Biocidal Products - registration: a moving target?
EU Regulatory Bulletin contents
- Biocides: scope of definition
- Pesticides: data sharing
- Dangerous Preparations Directive recast
- REACH: substance evaluation
- GMO: cultivation opt-out
On 1 March 2012, the Court of Justice handed down its judgment in Case C-420/10 Söll Gmbh v Tetra Gmbh in which it rules for the first time on the scope of the definition of "biocidal products" under the Biocidal Products Directive 98/8. The Judgment broadly follows the Opinion of the Advocate General, issued on 27 October 2011 (see our previous EU Regulatory Bulletin item on the Opinion), and upholds a broad concept of 'biocidal products' to include products which act only by indirect means on the target harmful organisms, where the active substance provokes a chemical or biological action as part of a causal chain whose objective is to inhibit the target organism.
In brief, the Biocidal Products Directive 98/8 provides that in order to be placed on the market, a biocidal product must be authorised by the relevant Member State. As a first step, the active substance contained in the biocidal product must be authorised at EU level, or be an 'existing' active substance currently in the process of being reviewed by the Commission under Regulation No 1451/2007.
Article 2(1)(a) of Directive 98/8 defines a biocidal product as "Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means. An exhaustive list of 23 product types with an indicative set of descriptions within each type is given in Annex V."
An 'active substance' is defined as "[a] substance or micro-organism including a virus or a fungus having general or specific action on or against harmful organisms". (Article 2(1)(d) of Directive 98/8).
The Judgment results from a legal action in Germany (Hamburg Regional Court), between Söll Gmbh ('Söll') and Tetra Gmbh ('Tetra'), two companies competing in the market for anti-algae products for use in ponds. The product at issue, known as TetraPond AlgoRem, contains the active substance aluminium chlorohydrate. When poured into water, that product forms, by hydrolysis, a precipitate composed of aluminium hydroxide, which is insoluble and therefore chemically and biologically inert, which takes the form of a net making it possible to gather the suspended algae (flocculation) by a mechanical and physical process (flocculation capture). Aluminium chlorohydrate was identified as an "existing" active substance but was not notified and hence was not part of the Commission's review programme for biocidal active substances. Accordingly, Söll argued that the product could not be legally placed on the market, as per Article 4(1) of Regulation No 1451/2007. Tetra argued that the product could not be classified as a biocidal product within the meaning of Directive 98/8 because the flocculation does not have any chemical effect on the algae and does not destroy, deter or render the algae harmless, or otherwise exert a controlling effect on them. In order to resolve the issue, the German Court asked the Court of Justice whether the concept of ‘biocidal products’ set out in Article 2(1)(a) of Directive 98/8 must be interpreted as including products containing active substances which, by reason of their specific mode of action, are intended to act, chemically or biologically, on the target harmful organisms only by indirect means and, where relevant, what is required of such an action.
The Court first looked at the definition of 'biocidal products' set out in Article 2(1)(a) of Directive 98/8. As regards the requirement that the purpose of a biocidal product is "to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means" the Court noted discrepancies in the different language versions of Directive 98/8, with the German, French, and Dutch versions suggesting a direct effect must be had on the target organism, and the English, Spanish and Italian versions also suggesting a 'controlling effect' is sufficient for a product to fall within the definition of biocidal product. Given that all language versions are equally authentic, in accordance with established case law, the Court looked to the "purpose and general scheme" of Directive 98/8 to ascertain the scope of the definition of a biocidal product.
The Court first considered the aim of Directive 98/8 to provide a high level of protection for humans, animals and the environment and concluded that such protection would be seriously jeopardised if the definition of a biocidal product excluded those where the active substance only exerts an indirect chemical or biological effect on the target organism. The Court held that "it is the presence of the active substances as such, in a product such as that in the main proceedings, which is liable to present a risk for the environment, irrespective of whether that substance acts directly or indirectly on the target organisms."
The Court then stated that "it is apparent" from the list of purposes of a biocidal product set out in Article 2(1)(a), that the EU legislature intended to cover "all products containing one or more active substances and having a chemical or biological mode of action, so long as those products are intended to have an inhibiting effect on the target harmful organisms." The Court also noted the gradation of such purposes, from destruction to prevention and lastly "otherwise" exerting a controlling effect, and concluded that that established that "the possibility of that product having the effect, even limited, of exerting greater control over the target harmful organisms or of facilitating their elimination is sufficient [to fall within the definition of biocidal product]". According to the Court, such an interpretation of the concept of ‘biocidal products’ also follows from the concept of ‘active substance’ as defined in Article 2(1)(d) of Directive 98/8 (i.e. general or specific action on or against harmful organisms).
Next, the Court looked at the practical application of the anti-algae product at issue and noted that "while it is true that the chemical action of the active substance […] does not combat the algae directly, the fact none the less remains that it contributes to the removal of the algae from the water." The Court concluded that "[i]n the light of the close connection between the chemical action and its effects of exerting greater control over the target harmful organisms, a product such as that at issue in the main proceedings must be regarded as being intended to act chemically on those organisms."
The final answer given by the Court to the question sent from the German Court is that " [t]he concept of ‘biocidal products’ set out in Article 2(1)(a) 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 must be interpreted as including even 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 interpretation given by the Court of the concept of ‘biocidal products’ set out in Article 2(1)(a) of Directive 98/8 is binding on the competent authorities of all the EU Member States and the EU Institutions.
From the wording of Article 2(1)(a) of Directive 98/8, the view could be taken that the active substance must directly affect the harmful organism. In effect, the Court upholds the classical view that for a product to fall within the definition of "biocidal product" it must, first, contain an active substance, and secondly, that active substance must provoke a chemical or biological action but takes the concept a step further by providing that the chemical or biological action need not be directly on the target organism but may form part of a causal chain of actions designed to inhibit the target organism. The concept of 'inhibit' appears to be an all encompassing term for the intentions listed in Article 2(1)(a) in all language versions.
It is interesting to note that the definition of 'biocidal products' in Article 3 of the draft Biocidal Products Regulation, expected to be formally adopted and to enter into force later in 2012, is slightly different from that under Directive 98/8 in that it refers to "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" (emphasis added). That definition is already broader than under Directive 98/8 as the explicit reference to a chemical or biological means is removed. The definition in the Biocidal Products Regulation also includes in-situ generated active substances and 'treated articles' which have a "primary biocidal function". It is highly likely the ruling of the Court, while strictly applicable to the Biocidal Products Directive (which will be repealed by the Biocidal Products Regulation), will also be used to interpret the definition of 'biocidal products' under the new regime to include indirect effects (as part of a causal chain of actions designed to inhibit the target organism) and may impact the understanding of the 'primary biocidal function' of a 'treated article'.
The Court's interpretation is guided by the purpose of Directive 98/8 which is to harmonise the procedures for placing biocidal products on the market across the EU, conditional upon a high level of protection for human health and the environment. In that regard the Court appears mindful to rule out any avoidance of the registration of a product as a biocide on the grounds that the impact is not direct but where the ultimate aim of the product is to act against a harmful organism. In that regard, the ruling may be seen as bridging the apparent gap between the definition in Directive 98/8 and that which will apply under Biocidal Products Regulation.
The ruling that the definition of a biocidal product includes products where the active substance has an 'indirect effect' on the target organism is a broader definition than many in industry and in Member State competent authorities would have expected. Accordingly, industry would be advised to review their products to check any possible new registration obligations.
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