EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11607/2016 CIS 
(POOL/E4/2016/11607/11607-EN CIS.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
renewing the approval of difenacoum as an acti ve substance for use in biocidal products 
of product-type 14 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
renewing the approval of difenacoum as an acti ve substance for use in biocidal products 
of product-type 14 
(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 concerning the making avai lable on the market and use of biocidal 
products
1, and in particular Ar ticle 14(4)(a) thereof, 
Whereas: (1) The active substance difenacoum is approve d for use in biocidal products of product-
type 14 as a rodenticide unde r Regulation (EU) No 528/2012. 
(2) In accordance with Article 13(1) of Regula tion (EU) No 528/2012, an application was 
submitted to the European Chemicals Agency ('the Agency') for the renewal of the approval of that active substance. This application was evaluated by the competent 
authority of Finland as the ev aluating competent authority.  
(3) On 24 March 2016, the evaluating competen t authority submitted its recommendation 
on the renewal of the approval of difenacoum to the Agency. 
(4) On 16 June 2016, the opinion of the Agency was formulated by its Biocidal Products 
Committee
2, having regard to the conclusions of the evaluating competent authority.   
(5) According to that opinion, difenacoum m eets the criteria in Regulation (EC) No 
1272/2008 of the European Parliament and of the Council3 to be classified as toxic for 
reproduction category 1B. The substance also m eets the criteria in Regulation (EC) No 
1907/2006 of the European Parliament and of the Council4 for being very persistent, 
bioaccumulative and toxic. Difenacoum theref ore meets the exclusion criteria set in 
points (c) and (e) of Article 5( 1) of Regulation (EU) No 528/2012. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 https://echa.europa.eu/regulations/biocidal-produc ts-regulation/approval-of-active-substances/bpc-
opinions-on-active-substance-approval   
3 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 Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1). 
4 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 and 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 (6) In addition, the use of products containing  difenacoum raises concerns in relation to 
instances of primary and secondary poisoning, even where restrictive risk management 
measures are applied and therefore difenac oum also satisfies the criterion to be a 
candidate for substitution in accordance with  Article 10(1)(e) of that Regulation. 
(7) Pursuant to Article 12 of Regulation (EU) No 528/2012, the approval of active 
substances meeting the exclusion criteria may only be renewed when at least one of 
the conditions for derogation set out in Article 5(2) of that  Regulation continues to be 
satisfied. 
(8) In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency 
organised a public consultation in order to collect relevant information on difenacoum, 
including information on available substitutes.  
(9) The Commission also carried out a specific public consul tation in order to gather 
information as to whether the conditions fo r derogation set out in  Article 5(2) of 
Regulation (EU) No 528/2012 we re satisfied. The Commissi on made the contributions 
to that consultation publicly available. 
(10) The contributions to the two above-menti oned public consultations, as well as the 
information regarding the availability of al ternatives to anticoagulant rodenticides 
included in Annex 1 to the Commission report on risk mitigation measures for anticoagulant rodenticides
5, were discussed with Memb er States in the Standing 
Committee on Biocidal Products. 
(11) Rodents can carry pathogen organisms that  are responsible for many zoonoses, which 
can pose serious dangers for human or anim al health. Non-chemical controls or 
prevention methods for rodent control, such as mechanical, electri cal or glue traps, 
may not be sufficiently efficient and may rais e further questions as to whether they are 
humane or whether they cause unnecessary suffering to rodents. Alternative active 
substances approved for use as rodenticides may not be suita ble for all user categories 
or efficient for all rodent species. As pr oper rodent control ca nnot rely on those non-
chemical controls or prevention methods onl y, difenacoum is considered essential to 
ensure appropriate rodent c ontrol in support of those alte rnatives. As a consequence 
the use of difenacoum would be to prevent or control a serious danger to human and 
animal health in which rodents are involved. Therefore, the conditi on set out in Article 
5(2)(b) is satisfied. 
(12) Rodent control currently reli es largely on the use of anti coagulant rodenticides, the 
non-approval of which could lead to insuffi cient rodent control. This may not only 
cause significant negative imp acts on human or animal health or the environment, but 
also affect the public's percepti on of its safety with regard to exposure to rodents or the 
security of a number of ec onomic activities that could be vulnerable to rodents, 
resulting in economic and social consequen ces. On the other hand, the risks to human 
health, animal health or the environmen t arising from use of products containing 
difenacoum can be mitigated if they are us ed according to certain  specifications and 
conditions. Therefore, the non-approval of di fenacoum as an active substance would 
have a disproportionate negative impact on so ciety in comparison to the risks arising 
from the use of the substance. The condition set out in Article 5( 2)(c) is thus also 
satisfied.  
                                                 
5 Risk mitigation measures for anticoagulant rodenticides – Final Report. European Commission (2014), 
Brussels, Belgium. 100 pp. ISBN 978-92-79-44992-5.  
EN 4   EN (13) It is therefore appropriate to renew the a pproval of difenacoum for use in biocidal 
products of product-type 14, subject to comp liance with certain specifications and 
conditions. 
(14) Difenacoum is a candidate for substitution in  accordance with points (a) and (e) of 
Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set 
out in Article 10(4) of th at Regulation should apply. 
(15) By Commission Implementing Decision (EU) 2014/3976, the initial expiry date of 
approval of difethialone and difenacoum fo r use in biocidal products of product-type 
14 was postponed to 30 June 2018. As the examination of the applications for the renewal of those approvals is now finalise d, it is appropriate to repeal Implementing 
Decision (EU) 2014/397.  
(16) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
The approval of difenacoum as an active subs tance for use in biocidal products of product-
type 14 is renewed, subject to  the specifications and condi tions set out in the Annex. 
Article 2 
Implementing Decision (EU) 2014/397 is repealed . 
Article 3 
This Regulation shall enter into force on the twentieth day following that 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 
 Jean-Claude JUNCKER  
                                                 
6 Commission Implementing Decision (EU) 2014/397 of 25 June 2014 postponing the expiry date of 
approval of difethialone and difenacoum for use in biocidal products for product-type 14 (OJ L 186, 
26.6.2014, p. 111).