EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11132/2015 ANNEX CIS 
(POOL/E3/2015/11132/11132-EN 
ANNEX CIS.doc) […](2015) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving biphenyl-2-ol as an existing active substance for us e in biocidal products for 
product-types 1, 2, 4, 6 and 13 
  
EN 2   EN ANNEX  
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 Date of 
approval Expiry 
date of 
approval Product 
type Specific conditions 
1 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
2 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following condition: 
For professional users, safe operational procedures and 
appropriate organisational measures shall be established. 
Products shall be used with ap propriate personal protective 
equipment where exposure cannot be reduced to an acceptable level by other means. Biphenyl-2-ol IUPAC Name:  
ortho-phenylphenol EC No: 201-993-5 CAS No: 90-43-7 995 g/kg 1st July 
2017 30 June 
2027 
4 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following conditions: 
(1) For industrial or professional users, safe operational 
procedures and appropriate organisational measures 
shall be established. Products shall be used with 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance us ed for the evaluation made in a ccordance with Article 16(2) of 
Directive 98/8/EC. The active subs tance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the 
evaluated active substance.  
EN 3   EN appropriate personal pr otective equipment where 
exposure cannot be reduced to an acceptable level by 
other means. 
(2) In view of the risks iden tified for the surface water, 
sediment and soil compartments, biocidal products shall 
not be authorised for large scale disinfection, unless it 
can be demonstrated that risks can be reduced to an acceptable level. 
(3) For products that may lead to residues in food or feed, 
the need to set new or to amend existing maximum 
residue levels (MRLs) in  accordance with  Regulation 
(EC) No 470/2009 of the European Parliament and of 
the Council
2 or Regulation (EC) No 396/2005 of the 
European Parliament and of the Council3 shall be 
verified, and any appropriate risk mitigation measures 
shall be taken to ensure th at the applicable MRLs are 
not exceeded. 
(4) Products shall not be incorp orated in materials and 
articles intended to come into contact with food within 
the meaning of Article 1(1) of Regulation (EC) No 
1935/2004, unless the Commission has established 
specific limits on the migration of biphenyl-2-ol into 
food or it has been established pursuant to that Regulation that such limits are not necessary. 
6 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
                                                                                                                                                                                                                                                    
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.200 9, p. 11). 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).  
EN 4   EN following conditions: 
(1) For industrial or professional users, safe operational 
procedures and appropriate organisational measures 
shall be established. Products shall be used with appropriate personal pr otective equipment where 
exposure cannot be reduced to an acceptable level by 
other means. 
(2) In view of the risks identified for the aquatic 
compartment, biocidal products shall not be authorised 
for the preservation of washing and cleaning fluids and 
other detergents for professional use, unless it can be demonstrated that risks can be reduced to an acceptable 
level. 
13 The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any uses covered 
by an application for authorisation, but not addressed in the 
Union level risk assessment of the active substance. 
 The authorisations of biocidal  products are subject to the 
following condition: 
For industrial or professional users, safe operational 
procedures and appropriate organisational measures shall be 
established. Products shall be used with appropriate personal protective equipment where exposu re cannot be reduced to an 
acceptable level by other means.