1.

What is a biocidal product?

2.

This question has been asked in the present preliminary ruling procedure and the answer to it can be found in a very broadly worded definition in the Biocides Regulation. ( 2 ) However, the Netherlands and the Commission take the view in particular that this definition must be interpreted restrictively in order to avoid practical difficulties in the application of the regulation.

3.

The main objective of the Biocides Regulation is set out in Article 1(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. …’

4.

Article 3(1) of the Biocides Regulation defines the term ‘biocidal product’:

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

5.

Pursuant to Article 17(1) of the Biocides Regulation, biocidal products require authorisation:

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

6.

Darie BV (‘Darie’) offers the product ‘Pure Air’. This is a product that (also) contains the bacterial species Bacillus ferment.

7.

A number of bacterial species are listed as active substances on the list of biocidal active substances maintained and published by the European Chemicals Agency (ECHA). The bacterial species Bacillus ferment has, however, not been registered as a biocidal active substance with the ECHA.

8.

The Staatssecretaris van Infrastructuur en Milieu (State Secretary for Infrastructure and the Environment, ‘the State Secretary’) designated ‘Pure Air’ a biocidal product within the meaning of Article 3(1)(a) of the Biocides Regulation. Authorisation has not been granted for this product. On account of having made unauthorised biocidal products available on the market, he therefore imposed on Darie an administrative order to stop offering the product, with effect from 14 January 2017, coupled with periodic penalty payments of EUR 1000 per week up to a maximum of EUR 25000.

9.

By the contested decision of 26 May 2017, the State Secretary declared the objections lodged by Darie against the primary decision to be unfounded. He based this on the reasoning, in abbreviated form and in so far as is relevant here, that in his view the product contained an active substance, Bacillus ferment, which was aimed at combating moulds. He made that deduction from the producer’s and the distributor’s descriptions of the efficacy of the product.

10.

Darie’s website contained the following statements:

‘Probiotic cleaning products work like traditional cleaning techniques. They eliminate visible contamination. There is an important difference, however. Potential pathogens such as mould and harmful bacteria also disappear. By removing their breeding grounds, the number of harmful bacteria and moulds will be greatly reduced. …’

11.

According to the instructions for use, first the mould must be removed, then the area must be thoroughly sprayed with the product, and this must be repeated every three to four weeks.

12.

On that basis, the State Secretary concluded that, if something happens on a surface with regard to micro-organisms, then there must be an active substance.

13.

According to the referring court, in the national proceedings Darie argued that the bacterial species Bacillus ferment in the product produces enzymes that absorb and digest all the organic waste that serve as food for microorganisms, so that no biotope can develop on the surface treated with the product on which microorganisms, such as mould, can thrive. By keeping the surface clean in this way, mould is kept at bay.

14.

Darie lodged an appeal before the College van Beroep voor het Bedrijfsleven (Administrative Court of Appeal for Trade and Industry, the Netherlands). That court puts the following questions to the Court of Justice in these proceedings:

15.

Darie B.V, the Kingdom of the Netherlands, the Republic of Austria, the Kingdom of Norway and the European Commission have submitted written observations.

16.

The following will firstly briefly address the admissibility of the action and will then specify the requirements for a biocidal product.

17.

Darie considers the request for a preliminary ruling to be inadmissible, as the applicable legislation does not give cause for doubts over interpretation and the national court has sufficient information available to it to give a ruling on the case.

18.

However, the following statements show that there are in fact differences of opinion on the interpretation of the relevant provisions, and these differences are significant for the decision of the national court. Its doubts are therefore justified.

19.

In addition, Darie fails to recognise that national courts can also bring a matter before the Court if the answer to a question is already clear from the case-law ( 3 ) or is obvious. ( 4 )

20.

The request for a preliminary ruling is therefore admissible.

21.

The answer to the first question is provided by the first indent of Article 3(1)(a) of the Biocides Regulation. Pursuant to that indent, the term ‘biocidal product’ covers 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. In addition, pursuant to Article 3(1)(c), the term ‘active substance’ covers any substance or a micro-organism that has an action on or against harmful organisms.

22.

At the core of these definitions is the question of whether the substance or mixture is intended to produce certain effects. The decisive factor is therefore the purpose that is subjectively associated with the substance or mixture concerned (the product), that is to say the function that it is intended to perform.

23.

This subjective determination must be made on the basis of objective factors. As in the present case, information from the seller, for example in instructions on use and in advertising, lends itself for this purpose, and the Netherlands correctly draws attention to this information.

24.

Pursuant to the first indent of Article 3(1)(a) of the Biocides Regulation, the function that a biocidal product is intended to perform consists in 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.

25.

