EN    EN  COMMISSION OF THE EUROPEAN COMMUNITIES  
Brussels,  
COM(2007) XXX  
  
Draft  
COMMISSION DIRECTIVE .../…/EC  
of […]  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
difenacoum as an active  substance in Annex I thereto  
EN  
EN 2   EN Draft  
COMMISSION DIRECTIVE .../…/EC  
of […]  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
difenacoum  as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMISSION O F THE EUROPEAN COMMUNITIES,  
Having regard to the Treaty establishing the European Community,  
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 
16 February  1998 concerning the placing of biocidal products on the market1, and in 
particular the second subparagraph of Article 16(2) thereof , 
Whereas:  
(1) Commission Regulation  (EC) No 2032/2003  of 4 November 2003 on the second phase 
of the 10 -year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parlia ment and of the Council concerning the placing of biocidal 
products on the market and amending Regulation (EC) No 1896/20002 establishes a 
list of active substances to be assessed, with a view to their possible inclusion in 
Annex I, IA or IB to Directive 9 8/8/EC. That list includes difenacoum . 
(2) Pursuant to Regulation (EC) No 2032/2003, difenacoum  has been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product -type14, 
rodenticides , as defined in Annex V to Directive 98/8/EC.  
(3) Finlan d was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recommendation, to the Commission on 21 March 
2006  in accordance with Article 10(5) and (7) of Regulation  (EC) No 2032/2003 . 
(4) The competent authority r eport was reviewed by the Member States and the 
Commission. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the 
findings of the review were incorporated , within  the Standing Committee on Biocidal 
Products on 29 November 2007 , in an assess ment report . 
                                                
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive 2007/20/EC (OJ L 94, 04.04.2007, p. 
23). 
2 OJ L 307, 24.11.2003, p. 1. Regulation as last amended by Regulation (EC) No 1849/2006 (OJ L 355, 
15.12.2006, p. 63).   
EN 3   EN (5) The review of difenacoum  did not reveal any open questions or concerns to be 
addressed by the Scientific Committee on Health and Environmental Risks.  
(6) It appears from the examinations made that biocidal products used as rodenticides and 
contain ing difenacoum  may be expected not to present a risk to humans except for 
accidental incidents with children. Regarding non -target animals and the environment 
a risk has been identified.  However, the target rodents are vermin and thus constitute a 
danger t o public health. Moreover, it has not yet been established that adequate 
alternatives to difenacoum exist, which are both equally effective and less damaging to 
the environment . It is therefore justified to include difenacoum  in Annex I  for a 
limited perio d, in order to ensure that in all Member States authorisations for biocidal 
products used as  rodenticides and containing difenacoum  can be granted, modified, or 
cancelled in accordance with Article 16(3) of Directive 98/8/EC .  
(7) In the light of the findings of the assessment report, it is appropriate to require that 
specific risk mitigation measures are applied at product authorisation level to products 
containing difenacoum  and used as rodenticides. Such measures sh ould be aimed at  
limiting the risk of prima ry and secondary exposure of humans and non -target animals 
as well as the long term effects of the substance on the environment . 
(8) Because of the identified risks and its characteristics, which render it potentially 
persistent, liable to bioaccumulate and to xic, or very persistent and very liable to 
bioaccumulate  difenacoum  should be included in Annex I for five years only and 
should be made  subject to a comparative risk assessment in accordance with the 
second subparagraph  of Article 10(5)(i)  of Directive 98 /8/EC  before its inclusion  in 
Annex I is renewed . 
(9) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal treatment of biocidal products on the market 
containing the active substance  difenacoum  and also to facilitate the proper operation 
of the biocidal products market in general.  
(10) A reasonable period should be allowed to elapse before an active substance is included 
in Annex I in order to permit Member States and the interested partie s to prepare 
themselves to meet the new requirements entailed and to ensure that applicants who 
have prepared dossiers can benefit fully from the 10 -year period of data protection, 
which, in accordance with Article 12 (1)(c)(ii) of Directive 98/8/EC, starts  from the 
date of inclusion.  
(11) After inclusion, Member States should be allowed a reasonable period to implement 
Article 16(3) of Directive 98/8/EC, and in particular, to grant, modify or cancel 
authorisations of biocidal products in product -type 14 containi ng difenacoum  to ensure 
that they comply with Directive 98/8/EC.  
(12) Directive 98/8/EC should therefore be amended accordingly.  
(13) The measures provided for in this Directive are in accordance with the opinion of the 
Standing Committee on Biocidal Products,   
EN 4   EN HAS A DOPTED THIS DIRECTIVE:  
Article 1  
Annex  I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.  
Article 2  
Transposition  
1. Member States shall adopt and publish, by 31 March  2009  at the latest, the laws, 
regulations and administrat ive provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Commission the text of those provisions 
and a correlation table between those provisions and this Directive.  
They shall apply those provisions fr om 1 April  2010 . 
When Member States adopt those provisions, they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official 
publication. Member States shall determine how such reference is to be made.  
2. Member Sta tes shall communicate to the Commission the text of the main 
provisions of national law which they adopt in the field covered by this Directive.  
Article 3  
This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, […]  
 For the Commission  
 Stavros Dimas  
 Member of the Commission   
EN 5   EN ANNEX  
The following entry ‘No. 9’ is inserted in Annex I to Directive 98/ 8/EC : 
  
No Common Name  
 IUPAC Name  
Identification Numbers  Minimum 
purity of the 
active substance 
in the biocidal 
product as 
placed on the 
market  Date of 
inclusion  Deadline for compliance with Article 16(3)  
(except for products containing more than one 
active substance, for which the deadline to 
comply with Article 16(3) shall be the one set 
out in the last of the inclusion decisions relating 
to its active substances)  Expiry date 
of inclusion  Product 
type Specific provisions (*)  
"9 Difenacoum  3-(3-biphenyl -4-yl-1,2,3,4 -
tetrahydro -1-naphthyl) -4-
hydroxycoumarin  
EC No: 259 -978-4 
CAS No: 56073 -07-5 960 g/kg   1 April  2010  31 March  2012  31 March  
2015  14 In view of the  fact that the active substance 
characteristics render it potentially persistent, liable 
to bioacc umulate and toxic, or very persistent and 
very liable to bioaccumulate , the active substance is 
to be subject to a comparative risk assessment in 
accordance with the second subparagraph of Article 
10(5)(i) of Directive 98/8/EC before its inclusion in 
this Annex is renewed.  
Member States shall ensure that authorisations are 
subject to the following conditions:  
(1) The nominal concentration of the active 
substance in the products shall not exceed 75 
mg/kg  and only ready -for-use products  shall be 
authorised.  
(2) Produ cts shall contain an aversive agent and, 
where appropriate, a dye.  
(3) Products shall not be used as tracking powder.  
(4) Primary as well as secondary exposure of 
humans, non -target animals and the environment 
are minimised, by considering and applying all 
appropr iate and available risk mitigation 
measures. These include, amongst others, the 
restriction to professional use only, setting an 
upper limit to the package size and laying down 
obligations to use tamper resistant and secured 
bait boxes ." 
(*) For the imple mentation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides /index.htm