EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10477/2017 
(POOL/E4/2017/10477/10477-EN.doc) 
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING R EGULATION (EU) …/... 
of XXX  
approving margosa extract,  cold-pressed oil of Azadirachta indica  seeds without shells 
extracted with super-critical car bon dioxide as an  existing act ive substance for use in 
biocidal products of product-type 19 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING  REGULATION (EU) …/... 
of XXX  
approving margosa extract, cold-pressed oil of Azadirachta indica  seeds without shells 
extracted with super-critical ca rbon dioxide as an existing act ive substance for use in 
biocidal products of product-type 19 
(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 Pa rliament and of the 
Council of 22 May 2012 concerning the making available on the m arket and use of biocidal 
products1, and in particular the third subpa ragraph of Article 89(1) the reof, 
Whereas: (1) Commission Delegated Regulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for their possible approval f or use in biocidal 
products. That list includes mar gosa extract, cold-pressed oil of Azadirachta indica  
seeds without shells extract ed with super-cri tical carbon dioxi de.  
(2) Margosa extract, cold-pressed oil of Azadirachta indica  seeds without shells extracted 
with super-critical carbon dioxide has been evaluated for use i n products of product-
type 19, repellents and attractant s, as described in Annex V to  Regulation (EU) 
No 528/2012. 
(3) Germany was designated as evaluating competent authority and su bmitted the 
assessment report together with its recommendations on 3 Decemb er 2015. 
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No  1062/2014, the 
opinion of the European Chemicals Agency was formulated on 3 Ma rch 2017 by the 
Biocidal Products Committee, having regard to the conclusions o f the evaluating 
competent authority. 
(5) According to that opinion, biocidal products of product-type 19  containing margosa 
extract, cold-pressed oil of Azadirachta indica  seeds without shells extracted with 
super-critical carbon dioxide may be expected to satisfy the cr iteria of Article 19(1)(b) 
of Regulation (EU) No 528/2012, pr ovided that certain specifica tions and conditions 
concerning their use are complied with. 
(6) It is therefore appropriate to  approve margosa extract, cold-pr essed oil of Azadirachta 
indica  seeds without shells extracted with super-critical carbon diox ide for use in 
                                                 
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 co ntained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of t he Council (OJ L 294, 10.10.2014, 
p. 1).  
EN 3   EN biocidal products of product-type 19, subject to compliance wit h certain specifications 
and conditions. 
(7) A reasonable period should be allowed to elapse before an activ e substance is 
approved in order to permit interested parties to take the prep aratory measures 
necessary to meet the new requirements. 
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Margosa extract, cold-pressed oil of Azadirachta indica  seeds without shells extracted with 
super-critical carbon dioxide is  approved as an active substanc e for use in biocidal products of 
product-type 19, subject to the s pecifications and conditions s et out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER