EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10092/2016 
(POOL/E4/2016/10092/10092-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Bacillus amyloliquefaciens  strain ISB06 as an existi ng active substance for use 
in biocidal products of product-type 3 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Bacillus amyloliquefaciens  strain ISB06 as an existing active substance for use 
in biocidal products of product-type 3 
(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 the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes Bacillus subtilis . 
(2) As a result of the evaluation of the activ e substance originally notified, it became 
apparent that it belonged in fact to the species Bacillus amyloliquefaciens strain 
ISB06. The evaluation did not allow for conc lusions to be drawn regarding any other 
substance complying with the definition of Bacillus subtilis  in the abovementioned list 
of active substances in Delegated Regul ation (EU) No 1062/2014. Therefore, only 
Bacillus amyloliquefaciens  strain ISB06 should be covered by this approval. 
(3) Bacillus amyloliquefaciens  strain ISB06 has been evaluated for use in products of 
product-type 3, veterinary hygiene as described in A nnex V to Regulation (EU) 
No 528/2012. 
(4) Germany was designated as evaluating competent authority and submitted the 
assessment report together with its  recommendations on 22 September 2014. 
(5) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agen cy was formulated on 10 December 2015 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(6) According to that opinion, biocidal pr oducts of product-type 3 and containing Bacillus 
amyloliquefaciens  strain ISB06 may be expected  to satisfy the criteria of 
Article 19(1)(b) of Regulati on (EU) No 528/2012, provided th at certain specifications 
and conditions concerning their use are complied with. 
                                                 
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 substan ces contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, 
p. 1).  
EN 3   EN (7) It is therefore appropriate to approve Bacillus amyloliquefaciens  strain ISB06 for use 
in biocidal products of product-type 3, subject to compliance with certain 
specifications and conditions. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet th e new requirements. 
(9) 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 amyloliquefaciens  strain ISB06 is approved as an ac tive substance for use in biocidal 
products of product-type 3, subject to the 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