1.

The present case provides the Court with the opportunity to consider, for the first time, the definition of the concept of ‘biocidal products’ and, consequently, the scope of Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market ( 2 ) (‘the Biocidal Products Directive’).

2.

The parties to the main proceedings, Söll GmbH (‘Söll’) and Tetra GmbH (‘Tetra’), are in dispute as to whether the anti-algae product TetraPond AlgoRem, the active substance of which is aluminium chlorohydrate, is a biocidal product within the meaning of the Biocidal Products Directive. The referring court, the Landgericht Hamburg (Hamburg Regional Court) (Germany), seeks in particular to ascertain what type of effect — direct or indirect — on the harmful organism is necessary for the purpose of the biological or chemical process required by that directive. According to the referring court, the product in question does not kill algae, but causes them to agglutinate, which facilitates their removal mechanically, as provided for in the instructions for use of the product.

3.

Under the system set up by the Biocidal Products Directive, it is a matter for the Member States to decide whether a product does or does not come within the scope of that directive. This frequently calls for a very detailed and complex assessment of the product in question. ( 3 ) Therefore, the Court cannot clarify and specify the definition in issue for all future cases, but can merely provide some useful guidelines for the interpretation of the Biocidal Products Directive to the referring court and the authorities of the Member States responsible for the application of that directive.

4.

The purpose of the Biocidal Products Directive is to establish a Community system for authorising biocidal products and placing them on the market for use.

5.

Article 2(1)(a), (d) and (f) of that directive provides:

‘For the purposes of this Directive, the following definitions apply:

…

…

6.

Annex V to the Biocidal Products Directive, entitled ‘Biocidal product-types and their descriptions as referred to in Article 2(1)(a) of this Directive’, provides, inter alia, as follows:

‘These product-types exclude products where they are covered by the Directives mentioned in Article 1(2) of this Directive for the purposes of these Directives and their subsequent modifications.

MAIN GROUP 1: Disinfectants and general biocidal products

…

Product-type 2: Private area and public health area disinfectants and other biocidal products

… as well as products used as algaecides.

Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air-conditioning systems; walls and floors in health and other institutions; chemical toilets, waste water, hospital waste, soil or other substrates (in playgrounds).

…’

7.

Under Article 16(2) of the Biocidal Products Directive, a work programme was implemented for the purpose of reviewing all active substances in biocidal products already on the market on 14 May 2000 (‘existing active substances’). Authorisation and placing on the market of biocidal products containing existing active substances are conditional on the inclusion of those substances in Annexes I, IA or IB to that directive.

8.

The first phase of that work programme was implemented by Commission Regulation (EC) No 1896/2000 of 7 September 2000 on the first phase of the programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council on biocidal products. ( 4 )

9.

In accordance with Article 3(1) of Regulation No 1896/2000, each producer of an existing active substance placed on the market for use in biocidal products is required to ‘identify’ that active substance by submitting to the Commission of the European Communities the information on the active substance referred to in Annex I to that regulation.

10.

Article 4 of Regulation No 1896/2000 provides, in particular, that producers, formulators and associations wishing to apply for the ‘inclusion’ in Annex I or Annex IA to the Biocidal Products Directive of an existing active substance in one or more product types are required to notify that active substance to the Commission.

11.

Pursuant to Article 6(1)(b) of Regulation No 1896/2000, a regulation laying down, inter alia, an exhaustive list of existing active substances for which the Commission had accepted at least one notification had to be adopted following the notification referred to in the previous paragraph, in accordance with the procedure laid down in Article 28 of the Biocidal Products Directive.

12.

Article 3 of Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8 and amending Regulation No 1896/2000 ( 5 ) refers to three annexes which relate to the identified and notified existing active substances. Annex I to Regulation No 2032/2003 contains the exhaustive list of existing active substances which have been identified. Annex II to that regulation contains the exhaustive list of existing active substances in respect of which, in particular, at least one notification has been accepted by the Commission. Annex III to that regulation contains the list of existing active substances that have been identified, but in respect of which there has been neither an accepted notification nor an expression of interest by a Member State.

13.

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC, ( 6 ) replaced Regulation No 2032/2003, which had been amended several times.

14.

The provisions of the Biocidal Products Directive were transposed into German law by the Law on biocidal products (Biozidgesetz) of 20 June 2002. ( 7 ) As a matter of legislative technique, those provisions were implemented in the Law on protection from dangerous substances (Gesetz zum Schutz vor gefährlichen Stoffen, known as the ‘Chemikaliengesetz’ (‘the ChemG’)), and in that Law, principally, in Paragraph 3b and Paragraphs 12a and 12j.

