EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/10211/2018 
(POOL/E4/2018/10211/10211 -EN 
CIS.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
pursuant to Article  3(3) of Regulation (EU) No  528/2012 of the European Parliament 
and of the Council on Wolbachia trans -infected mosquitos used for vector control 
purposes  
(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 (EU) …/…  
of XXX  
pursuant to Article  3(3) of Regulation (EU) No  528/2012 of the European Parliament 
and of the Council on Wolbachia trans -infected mosquitos used for vector control 
purposes  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on t he 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 28 September 2017 , France  requested the Commission to decide  whether bacteria 
of the species Wolbachia endobacterium ("the bacteria") or any preparation containing 
the bacteria injected into non -infected mosquitoes, and mosquitoes infected with the 
bacteria  ("the trans -infected mosquitoes") used in the context of vector control 
strategies are biocidal products within the  meaning of Article 3(1)(a) of Regulation 
(EU) No 528/2012 or treated article s within the meaning of Article 3(1)(l) of that 
Regulation or neither.  
(2) According to the information provided by France , these intracellular bacteria are 
transmitted vertically  and naturally present in arthropods . The infection of mosquitoes 
by the bacteria reduces the ability of some mosquitoes to transmit certain pathogenic 
viruses and parasites by interfering with th ose pathogens within the mosquitoes , and 
promotes the reproduct ion of infected females mosquitoes and the spread of the 
bacteria in the mosquito es' population. Therefore, vector control campaigns are based 
on the release of trans -infected mosquitoes  within a population  of mosquitoes  in order 
to reduce their ability to  transmit certain  pathogen s to humans . 
(3) According to the information provided by France , not all species of mosquitoes or 
individuals within one species are naturally infected with the bacteria, or with a strain 
of the bacteria that is exploitable for the v ector control purposes. Therefore, non -
natural infections have to be carried out under laboratory conditions in order to create 
trans -infected mosquitoes with a suitable strain of the bacteria. That can be achieved 
by different infection techniques, includ ing the inoculation of the bacteria into adult 
female mosquitoes or into the cytoplasm of mosquitoes' eggs.  
(4) For the purpose of the provisions in Article 3(3) of Regulation (EU) No 528/2012, it is 
therefore relevant to assess separately the status of the ba cteria or any preparation 
containing the bacteria inoculated  into non -infected mosquitoes and the status of the 
trans -infected mosquitoes, irrespectively of the  infection technique  used.  
                                                 
1 OJ L  167, 27.6.2012, p.  1.  
EN 2  EN (5) The bacteria are micro -organisms within the meaning of Article 3(1)(b ) of Regulation 
(EU) No 528/2012  
(6) The non -infected mosquitoes are  harmful organism s within the meaning of Article 
3(1)(g) of Regulation (EU) No 528/2012 , since they may  have an unwanted presence 
or a detrimental effect on humans or animals.   
(7) The bacteria has an action on or against non -infected mosquitoes and therefore  should 
be considered an active substance within the meaning of Article 3(1)(c) of Regulation  
(EU) No 528/2012 . 
(8) Product -type 18 , insecticides, acaricides and products to control other arthropods, as 
defined in Annex V to Regulation (EU) No 528/2012, includes products used for the 
control of arthropods, by means other than repulsion or attraction. Since the bacteria 
are inoculated into the non -infected mosquitoes with the intention  to exert a 
controlling effect on mosquitoes' populations, such use falls under the description of 
product -type 18.  
(9) The bacteria or the preparation containing the bacteria is exerting a controlling effect 
on the non-infected m osquitoes by other means than mere physical or mechanical 
action .  
(10) For the purposes of Article 3(1)(a) of Regulation (EU) No 528/2012, the bacteria or 
the preparation containing the bacteria should be considered a substance or a mixture, 
respectively, consisting of or containing an act ive substance. As a consequence, the 
bacteria or any preparation containing the bacteria, as it is supplied to the user carrying 
out the inoculation into non -infected mosquitoes, is a biocidal product within the 
meaning of the first indent of Article 3(1)( a) of Regulation (EU) No 528/2012  and 
falls within product -type 18.  
(11) Trans-infected mosquitoes  are not  micro -organism s within the meaning of Article 
3(1)(b) of Regulation (EU) No 528/2012 .  
(12) Trans -infected mosquitoes  are not  a substance or a mixture within the meaning of 
points 1 and 2 of Article 3 , respectively, of Regulation (EC) No 1907/2006. Therefore, 
pursuant to points (a) and (b) of Article 3(2) of Regulation (EU) No 528/2012, they are 
neither  a substance nor a mixture for the purposes of that Regulat ion.  
(13) As a consequence, trans -infected mosquitoes are not  an active substance within the 
meaning of Article 3(1)(c) of Regulation  (EU) No 528/2012. Therefore, trans -infected 
mosquitoes  cannot be  a biocidal product  within the meaning of the first indent of 
Article 3(1)(a) of that Regulation .  
(14) Trans -infected mosquitoes  are not  article s within the meaning of Article 3(3) of 
Regulation (EC) No 1907/2006 . Therefore,  pursuant to Article 3(2)( c) of Regulation 
(EU) No 528/2012, they are not  considered articles for the purposes of that 
Regulation.  Consequently, the trans -infected mosquitoes  cannot be  considered treated 
articles  within the meaning of Article 3(1)(l) of Regulation (EU) No 528/2012 .  
(15) The measures provided for in this Decis ion are in accordance with the opinion of the 
Standing  Committee on Biocidal Products,   
EN 3  EN HAS ADOPTED THIS DECISION:  
Article 1  
The bacteria of the species Wolbachia endobacterium  or any preparation containing those 
bacteria  used for the purpose of inoculating those bacteria into non -infect ed mosquitoes  with 
the objective of creating trans -infected mosquitoes for vector control shall be considered a 
biocidal product within the meaning of Article 3(1)(a) of Regulation (EU) No 528/2012 . 
Experimentally t rans-infected mosquitoes , irrespectively of the infection technique used, shall 
be considered neither a biocidal product nor a treated article within the meaning of points (a) 
and (l) of Article 3(1) , respectively , of Regulation (EU) No 528/2012.  
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  
 Jean -Claude JUNCKER