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 
brodifacoum 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 
brodifacoum 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 Counc il concerning the pl acing of biocidal 
products on the market 
2 establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directiv e 98/8/EC. That list 
includes brodifacoum. 
(2) Pursuant to Regulation (EC) No 1451/2007, brodifacoum has been evaluated in 
accordance with Article 11(2)  of Directive 98/8/EC for use in product-type 14, 
rodenticides, as defined in Annex V to Directive 98/8/EC. 
(3) Italy was designated as Rapporteur Memb er State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 5 June 2005 
in accordance with Article 14(4) a nd (6) of Regulation (EC) No 1451/2007. 
                                                 
1 OJ L 123, 24.4.1998, p. 1.  
2 OJ L 325, 11.12.2007, p. 3.  
EN 3   EN (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 20 February 2009, in an assessment report. 
(5) It appears from the examinations made that biocidal products used as rodenticides and 
containing brodifacoum may be  expected not to present a risk to humans except for 
accidental incidents with children. A risk has been identified regarding non-target 
animals and the environment. However, th e target rodents are vermin and thus 
constitute a danger to public health. Moreover, it has not yet been established that adequate alternatives to brodi facoum exist, which are both equally effective and less 
damaging to the environment. It is therefor e justified to include brodifacoum in Annex 
I for a limited period, in order to ensure th at in all Member States authorisations for 
biocidal products used as rodenticides and containing br odifacoum 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 assessmen t report, it is appropriate to require that 
specific risk mitigation measures are applie d at product authorisation level to products 
containing brodifacoum and used  as rodenticides. Such m easures should be aimed at 
limiting the risk of primary and secondary exposure of humans and non-target animals 
as well as the long term effects of the s ubstance on the environment. To this end, 
certain constraints such as the maximum concentration, the prohibition on marketing 
the active substance in products  used as tracking powder or  in products which are not 
ready for use, and the use of aversive agents should be impos ed across the board, 
while other conditions should be imposed by the Member States on a case by case 
basis.  
(7) Because of the identified risks and its char acteristics, which render it potentially 
persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, brodifacoum should be include d in Annex I for five years only and 
should be made subject to a comparative risk assessme nt in accord ance 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 brodifacoum an d also 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 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 Artic le 12(1)(c)(ii) of Directive 98/8/EC, starts from the 
date of inclusion. 
(10) 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 containing brodifacoum to 
ensure that they comply with Directive 98/8/EC.  
EN 4   EN (11) Directive 98/8/EC should therefore be amended accordingly. 
(12) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
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 30 June 2010 at th e latest, the laws, 
regulations and administrative provisions nece ssary to comply with this Directive. 
They shall apply those provisions from 1 July 2011. 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 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 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 ‘No. 25’ is insert ed 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 dead line 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* 
"25 brodifacoum 3-[3-(4'-
bromobiphenyl-4-
yl)-1,2,3,4-
tetrahydro-1-napthyl]-4-
hydroxycoumarin 
EC No: 259-980-5 
CAS No: 56073-10-
0 950 g/kg  1 July 2011 30 June 2013 30 June 
2016 14 In view of the fact that th e active substance characteristics 
render it potentially persistent, liable to bioaccumulate and 
toxic, or very persistent and very liable to bioaccumulate, the 
active substance is to be subject to a comparative risk assessment in accordance w ith 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 50 mg/kg and only ready-for-use 
products shall be authorised. 
(2) Products 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 a ppropriate 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 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/envi ronment/biocides/index.htm