15.

The statutory definition of biocidal products contained in Article 2(1)(a) of the Biocidal Products Directive was transposed into German law in Paragraph 3b(1)(1) of the ChemG.

16.

The referring court finds that it must take the interpretation of Article 2(1)(a) of the Biocidal Products Directive as a basis for the interpretation of Paragraph 3b(1)(1) of the ChemG.

17.

Söll and Tetra are competitors in the sale of anti-algae products for use in ponds, particularly in artificially created garden ponds, biotopes and swimming ponds, and are in dispute with regard to the classification of one of those products as a biocidal product.

18.

Söll, the applicant in the main proceedings, takes the view that the anti-algae product TetraPond AlgoRem is a biocidal product which may not be placed on the market. It is of the opinion that Tetra has infringed the provisions on unfair competition in breaching a rule of market conduct, by placing the anti-algae product TetraPond AlgoRem on the market, even though the latter was not marketable. Söll bases its arguments on Paragraphs 3 and 4(11) of the German Law on unfair competition (Gesetz gegen den unlauteren Wettbewerb), read in conjunction with Paragraphs 12a(1) and 28(8) of the ChemG.

19.

According to the referring court, if the product in question were to be classified as a ‘biocidal product’ within the meaning of the Biocidal Products Directive, the marketing of that product would be unlawful. ( 8 )

20.

The product’s particular characteristic is that it does not act directly, chemically or biologically, on the algae. On the contrary, it causes the algae to agglutinate but does not destroy them. This agglutination, or flocculation, facilitates the mechanical removal of the algae from the water.

21.

According to the referring court, the active substance at issue, aluminium chlorohydrate, has been identified pursuant to Article 3 of Regulation No 1896/2000 as an ‘existing active substance’ and is currently listed in Annex I to Regulation No 1451/2007. ( 9 ) However, since it was not notified pursuant to Article 4 of Regulation No 1896/2000, it was not included in Annex II to Regulation No 1451/2007 and therefore lost its capacity to be marketed as an active biocidal substance in accordance with Article 4(1) of that regulation.

22.

As it took the view that it was unable to give a clear answer to the questions relating to the interpretation and application of Community law raised in the case before it, the Landgericht Hamburg decided to stay the proceedings and to refer the following questions to the Court for a preliminary ruling:

23.

The reference for a preliminary ruling was received at the Court on 23 August 2010. Written observations were submitted by Söll, Tetra, the Kingdom of Belgium and the Commission. Söll and the Commission were represented at the hearing which took place on 22 June 2011.

24.

The two questions referred for a preliminary ruling by the referring court concern the definition of the concept of ‘biocidal products’. The referring court is unsure whether the biological or chemical effect of the product in issue on the harmful organism must be direct, in order to destroy, deter or render it harmless, or otherwise exert a controlling effect, or whether an indirect effect on that harmful organism is sufficient.

25.

In other words, the referring court seeks to ascertain whether only a product which acts directly on the harmful organism itself comes within the scope of the Biocidal Products Directive, or whether a product which acts only on the environment of that organism must also be included.

26.

The definition of a biocidal product in the Biocidal Products Directive consists of three essential elements: there must be an active substance; that substance must be intended to destroy, deter or render harmless a harmful organism, to prevent the action of that organism, or otherwise to exert a controlling effect over it; and, finally, the action of that substance must be chemical or biological.

27.

A simple reading of that directive confirms that products intended to act directly on the harmful organism itself come, in any event, within the scope of that directive. Indeed, the first elements of the definition given by the Biocidal Products Directive describe an effect of direct neutralisation (active substances and preparations intended to ‘destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect’). If a product which consists of one or more active substances is intended to be used for those purposes, and that by biological or chemical means, then it is a biocidal product.

28.

However, what is the position with regard to those products which affect only the environment of the harmful organism, and not the organism itself?

29.

It must be stressed at the outset that the wording of the Biocidal Products Directive does not preclude application of that directive in respect of such products.

30.

In the present case, it is necessary, in my view, to concentrate on the final part of the second element of the definition, concerning the purpose of that substance, and to consider the meaning of the term ‘otherwise exert a controlling effect’ on a harmful organism.

31.

In that respect, the parties have drawn attention to the discrepancies which exist between the different language versions of Article 2(1)(a) of the Biocidal Products Directive. ( 10 ) Indeed, some versions express that criterion in slightly more restrictive terms, in particular the German-language version cited by the referring court (‘in anderer Weise zu bekämpfen’) and the French-language version (‘combattre de toute autre manière’). ( 11 ) By contrast, a number of other language versions refer, in broader terms, to a ‘controlling’ effect, as in the English-language version (‘exert a controlling effect’) and also the Italian-language version (‘esercitare altro effetto di controllo’). ( 12 )

32.

The pursuit, by the Biocidal Products Directive, of objectives involving the protection of humans, animals and the environment, supports, in my opinion, the view that an interpretation of the term in issue as referring, very broadly, to the ‘controlling’ of harmful organisms is more in line with the aim of that directive, in the context in which products are dispersed in the environment.

33.

This approach is corroborated by the definition of an active substance. According to Article 2(1)(d) of the Biocidal Products Directive, an active substance is a substance or a micro-organism, including a virus or a fungus, which has a general or specific action on or against harmful organisms. Consequently, the classification of ‘biocidal product’ is not reserved exclusively for products containing active substances which exert an effect on the harmful organism. That classification also covers active substances which exert a general or specific effect against the harmful organism.

34.

In that regard, the reformulation proposed by the Commission strikes me as relevant. According to the Commission, the question, reformulated in more abstract terms, would be the following: does the Biocidal Products Directive also cover a product which may involve a risk to the environment by reason of its chemical or biological mode of action, but the direct effect of which on the targeted organisms is neither chemical nor biological?

35.

In other words, it is necessary to ask whether the product sets off a causal chain the result of which would be that the life of the harmful organism becomes more difficult, that its presence is reduced or that the harmful organism becomes more amenable to control. In such circumstances, the product in issue is an integral part of a process which precisely has the objective of combating or controlling the harmful organism. It is therefore to be classified as a biocide, even if the effect that it produces does not directly affect the harmful organism by chemical or biological means.

36.

It should also be added that the destruction of harmful organisms brought about by the active substance of the product is not required by the Biocidal Products Directive. In the present case, it has been pointed out, both by the parties and by the referring court, that the algae do not die following the treatment, but continue to photosynthesise, and that the flocculation created by the active substance can be destroyed by agitating the water. In that respect, it should be noted that Annex V to the Biocidal Products Directive mentions, among the products identified at No 19 (‘repellents and attractants’) in particular the ‘products used to control harmful organisms …, by repelling or attracting’. If a product which repels harmful organisms is mentioned among biocidal products, that means that the destruction of harmful organisms is not a necessary condition for classification of that product as a biocidal product.

37.

The concept of ‘biocidal product’ in the Biocidal Products Directive should thus be given a broad interpretation and, consequently, it should be acknowledged that that concept does not exclude products which exert a chemical or biological affect on the environment of the harmful organism and not on the organism itself.

38.

However, while the Biocidal Products Directive is intended to apply to biocidal products as defined in Article 2(1)(a) thereof, it nonetheless excludes products which are defined in or come within the scope of the other directives listed in Article 1(2). Account should thus be taken of the fact that the Biocidal Products Directive operates in the midst of some twenty other directives. Its field of application must be interpreted in such a way as not to cause overlap with the other directives mentioned in its Article 1(2). ( 13 )

39.

Furthermore, the scope of the Biocidal Products Directive must be capable of being defined in specific cases on the basis of objective factors. In the present case, two specific factors have to be noted.

40.

First, according to the referring court, the active substance in issue is listed in Annex I to the Biocidal Products Directive. It follows from that listing that that active substance has been identified as an existing active substance used in biocidal products.

41.

Secondly, it should be noted that algaecides, as a type of product covered by that directive, are mentioned as an example in Annex V (among the products referred to at No 2) to the Biocidal Products Directive. It must therefore be concluded that the European Union legislature intended to bring the products for combating algae within the scope of the Biocidal Products Directive. Due account must be taken of the examples given by the legislature, which are evident from that directive, in order to interpret the criteria which define its scope.

42.

That said, these are merely objective indicia which cannot be applied mechanically. ( 14 ) It should be recalled that the Biocidal Products Directive is intended to apply to a very wide range of areas, a fact which is well illustrated by the examples cited in the Manual of Decisions drafted by the Commission for the Member States’ authorities for the application of the Biocidal Products Directive. ( 15 ) On the basis of those examples, it is clear that each case must be analysed in great detail by the national authorities. ( 16 )

43.

In the light of the foregoing considerations, I propose that the Court should answer as follows the two questions referred by the Landgericht Hamburg: