Opinion of the Advocate General — ECLI:EU:C:2019:880
Date: 2019-10-17
Language of the case: Dutch
Subject matter: Provisions governing the Institutions;Approximation of laws
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Translation C-592/18 — 1 
Case C-592/18 
Request for a preliminary ruling 
Date lodged: 
21 September 2018 
Referring court: 
College van Beroep voor het Bedrijfsleven (Netherlands) 
Date of the decision to refer: 
18 September 2018 
Appellant: 
Darie B.V. 
Respondent: 
Staatssecretaris van Infrastructuur en Milieu 
  
Judgment 
COLLEGE VAN BEROEP VOOR HET BEDRIJFSLEVEN  
(ADMINISTRATIVE COURT FOR TRADE AND INDUSTRY) 
[...] 
order for reference of the meervoudige kamer (full bench division) of 
18 September 2018 in the case between 
Darie B.V., of Venlo, appellant 
[...] 
and 
the staatssecretaris van Infrastructuur en Milieu (State Secretary for 
Infrastructure and the Environment), respondent 
[...] 
EN 
REQUEST FOR A PRELIMINARY RULING OF 18. 9. 2018 — CASE C-592/18 
 
2  
Procedure 
By decision of 13 January 2017 (the primary decision), the respondent imposed on 
the appellant an administrative order for periodic penalty payments pursuant to 
Article 43 and Article 86 of the Wet gewasbeschermingsmiddelen en biociden 
(Law on Plant Protection Products and Biocidal Products; ‘Wgb’), Article 17(1) of 
Regulation (EU) No 528/2012 of the European Parliament and the Council of 
22 May 2012 concerning the making available on the market and use of biocidal 
products (Regulation 528/2012) and Article 5:32 of the Algemene wet 
bestuursrecht (General Law on Administrative Law; ‘Awb’). 
By decision of 26 May 2017 (the contested decision), the respondent declared the 
objection lodged by the appellant to be unfounded. 
The appellant lodged an appeal against the contested decision.  
[Or. 2] [...] [details of the national procedure] 
Grounds 
The facts 
1.  The College takes the following facts as its point of departure. 
1.1  The appellant makes available on the market the product Pure Air (‘the 
product’). This is a bacterial product, (also) containing the bacterial species 
‘Bacillus ferment’.  
1.2  The respondent has designated the product a biocidal product within the 
meaning of Article 3(1)(a) of Regulation 528/2012. That product has not been 
authorised by the College van gewasbescherming en biociden (Board for the 
Authorisation of Plant Protection Products and Biocidal Products; ‘Ctgb’). 
1.3  The Inspectie Leefomgeving en Transport (Human Environment and 
Transport Inspectorate; ‘ILT’) has investigated the use of disinfectants in the 
cleaning and industrial cleaning sector. In that context, the ILT carried out an 
inspection at a cleaning company (CSU) that used the product at the time. A 
penalty report in that regard was drawn up on 29 December 2016. 
The report stated, in so far as is relevant here, that an ILT inspector had observed 
how the product was used by CSU in practice and that a CSU employee [Or.3] 
had explained to the inspector that the existing mould had earlier been removed 
with brushes, and that the walls were subsequently treated with the product 
several times per year.  
DARIE 
 
3 
The statement by CSU’s KAM (kwaliteit, arbeidsomstandigheden en milieu: 
quality, working conditions and environment) manager, included in the penalty 
report, in so far as is relevant here, reads as follows: 
‘(...) In 2015 CSU started using probiotics from the company Green XL. We used 
that product as prescribed by the supplier. The supplier was present at the start. I 
do not know whether CSU disinfected prior to the treatment with probiotics. The 
person who was in charge at the time, is no longer employed by CSU. I cannot 
now ascertain whether they disinfected at the time. It is not apparent from the 
instructions provided by the supplier that it was necessary to first disinfect. (...)’ 
The penalty report also contains a statement by the director/manager of the 
appellant. That statement reads, in so far as is relevant here, as follows: ‘(...) This 
product ensures, after the mould has been removed from the walls and floors of 
holiday accommodation by means of a biocidal product, that those surfaces are 
cleaned biologically by the production of enzymes. Because the wall that has been 
cleaned with a biocidal product is then mould-free, Pure Air ensures that the wall 
remains clean. Before customers use my Pure Air, I tell them that they must first 
remove any existing mould with a biocidal product. (...)’ 
1.4  The CSU website stated the following on 5 October 2016, in so far as is 
relevant here:  
‘(...) Combating mould with probiotics  
Mould and bacteria can be a stubborn problem. (...) CSU has the answer: 
nebulising or atomising with probiotics. A method which addresses the breeding 
grounds and thus also the living environment. (...)’  
1.5  The appellant’s website stated the following on 22 March 2017, in so far as 
is relevant here: 
‘(...) Probiotic cleaning products work like traditional 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. In addition, the product is safe and long-lasting. Its basic components are 
good bacteria and water, which makes it the most environmentally friendly 
product available in the professional market. The products can be used anywhere 
and generally ensure a healthy working environment. (...)’ 
1.6  The product label states, in so far as is relevant here:  
[Or. 4] 
‘Green XL Pure Air is a concentrated biodegradable nebulising liquid, enriched 
with probiotics. (...) elimination and prevention of unpleasant odours • 
introduction of healthy and safe microflora on surfaces. 
REQUEST FOR A PRELIMINARY RULING OF 18. 9. 2018 — CASE C-592/18 
 
