EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12536/2020  
(POOL/E4/2020/12536/12536 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
determining whether the product Sadolin Husrens containing Alkyl (C 12-16) 
dimethylbenzyl ammonium chloride is a biocidal product, pursuant to Article 3(3) of 
Regulation (EU) No 528/2012 of the European Parliament and of the Council  
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission. Any 
views expressed are the preliminary views of the Commission services and may not 
in any circumstances be regarded as stating an official position of the Commission.    
EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
determining whether the product Sadolin Husrens containing Alkyl (C 12-16) 
dimethylbenzyl ammonium chloride is a biocidal product, pursuant to Article 3(3) of 
Regulation (EU) No 528/2012 of the European Parliament and of the Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) No  528/2012 of the European Parliament and of the 
Council of 22  May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular Article  3(3) thereof,  
Whereas:  
(1) On 2 July 2020 , Denmark  requested the Commission to decide  whether  the product 
Sadolin Husrens,  which contains Alkyl (C 12-16) dimethylbenzyl ammonium chloride 
(ADBAC/BKC (C 12-C16)) in a concentration of 2,4%  and is marketed  in Denmark by 
the manufacturer as a cleaning agent (“the product ”), is a biocidal product as defined 
in Article 3(1) , point (a), of Regulati on (EU) No 528/2012 . 
(2) Alkyl ( C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC ( C12-C16)) is listed  
in Annex II  to Commission Delegated Regulation (EU) No 1062/20142 on the work 
programme for the systematic examination of all existing active substances . 
ADBAC/BKC (C 12-C16) is included in the review programme  for, amon g others, 
product -type 2, namely , ‘disinfectants and algaecides not intended for direct 
application to humans or animals ’, as defined in  Annex V to Regulation (EU) No 
528/2012 . The product  therefore  contains an active substance as defined in  Article 
3(1), point ( c), of that Regulation.  
(3) As held by the Court of Justice , in its judgment of 19 December 2019 , in Case 
C‑592/18  Darie3, “the concept of ‘biocidal product’, within the meaning of Article 
3(1)(a) of Regulation No 528/2012, is broad […]. That broad interpretation is 
supported by the objective set out in Article 1 of that regulation, based on the 
preca utionary principle, to ensure ‘a high level of protection of human and animal 
health and the environment’”4.   
(4) As also noted  in that judgment, the  categorisation as “biocidal product” for the 
purposes of Article 3(1) , point (a), of Regulation  (EU)  No 528/2 012 is subject , among 
other  things , to the fact that the product has the “intention of destroying, deterring, 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012  of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 
1). 
3 Judgment of the Court of Justice of 19 December 2019, Darie , C-592/18, ECLI:EU:C:2019:1140 . 
4 See C-592/18 Darie , op. cit., paragraph  42.  
EN 2  EN rendering harmless, preventing the action of or otherwise exerting a controlling effect 
on, any harmful organism”5. 
(5) In the same judgment, t he Court also stressed that “detergent products are not 
excluded from the scope of Regulation No  528/2012. Moreover, as is apparent from 
recital  21 of Regulation No  648/2004, a product can be described both as a ‘detergent’ 
within the meaning of Article  2(1) of that regulation and as a ‘biocidal product’ within 
the meaning of Article  3(1)(a) of Regulation No  528/2012 ”6. In any event,  a product 
can be considered as  a biocidal product within the meaning of Article 3(1), point ( a), 
of Regulation  (EU) No  528/2012  regardless  of whether it falls within the scope of 
Regulation (EC) No 648/20047. 
(6) If the fact that a product is claimed by the manufacturer to be a  “cleaning” product  was 
sufficient to conclude that that product  has no biocidal purpose  and, therefore, is not a 
biocidal product , the requirements  of Regulation (EU) No 528/2012  could be easily 
circumvented and its objectives undermined.  Such an approach would contradict the 
interpretation of the notion of “biocidal product” provided by the Court of Justice.  
Therefore, all information provided by the manufacturer, by distributors and at points 
of sale should be taken into account to assess whether a product is placed on the 
market with a biocidal intent within the meaning of Article 3(1), point (a), of 
Regulat ion (EU)  No 528/2012 . 
(7) The presence of active substances above c ertain levels of concentration in a product 
imply in practice that the product  will have a controlling effect on one or several 
harmful organism s. Therefore, such levels of concentration  may pr ovide an indication 
that the product is placed on the market with a biocidal intent within the meaning of 
Article 3(1), point (a), of Regulation  (EU)  No 528/2012 . 
(8) Based on the information submitted by Denmark, the product contains the active 
substance ADBA C/BKC  (C12-C16) at a concentration of 2 ,4% and can be used 
undiluted or used diluted at 50%. This concentration is similar to the one for the same 
active substance when  the algae -removing biocidal products  LUXAN ALGENDOOD  
and Benecura Groene aanslag reiniger , authorised in the Netherlands , are diluted for 
use in line with use instructions for the biocidal product s.  
(9) According to  the information  submitted by Denmark, the manufacturer describes the 
product as a long -acting cleaning agent for removing la yers of build -up on timber, 
brickwork, roofing slabs, paving stones, and other surfaces  and, in the technical 
datasheet, it indicates  that the product is to be used only outdoor s. The manufacturer  
also states that heavily soiled surfaces should first be cl eaned using a deter gent from 
the same manufacturer  before the surface is treated with the product. Denmark further 
submitted information from  a distributor and from online points of sale. The 
distributor claims that the product breaks down growth and provi des protection from 
regrowth.  According to the distributor, s uch growth can be seen as a green  build -up on 
the surface or as dark stains – particularly in places which are shaded from the sun by 
trees or shrubs, on north -facing sides, and where there is a lot of moisture.  The 
distributor specifies that this build -up of growth does not directly damage the timber, 
but spreads into a large, continuous mass, which prevents moisture from escaping . In 
an online point of sale, it is claimed that the product has preventive effects . Denmark 
                                                 
5 See C-592/18 Darie ,  op.cit., paragraph  32. 
6 See C-592/18, Darie , , op. cit., paragraph  48. 
7 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on 
detergents  (OJ L 104, 8.4.2004, p. 1 ).  
EN 3  EN also submitted that, in an other  online point of sale, the product is included in a 
category of products aimed at cleaning wood, paving and roofs and which are 
described as having a direct effect on algae on surfaces.   
(10) It therefore appears  that the product  is intended to prevent and control the growth of  
unwanted  algae , which meet the definition of  a harmful organism as set out in Article 
3(1), point (g), of Regulation (EU) No 528/2012 . 
(11) Given that the  product contains an  active substance  and is intended to exert a 
controlling effect on a harmful organism by a mode of action that is not merely 
physical or mechanical , the product should be considered  a biocidal product as defined 
in Article 3(1) , point (a), of Regulation (E U) No 528/2012 . 
(12) Since product -type 2, as defined in Annex V to Regulation (EU) No 528/2012, covers 
products used as algaecides  not intended for direct application to humans or animals , 
the product should fall within product -type 2.  
(13) The measures provided fo r in this Decis ion are in accordance with the opinion of the 
Standing  Committee on Biocidal Products,  
HAS ADOPTED THIS DECISION:  
Article 1  
The product Sadolin Husrens, containing the active substance  Alkyl ( C12-16) dimethylbenzyl 
ammonium chloride  in a concentration of 2 ,4%, shall be considered a biocidal product within 
the meaning of Article 3(1) , point (a), of Regulation (EU) No 528/2012  and shall fall within 
product -type 2  as defined in Annex V to that Regulation.  
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN