DIRECTIVES
COMMISSION DIRECTIVE 2008/81/EC
of 29 July 2008
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 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 placingof 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-yearwork programme referred to in Article 16(2) of Directive98/8/EC of the European Parliament and of the Councilconcerning the placing of biocidal products on themarket (
2) establishes a list of active substances to be
assessed, with a view to their possible inclusion inAnnex I, IA or IB to Directive 98/8/EC. That listincludes difenacoum.
(2) Pursuant to Regulation (EC) No 1451/2007, difenacoumhas been evaluated in accordance with Article 11(2) ofDirective 98/8/EC for use in product-type 14, ro­denticides, as defined in Annex V to Directive 98/8/EC.
(3) Finland was designated as Rapporteur Member State andsubmitted the competent authority report, together witha recommendation, to the Commission on 21 March2006 in accordance with Article 14(4) and (6) of Regu­lation (EC) No 1451/2007.
(4) The competent authority report was reviewed by theMember States and the Commission. In accordancewith Article 15(4) of Regulation (EC) No 1451/2007,the findings of the review were incorporated, withinthe Standing Committee on Biocidal Products on29 November 2007, in an assessment report.(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 biocidalproducts used as rodenticides and containing difenacoummay be expected not to present a risk to humans exceptfor accidental incidents with children. Regarding non-target animals and the environment a risk has been iden­tified. However, the target rodents are vermin and thusconstitute a danger to public health. Moreover, it has notyet been established that adequate alternatives todifenacoum exist, which are both equally effective andless damaging to the environment. It is therefore
justified to include difenacoum in Annex I for a limited
period, in order to ensure that in all Member Statesauthorisations for biocidal products used as rodenticidesand containing difenacoum can be granted, modified, orcancelled in accordance with Article 16(3) of Directive98/8/EC.
(7) In the light of the findings of the assessment report, it isappropriate to require that specific risk mitigationmeasures are applied at product authorisation level toproducts containing difenacoum and used as ro­denticides. Such measures should be aimed at limitingthe 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.
(8) Because of the identified risks and its characteristics,which render it potentially persistent, liable to bioaccu­mulate and toxic, or very persistent and very liable tobioaccumulate difenacoum should be included in AnnexI for five years only and should be made subject to acomparative risk assessment in accordance with thesecond subparagraph of Article 10(5)(i) of Directive98/8/EC before its inclusion in Annex I is renewed.
(9) It is important that the provisions of this Directive beapplied simultaneously in all the Member States in orderto ensure equal treatment of biocidal products on themarket containing the active substance difenacoum andalso to facilitate the proper operation of the biocidalproducts market in general.EN L 201/46 Official Journal of the European Union 30.7.2008
(1) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Directive
2008/31/EC (OJ L 81, 20.3.2008, p. 57).
(2) OJ L 325, 11.12.2007, p. 3.(10) A reasonable period should be allowed to elapse before
an active substance is included in Annex I in order topermit Member States and the interested parties toprepare themselves to meet the new requirementsentailed and to ensure that applicants who haveprepared dossiers can benefit fully from the 10-yearperiod of data protection, which, in accordance withArticle 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) ofDirective 98/8/EC, and in particular, to grant, modifyor cancel authorisations of biocidal products inproduct-type 14 containing difenacoum to ensure thatthey comply with Directive 98/8/EC.
(12) Directive 98/8/EC should therefore be amendedaccordingly.
(13) 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
Transposition
1. Member States shall adopt and publish, by 31 March
2009 at the latest, the laws, regulations and administrativeprovisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of thoseprovisions and a correlation table between those provisions andthis Directive.
They shall apply those provisions from 1 April 2010.When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such areference on the occasion of their official publication. MemberStates 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 inthe 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 2008.
For the Commission
Stavros DIMAS
Member of the CommissionEN 30.7.2008 Official Journal of the European Union L 201/47ANNEX
The following entry ‘No 9 ’is inserted in Annex I to Directive 98/8/EC:
No Common nameIUPAC name
Identification numbersMinimum purity of
the active substance
in the biocidal
product as placed
on the marketDate of inclusionDeadline 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
inclusionProduct 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: 56073-07-5960 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 bioaccumulate and toxic, or verypersistent and very liable to bioaccumulate, theactive substance is to be subject to a
comparative risk assessment in accordance
with the second subparagraph ofArticle 10(5)(i) of Directive 98/8/EC before itsinclusion 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 exceed75 mg/kg and only ready-for-use productsshall 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 envi­
ronment are minimised, by consideringand applying all appropriate and availablerisk mitigation measures. These include,
amongst others, the restriction to profes­
sional use only, setting an upper limit tothe 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 available on the Commission web site: http://ec.europa.eu/comm/environment/biocides/index.htmEN L 201/48 Official Journal of the European Union 30.7.2008