EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels,  
C(2009) XXX final  
  
Draft 
COMMISSION DIRECTIVE ../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
warfarin sodium as an active  substance in Annex I thereto  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EC 
of  
amending Directive 98/8/EC of the European Parliament and of the Council to include 
warfarin sodium as an active  substance in Annex I thereto 
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 1451/2007 of 4 December 2007 on the second phase 
of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the C ouncil concerning the placing of biocidal 
products on the market
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusio n in Annex I, IA or  IB to Directive 98/8/EC. That list 
includes warfarin sodium. 
(2) Pursuant to Regulation (EC)  No 1451/2007, warfarin sodium has been evaluated in 
accordance with Article 11(2) of Directiv e 98/8/EC for use in product-type 14, 
rodenticides, as defined in Annex V to Directive 98/8/EC. 
(3) Ireland was designated as Rapporteur Member State and submitted its report, together 
with a recommendation, to the Commission on 3 October 2005 in accordance with Article 14(4) and 14(6) of  Regulation (EC) No 1451/2007. 
(4) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 18 September 2009, in an assessment report. 
(5) It appears from the examinations made that biocidal products used as rodenticides and 
containing warfarin sodium ma y be expected not to present a risk to humans except for 
accidental incidents with children. A risk has been identified regarding non-target 
                                                
 
1 OJ L 123, 24.4.1998, p. 1. 
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN animals. However, warfarin sodium is for the time being considered essential for 
reasons of public health and hygiene. It is therefore appr opriate to include warfarin 
sodium in Annex I, in order to ensure that  in all Member States authorisations for 
biocidal products used as rodenticides and containing warfarin sodium can be granted, 
modified, or cancelled in accordance with Article 16(3) of Directive 98/8/EC.  
(6) In the light of the findings of  the assessment report, it is appropriate to require that 
specific risk mitigation measures are applie d at product authorisation level to products 
containing warfarin sodium and used as r odenticides. Such measures should be aimed 
at limiting the risk of primary and s econdary exposure of humans and non-target 
animals. To this end, certain constraint s such as the maximum concentration, the 
prohibition on marketing the active substance in products which are not ready to use 
and the use of aversive agents should be imposed for all rodenticides containing 
warfarin sodium, while other conditions s hould be imposed by the Member States on a 
case by case basis. 
(7) In view of the identified risks, warfarin s odium 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.  
(8) It is important that the provisions of this Directive be applied simultaneously in all the 
Member States in order to ensure equal tr eatment of biocidal products on the market 
containing the active substance warfarin sodi um and to facilitate  the proper operation 
of the biocidal products market in general. 
(9) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member States  to bring into force the laws, regulations 
and administrative provisions necessary to comply with this Directive. 
(10) A reasonable period should be allowed to elap se before an active substance is included 
in Annex I in order to permit Member Stat es and the interested parties to prepare 
themselves to meet the new requirements enta iled and to ensure that applicants who 
have prepared dossiers can benefit fully fr om 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 gran t, modify or cancel 
authorisations of bioc idal products in produ ct-type 14 containing warfarin sodium 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 Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
EN 4   EN HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex I to Directive 98/8/EC is amended in a ccordance with the Annex to this Directive. 
Article 2 
1. Member States shall adopt and publish, by  31 January 2011 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those provi sions from 1 February 2012. 
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 determin e how such reference is to be made. 
2. Member States shall communicate to the Co mmission 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 tw entieth 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 for the substance warfarin sodi um is added 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 d eadline 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 (*) 
"(**) [OPOCE: 
please insert substance 
number] Warfarin sodium Sodium 2-oxo-3-(3-oxo-1-
phenylbutyl)chromen-4-olate 
EC No: 204-929-4 
CAS No: 129-06-6 910 g/kg 1 February 
2012 31 January 2014 31 January 
2017 14 The active substance shall 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 shall not exceed 
790 mg/kg and only ready-for-use 
baits shall be authorised. 
(2) Products shall contain an 
aversive agent and, where 
appropriate, a dye. 
(3) Primary and secondary 
exposure of humans, non-target 
animals and the environment are minimised, by considering and 
applying all appropriate and 
available risk mitigation measures. These include, amongst others, the 
possibility of restriction to 
professional use only, setting an upper limit to the package size and 
laying down obligations to use 
tamper resistant and secured bait  
EN 6   EN 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 d eadline 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 (*) 
boxes." 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm