EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11132/2015 CIS 
(POOL/E3/2015/11132/11132-EN 
CIS.doc) […](2015) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving biphenyl-2-ol as an existing active substance for us e in biocidal products for 
product-types 1, 2, 4, 6 and 13 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving biphenyl-2-ol as an existing active  substance for use in biocidal products for 
product-types 1, 2, 4, 6 and 13 
(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 in cludes biphenyl-2-ol. 
(2) Biphenyl-2-ol has been evaluated for us e in product-type 1, human hygiene, in 
product-type 2, disinfectants and algaecides not intended for direct application to 
humans or animals, product-type 4, food and feed area, product-t ype 6, preservatives 
for products during storage, and product-type 13, working or cutting fluid preservatives, as defined in A nnex V to Regulation (EU) No 528/2012. 
(3) Spain was designated as evaluating competent authority and submitted the assessment 
reports together with its recommendations on 2 June 2014. 
(4) In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agency  were formulated on 5 February 2015 and 
15 June 2015 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. 
(5) According to those opinions, biocidal products used for product-types 1, 2, 4, 6, and 
13 and containing biphenyl-2-ol may be expe cted to satisfy the requirements of 
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 biphenyl-2-ol for use in biocidal products for 
product-types 1, 2, 4, 6, and 13 subject to compliance with certain specifications and 
conditions. 
(7) For the use in product-type 4, the evaluati on did not address the incorporation of 
biocidal products containing biphenyl-2-ol in  materials and articles intended to come 
                                                
 
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 into contact directly or indi rectly with food within the meaning of Article 1(1) of 
Regulation (EC) No 1935/2004 of the Eur opean Parliament and of the Council3. Such 
materials may require the establishment of specific limits on the migration into food, 
as referred to in Article 5(1)(e) of that  Regulation. The approva l should therefore not 
cover such use unless the Commission has established such limits or it has been established pursuant to that Regulati on that such limits are not necessary. 
(8) 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. 
(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 
Biphenyl-2-ol is approved as an active subs tance for use in biocidal products for product-
types 1, 2, 4, 6 and 13, subject to the specifi cations 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  
                                                
 
3 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact  with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).