EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10559/2016 (POOL/E4/2016/10559/10559-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Bacillus thuringiensis  subsp. kurstaki , serotype 3a3b, strain  ABTS-351, as an 
active substance for use in biocidal products of product-type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Bacillus thuringiensis  subsp. kurstaki , serotype 3a3b, strain ABTS-351, as an 
active substance for use in bioc idal products of product-type 18 
(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 avai lable on the market and use of biocidal 
products
1, and in particular Article 90(2) thereof, 
Whereas: (1) France received on 30 January 2013 an applic ation, in accordance with Article 11(1) 
of Directive 98/8/EC  of the European Parliament and of the Council
2, for the inclusion 
of the active substance Bacillus thuringiensis  subsp. kurstaki , serotype 3a3b, strain 
ABTS-351 , in Annex I of that Directive for us e in products of product-type 18, 
insecticides, acaricides and pr oducts to control other arthropods, as defined in Annex 
V to that Directive, which corresponds to product-type 18 as de fined in Annex V to 
Regulation (EU) No 528/2012.  
(2) France submitted the assessment report together with its recommendations on 29 May 
2015 in accordance  with Article 90(2) of Regulation (EU) No 528/2012. 
(3) The opinion of the European Chemicals Agency was formulated on 16 February 2016 
by the Biocidal Products Committee, havi ng regard to the conclusions of the 
evaluating competent authority. 
(4) According to that opinion, biocidal pr oducts of product-type 18 and containing 
Bacillus thuringiensis  subsp. kurstaki , serotype 3a3b, strain ABTS-351 , may be 
expected to satisfy the criteria of Artic le 19(1)(b) of Regulation (EU) No 528/2012, 
provided that certain specifications and conditions concerning their use are complied 
with. 
(5) It is therefore appropriate to approve Bacillus thuringiensis  subsp. kurstaki , serotype 
3a3b, strain ABTS-351 , for use in biocidal products  of product-type 18, subject to 
compliance with certain sp ecifications and conditions. 
(6) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
Bacillus thuringiensis  subsp. kurstaki , serotype 3a3b, strain ABTS-351 , is approved as an 
active substance for use in bioc idal products of produc t-type 18, subject to the specifications 
and conditions set out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER