EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10783/2016 ANNEX (POOL/E4/2016/10783/10783-EN ANNEX.doc) 
[…](2016) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving chlorocresol as an existing active  substance for use in biocidal products of 
product-types 1, 2, 3, 6 and 9 
  
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 Prod
uct 
type Specific conditions 
1 The authorisations of biocidal  products are subject to the 
following condition: 
The product assessment shall pay particular attention to the 
exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the 
Union-level risk assessment of the active substance. 
2 The authorisations of biocidal  products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active 
substance. 
2) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to: 
a) industrial and professional users; 
b) children for products used in private and institutional 
areas. Chlorocresol IUPAC Name:  
4-chloro-3-methylphenol 
 EC No: 200-431-6 CAS No: 59-50-7 99.8% w/w 1 May 
2018 30 April 2028 
3 The authorisations of biocidal  products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
covered by an application for authorisation, but not 
addressed in the Union-level risk assessment of the active substance. 
2) In view of the risks identified for the uses assessed, the 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance ev aluated in accordance with Arti cle 89(1) of Regulation (EU) No 528/2012. 
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be techni cally equivalent to the evaluated active 
substance.  
EN 3   EN product assessment shall pay particular attention to: 
a) professional users; 
b) soil compartment. 
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 m easures shall be taken to 
ensure that the applicable  MRLs are not exceeded. 
6 The authorisations of biocidal  products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active 
substance. 
2) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to: 
a) professional users during the formulation of product 
to be preserved and during the application of the 
preserved product in paper production; 
b) infants crawling on a surface that has been cleaned 
with the preserved product. 
9 The authorisations of biocidal  products are subject to the 
following conditions: 
1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any use 
                                                                                                                                                                                                                                                    
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 covered by an application for authorisation, but not 
addressed in the Union-level risk assessment of the active 
substance. 
2) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to 
professional users.