COMMISSION DIRECTIVE 2009/85/EC  
of 29 July 2009  
amending Directive 98/8/EC of the European Parliament and of the Council to include coumatetralyl 
as an active substance in Annex I thereto  
(Text with EEA relevance)  
THE COMMISSION OF 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 market (  1 ), 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 Council 
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 inclusion in 
Annex I, IA or IB to Directive 98/8/EC. That list 
includes coumatetralyl.  
(2) Pursuant to Regulation (EC) No 1451/2007, coumate ­
tralyl 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) Denmark was designated as Rapporteur Member State 
and submitted the competent authority report, together 
with a recommendation, to the Commission on 
29 September 2005 in accordance with Article 14(4) 
and (6) of Regulation (EC) No 1451/2007.  
(4) The competent authority report was reviewed 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 coumate ­
tralyl 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. However, 
coumatetralyl is for the time being considered essential 
for reasons of public health and hygiene. It is therefore justified to include coumatetralyl in Annex I, in order to 
ensure that in all Member States authorisations for 
biocidal products used as rodenticides and containing 
coumatetralyl 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 applied at product authorisation level to 
products containing coumatetralyl and used as rodenti ­
cides. Such measures should be aimed at limiting the risk 
of primary and secondary exposure of humans and non- 
target animals. To this end, certain constraints 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 across the board, while other conditions 
should be imposed by the Member States on a case-by- 
case basis.  
(7) In view of the identified risks, coumatetralyl 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 treatment of biocidal products on the 
market containing the active substance coumatetralyl 
and also to facilitate the proper operation of the 
biocidal products market in general.  
(9) 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 parties 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.  
(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 coumatetralyl to ensure 
that they comply with Directive 98/8/EC.EN L 198/28 Official Journal of the European Union 30.7.2009  
( 1 ) OJ L 123, 24.4.1998, p. 1.  
( 2 ) OJ L 325, 11.12.2007, p. 3.(11) Directive 98/8/EC should therefore be amended accord ­
ingly.  
(12) The measures provided for in this Directive 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 accordance with 
the Annex to this Directive.  
Article 2  
1. Member States shall adopt and publish, by 30 June 2010 
at the latest, the laws, regulations and administrative provisions 
necessary 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 determine 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 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 29 July 2009.  
For the Commission  
Stavros DIMAS  
Member of the CommissionEN 30.7.2009 Official Journal of the European Union L 198/29ANNEX  
The following entry ‘No 28’ 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 (*)  
‘28 Coumatetralyl  Coumatetralyl 
EC No: 227-424-0 
CAS No: 5836-29-3  980 g/kg  1 July 2011  30 June 2013  30 June 2016  14  In view of the identified risks for non-target 
animals, 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 in products other than tracking 
powder shall not exceed 375 mg/kg and only 
ready-for use products shall be authorised. 
2. Products shall contain an aversive agent and, 
where appropriate, a dye. 
3. 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.’  
(*) 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.htmEN L 198/30 Official Journal of the European Union 30.7.2009