EN    EN  
 
 
 
EN EN 1   EN  
 
 
Draft 
COMMISSION DIRECTIVE .../…/EC 
of […] 
amending Directive 98/8/EC of the European Parliament and of the Council to include 
bromadiolone 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 bromadiolone. 
(2) Pursuant to Regulation (EC) No 1451/2007, bromadiolone 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) Sweden was designated as Rapporteur Member State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 30 June 2006 
in accordance with Article 14(4) a nd (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 
                                                 
1 OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2007/70/EC (OJ L 312, 
30.11.2007, p. 26). 
2 OJ L 325, 11.12.2007, p. 3. EN 2   EN findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on 30 May 2008, in an assessment report. 
(5) It appears from the examinations made that biocidal products used as rodenticides and 
containing bromadiolone may be expected not  to present a risk to humans except for 
accidental incidents with children. Regardi ng non-target animals and the environment 
a risk has been identified. However, the targ et rodents are vermin and thus constitute a 
danger to public health. Mo reover, it has not yet been established that adequate 
alternatives to bromadiolone exist, which are both equally effective and less damaging 
to the environment. It is therefore justifie d to include bromadiolone in Annex I for a 
limited period, in order to ensure  that in all Member States authorisations for biocidal 
products used as rodenticides  and containing bromadiolone  can be granted, modified, 
or cancelled in accordance with Arti cle 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 bromadiolone and used as roden ticides. Such measures 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 substance on the environment. 
(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 bromadiolone should be included 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 bromadiol one and also to facilitate the proper 
operation of the biocidal pr oducts 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 bromadiolone to 
ensure that they comply with Directive 98/8/EC. 
(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, EN 3   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 30 September 2009 at the latest, the laws, 
regulations and administrative provisions necessary to comply with this Directive. 
They shall forthwith communicate to the Commission the text of those provisions and a correlation table between thos e provisions and this Directive. 
They shall apply those pr ovisions from 1 October 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 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 4   EN ANNEX  
The following entry ‘No. 17’ 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* 
 
 
"17 bromadiolone 3-[3-(4'-Bromo[1,1'-
biphenyl]-4-yl)-3-
hydroxy-1-
phenylpropyl]-4-hydroxy-2H-1-
benzopyran-2-one 
EC No: 249-205-9 CAS No: 28772-56-
7 
 969 g/kg 1 October 
2010 30 September 2012 30 
September 
2015 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 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 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 appropriate 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.'' 
  
EN 5   EN * For the implementation of the common principles of Annex VI, the content and conclusions of asse ssment reports are available on  the Commission website: http://ec.europa.eu/comm/envir onment/biocides/index.htm