EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP41-Doc.xx 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving Bacillus thuringiensis subsp.  israelensis serotype H14 , strain SA3A as an 
active substance for use in biocidal products for product-type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving Bacillus thuringiensis subsp.  israelensis serotype H14 , strain SA3A as an 
active substance for use in bioc idal products for 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 av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Regul ation (EU) No XX/2014
2 establishes a list of active 
substances to be evaluated with a view to  their possible approval for use in biocidal 
products or inclusion into A nnex I to Regulation (EU) No  528/2012. That list includes 
Bacillus thuringiensis subsp.  israelensis serotype H14. 
(2) Bacillus thuringiensis subsp.  israelensis serotype H14  has been evaluated in 
accordance with Article 90(2) of Regulati on (EU) No 528/2012 for use in biocidal 
products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Anne x V to Regulation (EU) No 528/2012. 
(3) The data submitted for the purpose of the evaluation allowed conclusions to be drawn 
only regarding a certain form of Bacillus thuringiensis subsp.  israelensis serotype 
H14, i.e. Bacillus thuringiensis subsp.  israelensis serotype H14, st rain SA3A. The 
evaluation did not allow conclusions to be drawn regarding any other substance 
complying with the definition of Bacillus thuringiensis subsp.  israelensis serotype 
H14 in the abovementioned list of active s ubstances in Regulati on (EU) No XX/2014. 
Therefore, only Bacillus thuringiensis subsp.  israelensis serotype H14, strain SA3A 
should be covered by this approval. 
(4) Italy was designated as evaluating compet ent authority and submitted an assessment 
report, together with its recommendati ons, to the Commission on 12 June 2009 in 
accordance with paragraphs 4 and 6 of Artic le 14 of Commission Regulation (EC) No 
1451/2007
3. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No XX/2014 of XXXX 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 and of the Council (OJ L XX, XXX, p. X). 
3 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).  
EN 3   EN (5) The opinion of the European Chemicals Agency was formulated on 19 June 2014 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
(6) According to that opinion, biocidal products used for product-type 18 and containing 
Bacillus thuringiensis subsp.  israelensis serotype H14 , strain SA3A may be expected 
to satisfy the requirements laid down in  Article 5 of Directive 98/8/EC of the 
European Parliament and of the Council4 provided that certain specifications and 
conditions relating to its  use are satisfied.  
(7) It is therefore appropriate to approve Bacillus thuringiensis subsp.  israelensis serotype 
H14, strain SA3A for use in biocidal pr oducts for product-type 18 subject to 
compliance with certain speci fications and conditions.  
(8) Since the evaluations did not address nanom aterials, the approva l should not cover 
such materials in accordance with Arti cle 4(4) of Regula tion (EU) No 528/2012. 
(9) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet th e new requirements.  
(10) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Bacillus thuringiensis subsp.  israelensis serotype H14 , strain SA3A shall be approved as an 
active substance for use in biocidal products fo r product-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 
  
                                                 
4 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) .