HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 48/14
EN
Official Journal of the European Union
21.2.2013
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 19 February 2013
approving restrictions of authorisations of biocidal products containing difenacoum notified by
Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
(notified under document C(2013) 772)
(Only the German text is authentic)
(2013/95/EU)
THE EUROPEAN COMMISSION,
(4) The
company
Zapi
S.p.A.
(‘the
applicant’)
has,
in
accordance with Article 8 of Directive 98/8/EC,
submitted an application to the United Kingdom for
Having regard to the Treaty on the Functioning of the European
authorisation of four rodenticides containing difenacoum
Union,
(‘the products’).
Having regard to Directive 98/8/EC of the European Parliament
and of the Council of 16 February 1998 concerning the placing
(5) The
United
Kingdom
granted
the
authorisations
on
of biocidal products on the market ( 1 ), and in particular
19 September 2011. The products were authorised
Article 4(4) thereof,
with restrictions to ensure the conditions of Article 5
of Directive 98/8/EC were met in the United Kingdom.
Those restrictions did not include restriction to trained or
Whereas:
licensed professional users.
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active
substances approved at Union level for inclusion in
(6) On
30
June
2010,
the
applicant
submitted
a
complete
biocidal products. Commission Directive 2008/81/EC of
application to Germany for mutual recognition of the
29 July 2008 amending Directive 98/8/EC of the
first authorisations in respect of the products.
European Parliament and of the Council to include
difenacoum as an active substance in Annex I thereto ( 2 )
added the active substance difenacoum to belonging to
(7) On
8
June
2012,
Germany
notified
the
Commission,
the
product type 14, Rodenticides, as defined in Annex V to
other Member States and the applicant of its proposal to
Directive 98/8/EC.
restrict the first authorisations in accordance with
Article 4(4) of Directive 98/8/EC. Germany proposed to
impose a restriction on the products to use by trained or
(2) Difenacoum
is
an
anticoagulant
rodenticide
known
to
licensed professionals.
pose risks of accidental incidents with children, as well
as risks for animals and the environment. It has been
identified as potentially persistent, liable to bioac
cumulate and toxic (‘PBT’), or very persistent and very
(8) The
Commission
invited
the
other
Member
States
and
liable to bioaccumulate (‘vPvB’).
the applicant to submit comments to the notification

in writing within 90 days in accordance with
Article 27(1) of Directive 98/8/EC. No comments were
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
submitted within that deadline. The notification was also
theless found to be justified to include difenacoum and
discussed between the Commission and Member States’
other anticoagulant rodenticides in Annex I to Directive
Competent Authorities for biocidal products in the
98/8/EC, thus allowing Member States to authorise difen
meeting of the Product Authorisation and Mutual Recog
acoum-based products. However, Directive 2008/81/EC
nition Facilitation Group of 3-4 July 2012.
obliges Member States to ensure, when granting auth
orisation of products containing difenacoum, that
primary as well as secondary exposure of humans,
(9) In
accordance
with
Directive
2008/81/EC,
authorisations
non-target animals and the environment is minimised,
of biocidal products containing difenacoum are to be
by considering and applying all appropriate and
subject to all appropriate and available risk mitigation
available risk mitigation measures. The risk mitigation
measures, including the restriction to professional use
measures mentioned in Directive 2008/81/EC therefore
only. The scientific evaluation leading to the adoption
include, amongst others, restriction to professional use
of Directive 2008/81/EC concluded that only profes
only.
sional users could be expected to follow the instructions
minimising the risk of secondary poisoning of non-target
( 1 ) OJ L 123, 24.4.1998, p. 1.
animals, and to use products in a way that prevents the
( 2 ) OJ L 201, 30.7.2008, p. 46.
development and spreading of resistance. A restriction to

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EN
21.2.2013 Official
Journal
of
the
European
Union L
48/15
professional users should therefore in principle be
HAS ADOPTED THIS DECISION:
considered to be an appropriate risk mitigation
measure, in particular in Member States where resistance
Article 1
to difenacoum occurs.
Germany may restrict the authorisations granted in accordance
(10) In the absence of any indication to the contrary,
with Article 4 of Directive 98/8/EC for the products mentioned
restriction to professional users is therefore an appro
in the Annex to this Decision to use by trained or licensed
priate and available risk mitigation measure for the auth
professionals.
orisation of products containing difenacoum in Germany.
This conclusion is reinforced by the arguments put
Article 2
forward by Germany that resistance against difenacoum
in rats has been found and is thought to be developing in
This Decision is addressed to the Federal Republic of Germany.
the country. Furthermore, Germany has a well-func
tioning infrastructure of trained pest control operators
and licensed professionals, such as farmers, gardeners
and foresters who received professional training, which
Done at Brussels, 19 February 2013.
means that the proposed restriction does not hinder
infection prevention.
For the Commission
(11) The
measures provided for in this Decision are in
accordance with the opinion of the Standing
Janez POTONIK
Committee on Biocidal Products,
Member of the Commission

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L 48/16
ANNEX
Products for which Germany may restrict the authorisations granted in accordance with Article 4 of Directive 98/8/EC to use by trained or licensed professionals:
Product name in UK
UK application reference number in the Register for
Biocidal Products
Product name in Germany
German application reference number in the Register for
Biocidal Products
EN
Bonirat Wax Block 2010/4089/5286/UK/AA/6165 Bonirat
Blcke 2010/4089/5286/DE/MA/10012

Bonirat Pasta Bait 2010/4089/5346/UK/AA/6225 Bonirat
Pasta 2010/4089/5346/DE/MA/10018
Bonirat Pellet 2010/4089/5366/UK/AA/6245 Bonirat
Pellet 2010/4089/5366/DE/MA/10023
Bonirat Wheat 2010/4089/5367/UK/AA/6246 Bonirat
Korn 2010/4089/5367/DE/MA/10024
Off
icial
Jour
nal
of
the
European
Union
21.2.2013

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Document Outline

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