application for approval of the substance.