4  
(...) 
Instructions for use 
Nebulise the environment that needs to be stabilised thoroughly but sparingly. 
(...) 
Contains: 
Composition in conformity with E.C. Directives: Bacillus ferment.’ 
1.7  The step-by-step plan for using the product Pure Air reads as follows, in so 
far as is relevant here: 
‘(...) 
To start the process 
- You will first have to remove the mould to the point where it is totally 
eliminated 
- (...) 
- Make sure that the rooms are well nebulised, thoroughly spraying those 
areas which were heavily covered with mould.  
(...) 
- To ensure that the mould does not recur, it is important to continue 
nebulising once every 3 to 4 weeks, depending on the level of humidity in the 
home. 
(...)’  
1.8  The CSU Lommerbergen Procedures Manual, compiled on 18 August 
2016, reads as follows, in so far as is relevant here: 
‘(...) Procedure: Before treating with Probiotics, the mould in the area to be treated 
will first have to be removed to the point where it is totally eliminated.  
(...)’ 
1.9  The distributor of Green Cleaning Products had earlier asked the Ctgb to 
give its opinion on the claim that the product Green XL Car Airco (an air 
conditioner cleaner for cars) is not a biocidal product. A letter from the Ctgb of 
22 May 2014, setting out the Ctgb’s assessment, reads as follows, in so far as is 
relevant here:  
‘ (...) 
DARIE 
 
5 
Considerations of the Ctgb 
Having regard also to the currently available documentation, the appellant 
successfully challenges the Ctgb’s initial argument that the probiotics were added 
apparently because of their biocidal function. The [Or. 5] Ctgb accepts that the 
probiotics could have been added because of their long-term cleaning function. 
Legally non-binding conclusion of the Ctgb 
If the label clearly states that in order to avoid bad smells, a dirty air conditioner 
must first be treated with a disinfectant, the Ctgb is of the opinion, based on the 
currently available information, that there are good reasons for Green Airco 
Cleaner, based on the operation of Bacillus spores, to be considered as a bacterial 
cleaner for keeping the plates of air conditioners in vehicles clean by means of the 
enzymatic breakdown of organic material by the Bacillus bacteria. (...)’  
1.10  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 not (yet) been 
registered as a biocidal active substance with the ECHA.  
The contested decision 
2.  By the primary decision, the respondent imposed on the appellant, with 
effect from 14 January 2017, an administrative order for periodic penalty 
payments of EUR 1 000 per week up to a maximum of EUR 25 000 — due to the 
infringement of Article 43 of the Wgb, in conjunction with Article 17(1) of 
Regulation 528/2012 (making unauthorised biocidal products available on the 
market).  
3.  By the contested decision, the respondent declared the objections lodged 
by the appellant against the primary decision to be unfounded. The respondent 
held in that regard, in abbreviated form and in so far as is relevant here, that the 
product is not comparable to the product Green XL Car Airco Cleaner, so that the 
conclusion of the Ctgb in respect of the latter product is not also applicable to the 
product Pure Air. In addition, according to the respondent, the product contains an 
active substance, bacillus ferment, which is aimed at combating moulds. The 
respondent has made that deduction from the producer’s and the distributor’s 
descriptions of the efficacy of the product, which the respondent regards as a 
claim that the product has a biocidal function. On that basis, the respondent has 
concluded that, if something happens on a surface with regard to micro-
organisms, there must then be an active substance.  
[Or. 6] 
REQUEST FOR A PRELIMINARY RULING OF 18. 9. 2018 — CASE C-592/18 
 
