EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
SANTE/12069/2017 ANNEX CIS 
(POOL/E4/201712069/12069 -EN 
ANNEX CIS.doc)  
[…](2018) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
approving cyphenothrin as an existing active substance for use in biocidal products of 
product -type 18  
   
EN 1  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  
Cyphenothrin  IUPAC Name:  
(RS) -α-cyano -3-
phenoxybenzyl 
(1RS,3RS;1RS,3SR) -2,2-
dimethyl -3-(2-methylprop -1-
enyl)cyclopropanecarboxylate  
 
EC No: 254-484-5 
CAS No: 39515 -40-7 92% w/w (total 
isomers)  1 January  
2020 31 
December 
2029  18 Cyphenothrin  is considered a candidate for substitution in 
accordance with point (d) of Article  10(1) of Regulation (EU) 
No 528/2012.  
 
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 uses 
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 as sessed, the 
product assessment shall pay particular attention to:  
a) professional users;  
b) toddlers ; 
c) surface water, sediment, soil and groundwater, 
following indoor surface treatment ; 
d) earthworm -eating mammals and fish -eating mammals 
due to secondary poisoning, following indoor surface 
treatment . 
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 
Council2 or Regulation (EC) No 396/2005 of the 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the e valuated active substance . 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regula tion (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, 16.6.2009, p. 11).   
EN 2  EN European Parliament and of the Council3 shall be verified, 
and any appropriate risk mitigation measures shall be 
taken to ensure that the applicable MRLs are not 
exceeded . 
 
                                                 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides 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 ).