EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11610/2016 CIS 
(POOL/E4/2016/11610/11610-EN CIS.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
renewing the approval of difethia lone as an active substance fo r 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 difethial one as an active substance fo r 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 Pa rliament and of the 
Council of 22 May 2012 concerning the making available on the m arket and use of biocidal 
products1, and in particular Artic le 14(4)(a) thereof, 
Whereas: (1) The active substance difethialone is approved for use in biocid al products of product-
type 14 as a rodenticide unde r Regulation (EU) No 528/2012. 
(2) In accordance with Article 13(1) of Regulation (EU) No 528/2012 , an application was 
submitted to the European Chemicals Agency ('the Agency') for t he renewal of the 
approval of that active substance.  This application was evaluat ed by the competent 
authority of Norway as the eval uating competent authority.  
(3) On 21 March 2016, the evaluating competent authority submitted its recommendation 
on the renewal of the approval of  difethialone to the Agency. 
(4) On 16 June 2016, the opinion of the Agency was formulated by it s Biocidal Products 
Committee
2, having regard to the conclusions  of the evaluating competent authority.   
(5) According to that opinion, difeth ialone meets the criteria in R egulation (EC) No 
1272/2008 of the European Parliament and of the Council3 to be classified as toxic for 
reproduction category 1B. The subs tance also meets the criteria  in Regulation (EC) No 
1907/2006 of the European Parliament and of the Council4 for being very persistent, 
bioaccumulative and toxic. Difethialone therefore meets the exc lusion criteria set in 
points (c) and (e) of Article 5( 1) of Regulation (EU) No 528/20 12. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 https://echa.europa.eu/regulations/biocidal-products-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 mixtu res, 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 Rest riction of Chemicals (REACH), 
establishing a European Chemical s Agency, amending Directive 19 99/45/EC and repealing Council 
Regulation (EEC) No 793/93 and Commission Regulation (EC) No 14 88/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/6 7/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  difethialone raises concerns in relation to 
instances of primary and seconda ry poisoning, even  where restri ctive risk management 
measures are applied and therefore difethialone also satisfies the criterion to be a 
candidate for substitution in acco rdance with Article 10(1)(e) of that Regulation. 
(7) Pursuant to Article 12 of Regulation (EU) No 528/2012, the appr oval of active 
substances meeting the exclusion criteria may only be renewed w hen at least one of 
the conditions for derogation set out in Article 5(2) of that R egulation 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 in formation on difethialone, 
including information on available substitutes.  
(9) The Commission also carried out a specific public consultation in order to gather 
information as to whether the conditions for derogation set out  in Article 5(2) of 
Regulation (EU) No 528/2012 were s atisfied. The Commission made  the contributions 
to that consultation publicly available. 
(10) The contributions to the two a bove-mentioned public consultatio ns, as well as the 
information regarding the availability of alternatives to antic oagulant rodenticides 
included in Annex 1 to the Commission report on risk mitigation  measures for 
anticoagulant rodenticides5, were discussed with Member States in the Standing 
Committee on Biocidal Products. 
(11) Rodents can carry pathogen orga nisms that are responsible for m any zoonoses, which 
can pose serious dangers for hum an or animal health. Non-chemic al controls or 
prevention methods for rodent control, such as mechanical, elec trical or glue traps, 
may not be sufficiently efficient and may raise further questio ns 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 suitable  for all user categories 
or efficient for all rodent species. As proper rodent control c annot rely on those non-
chemical controls or prevention methods only, difethialone is c onsidered essential to 
ensure appropriate rodent control in support of those alternati ves. As a consequence 
the use of difethialone would be to prevent or control a seriou s danger to human and 
animal health in which rodents are involved. Therefore, the con dition set out in Article 
5(2)(b) is satisfied. 
(12) Rodent control currently relies largely on the use of anticoagu lant rodenticides, the 
non-approval of which could lead to insufficient rodent control . This may not only 
cause significant negative impacts on human or animal health or  the environment, but 
also affect the public's percepti on of its safety with regard t o exposure to r odents or the 
security of a number of economic activities that could be vulne rable to rodents, 
resulting in economic and social consequences. On the other han d, the risks to human 
health, animal health or the environment arising from use of pr oducts containing 
difethialone can be mitigated if they are used according to cer tain specifications and 
conditions. Therefore, the non-ap proval of difethialone as an a ctive substance would 
have a disproportionate negative impact on society in compariso n to the risks arising 
from the use of the substance. The condition set out in Article  5 ( 2 ) ( c )  i s  t h u s  a l s o  
satisfied.  
                                                 
5 Risk mitigation measures for anticoagulant rodenticides – Fina l Report. European Commission (2014), 
Brussels, Belgium. 100 pp. ISBN 978-92-79-44992-5.  
EN 4   EN (13) It is therefore appropriate to re new the approval of difethialo ne for use in biocidal 
products of product-type 14, subject to compliance with certain  specifications and 
conditions. 
(14) Difethialone is a candidate for substitution in accordance with  points (a) and (e) of 
Article 10(1) of Regulation (E U) No 528/2012 and therefore the period of renewal set 
out in Article 10(4) of tha t Regulation should apply. 
(15) As the examination of the applications for the renewal of the a pproval of difethialone 
and difenacoum for use in biocidal products of product-type 14 is now finalised, 
Implementing Decision (EU) 2014/3976 is repealed by Implementing Regulation (EU) 
2017/XXX [ OJ please insert reference number and publication details of the 
Implementing Regulation renewing the approval  of difenacoum as an active substance 
for use in biocidal products of product-type 14 ].  
(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 
The approval of difethialone as an active substance for use in biocidal products of product-
type 14 is renewed, subject to th e specifications and condition s set out in the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
This Regulation shall be binding i n its entirety and directly a pplicable 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 pro ducts for product-type 14 (OJ L 186, 
26.6.2014, p. 111).