This function clearly is worded very broadly. In particular, an action for otherwise exerting a controlling effect on any harmful organism could be considered to be broadly worded and encompasses the use of bacteria, enzymes or other constituents that is referred to in the request for a preliminary ruling.

26.

The definition is significantly limited by the fact that mere physical or mechanical action is excluded. However, it is not apparent that the product at issue is based on such action.

27.

As the definition is worded so broadly, the first indent of Article 3(1)(a) of the Biocides Regulation also contains no restriction on biological or chemical action, contrary to the view taken by the Commission. On the contrary, the legislative history shows that the legislature intentionally worded the definition more broadly. The reason for this is that the previously applicable provision pursuant to Article 2(1)(a) of the Biocides Directive ( 5 ) and the Commission Proposal for the Biocides Regulation ( 6 ) in fact expressly restricted the term ‘biocidal product’ to biological and chemical effects.

28.

For this reason, the Commission’s reference to the judgment in Söll ( 7 ) is also unconvincing. It is true that in that judgment the Court ruled that the term ‘biocidal product’ includes even products which act only indirectly 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. That judgment concerned the previous legislation, however, and therefore necessarily related to the biological and chemical effects expressly referred to in it.

29.

However, the finding in the Söll judgment that not only direct but also indirect effects are covered continues to be applicable. ( 8 ) This is in line with the purpose of ensuring a high level of protection of both human and animal health and the environment, which is not only to be pursued as a general principle pursuant to Article 114(3) TFEU, but is also specifically laid down in Article 1(1) of the Biocides Regulation.

30.

The view taken by the Netherlands that a biocidal product must disinfect an area and thus eliminate the harmful organisms in their entirety is not compatible with that. If it is sufficient that the active substance is intended to exert a controlling effect on harmful organisms by other means, including indirectly, neither disinfection nor a full elimination effect can be necessary.

31.

Furthermore, products that have a lower degree of effectiveness can also pose a risk to health or the environment and are therefore covered by the purpose of the legislation set out in Article 1 of the Biocides Regulation.

32.

Contrary to what is suggested by Darie, it is also not possible to draw a clear distinction between detergents and biocidal products. This is clear simply from the fact that the Biocides Regulation does not contain any exceptions for detergents.

33.

Article 3(1) of the Detergents Regulation ( 9 ) also makes express provision for special rules for detergents if they contain surfactants that are active substances within the meaning of the Biocides Directive and are used as disinfectants. Due to the replacement of the Biocides Directive by the Biocides Regulation, which is expressly laid down in Article 96 and Annex VII of the Biocides Regulation, these special rules in the Detergents Regulation now apply to active substances within the meaning of Article 3(1)(c) of the Biocides Regulation that are used as disinfectants. As is also clear from recital 21 to the Detergents Regulation, at least these surfactants can therefore be both detergents and biocides.

34.

In so far as the Netherlands ultimately infers from two Commission documents that a side effect is not sufficient for a biocidal product, its interpretation of those documents is not convincing.

35.

According to the document on odour mitigation, ( 10 ) a product is a biocidal product if it attacks the nutriments of harmful organisms. The Commission does not discuss whether this constitutes a side effect. Rather, it confirms that not only chemical or biological effects are covered.

36.

Although Implementing Decision (EU) 2015/646 ( 11 ) states that certain bacterial cultures are not biocidal products, the potentially relevant side effects were ‘not intended’, according to that decision. The subjective characteristic of a biocidal product is therefore not present in respect of the relevant product in that decision. By contrast, the question of whether side effects are involved appears to be of secondary importance.

37.

As regards the objection that the Biocides Regulation is not practicable on the basis of such an interpretation, it is the task of the legislator to assess this provision in the light of practical experience and, if necessary, amend it.

38.

Consequently, Article 3(1)(a) of the Biocides Regulation is to be interpreted as meaning that the term ‘biocidal product’ also comprises substances which consist of one or more types of bacteria, enzymes or other constituents, where, due to the specific way in which they act, they are not to have a direct effect on the harmful organism for which they are intended, but rather to have an effect on the creation or maintenance of the potential habitat of that harmful organism, unless that action is of a mere physical or mechanical nature.

39.

The second question seeks to ascertain whether it is sufficient for a biocidal product if such effects merely prevent the re-establishment of harmful organisms and, therefore, the organisms must firstly be eliminated using other means. According to my understanding, the third question asks whether a permanent effect is necessary or whether it is sufficient if the effect lasts for a number of weeks before a re-treatment is necessary.

40.

On account of the broad definition discussed above, the answer to be given to both these questions is that neither the question whether the conditions in which such a product is used are free of the harmful organism nor the period within which the effect takes place is significant for the application of Article 3(1)(a) of the Biocides Regulation.

41.

I therefore propose that the Court give the following answer to the request for a preliminary ruling: