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31.10.2013 Official
Journal
of
the
European
Union L
289/65
DECISIONS
COMMISSION IMPLEMENTING DECISION
of 29 October 2013
approving restrictions of the authorisation of one biocidal product containing bromadiolone
notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of
the Council
(notified under document C(2013) 7034)
(Only the German text is authentic)
(2013/630/EU)
THE EUROPEAN COMMISSION,
humans, non-target animals and the environment is
minimised, by considering and applying all appropriate
and available risk mitigation measures. The risk miti
Having regard to the Treaty on the Functioning of the European
gation measures mentioned in Directive 2009/92/EC
Union,
therefore include, amongst others, restriction to profes
sional use only.
Having regard to Directive 98/8/EC of the European Parliament
(4) The
company
Lipha
Tech
S.A.S.
(‘the
applicant’)
has,
in
and of the Council of 16 February 1998 concerning the placing
accordance with Article 8 of Directive 98/8/EC,
of biocidal products on the market ( 1 ), and in particular
submitted an application to the Netherlands for authori
Article 4(4) thereof,
sation of one rodenticide containing bromadiolone (‘the
product’). The product’s name and reference numbers in
the Register for Biocidal Products (‘R4BP’) are indicated in
Whereas:
the Annex to this Decision.
(1) Annex
I
to
Directive
98/8/EC
contains
the
list
of
active (5) The Netherlands granted the authorisation on
substances approved at Union level for inclusion in
2 November 2012. The product was authorised with
biocidal products. Commission Directive 2009/92/EC (
restrictions to ensure that the conditions of Article 5

2 )
added the active substance bromadiolone for use in
of Directive 98/8/EC were met in the Netherlands.
products belonging to product-type 14, Rodenticides, as
Those restrictions did not include restriction to trained
defined in Annex V to Directive 98/8/EC.
or licensed professional users.
(6) On
20
December
2012,
the
applicant
submitted
a
(2) Bromadiolone
is
an
anticoagulant
rodenticide
known
to
complete application to Germany for mutual recognition
pose risks of accidental incidents with children, as well as
of the first authorisation in respect of the product.
risks for non-target animals and the environment. It has
been identified as potentially persistent, liable to bioac
cumulate and toxic (‘PBT’), or very persistent and very
liable to bioaccumulate (‘vPvB’).
(7) On
10
April
2013,
Germany
notified
the
Commission,
the other Member States and the applicant of its proposal
to restrict the first authorisation in accordance with
Article 4(4) of Directive 98/8/EC. Germany proposed to
(3) For
reasons
of
public
health
and
hygiene,
it
was
never
impose a restriction on the product to use by trained or
theless found to be justified to include bromadiolone and
licensed professionals.
other anticoagulant rodenticides in Annex I to Directive
98/8/EC, thus allowing Member States to authorise
bromadiolone-based products. However, Directive
2009/92/EC obliges Member States to ensure, when
(8) The
Commission
invited
the
other
Member
States
and
granting authorisation of products containing bromad
the applicant to submit comments to the notification
iolone, that primary as well as secondary exposure of
in writing within 90 days in accordance with
Article 27(1) of Directive 98/8/EC. No comments were
submitted within that deadline. The notification was also
( 1 ) OJ L 123, 24.4.1998, p. 1.
discussed between the Commission and Member States’
( 2 ) Commission Directive 2009/92/EC of 31 July 2009 amending
Competent Authorities for biocidal products in the
Directive 98/8/EC of the European Parliament and of the Council
to include bromadiolone as an active substance in Annex I thereto
meeting of the Product Authorisation and Mutual Recog
(OJ L 201, 1.8.2009, p. 43).
nition Facilitation Group of 14 May 2013.

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L 289/66
EN
Official Journal of the European Union
31.10.2013
(9) In
accordance
with
Directive
2009/92/EC,
authorisations (11) The measures provided for in this Decision are in
of biocidal products containing bromadiolone are to be
accordance with the opinion of the Standing
subject to all appropriate and available risk mitigation
Committee on Biocidal Products,
measures, including the restriction to professional use
only. The scientific evaluation leading to the adoption
of Directive 2009/92/EC concluded that only profes
sional users could be expected to follow the instructions
HAS ADOPTED THIS DECISION:
minimising the risk of secondary poisoning of non-target
animals, and to use products in a way that prevents the
selection and spreading of resistance. A restriction to
Article 1
professional users should therefore in principle be
considered to be an appropriate risk mitigation
Germany may restrict the authorisation granted in accordance
measure, in particular in Member States where resistance
with Article 4 of Directive 98/8/EC for the product mentioned
to bromadiolone occurs.
in the Annex to this Decision to use by trained or licensed

professionals.
(10) In the absence of any indication to the contrary,
restriction to professional users is therefore an appro
Article 2
priate and available risk mitigation measure for the auth
orisation of products containing bromadiolone in
This Decision is addressed to the Federal Republic of Germany.
Germany. This conclusion is reinforced by the
arguments put forward by Germany that resistance
against bromadiolone in rats has been found and is
Done at Brussels, 29 October 2013.
thought to be developing in the country. Furthermore,
Germany has a well-functioning infrastructure of trained
pest control operators and licensed professionals, such as
For the Commission
farmers, gardeners and foresters who received profes
sional training, which means that the proposed
Janez POTONIK
restriction does not hinder infection prevention.
Member of the Commission

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31.10.2013 Off
ANNEX
Product for which Germany may restrict the authorisation granted in accordance with Article 4 of Directive 98/8/EC to use by trained or licensed professionals:
Product name in the Netherlands
Dutch application reference number in the Register for
Biocidal Products
Product name in Germany
German application reference number in the Register for
Biocidal Products
EN
Maki Pat’ 2011/4329/10506/NL/AA/20379 Maki
Pat’ 2011/4329/10506/DE/MA/20799

icial
Jour
nal
of
the
European
Union
L
289/67

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Document Outline

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