EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10388/2020 ANNEX 
(POOL/E4/2020/10388/10388 -EN 
ANNEX.docx)  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving carbendazim as an existing active substance for use in biocidal products of 
product -types 7 and 10    
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  
Carbendazim  IUPAC Name:  
Methyl -benzimidazol -2-
ylcarbamate  
 
EC No: 234-234-0 
CAS No: 10605 -21-7 99,0% w/w 1 
February   
2022 31 January  
2025  7 Carbendazim is considered a candidate for substitution in 
accordance with point s (a) and (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. In addition, pursuant to point 10 of Annex VI 
to Regulation (EU) No 528/2012, the product assessment 
shall include an evaluation as t o whether the conditions of 
Article 5(2) of Regulation (EU) No 528/2012 can be 
satisfied.  
2) Products shall only be authorised for use in Member 
States where at least one of the conditions laid down  in 
Article 5(2) of Regulation (EU) No  528/2012  is met.  
3) In vi ew of the risks identified for the uses assessed, the 
product assessment s hall pay particular attention to 
surface water, sediment, soil and groundwater for products 
used in paints which are intended to be used outdoors.  
 
The placing on the market of treated articles is subject to the  
condition  that t he person responsible for the placing on the 
market of a treated article treated with or incorporating 
carbendazim  shall ensure that the label of that treated article 
provides the information listed in th e second subparagraph of 
                                                 
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 evaluated active substance .  
EN 2  EN Article 58(3) of Regulation (EU) No  528/2012.  
10 Carbendazim is considered a candidate for substitution in 
accordance with point s (a) and (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 a ssessment of the active 
substance. In addition, pursuant to point 10 of Annex VI 
to Regulation (EU) No 528/2012, the product assessment 
shall include an evaluation as to whether the conditions of 
Article 5(2) of Regulation (EU) No 528/2012 can be 
satisfied . 
2) Products shall only be authorised for use in Member 
States where at least one of the conditions laid down  in 
Article 5(2) of Regulation (EU) No  528/2012  is met.  
3) In view of the risks identified for the uses assessed, the 
product assessment s hall pay parti cular attention to 
surface water, sediment, soil and groundwater for products 
used in paints which are intended to be used outdoors.  
 
The placing on the market of treated articles is subject to the 
condition  that the person responsible for the placing on the 
market of a treated article treated with or incorporating 
carbendazim  shall ensure that the label of that treated article 
provides the information listed in the second subparagraph of 
Article 58(3) of Regulation  (EU) No  528/2012.