Regulation (EU) no 528/2012 of the European Parliament and of the Council of 22 May 2012 ("Regulation 528/2012") regulates the use and making available on the market of biocidal products. The purpose of this regulation is to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment.
The cornerstone of this framework is the requirement for biocidal products to be authorised in accordance with this regulation before they can be used or made available on the market. This obligation is implemented under domestic law.
A 'biocidal product' is defined according to article 3 of Regulation 528/2012 as:
- "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."
A treated article that has a primary biocidal function equally qualifies as a biocidal product in the sense of Regulation 528/2012. Annex V to Regulation 528/2012 furthermore provides for a list of types of biocidal products that fall within the scope of this regulation, divided in four categories:
- Main group 1: disinfectants;
- Main group 2: preservatives;
- Main group 3: pest control; and
- Main group 4: other biocidal products.
Cleaning products that are not intended to have a biocidal effect are explicitly excluded from main group 1, while preservatives (main group 2) merely include products to prevent microbial and algal development, unless specified otherwise.
The (non-)qualification as a 'biocidal product' has important implications, as Regulation 528/2012 provides that "Member States shall lay down the provisions on penalties applicable to infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented."
Before discussing this preliminary ruling, it is useful to review the well-established case-law.
Case-law of the CJEU
The CJEU applies the broad definition of 'biocidal product' in its case-law. In its judegment of 1 March 2012, for example, the CJEU ruled that 'biocidal products' include products which act only by indirect means on the target harmful organisms, provided that 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.
This case concerned an anti-algae product for use in ponds, in particular artificially created garden ponds, biotopes and swimming ponds. This product generates, when added to water, a chemical reaction and causes the algae flocculate, which means that they bond with one another in a mechanical-physical process to form lager units, which in turn can be removed from the water (more easily).
The Dutch Administrative Court of Appeal for Trade and Industry requested a preliminary ruling on 18 September 2018 concerning the product 'Pure Air' which, according to its label, can be used "to ensure the absence of mould" and for "the elimination and prevention of unpleasant odours". The accompanying instructions for the use of the product furthermore explicitly stated that before applying the product, the mould must be removed "to the point where it is totally eliminated".
In the dispute in the main proceedings, the Dutch Secretary of State imposed a penalty payment on Darie (the company responsible for making the product available on the market) to discontinue the making available on the market of Pure Air, which had not been authorised by the body empowered to license plant protection and biocidal products. Dairie appealed this decision, arguing that Pure Air does not qualify as a 'biocidal product'.
The Dutch court therefore referred the following questions to the CJEU:
- Should the term “biocidal products” in Article 3 of Regulation 528/2012 be interpreted as also referring to substances which consist of one or more types of bacteria, enzymes or other constituents, given that, due to the specific way in which they act, they have no direct effect on the harmful organism for which they are intended, but on the creation or maintenance of the potential habitat of that harmful organism, and what requirements must then, where appropriate, be imposed on such an effect?
- In answering question 1, is it relevant whether the situation in which such a product is used is free of the harmful organism, and, if so, what criterion should be used to assess whether the latter is present?
- In answering question 1, does the period within which the effect takes place have any relevance?"
Judgement of the Court
The CJEU decided with respect to the first question that products containing one or more bacterial species, enzymes or other constituents which, due to the specific way in which they act, have no direct effect on the harmful organism for which they are intended, but on the creation or maintenance of a potential habitat of that harmful organism qualify as 'biocidal product', provided that those products involve an action other than mere physical or mechanical 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.
It should be noted the CJEU (also) justified the broad interpretation of 'biocidal product' referring to the Opinion of the Advocate General, who referred to the ratio legis of this extended definition. Contrary to the Commission's proposal to expressly limit the concept of 'biocidal product' to biological and chemical effects, Regulation 528/2012 extends 'biocidal product' to any "action other than simple physical or mechanical action." The latter is, according to the CJEU, consistent with the objective (recalled in recital 5) of the regulation to ensure an increased level of protection of human and animal health and of the environment.
According to the CJEU, it is furthermore irrelevant that a product must be applied to the surface to be treated only after the removal of target harmful organisms present on that surface. Hence, the period within which a product takes effect does not affect the classification of that product as a ‘biocidal product’ (questions 2-3).
While everyday cleaning products in most cases will not qualify as a 'biocidal product' under Regulation 528/2012, it will have to be assessed on a case-by-case basis whether such products are intended to have a biocidal effect, and therefore potentially qualify as a 'biocidal product'. The latter concept is to be interpreted broadly, as evidenced by the case-law of the CJEU.
It goes without saying that such broad interpretation of the legal framework on the making available on the market and use of biocidal products is likely to have an impact on the biocides industry.
We will keep you updated on any new developments in this branch of European environmental law.