EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10388/2020 
(POOL/E4/2020/10388/10388 -EN.docx)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving carbendazim as an existing active substance for use in biocidal products of 
product -types 7 and 10  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving carbendazim as an existing active substance for use in biocidal products of 
product -types 7 and 10  
(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 concer ning the making available on the market and use of biocidal 
products1, and  in particular the third subparagraph of Article  89(1) thereof , 
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be eva luated for their possible approval for use in biocidal 
products. That lists includes carbendazim . 
(2) Carbendazim has been evaluated for use in biocidal products of product -type 7, film 
preservatives, and product -type 10, masonry preservatives, as described in  Annex V to 
Directive 98/8/EC of the European Parliament and of the Council3, which correspond 
respectively to product -types 7 and 10 as described in Annex V to Regulation (EU) No 
528/2012.  
(3) The evaluating competent authority of Germany submitted the assess ment reports 
together with its conclusions to the Commission on 2 August 2013.  
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
opinion s of the European Chemicals Agency4 (the ‘Agency’)  were adopted on 10 
December  2019 by the Biocidal Products Committee, having regard to the conclusions 
of the evaluating competent authority.  
(5) It can be derived from Article  90(2) of Regulation (EU) No 528/2012 that substances 
for which the Member States' evaluation has been completed  by 1  September 2013 
should be evaluated in accordance with the provisions  of Directive  98/8/EC.  
                                                 
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 substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament a nd of the Council (OJ L 294, 10.10.2014, 
p. 1). 
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).  
4 Biocidal Products Committee (BPC)  opinion on the application for approval of the active substance 
Carbe ndazim, Product type: 7, ECHA/BPC/2 34/2019, adopted on 10 December  2019 ; Biocidal 
Products Committee (BPC) opinion on the application for approval of the active substance 
Carbe ndazim, Pr oduct type: 10, ECHA/BPC/235/2019, adopted on 10 December 2019.  EN 2  EN (6) According to the opinion s of the Agency, biocidal products of product -types 7 and 10  
containing c arbendazim  may be expected to satisfy the requirements of Art icle 5 of 
Directive  98/8/EC, provided that certain specifications and conditions concerning their 
use are complied with.  
(7) It is therefore appropriate to approve c arbendazim for use in biocidal products of 
product -types 7 and 10 , subject to compliance with c ertain specifications and 
conditions.  
(8) The opinions of the Agency conclude that carbendazim meets the criteria for 
classification as mutagen  category 1B  and repr oductive toxicant  category 1B  in 
accordance with Regulation (EC) No  1272/2008 of the European Pa rliament and of the 
Council5.  
(9) Since carbendazim  should be approved under the terms of Directive  98/8/EC, taking 
into account those properties , the period of approval should be considerably shorter  
than 10 years in accordance with the latest practice estab lished under that Directive.  In 
addition, s ince carbendazim has benefitted from the transitional period provided for in 
Article 89 of Regulation (EU) No 528/2012  since 14 May 2000  and has been under 
peer review since 2 August 2013 , and with the view to examine at  Union level as soon 
as possible in the context of a potential renewal of approval whether the conditions of 
Article 5(2)  of Regulation (EU) No 528/2012  can be satisfied for carbendazim , the 
period of approval should be three years.  
(10) Furthermore, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the 
competent authorities of the Member States should evaluate whether the conditions of 
Article 5(2) of that Regulation can be  satisfied  in their territories  in order  to decide 
whether  a biocidal product containing carbendazim can be authorised.   
(11) The opinions of the Agency also conclude that carbendazim meets the criteria for 
being a persistent and toxic substance in accordance with Annex XIII to Regulation 
(EC) No 1907/ 2006 of the European Parliament and of the Council6. 
(12) For the purposes of Article  23 of Regulation (EU) No  528/2012, carbendazim  meets 
the condition laid down in point s (a) and (d) of Article 10(1)  of that Regulation and 
should therefore be considered a candidate for substitution. The competent authorities  
of the Member States  should  therefore  perform a comparative assessment as part of the 
evaluation of an application for authorisation or for renewa l of authorisation of a 
biocidal product containing carbendazim . 
(13) Since , as concluded by the Agency,  carbendazim  meets the criteria for classification as 
mutagen category  1B, reproductive toxicant category 1B , and as skin sensitiser 
category 1  in accordance  with Annex  I to Regulation (EC) No  1272/2008, treated 
articles treated with or incorporating carbendazim  should be appropriately labelled 
when placed on the market.  
                                                 
5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing D irectives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, 
p. 1). 
6 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 
establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council 
Regulation (EEC) No  793/93 and Commission Regulation (EC) No 1488/94 as well as Council 
Directive 76/769/EEC a nd Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1) . EN 3  EN (14) This Regulation  does not affect  the application of Union  law in the area of health and 
safety at work, in particular Council Directive s 89/391/EEC7 and 98/24 /EC8, and  
Directive 2004/37 /EC of the European Parliament and of the Council 9. 
(15) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet the new requirements.  
(16) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article  1 
Carbendazim  is approved  as an active substance for use in biocidal products of product -types 
7 and 10 , subject to the specifications and conditions set out in the Annex.  
Article  2 
This Regulation shall enter into force on the twentieth day following tha t 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  
 Ursula VON DER LEYEN  
                                                 
7 Council Directive 89/391/EEC of 12 June 1989 on the introd uction of measures to encourage  
improvements in the safety and health of workers at work (OJ L 183, 29.06.1989, p. 1).  
8 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the risks related to chemical agents at work (fourteenth individual Directive within the meaning of 
Article 16(1) of Directive  89/391/EEC) (OJ L 131, 05.5.1998, p. 11).  
9 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection 
of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual 
Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004).