EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10089/2015 (POOL/E3/2015/10089/10089-EN.doc) 
[…](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Pythium oligandrum  strain M1 as an active s ubstance for use in biocidal 
products for product-type 10 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving Pythium oligandrum  strain M1 as an active substance for use in biocidal 
products for product-type 10 
(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 Article 90(2) thereof, 
Whereas: (1) The Czech Republic received on 12 July 2005 an application, 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 Pythium oligandrum  strain M1 in its Annex I for 
use in product-type 10, construction material preservatives, as defined in Annex V to 
that Directive.  
(2) Pythium oligandrum  strain M1 was not on the market on 14 May 2000 as an active 
substance of a biocidal product.  
(3) The Czech Republic submitted an assessment report, together with its 
recommendations, to the European Ch emicals Agency on 8 November 2011 in 
accordance with in accordance with Ar ticle 11(2) of Directive 98/8/EC. 
(4) The opinion of the European Chemicals Agency was formulated on 2 December 2014 
by the Biocidal Product Committee,  having regard to the conclusions of the evaluating 
competent authority.  
(5) According to that opinion, biocidal products used for product-type 10 and containing 
Pythium oligandrum  strain M1 may be expected to satisfy the requirements laid down 
in Article 19(1)(b) of Regulation (EU) No  528/2012, provided that certain conditions 
concerning its use are complied with.  
(6) It is therefore appropriate to approve Pythium oligandrum  strain M1 for use in biocidal 
products for product-type 10 subject to co mpliance with certain specifications and 
conditions.  
(7) 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 
Pythium oligandrum  strain M1 is approved as an active substance for use in biocidal products 
for product-type 10, subject to the specifica tions and conditions se t 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