EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/2020/12424 
(POOL/E4/2020/12424/12424 -EN.docx)  
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the non -approval of certain active substances in biocidal products pursuant to 
Regulation (EU) No 528/2012 of the European Parliament and of the Council  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
on the non -approval of certain active substances in biocidal products pursuant to 
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 t he 
Council of 22 May 2012 concerning the making available on the market and use of biocidal 
products 1, and in particular the third subparagraph of Article 89(1) thereof,  
Whereas:  
(1) Commission Delegated  Regulation (EU ) No 1062 /20142 establishes  in its Annex II a 
list of active substance/product -type combinations  included in the review programme 
of existing active substances in biocidal products on  30 March 2019.  
(2) For a number of active substance/product -type combinations included in that list, all 
the particip ants have withdrawn or are considered  to have withdrawn  their support in a 
timely manner . 
(3) In accordance with Article 14(1) of Delegated Regulation (EU) No 1062/2014, the 
European Chemicals Agency ( ‘the Agency ’) published an open  invitation to take over 
the role of participant for those active substance/product -type combinations for which 
the role of participant had not previously been taken over. For some of those 
combinations no notification has been submitted or the notificatio n has been rejected 
pursuant to Article 17( 4) or (5) of that Regulation . Those active substance/product -
type combinations which, i n accordance with Article 20 , first paragraph, point (b) , of 
Delegated Regulation (EU) No 1062/2014, should not be approved for use in biocidal 
products are the following : metam -sodium (product -types 9 and 11); thiram (product -
type 9); bronopol (product -type 9); peroxyoctanoic acid (product -type 2, 3, 4); Malt, 
ext. - Extractives and their physically modified derivatives such as tinctures, concretes, 
absolutes, essential oils, oleoresins, terpenes, terpene -free fractions, distillates, 
residues, etc., obtained from Hordeum, Gramineae  (product -type 19) ; 2,2-Dibromo -2-
cyanoacetamide (product -type 13) . 
(4) In addition , in accordance with Article 12 (3) of Delegated Regulation (EU) No 
1062/2014 , the Agency informed the Commission of those  active substance/product -
type combinations for which all participants have withdrawn or  are considered to have 
withdrawn  their support in a timely manner , and for which the role of participant had 
                                                 
1 OJ L 167, 27.6.2012 , p. 1.  
2 Commission Delegated Regulation (EU ) No 1 062/2014 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 Eu ropean Parliament and of the Council (OJ L 294, 10.10.2014 , 
p. 1). EN 2  EN previously been taken over.  Those active substance/product -type combinations  which,  
in accordance with Article 20 , first paragraph,  point (a) , of that Regulation, should not 
be approved for use in biocidal products  are the following : silver, as a nanomaterial 
(product -types 2, 4, 9); eucalyptus citriodora  oil and citronellal, hydrated, cyclized 
(product -type 19); 2 -Hydroxy -α,α,4 -trimethylcyclohexanemethanol (product -type 19);  
chlorine dioxide generated from sodium chlorite and sodium persulfate (product -types 
2, 3, 4, 5, 11) . 
(5) The measures provided for in t his Decision are in accordance with the opinion of the 
Standing  Committee on Biocidal Products , 
HAS ADOPTED THIS DECISION:  
Article 1  
The active substances listed in the Annex are not approved for the product -types indicated 
therein . 
Article  2 
This Decisio n 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 L EYEN