EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11336/2021 
(POOL/E4/2021/11336/11336 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving N -(3-aminopropyl) -N-dodecylpropane -1,3-diamine as an existing active 
substance for use in biocidal products of product -type 8  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING DECISION  
of XXX  
not approving N -(3-aminopropyl) -N-dodecylpropane -1,3-diamine as an existing active 
substance for use in biocidal products of product -type 8  
(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 Ma y 2012 concerning the making available on the market and use of biocidal 
products1, and in particular  of Article 89(1), third subparagraph,  thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of e xisting 
active substance s to be evaluated for their possible approval for use in biocidal 
products. That lists includes N-(3-aminopropyl) -N-dodecylpropane -1,3-diamine  (EC 
No: 219-145-8; CAS No : 2372 -82-9). 
(2) N-(3-aminopropyl) -N-dodecylpropane -1,3-diamine  has been evaluated for use in 
biocidal products of product -type 8, wood preservatives , as described in Annex V to 
Directive 98/8/EC of the European Parliament and of the Council3, which corresponds 
to product -type 8 as described in Annex V to Regulation (EU) No 528/2012.  
(3) Portugal wa s designated as the rapporteur Member State and its  evaluating competent 
authority submitted the assessment report together with its conclusions to the 
Commission on 9 November 2005 . After the submission of the assessment report, 
discussions took place in technical meetings organised by the Commission and, after 1 
September 2013, by the European Chemicals Agency (‘the Agency’).  
(4) It can be derived from Article 90(2) of Regulation (EU) 528/2012 that substances for 
which the Member States’ evaluation has been completed by 1 September 2013 should 
be evaluated in accordance with the provisions of Directive 98/8/EC.  
(5) In accordance with  Article 75(1) of Regulation (EU) No 528/2012, the Biocidal 
Products Committee prepare s the opinion of the Agency regarding the appl ication s for 
approval of active substances.  In accordance with Article 7(2) of Delegated Regulation 
(EU) No  1062/2014, the Biocidal Products Committee adopted the opinion of the 
                                                 
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 a nd of the Co uncil (OJ L 294, 10.10.2014, 
p. 1). 
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).  EN 2  EN Agency on 2 December  20204, having regard to the conclusions of the evaluating  
competent authority.  
(6) It can be derived from that opinion  that biocidal products of product -type 8 containing 
N-(3-aminopropyl) -N-dodecylpropane -1,3-diamine  may not be expected to meet  the 
criteria  laid down in Article 5(1), point (b) of Directive 98/8/EC which correspond to 
the criteria laid down in provisions Article 19(1) , point (b), of Regulation (EU) No 
528/2012  as unacceptable risks  for human health have been identified,  and no suitable 
risk mit igation meas ure could be identified .   
(7) In the discussions with the representatives of the Member States within the Standing 
Committee on Biocidal Products, it was considered that the evaluation was made 
according to realistic worst case conditions, and that limiting t he number of cycles of 
treatment of wood to two per day per operator would not be a suitable risk mitigation 
measure to reduce the identified risks to human health to an acceptable level , due to 
difficulties of enforcement and control.  
(8) Taking into account the opinion of the Agency  and the discussions in the Standing 
Committee on Biocidal Products , it is not appropriate to approve N-(3-aminopropyl) -
N-dodecylpropane -1,3-diamine  for use in biocidal products of product -type 8.  
(9) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee  on Biocidal Products,  
HAS ADOPTED THIS DECISION:  
Article 1  
N-(3-aminopropyl) -N-dodecylpropane -1,3-diamine  (EC No: 219-145-8; CAS No : 2372 -82-9) 
is not approved as an active substance for use in biocidal products of product -type 8. 
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  
                                                 
4 Biocidal Products Committee  Opinion on the application for approval of the active substance : N-(3-
aminopropyl) -N-dodecylpropane -1,3-diamine , Product type: 8, ECHA/BPC/2 70/2020, a dopted on 2 
December  2020.