Articles

Does your everyday cleaning product qualify as a 'biocidal product' under European legislation?

Does your everyday cleaning product qualify as a biocidal product und

Does your everyday cleaning product qualify as a 'biocidal product' under European legislation?

14.02.2020 EU law

On 19 December 2019, the Court of Justice of the European Union (CJEU) ruled on the concept of 'biocidal product', as defined in article 3 of Regulation 528/2012 on the making available on the market and use of biocidal products, in a case on a cleaning product primarily used "to ensure the absence of mould". According to the CJEU, the concept of ‘biocidal product’ is to be interpreted broadly, hereby also broadening the scope of application of Regulation 528/2012.

Legal framework

Principles

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.

'Biocidal product'

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).

Preliminary ruling

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:

  1. 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?
  2. 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?
  3. 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).

Conclusion

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.

Team

Related news

26.02.2020 NL law
De Wet maatschappelijke ondersteuning als proeftuin voor integrale geschilbeslechting in het bestuursrecht

Short Reads - De eerste vraag die bestuursrechtjuristen vaak stellen bij het behandelen van een nieuwe zaak is of de bestuursrechter dan wel de civiele rechter daarnaar moet kijken. Die vraagt leidt in een niet onaanzienlijk aantal gevallen tot lange deliberaties met soms ook nog eens als conclusie dat het antwoord niet duidelijk is. Daarnaast blijkt in sommige zaken dat een geschil deels bij de bestuursrechter en deels bij de civiele rechter thuishoort.

Read more

12.02.2020 NL law
Het oproepen en horen van getuigen in het bestuursrecht: hoe zit het ook al weer?

Short Reads - Het oproepen van getuigen en het horen daarvan ter zitting door de bestuursrechter heeft de Hoge Raad in zijn arrest van 15 november 2019 overzichtelijk in kaart gebracht. Dat arrest, dat door de belastingkamer in een bestuurlijke boetezaak is gewezen, is ook voor andere terreinen van het bestuursrecht van belang. Mede ook omdat het horen van getuigen buiten het fiscale bestuursrecht nog in de kinderschoenen staat. In dit bericht bespreken we daarom de mogelijkheden die er bestaan om getuigen te (laten) oproepen en hoe de bestuursrechter daarmee moet omgaan.

Read more

12.02.2020 NL law
Omgevingsrecht en mobiliteit: hoe werkt het afwijken van parkeernormen in bestemmingsplannen?

Short Reads - Op grond van artikel 3.1.2, tweede lid, Bro kan een bestemmingsplan ten behoeve van een goede ruimtelijke ordening regels bevatten waarvan de uitleg bij de uitoefening van een daarbij aangegeven bevoegdheid afhankelijk wordt gesteld van beleidsregels. Van deze mogelijkheid maken gemeenteraden in hun bestemmingsplannen vaak gebruik als het gaat om parkeernormen

Read more

24.02.2020 EU law
MER-screening: Raad van State zet de puntjes op de ā€˜iā€™

Articles - De opmaak van een ruimtelijk uitvoeringsplan is een tijdrovend en kostelijk proces. De noodzaak tot de opmaak van een MER-rapport maakt dit proces er niet eenvoudiger op. Plan-MER-screenings kunnen het planproces op lokaal niveau sterk vereenvoudigen. Dit mag evenwel niet licht opgevat worden. Een juiste toepassing van de regelgeving is cruciaal. Een onzorgvuldige screening kan immers een heel plan hypothekeren.

Read more

This website uses cookies. Some of these cookies are essential for the technical functioning of our website and you cannot disable these cookies if you want to read our website. We also use functional cookies to ensure the website functions properly and analytical cookies to personalise content and to analyse our traffic. You can either accept or refuse these functional and analytical cookies.

Privacy ā€“ en cookieverklaring