6  
Grounds of appeal 
4.1  The appellant argues that the respondent is erroneously of the view that at 
issue here is a biocidal product as referred to in Article 3(1)(a) of Regulation 
528/2012. The conclusion drawn by the respondent that the product contains an 
active substance and is aimed at destroying a harmful organism is speculative and 
not indicative of any investigation by the respondent. That conclusion cannot 
therefore form the basis of the imposed administrative order for periodic penalty 
payments, the appellant disputes that there is any claim that the product has a 
biocidal function. It argues in that regard that the wording on the product label ‘To 
ensure that the mould does not recur’ and ‘elimination and prevention of 
unpleasant odours’ is not the same as ‘destroying, deterring, rendering harmless, 
preventing the action of, or exerting a controlling effect on’, as referred to in 
Article 3(1)(a) of Regulation 528/2012. At issue here is not the combating of 
micro-organisms, but the prevention of micro-organisms. When mould does not 
recur because a surface is kept clean, that is not a biocidal effect and thus also not 
a claim that the product has a biocidal function. Furthermore, the bacterial species 
‘Bacillus ferment’ which the product contains was never registered as an active 
substance as such by the ECHA. According to the appellant, the product Pure Air 
is comparable to the product Green XL Car Airco Cleaner. Both products work in 
the same way; the probiotics remove all organic waste from a surface so that no 
biotope can form there. Furthermore, in the case of both products, all existing 
micro-organisms must first be removed with a biocide. That prior disinfection is 
required, is evident from the instruction sheet that accompanies the product Pure 
Air. Moreover, the product does not pose any danger to people and nature. 
Position of the respondent 
4.2  The respondent takes the position that the appellant, although requested to 
do so, did not want to disclose the exact composition of the bacterial strains 
concerned. As a result, the respondent was unable to conduct an investigation into 
the composition of the product. The fact that the bacterial species ‘Bacillus 
ferment’ is not on the ECHA list, does not mean that there is no active substance. 
The fact that (other) bacterial strains are included on the ECHA list in fact shows 
that bacteria can be classified as active substances.  
[Or. 7] The respondent is of the view that the facts and circumstances, viewed in 
conjunction with each other, indicate that the product is intended to destroy, deter, 
render harmful organisms harmless, or to prevent the action thereof and that it 
therefore is a biocide. The respondent noted in that regard that even in a 
previously cleaned environment, fungal threads always remain. The respondent 
maintains his position that the appellant cannot derive any rights from the ruling 
of the Ctgb with regard to the product Green XL Car Airco Cleaner.  
Finally, the respondent argues that the assessment of whether the product 
constitutes a danger for people and nature is the prerogative of the Ctgb. 
DARIE 
 
7 
The subject of the dispute 
5.  The question which arises in these proceedings is whether the respondent 
had the power to impose an administrative order for periodic penalty payments 
and, if so, whether it was able to use that power. The question in that context is 
whether the respondent was correct in regarding the product Pure Air as a biocidal 
product as referred to in Article 3(1)(a), read in conjunction with Article 3(1)(c), 
of Regulation 528/2012.  
The regulatory framework 
6.1  Regulation 528/2012, in so far as is relevant here, reads as follows: 
‘Article 3 
Definitions 
1. For the purposes of this Regulation, the following definitions shall 
apply:  
a) ‘biocidal product’ means  
— 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 [Or. 
8] by any means other than mere physical or mechanical action.  
(...) 
c) ‘active substance’ means a substance or a micro-organism that has an 
action on or against harmful organisms; 
(...)’ 
Article 17 
Making available on the market and use of biocidal products 
1.  Biocidal products shall not be made available on the market or used 
unless authorised in accordance with this Regulation.  
REQUEST FOR A PRELIMINARY RULING OF 18. 9. 2018 — CASE C-592/18 
 
8  
2. Applications for authorisation shall be made by, or on behalf of, the 
prospective authorisation holder. 
Applications for national authorisation in a Member State shall be submitted 
to the competent authority of that Member State (‘the receiving competent 
authority’). 
Applications for Union authorisation shall be submitted to the Agency. 
3. An authorisation may be granted for a single biocidal product or a 
biocidal product family.  
4. An authorisation shall be granted for a maximum period of 10 years. 
5. Biocidal products shall be used in compliance with the terms and 
conditions of the authorisation stipulated in accordance with Article 22(1) 
and the labelling and packaging requirements laid down in Article 69.  
Proper use shall involve the rational application of a combination of 
physical, biological, chemical or other measures as appropriate, whereby the 
use of biocidal products is limited to the minimum necessary and 
appropriate precautionary steps are taken.  
Member States shall take necessary measures to provide the public with 
appropriate information about the benefits and risks associated with biocidal 
products and ways of minimising their use.  
6. The authorisation holder shall notify each competent authority that has 
granted a national authorisation for a biocidal product family of each 
product within the biocidal product family at least 30 days before placing it 
on the market, except where a particular product is explicitly identified in 
the authorisation or the variation in composition concerns only pigments, 
perfumes and dyes within the permitted variations. The notification shall 
indicate the exact composition, trade name and suffix to the authorisation 
number. In the case of a Union authorisation, the authorisation holder shall 
notify the Agency and the Commission.  
7. The Commission shall, by means of an implementing act, specify 
procedures for the authorisation of the same biocidal products by the same 
or different enterprises under the same terms and conditions. That 
implementing act shall be adopted in accordance with the examination 
procedure referred to in Article 82(3).’  
6.2  The Wgb, in so far as is relevant here, reads as follows: 
‘Article 1. Definitions 
DARIE 
 
