EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10095/2016 
(POOL/E4/2016/10095/10095-EN.doc) 
[…](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving biphenyl-2-ol as an existing 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 biphenyl-2-ol 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 in cludes biphenyl-2-ol. 
(2) Biphenyl-2-ol has been evalua ted for use in products of product-type 3, veterinary 
hygiene, as described in Annex V to Regulation (EU) No 528/2012. 
(3) Spain was designated as evaluating competent authority and submitted the assessment 
report together with its r ecommendations on 2 June 2014. 
(4) 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 8 December 2015 by 
the Biocidal Products Committee, having rega rd to the conclusions of the evaluating 
competent authority. 
(5) According to that opinion, biocidal produc ts of product-type 3 and containing 
biphenyl-2-ol may be expected to satisfy the criteria of Article 19(1)(b) of Regulation 
(EU) No 528/2012, provided that certain spec ifications and conditions concerning 
their use are complied with. 
(6) It is therefore appropriate to approve biphenyl-2-ol for use in biocidal products of 
product-type 3, subject to compliance with certain sp ecifications and conditions. 
(7) 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. 
(8) 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 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 HAS ADOPTED THIS REGULATION: 
Article 1 
Biphenyl-2-ol is approved as an active substa nce for use in biocidal products of product-
type 3, 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