9 
1 In this Law and the provisions based on it, the following definitions 
shall apply: 
(...) 
biocidal product: a biocidal product as referred to in Article 3(1)(a) of 
Regulation (EU) No 528/2012; 
Article 43. Infringements of the Regulation 
1 It shall be prohibited to act in contravention of Articles 17(1), 17(5) 
and17(6), 27(1), 47(1), 56, 58(1) to 58(6), 62, 68(1), 69(1) and 69(2), and 
72(1) and 72(3) of Regulation (EU) Nr. 528/2012 or the regulations adopted 
in implementation thereof. 
2 The first paragraph shall not apply if the act referred to in the first 
paragraph is permitted in accordance with Regulation (EU) No 528/2012. 
3 It shall be forbidden to have biocidal products to hand or in stock 
without authorisation.  
4 It shall be prohibited to act in contravention of an appropriate 
provisional measure, as referred to in Article 88 of Regulation (EU) 
No 528/2012. 
(...) 
Article 86. Administrative coercion 
The Minister is authorised to impose an order under administrative coercion 
to enforce the rules laid down by or pursuant to this Law and Article 5:20 of 
the Algemene wet [Or. 10] bestuursrecht (General Law on Administrative 
Law), in so far as it concerns the obligation to cooperate with officials 
appointed under Article 82.’  
Reasons for the referral 
7.1  The College states first and foremost that there is no dispute between the 
parties that, under Articles 43 and 86 of the Wgb, the respondent has the power to 
impose on the appellant an administrative order for periodic penalty payments if, 
in contravention of article 17 of Regulation 528/2012, it has made available on the 
market a biocidal product for which authorisation has not been granted in 
accordance with Regulation 528/2012. 
7.2  Under Article 3(1)(a), read in conjunction with Article 3(1)(c), of 
Regulation 528/2012, a biocidal product means 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 
REQUEST FOR A PRELIMINARY RULING OF 18. 9. 2018 — CASE C-592/18 
 
10  
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, where an active substance is deemed to be a substance or a micro-organism 
that has an action on or against harmful organisms, or; 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. 
7.3  The intended use of the product by the appellant is aimed at the eradication 
of mould and the elimination of unpleasant odours. To that end, the product 
should be sprayed evenly with a nebulising device onto surfaces such as walls and 
floors. The existing mould on the surfaces to be treated should be completely 
removed prior to the application of the product.  
The appellant claims that the bacterial species ‘Bacillus ferment’ in the product 
produces enzymes that absorb and digest all the organic waste that serves 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. 
The question is whether that function of the product, as claimed by the appellant, 
which means that it is not the organism itself but rather, the creation or the 
maintenance [Or. 11] of the potential habitat of the organism which is being 
combated, falls within the definition of a biocidal product in Article 3(1)(a), read 
in conjunction with Article 3(1)(c), of Regulation 528/2012. The answer to that 
question requires an interpretation of the term ‘active substance’ in the context of 
the function of the product as described above. 
8.  In the light of the various positions that the parties have taken, and the 
considerations as set out in 7.1 to 7.3 above, the meaning of Article 3 of 
Regulation 528/2012, and in particular, the interpretation to be given to the term 
‘active substance’, is not so clear that its interpretation is not open to reasonable 
doubt. Given that an interpretation of that provision is necessary for the purpose of 
resolving the present dispute, the College is obliged, pursuant to Article 267 
TFEU, to seek a preliminary ruling from the Court of Justice in that regard. The 
College will therefore request a preliminary ruling from the Court of Justice on 
the questions formulated below.  
[...] [suspension of the national procedure] 
Decision 
The College: 
- requests the Court of Justice to give a preliminary ruling on the following 
questions: 
DARIE 
 
11 
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?  
[Or. 12] 
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? 
[...] 
[suspension of the national procedure, closing formula and signature]